Les Données de l'Étude Pivot DREAM de Nyxoah publiées dans le Journal of Clinical Sleep Medicine

Les Données de l'Étude Pivot DREAM de Nyxoah publiées dans le Journal of Clinical Sleep Medicine

Mont–Saint–Guibert, Belgique – 28 juillet 2025, 22h05 CET / 16h05 ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (« Nyxoah » ou la « Société »), une société de technologie médicale développant des alternatives thérapeutiques révolutionnaires pour l'apnée obstructive du sommeil (AOS) par la neuromodulation, a annoncé aujourd'hui que les données de son étude pivot DREAM ont été publiées en ligne dans le Journal of Clinical Sleep Medicine. L'étude pivot DREAM présente des résultats complets de sécurité et d'efficacité sur 12 mois, qui ont étayé la demande d'autorisation de mise sur le marché (PMA) de la Société auprès de la FDA. La publication “peer–reviewed” fournit une analyse détaillée des performances du système Genio® à travers de multiples critères d'évaluation clinique.

La publication révèle de nouvelles données sur l'utilisation de l'appareil et la satisfaction des patients qui ne figuraient pas dans les annonces précédentes de la Société. Ces résultats supplémentaires montrent que l'utilisation nocturne de l'appareil a été supérieure à 4 heures pendant plus de 70 % des nuits chez 84,3 % des participants ayant rempli un journal au cours des 3 mois précédant la visite à 12 mois. Dans l'ensemble, l'appareil a été utilisé plus de 70 % des nuits par 85,9 % des participants.

La publication indique également que 90 % des patients se sont déclarés satisfaits de la thérapie. En outre, les données montrent que le score de ronflement des patients1 est passé de 83,5 % au départ à 30,4 % après 12 mois.

“L'étude DREAM a démontré l'efficacité de la stimulation bilatérale du nerf hypoglosse à l'aide de Genio pour le traitement de l'apnée obstructive du sommeil,” a déclaré B. Tucker Woodson, MD, Chief, Professor – Medical College of Wisconsin et Investigateur principal de l'étude DREAM. “Genio a démontré un effet important dans la réduction du fardeau de la maladie et l'amélioration de la qualité de vie en réduisant de manière significative la quantité d’apnées–hypopnées, encourageant l'adhésion et la satisfaction du patient. La conception de Genio, centrée sur le patient, et la stimulation bilatérale du HGNS constituent une avancée importante dans le traitement des patients souffrant d'AOS qui ne parviennent pas à utiliser la PPC ou qui refusent de l'utiliser.”

“Ces résultats récemment publiés correspondent exactement à ce que nous attendions”, a déclaré Olivier Taelman, CEO de Nyxoah. “La grande satisfaction des patients et l’adhésion à la thérapie confirment notre conviction que la conception sans sonde et à alimentation externe de Genio répond aux besoins réels des patients. L'amélioration significative de la qualité du sommeil des partenaires montre l'impact plus large que notre technologie peut avoir sur les patients souffrant d'AOS et leurs familles.”

La publication inclut des données précédemment annoncées démontrant que l'étude a atteint ses objectifs co–primaires, à savoir le taux de répondeurs à l'IAH à 12 mois, selon le critère de Sher, et le taux de répondeurs à l'indice de désaturation en oxygène (IDO), tous deux en intention de traiter (ITT). Dans l'étude pivot DREAM U.S., 115 patients ont reçu l'implant Genio® et ont été inclus dans l'analyse de sécurité. Ces patients présentaient un IAH moyen de 28,0, un IDO moyen de 27,0 et un indice de masse corporelle moyen de 28,5 au début de l'étude. Après 12 mois, 73 sujets ont été considérés comme répondeurs à l'IAH, selon le critère de Sher, soit un taux ITT de répondeurs à l'IAH de 63,5 % (p=0,002), et 82 sujets ont été considérés comme répondeurs à l'IDO, soit un taux de répondeurs à l'IDO de 71,3 % (p<0,001). Les résultats en matière de sécurité étaient conformes à ceux d'autres thérapies de neuromodulation, avec 11 événements indésirables graves, ou EIG, chez dix sujets, soit un taux d'EIG de 8,7 %. Sur les 11 EIG, trois étaient liés au dispositif et il y a eu trois explantations.

La publication inclut également des données précédemment annoncées démontrant une réduction similaire de l'IAH en position dorsale et non dorsale. La stimulation bilatérale Genio a entraîné une réduction médiane cliniquement significative de 66,6 % de l'IAH en décubitus dorsal à 12 mois par rapport à la valeur de référence. Cette réduction est à comparer à une réduction médiane de l'IAH à 12 mois de 70,8 % dans toutes les positions de sommeil.

En ce qui concerne les critères d'évaluation secondaires rapportés à l'ISSS, les sujets ont montré des améliorations significatives de la qualité de vie. Plus précisément, une augmentation moyenne de 2,3 points a été observée dans l'évaluation du questionnaire sur les résultats fonctionnels du sommeil (FOSQ). En outre, le score de somnolence d'Epworth a été réduit de 3,4 points en moyenne par rapport à la situation initiale.

A propos de Nyxoah

Nyxoah opère dans le secteur des technologies médicales. Elle se concentre sur le développement et la commercialisation de solutions innovantes destinées à traiter le Syndrome d’Apnées Obstructives du Sommeil (SAOS). La principale solution de Nyxoah est le système Genio®, une thérapie de neurostimulation du nerf hypoglosse sans sonde et sans batterie qui a reçu le marquage CE, centrée sur le patient et destinée à traiter le Syndrome d’Apnées Obstructives du Sommeil (SAOS), le trouble respiratoire du sommeil le plus courant au monde. Ce dernier est associé à un risque accru de mortalité et des comorbidités, dont les maladies cardiovasculaires. La vision de Nyxoah est que les patients souffrant de SAOS doivent pouvoir profiter de nuits réparatrices et vivre pleinement leur vie.

À la suite de la finalisation probante de l’étude BLAST OSA, le système Genio® a reçu le marquage européen CE en 2019. Nyxoah a réalisé avec succès deux IPO : l’une sur Euronext Bruxelles en septembre 2020 et l’autre sur le NASDAQ en juillet 2021. Grâce aux résultats positifs de l'étude BETTER SLEEP, Nyxoah a reçu le marquage CE pour l’extension de ses indications thérapeutiques aux patients souffrant de collapsus concentrique complet (CCC), pour lesquels les thérapies concurrentes sont actuellement contre–indiquées. En outre, la Société a annoncé les résultats positifs de l'étude pivot DREAM IDE.

Pour plus d’informations, visitez www.nyxoah.com

Attention – Marquage CE depuis 2019. Dispositif de recherche aux États–Unis. Limité à un usage expérimental aux États–Unis par la loi fédérale américaine.

Déclarations Prospectives

Certaines déclarations, croyances et opinions contenues dans le présent communiqué de presse sont de nature prospective et reflètent les attentes actuelles de la Société ou, le cas échéant, des administrateurs ou de la direction de la Société concernant le système Genio®, les études cliniques prévues et en cours sur le système Genio®, les avantages potentiels du système Genio®, les objectifs de Nyxoah concernant le développement, la voie réglementaire et l'utilisation potentielle du système Genio®, l'obtention de l'approbation de la FDA, l'achèvement satisfaisant de l'examen des installations de fabrication, des méthodes et des contrôles, et le calendrier prévu pour ce qui précède, l'entrée sur le marché américain, ainsi que les résultats d'exploitation, la situation financière, les liquidités, les performances, les perspectives, la croissance et les stratégies de la Société. De par leur nature, les déclarations prévisionnelles impliquent un certain nombre de risques, d'incertitudes, d'hypothèses et d'autres facteurs qui pourraient faire en sorte que les résultats ou les événements réels diffèrent matériellement de ceux exprimés ou sous–entendus dans les déclarations prévisionnelles. Ces risques, incertitudes, hypothèses et facteurs pourraient avoir une incidence négative sur les résultats et les effets financiers des plans et des événements décrits dans le présent document. En outre, ces risques et incertitudes comprennent, sans s'y limiter, les risques et incertitudes énoncés dans la section « Facteurs de risque » du rapport annuel de la Société sur le formulaire 20–F pour l'exercice clos le 31 décembre 2024, déposé auprès de la Securities and Exchange Commission (« SEC ») le 20 mars 2025, et des rapports ultérieurs que la Société dépose auprès de la SEC. Une multitude de facteurs, y compris, mais sans s'y limiter, les changements dans la demande, la concurrence et la technologie, peuvent faire en sorte que les événements, les performances ou les résultats réels diffèrent de manière significative de tout développement anticipé. Les déclarations prospectives contenues dans le présent communiqué de presse concernant des tendances ou des activités passées ne constituent pas des garanties de performances futures et ne doivent pas être considérées comme une déclaration selon laquelle ces tendances ou activités se poursuivront à l'avenir. En outre, même si les résultats ou développements réels sont conformes aux déclarations prospectives contenues dans le présent communiqué de presse, ces résultats ou développements peuvent ne pas être représentatifs des résultats ou développements des périodes futures. Aucune déclaration ou garantie n'est donnée quant à l'exactitude ou à la justesse de ces déclarations prospectives. En conséquence, la Société décline expressément toute obligation ou tout engagement de publier des mises à jour ou des révisions des déclarations prospectives contenues dans le présent communiqué de presse à la suite d'un changement des attentes ou d'un changement des événements, conditions, hypothèses ou circonstances sur lesquels ces déclarations prospectives sont basées, sauf si la loi ou la réglementation l'exige expressément. Ni la Société, ni ses conseillers ou représentants, ni aucune de ses filiales, ni les dirigeants ou employés de ces personnes ne garantissent que les hypothèses sous–jacentes à ces déclarations prospectives sont exemptes d'erreurs et n'acceptent aucune responsabilité quant à l'exactitude future des déclarations prospectives contenues dans ce communiqué de presse ou quant à la survenance effective des développements prévus. Vous ne devriez pas accorder une confiance excessive aux déclarations prospectives, qui ne sont valables qu'à la date du présent communiqué de presse.

Contacts :

Nyxoah
John Landry, CFO
[email protected]

Medias
Aux États–Unis
FINN Partners – Alyssa Paldo
[email protected]

International / Allemagne
MC Services – Anne Hennecke
nyxoah@mc–services.eu

Belgique / France
Backstage Communication – Gunther De Backer
[email protected]


1 Parmi ceux qui ont déclaré que leur partenaire de lit avait quitté la chambre, qu'il avait ronflé très fort ou fort

Pièce jointe


GLOBENEWSWIRE (Distribution ID 1001120139)

Nyxoah’s DREAM Pivotal Study Data Published in the Journal of Clinical Sleep Medicine

Nyxoah’s DREAM Pivotal Study Data Published in the Journal of Clinical Sleep Medicine

Mont–Saint–Guibert, Belgium – July 28, 2025, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA), today announced that data from its DREAM pivotal study was published online in the Journal of Clinical Sleep Medicine. The DREAM pivotal study presents comprehensive 12–month safety and efficacy results that supported the Company's PMA submission to the FDA. The peer–reviewed publication provides detailed analysis of the Genio® system's performance across multiple clinical endpoints.

The publication reveals new data on device usage and patient satisfaction that was not included in the Company's previous announcements. These additional findings show that nightly device usage was greater than 4 hours in more than 70% of nights in 84.3% of participants completing diary entries in the 3 months preceding the 12–month visit. Overall, the device was used over 70% of the nights by 85.9% of the participants.  

 The publication also reports 90% of patients expressed satisfaction with the therapy. Additionally, data shows that a patient’s snoring score1 was reduced from 83.5% at baseline to 30.4% at 12 months.

“The DREAM study demonstrated efficacy of bilateral hypoglossal nerve stimulation using Genio for the treatment of obstructive sleep apnea,” said B. Tucker Woodson, MD, Chief, Professor – Medical College of Wisconsin and Principal Investigator of the DREAM study. “Genio demonstrated a strong effect in reducing disease burden and improving quality of life by significantly reducing the apnea hypopnea burden encouraging patient adherence and satisfaction. Genio's patient–centric design and bilateral HGNS stimulation offer an exciting advancement in treatment of OSA patients who fail or refuse CPAP.”

“These newly published outcomes are exactly what we expected to see,” said Olivier Taelman, CEO of Nyxoah. “The high patient satisfaction and consistent usage patterns validate our belief that Genio's leadless, externally powered design addresses real patient needs. The significant improvement in bedpartner sleep quality shows the broader impact our technology can have on OSA patients and their families.”

The publication included previously announced data demonstrating that the study achieved its co–primary endpoints of 12–month AHI responder rate, per the Sher criteria, and Oxygen Desaturation Index (ODI) responder rate, both on an Intent–To–Treat (ITT) basis. In the DREAM U.S. pivotal study, 115 patients received the Genio® implant and were included in the safety analysis. These patients had a mean AHI of 28.0, mean ODI of 27.0 and mean body mass index of 28.5 at baseline. At 12 months, 73 subjects were determined to be AHI responders, per the Sher criteria, resulting in an ITT AHI responder rate of 63.5% (p=0.002), and 82 subjects were determined to be ODI responders, resulting in an ODI responder rate of 71.3% (p<0.001). Safety results were in line with other neuromodulation therapies, with 11 serious adverse events, or SAEs, in ten subjects resulting in an SAE rate of 8.7%. Out of the 11 SAEs, three were device related, and there were three explants.

 The publication also included previously announced data demonstrating similar AHI reduction in supine and non–supine positions. Genio bilateral stimulation resulted in a clinically meaningful 66.6% median reduction in supine AHI at 12 months compared with baseline. This reduction compares to a median 12–month AHI reduction of 70.8% across all sleeping positions.

 With respect to secondary endpoints reported at ISSS, subjects demonstrated significant improvements in quality–of–life outcomes. Specifically, a mean increase of 2.3 points was observed in the Functional Outcomes of Sleep Questionnaire (FOSQ) assessment. Additionally, the Epworth Sleepiness Score was reduced by a mean of 3.4 points from baseline.

About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a patient–centered, leadless and battery–free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.

Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study.

For more information, please visit http://www.nyxoah.com/.

Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States

FORWARD–LOOKING STATEMENTS
Certain statements, beliefs and opinions in this press release are forward–looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio® system; receipt of FDA approval; satisfactory completion of a manufacturing facilities, methods and controls review, and the anticipated timing of the foregoing; entrance to the U.S. market; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward–looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward–looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20–F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward–looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward–looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward–looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward–looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward– looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward–looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward–looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward–looking statements, which speak only as of the date of this press release.

Contacts: Nyxoah
John Landry, CFO
[email protected]

For Media

In United States
FINN Partners – Glenn Silver
[email protected]

In International/Germany
MC Services – Anne Hennecke nyxoah@mc–services.eu

In Belgium/France
Backstage Communication – Gunther De Backer [email protected]


1   In those that reported bedpartner leaving the room, very loud or loud snoring

Attachment


GLOBENEWSWIRE (Distribution ID 1001120139)

Entera Bio Receives FDA Agreement on BMD as Primary Endpoint for EB613 Registrational, Phase 3 Study in Post-Menopausal Women with Osteoporosis

JERUSALEM, July 28, 2025 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and protein replacement therapies, announced today that in a written response to a Type A meeting request, the U.S. Food and Drug Administration (FDA) agreed with the Company’s proposal that the NDA marketing application filing for EB613 would be supported by a single multinational, randomized, double–blind, placebo–controlled, 24 month phase 3 study in women with postmenopausal osteoporosis, where change in total hip BMD is evaluated as the primary endpoint, and incidence of new or worsening vertebral fractures is evaluated as the key secondary endpoint. This marks a shift from precedent placebo–controlled phase 3 studies of new osteoporosis drugs which required incidence of fracture as the primary endpoint.

“This regulatory update is a major milestone for Entera and the entire osteoporosis community,” said Miranda Toledano, CEO of Entera. “Our alignment with the FDA reflects the strength of our data and collaborative discussions. Importantly, it allows us to advance our clinical development program without having to wait for FDA’s qualification of the Study to Advance Bone Mineral Density as a Regulatory Endpoint (SABRE), which is still expected this year. We thank the FDA and the Review Team at the Division of Endocrinology for their constructive approach. We also thank the SABRE team for paving the path to innovation for osteoporosis treatment,” said Toledano.

“Osteoporosis afflicts more women than heart attack, stroke and breast cancer combined. Over 200 million women globally are estimated to have osteoporosis and remain vastly undertreated, despite efficacious injectable anabolic (bone forming) treatments. One in two women over the age of 50 will suffer a fracture due to osteoporosis. No new drug for osteoporosis has been approved by FDA since 2019; and innovation has stalled for close to a decade due to the size, duration, cost and ethical constraints associated with fracture endpoint studies. In a silent disease, patient and clinician access to novel and alternative forms of validated mechanisms of action is important. We are developing EB613 as the first oral, once–daily anabolic tablet treatment to potentially serve this unmet medical need. EB613 is intended to increase skeletal mass, improve bone microarchitecture and reduce the risk of fracture,” said Miranda Toledano, CEO of Entera.

About EB613

Substantial evidence supports the efficacy of anabolic therapies over bisphosphonates for lowering fracture risk in osteoporosis patients at high risk. However, all available anabolic therapies are administered by subcutaneous (SC) injection and used in a minority of eligible patients. EB613 (oral PTH (1–34), teriparatide), is being developed as the first oral, once–daily anabolic tablet treatment for osteoporosis. EB613 completed a phase 2, 6–month, 161–patient, placebo–controlled study that met all biomarker and BMD endpoints without significant safety concerns in women with postmenopausal osteoporosis or low BMD (JBMR 2024). EB613 produced rapid dose–proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increased lumbar spine, total hip, and femoral neck BMD. The effects of EB613 on trabecular and cortical bone using 3D–DXA showed increases with EB613 compared with placebo in a variety of indices, including integral volumetric BMD and trabecular volumetric BMD, cortical thickness, and cortical surface BMD. Mechanistically, the findings suggest that bone strengthening, and fracture resistance may occur rapidly with EB613. Furthermore, the data are consistent with those of published subcutaneous teriparatide at the 6–month time point. Further abstracts have been submitted to ASBMR and NAMS 2025 conferences.

About Entera Bio

Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N–Tab™) and its pipeline of first–in–class oral peptide programs targeting PTH(1–34), GLP–1 and GLP–2. The Company’s most advanced product candidate, EB613 (oral PTH(1–34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis. A placebo–controlled, dose–ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). The EB612 program is being developed as the first oral PTH(1–34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity and metabolic syndromes; and first oral GLP–2 peptide as an injection–free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.

About SABRE

The Study to Advance BMD as a Regulatory Endpoint (SABRE) initiative, which started as a public private partnership sponsored by the FNIH in 2013, has amassed the strongest evidence to date that treatment–related gains in Bone Mineral Density (BMD) reliably and quantitatively predict fracture–risk reduction. In November 2023, the SABRE team submitted a full qualification package to FDA’s Biomarker Division as part of the Drug Development Tool Biomarker Qualification Pathway to potentially qualify BMD as a surrogate endpoint to fracture; in March 2024, the FDA Biomarker Division indicated to the SABRE project team that a decision would be issued within 10 months. The single most important predictor of osteoporotic fractures in postmenopausal women without a previous fracture is BMD. Treatment guidelines in the U.S. strongly recommend pharmacologic therapy for patients with a BMD T–score of –2.5 or lower in the spine, femoral neck, total hip. SABRE final FQP meta–analysis included data from 22 randomized, placebo–controlled trials (63,000 participants across seven drug classes) and showed that treatment–related gains in total–hip BMD explain 72% of the observed fracture–risk reduction. The R2 for this correlation was 0.73—double the correlation between blood pressure and stroke (R² = 0.37), which is the well accepted basis for the value of antihypertensive therapy.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this presentation are “forward–looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this presentation regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera’s forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s ability to establish and maintain development and commercialization collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statement Regarding Forward–Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10–K filed with the SEC, as well as Entera’s subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this presentation. The information in this presentation is provided only as of the date of this presentation, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.


GLOBENEWSWIRE (Distribution ID 9501141)

WeRide Robotaxi Secures Autonomous Driving Permit in Saudi Arabia, Products Now Licensed in Six Countries

RIYADH, Saudi Arabia, July 28, 2025 (GLOBE NEWSWIRE) — WeRide (NASDAQ: WRD), a global leader in autonomous driving technology, has announced today that its Robotaxi was granted Saudi Arabia's first Robotaxi autonomous driving permit, making it the world's only technology company with products holding autonomous driving permits in six countries: Saudi Arabia, China, the UAE, Singapore, France, and the US.

WeRide's Robotaxi in Riyadh, Saudi Arabia

With this permit, WeRide is authorized to operate an autonomous vehicle (AV) business and deploy Robotaxis nationwide in Saudi Arabia, starting with its pilot operations in Riyadh with Uber and local partner Ai Driver.

Launched earlier this month, the pilot covers King Khalid International Airport and several key locations throughout Riyadh, including major highways and selected city center destinations. A full–scale commercial Robotaxi service is expected to launch by end–2025 through a partnership between WeRide and Uber.

WeRide's Robotaxi was granted the permit at an official ceremony last week, attended by His Excellency Eng. Saleh bin Nasser Al–Jasser, Minister of Transport and Logistics Services and Chairman of the Transport General Authority (TGA); Jennifer Li, CFO and Head of International at WeRide; and other senior Saudi government officials.

WeRide is the first AV technology company whose Robotaxi has completed the TGA's Regulatory Sandbox for AV Piloting in Saudi Arabia. The approval process, conducted in coordination with multiple government agencies, includes rigorous testing, assessments, and technology validation to secure the Robotaxi autonomous driving permit, to ensure the highest standards of safety and performance.

“This permit marks a major step in our global expansion, enabling us to scale Robotaxi services and unlock new commercial opportunities in Saudi Arabia. It drives large–scale deployment, unlocks new revenue streams, and reinforces our commitment to making autonomous mobility a reality worldwide. We thank the TGA for supporting our vision for safer, smarter transportation at scale,” said Jennifer Li, CFO and Head of International at WeRide.

This announcement follows WeRide’s entry into Saudi Arabia in May 2025. In addition to its Robotaxi plans, WeRide has been testing and operating its Robobus in key locations including King Fahad Medical City, Aramco residential communities, AlUla, and the Ritz–Carlton, Riyadh. Its Robosweeper S1 is also in operation at King Fahad Medical City, Riyadh Second Health Cluster, marking the first monetized autonomous sanitation project in both Saudi Arabia and the wider Middle East.

Beyond Saudi Arabia, WeRide has been rapidly expanding across the region in the last few months. Its Robotaxis are currently undergoing fully driverless Robotaxi testing in Abu Dhabi — the first deployment of its kind in Middle East — and will also soon extend its Robotaxi service to Dubai.

About WeRide
WeRide is a global leader and a first mover in the autonomous driving industry, as well as the first publicly traded Robotaxi company. Our autonomous vehicles have been tested or operated in over 30 cities across 10 countries. We are also the first and only technology company whose products have received autonomous driving permits in six markets: China, France, Saudi Arabia, Singapore, the UAE, and the US. Empowered by the smart, versatile, cost–effective, and highly adaptable WeRide One platform, WeRide provides autonomous driving products and services from L2 to L4, addressing transportation needs in the mobility, logistics, and sanitation industries. WeRide was named in Fortune Magazine’s 2024 “The Future 50” list.

Media Contact
[email protected]

Safe Harbor Statement
This Report (including its exhibit) contains statements that may constitute “forward–looking” statements pursuant to the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward–looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “aims,” “future,” “intends,” “plans,” “believes,” “estimates,” “likely to,” and similar statements. Statements that are not historical facts, including statements about WeRide’s beliefs, plans, and expectations, are forward–looking statements. Forward–looking statements involve inherent risks and uncertainties. Further information regarding these and other risks is included in WeRide’s and Uber’s filings with the U.S. Securities and Exchange Commission. All information provided in this Report is as of the date of this Report. Neither WeRide nor Uber undertakes any obligation to update any forward–looking statement, except as required under applicable law.

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Violence Escalates in Sudan as Humanitarian Aid Struggles to Meet Growing Needs

A Sudanese mother and her child at a shelter in Tawila, North Darfur. Credit: UNICEF/Mohammed Jamal

By Oritro Karim
UNITED NATIONS, Jul 28 2025 – Earlier this month, Sudanese civilians began facing a considerable escalation of hostilities, with the most recent attacks from the Rapid Support Forces (RSF) and the Sudanese Armed Forces (SAF) claiming dozens of lives. Amid a rapidly growing scale of needs and an overwhelming lack of funding, the United Nations (UN) and its partners have struggled to deliver adequate amounts of humanitarian aid.

On July 23, the RSF coordinated an attack on the Brima Rashid area in West Kordofan State, with combatants entering on assault vehicles and indiscriminately firing at homes and a market. According to the Office for the Coordination of Humanitarian Affairs (OCHA), this attack killed over 30 people and severely injured 40 others, with a significant amount of these casualties being women and young children.

“Medical sources say many of the wounded need urgent surgical care,” said Farhan Haq, the UN Deputy Spokesperson for the Secretary-General at a press briefing. “OCHA stresses that events in Brima Rashid underscore the growing risks facing civilians in the Kordofan region and the urgent need for a cessation of hostilities, protection of civilians, and safe, sustained access to humanitarian assistance and services.”

This is just the latest in a series of attacks that have marked a sharp rise in violence across the Kordofan and North Darfur regions. Between July 10 and 13, the Rapid Support Forces (RSF) launched a series of attacks on North Kordofan’s Bara locality. The Office of the United Nations High Commissioner of Human Rights (OHCHR) estimates that these attacks resulted in 60 civilian deaths, while figures from independent civil society groups estimate up to 300 deaths.

Concurrently, the Sudanese Armed Forces (SAF) launched a series of attacks on the Al Fula and Abu Zabad villages in West Kordofan State, including an airstrike on a school that was being used as a makeshift displacement shelter, killing over 20 people. On July 17, the SAF also targeted a family in an airstrike in Bara, killing at least 11 civilians. Additional attacks and civilian casualties were recorded in El Fasher and the Abu Shouk camp.

“An escalation of hostilities in North Darfur and Kordofan will only further aggravate the already severe risks to civilians and the dire humanitarian situation in a conflict that has already wrought untold suffering on the Sudanese people,” said the UN High Commissioner for Human Rights Volker Türk. “I urge those with influence to act to prevent such an escalation, and to ensure that both parties uphold their obligations under international law, including on the protection of civilians and civilian infrastructure.”

According to the International Organization for Migration (IOM), as of July 14 there have been over 3,400 internal displacements as a result of the recent attacks in North Kordofan. These numbers were further inflamed by a period of heavy rain and flooding from July 14 and 15, resulting in 400 additional displacements.

The majority of these displaced individuals are currently residing with host communities and face a dire lack of access to basic services, such as food, water, shelter, and healthcare. The Office for the Coordination of Humanitarian Affairs (OCHA) estimates that approximately 30 million people are in dire need of humanitarian assistance and protection, which is roughly half of Sudan’s population.

Conditions are particularly dire in the Tawila locality of North Darfur, which currently hosts over 560,000 internally displaced civilians. OCHA’s partners report that a significant amount of water, sanitation, and hygiene (WASH) needs are not being met, as there is a critically low ratio of one latrine for every 150 people. Humanitarian experts have expressed concern due to the rising cases of cholera in Tawila. According to figures from Sudan’s Health Ministry, there have been over 1,300 cases of cholera and 18 related deaths recorded across 35 localities, with 519 of these cases being recorded in Tawila alone.

Additionally, Sudan’s hunger crisis has taken a considerable turn for the worse in recent weeks, with food prices having skyrocketed immensely. According to OCHA, South Darfur had been hit particularly hard, with flooding cutting off critical supply routes from Chad and the north of Sudan. Over the course of a month, the price of wheat has risen by 31 percent and the price of sugar has risen by 21 percent, pushing these essential items out of reach for thousands.

Figures from the World Food Programme (WFP) show that famine has been confirmed in 10 states across Sudan, with nearly half of the population facing extreme levels of hunger. OCHA projects that women are disproportionately impacted by the hunger crisis, with rates of food insecurity among female-headed households nearly doubling from 14 percent in 2024 to 26 percent in 2025.

The persistence of widespread hunger and disease across Sudan is a testament to Sudan’s fragile healthcare system. According to OCHA, heightened insecurity has resulted in the closures of over 32 health facilities in Sudan. The centers that are still functional face a critical shortage of essential supplies such as vaccines, medication, and surgical equipment. It is estimated that thousands lack access to life-saving care.

On July 25, the United Nations High Commissioner for Refugees (UNHCR) and IOM released a joint report that analyzed the conditions facing Sudanese refugees who had returned home after fleeing to Egypt and South Sudan. According to the report, roughly 320,000 refugees had returned to Sudan throughout the past year, with many struggling to access basic services .

“Without urgent action, people will be coming back to cities that are in ruins,” said Abdallah Al Dardari, Director of the Regional Bureau for Arab States in the United Nations Development Programme (UNDP). “We are in a race against time to clear the rubble and provide water, power and healthcare.”

The report underscores the vast array of dangers that await Sudanese returnees, including the risk of injury or death from unexploded ordnance, high rates of gender-based and sexual violence toward women and girls, as well as a lack of psychosocial support services for traumatized individuals.

The UN and its partners remain hopeful that the current influx of returnees is an indication of stabilization in Sudan. “Those heading home are not passive survivors. They are vital to Sudan’s recovery,” said Othman Belbeisi, IOM Regional Director for the Middle East and North Africa. “Yes, the humanitarian situation is dire, but with the right support, returnees can revive local economies, restore community life and foster hope where it’s needed most”.

Despite this, increased funding for humanitarian affairs and a sustainable end to hostilities is the only way to ensure lasting peace and stability in Sudan. The UN projects that approximately USD 4.2 billion dollars is needed to keep up aid operations in Sudan for the next year. However, only 23 percent of the required funds have been met, indicating that services may need to be scaled back next year.

“More than evidence of people’s desire to return to their homeland, these returns are a desperate call for an end to the war so that people can come back and rebuild their lives,” said Mamadou Dian Balde, UNHCR Regional Refugee Coordinator for the Sudan crisis, shortly after returning from Khartoum and Wadi Halfa at the border with Egypt. “Not only do they mark a hopeful but fragile shift, they also indicate already stretched host countries under increasing strain. We urge stronger international solidarity with the Sudanese people uprooted by this horrifying war and with the countries that have opened their doors to them.”

IPS UN Bureau Report

 


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Mining on the Rise as Clean Energy Demands Shifts Global Commodity Exports

Oil tankers entering and departing a busy port. Credit: Unsplash/Ramona Flwrs

By Maximilian Malawista
NEW YORK, Jul 28 2025 – Two-thirds of the developing world, or ninety-five out of 143 economies, are dependent on commodities for export value, making up 60 percent of their merchandise exports. For the least developed world, this number rises to 80 percent, leaving entire nation’s revenue vulnerable to price swings, fiscal shocks, and evolving trade compositions. Hidden behind the numbers lies a deeper transformation, one disrupting fossil fuel trade, triggering a higher reliance on mineral exports, particularly on mining essential for green technologies.

In 2024, during a special climate panel, on critical energy transition minerals, UN Secretary-General António Guterres remarked, “A world powered by renewables is a world hungry for critical minerals. For developing countries, critical minerals are a critical opportunity – to create jobs, diversify economies, and dramatically boost revenues. But only if they are managed properly.”

Guterres signaled a clear message that this change can indeed boost economies and create jobs, especially in the places which need it most, but only if those countries are then willing to invest in diversification strategies through proper economic management.

At this year’s UN High Level Political Forum Guterres reaffirmed his stance on July 22, stating: “Fossil fuels are outdated. The sun is rising on a new era − the era of clean energy.” Guterres present a six-point action plan forward, which would phase out fossil fuels and secure energy access to all, by outlining methods of financing green transition.

A shift in the tides: oil to ore

Between 2012-2014 and 2021-2023, the share of commodity exports in of global trade have slightly declined, from 35.5 percent to 32.7 percent. At the same time, overall merchandise trade grew by 25.6 percent, with commodity exports growing by 15.5 percent. This 10 percent gap accounts for a 619 billion dollar shortfall due to declining and stagnating energy exports, which currently dominate the commodity trade.

Energy exports once led the commodity trade but are now showing obvious signs of stagnation and future decline. From 2021 to 2023, global energy exports amounted to 3.16 trillion on average, slightly decreasing 1.3 percent from the 2012-2014. The acceleration of renewable energy projects and the UN’s 2030 Agenda have been main proponents in this, driving down the reliance on oil and coal, and improving energy efficiency through global investment in green technologies.

Western Asia, once a dominant region in energy exports, particularly oil, saw its share fall from 31.3 percent to 24.7 percent over the past decade. Russia, once the world’s top energy exporter saw its export value drop by 26.6 percent.

However, in this same period, the United States became the world’s leading energy exporter, driven by its massive quantities of liquefied natural gas and shale oil mining. This shift too even reflects a greener transition, as liquefied natural gas is seen increasingly as a bridge to clean energy, as it presents cleaner effects on the environment, and is overall considered cleaner than oil and coal by a large margin.

In contrast to this overall decline in energy demand, mining exports have been surging. In Asia and Oceania, the regions’ share grew from 33.8 percent to 37.6 percent. Looking at Australia alone, they grew their mining export value from USD 105.7 billion to USD 171 billion due to higher demand from China and other global consumers for metals like copper, cobalt, and lithium. These materials are necessary for solar panels, wind turbines and electric car batteries, which are all considered essential components to a green economy.

Suppliers of the green future: Africa

While much of the world is expanding looking towards the future, Africa is still largely behind in development, creating lags in green agendas. Most of the continent lacks basic access to electricity. Africa is home to twenty of the world’s thirty-three mining export-dependent economies, making them the provider of many materials for green technologies, but not the constructors.

In Western and Eastern Africa, these mining exports make up 65 percent and 57 percent of all merchandise exports. Southern Africa is also particularly reliant, with nations like Botswana presenting mining exports of 91.5 percent. This lack of diversification makes African economies extremely vulnerable to supply chain shifts and price volatility, especially in the event of value chain swaps. Even in countries where mining is not as prevalent like Nigeria, Algeria and Angola, the lowering of oil prices by 20 percent in economies with an 80 percent export value on energy, shows early signs of dangerous fiscal dependency on a lacking financial flow.

The inevitable shift

Secretary-General of UN Trade and Development (UNCTAD) Rebecca Grynspan said: “There is now an opportunity to leverage these new commodities to update our trade regime, promote structural diversification and turn the tide of commodity dependence once and for all.”

The clean energy shift is not theory, it is happening real time and its reshaping supply chains fast. Countries like the U.S. and Australia have successfully adapted their economies to this shift, preparing for a new landscape of green domination. The rise in mining exports supports a demand from advanced economies needing critical minerals, but this financial flow for the exporting countries might not stay forever, especially if more competitors break into the market driving down the price further and further: much like what is happening to oil. A country’s path to clean energy now lies as an indicator of working economic models and the ablution of outdated financial flows.

IPS UN Bureau Report

 


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How Clustering Multilateral Environmental Agreements Can Bring Multiple Benefits to the Environment

Plastic pollution from Amadi River by Iwai-Dialax. Creative Commons Attribution-Share Alike 4.0 International

By Michael Stanley-Jones
RICHMOND HILL, Ontario, Canada, Jul 28 2025 – The UN80 Initiative, unveiled in March by Secretary-General António Guterres, is a system-wide effort to reaffirm the UN’s relevance for a rapidly changing world.

The Initiative comes at a time of brutal budget cuts across the UN system. The United Nations High Commission for Refugees is cutting 3,500 jobs and making reductions in senior positions and offices to manage budget shortfalls. The World Health Organisation is expected to cut 20-25% of its global staff. Cuts at The World Food Programme range up to 30%.

And yet the needs served by the United Nations remain stark. The UN appealed for US$29 billion funding for the Global Humanitarian Overview 2025 to assist nearly 180 million vulnerable people, including refugees, in December 2024. Near the midpoint of the year, just $5.6 billion – less than 13 per cent – had been received.

Facing this harsh fiscal environment, the Secretary-General established seven thematic clusters under the UN80 Initiative covering peace and security, humanitarian action, development (Secretariat and UN system), human rights, training and research, and specialised agencies to improve coordination, reduce fragmentation, and realign functions where needed.

The UN80 Task Force is scheduled to release its recommendations at the end of July.

In their timely opinon piece, “UN Reform: Is it Time to Renew the Idea of Clustering the Major Environmental Agreements?”, Felix Dodds and Chris Spence advocate for “clustering key conventions and bringing scientific bodies to strengthen international environmental governance, while also offering potential cost savings.”

“Currently, there are hundreds of different multilateral environmental agreements (MEAs) in force but perhaps only 20-30 core global MEAs with broad international participation,” Dodds and Spence write.

Bringing the fragmented set of environmental conventions together in clusters to address the interconnected issues they address could strengthen their work, reduce inefficiencies, and fill significant gaps in how the UN approaches the triple plenary crises of biodiversity loss, climate change and pollution.

There is one experience which suggests how such a clustering of MEAs secretariats could be accomplished. In 2009, on an ad interim basis, the Joint Convention Services of the Basel, Rotterdam and Stockholm Conventions was set up, preparatory to a decision by an extraordinary conferences of the parties of the three chemicals and wastes conventions to establish a joint Secretariat in February 2010.

I was hired as the first staff member assigned to serve the three conventions equally in December 2009, holding the position of Public Information Officer in the Rotterdam Convention Secretariat while acting on behalf of the Basel, Rotterdam and Stockholm conventions until August 2014. This gave me a ring-side view of the process of “synergies” between the three clustered conventions.

The experience of the Basel, Rotterdam and Stockholm conventions with clustering their instruments provides a proof of concept of the benefits that may be gained by other closely related MEAs joining forces. The conventions addressing biological diversity and climate change may be ripe for applying the lessons learned from the three global chemicals and waste conventions.

The “synergies process” streamlined the three conventions’ implementation, reduced administrative burdens, and maximized the efficient use of resources.

Future conferences of the Parties (COPs) of the Basel, Rotterdam and Stockholm conventions are now held back-to-back on a biennial schedule. For the more than 180 governments which attend the ‘SuperCOPs’, the efficiencies gained in time, travel and expense are obvious. The joint nature of the conferences also allows for a greater exchange of information and views between the parties to the conventions, helping close gaps in implementation and increasing at the technical and scientific level understanding of how the actions of any one MEA impact the others.

The listing of a chemical in the Stockholm Convention’s annexes may trigger classification of products containing the substance as hazardous under the Basel Convention. Hazardous constituents that may be found in plastic waste due to their use as additives in various applications include halogenated organic compounds used as flame retardants. Several halogenated organic compounds used as flame retardants are listed under the Stockholm Convention’s Annex A to be eliminated or severely restricted. The adoption of amendments to the Basel Convention in 2019) sought to enhance the control of the transboundary movements of plastic waste and clarify the scope of the Convention as it applies to such waste.

Close coordination between the two instruments is therefore welcome.

Another important lesson concerns how the groundwork was successfully laid for the establishment of a joint ‘BRS’ Secretariat. The process needs to be owned and embraced by the Parties to the Conventions themselves. As legally independent entities, they must be the drivers of any envisioned reform.

A series of decisions taken by the parties to the conventions in 2008 and 2009 established an ad hoc joint working group on enhancing cooperation and coordination among the Basel, Rotterdam and Stockholm conventions. Under co-chairs nominated by the parties and drawn from the North and the South to steer the process, the ad hoc working group was mandated to prepare joint recommendations on enhancing cooperation and coordination among the three conventions at the administrative and programmatic levels. This ensured that the changes would have the political backing of the parties themselves.

A further lesson is that the leadership of the newly formed cluster of conventions’ secretariat needed to be placed in one team. In practice, this meant consolidating the executives of the three conventions (on the UNEP side, as Rotterdam has a joint secretariat shared by UNEP and FAO). Having multiple executives hindered the synergies process. Reducing three executive posts down to one brought coherence as well as additional cost savings. The streamlining of secretariat staff further contributed to creating a more efficient, less costly secretariat.

My assignment in the ‘BRS’ Secretariat covered media relations, public information and outreach, including helping manage the joint conventions’ synergies website. Public information provided a fertile ground for joint activity between the three legally independent conventions.

The benefits brought by such administrative measures are minor when placed alongside the larger structural reforms of the synergies process which serve the ultimate purpose of promoting exchange of information, environmentally sound management, and the restriction or elimination of a broad range of undesirable hazardous substances from the planet.

Ultimately, this may be the highest benefit the clustering of the thematically-related hazardous chemical and wastes instruments bring to global environmental governance.

Felix Dodds and Chris Spence (July 17, 2025). UN Reform: Is it Time to Renew the Idea of Clustering the Major Environmental Agreements? Inter Press Service.

United Nations (June 16, 2025). Brutal cuts mean brutal choices warns UN relief chief, launching ‘survival appeal’. UN News.

United Nations (June 23, 2025). UN80 Initiative: What it is – and why it matters to the world | UN News.

Michael Stanley-Jones is an Environmental Policy and Governance Fellow at the United Nations University Institute for Water, Environment and Health, in Richmond Hill, Ontario, Canada.

IPS UN Bureau

 


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You’re Invited: Mark the Panda Twins’ Birthday in Hong Kong with Citywide Celebrations and a Birthday-edition LABUBU x Panda Twins Lucky Draw

HONG KONG, July 28, 2025 (GLOBE NEWSWIRE) — This summer, Hong Kong is going into cuteness overload with a citywide celebration marking the first birthday of its beloved panda twins: Jia Jia and De De! Born to giant panda parents Ying Ying and Le Le – longtime residents of Ocean Park, Hong Kong’s iconic nature–themed resort destination – on 15 August 2024, the twins have quickly captured hearts worldwide.

Panda lovers everywhere are invited to join the fun, with a special birthday–edition LABUBU x Panda Twins vinyl toy, special events at Ocean Park, and photogenic panda–themed displays across the city.

A Birthday Surprise: A Special Birthday–edition LABUBU x Panda Twins Vinyl Toy, Unveiled

To celebrate the panda twins’ upcoming birthday, Hong Kong Tourism Board (HKTB) and Ocean Park have teamed up with the monster–elf’s creator, artist and author Kasing Lung, to create a special birthday–edition LABUBU x Panda Twins vinyl toy. The design features a bamboo–inspired green LABUBU wearing a polka–dotted birthday hat and holding the adorable panda twins. Moreover, it comes packaged in a custom gift box with a handcrafted birthday card from Kasing.

“I am delighted to collaborate with the HKTB and design this Panda Twins birthday special edition of LABUBU to share Hong Kong’s joyful energy with fans worldwide, and to play a part in promoting our city,” said Kasing.

Starting 25 July onwards, all Ocean Park Hong Kong visitors – both locals and travellers – can pre–register on the event website (https://www.oceanpark.com.hk/en/park–experience/labubu–panda–twins–lucky–draw) to join the lucky draw at the Park from 1 to 31 August for a chance to win one of approximately 300 birthday gift boxes, each containing the birthday–edition LABUBU and a commemorative birthday card. Additional gift boxes will be available during the birthday celebrations from 15 to 17 August.

Trade Promotion Competition Licence No.: 60184–60369 (Only applicable to lucky draw). 

The LABUBU X Panda Twins gift box includes a birthday–edition LABUBU and a birthday card showing LABUBU celebrating the pandas’ birthday against a backdrop of Victoria Harbour.
 

A Summer of Birthday Fun at Ocean Park

As the home of the panda twins, Ocean Park will be the heart of the celebrations! This summer, Ocean Park has teamed up with LINE FRIENDS characters to present the Panda Friends Summer Splash – a memorable mix of whimsical photo spots, water adventures and interactive games. Guests can dive into the Ball Pit Party, cool off at the Panda Friends Splash Playground or go all–in at the Water Battle Zone. Across the Park, you’ll find pop–up panda games, surprise giveaways like panda badges and party hats, and Instagrammable moments galore.

Starting in August, the park comes alive with vibrant Panda Friends decorations and panda graphics skilfully painted by water–gun artists, while nightfall brings the Gala of Lights – Panda Birthday Edition, featuring dazzling projections, dancing fountains and celebratory music. Park visitors may receive delightful surprise gifts when visiting the park from 15 to 17 August, adding an extra layer of excitement to their visit.

Top it all off with themed snacks, exclusive merchandise – including Jia Jia and De De plushies in kindergarten uniforms – and special offers, like the “Twin Park Package Ticket”, which includes access to both Ocean Park and Water World within a seven–day period.

Follow the Panda Trail Across Hong Kong

The panda party doesn’t stop at Ocean Park – it’s taking over the entire city! Creative tributes to the panda twins can be spotted around every corner, from panda–themed MTR station takeovers to 32 panda–ified road signs.

If you’re a panda lover, this is one birthday celebration you won’t want to miss. Join the fun across Hong Kong – and enter for your chance to win a special birthday–edition LABUBU x Panda Twins collectable in our birthday lucky draw.

Visit the Discover Hong Kong Panda Website now for everything you need to plan your next trip to Hong Kong.

Click here to download high–res images.

For media enquiries, please contact:

Ms. Annice Li 
Email: [email protected]  
Ms. Claris Lam 
Email: [email protected]  
   

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/100071e9–8eb2–4c72–95c0–92d074ba2072

https://www.globenewswire.com/NewsRoom/AttachmentNg/2fc6a958–dbd2–4f32–a653–f39c15cb7241

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GLOBENEWSWIRE (Distribution ID 9501212)

Western Powers Are Complicit in Crimes Against Humanity in Gaza

An UNRWA school turned shelter in Al Bureij, Gaza, lies in ruins following a missile attack in May 2025. Credit: UNRWA

By Alon Ben-Meir
NEW YORK, Jul 28 2025 – The West, led by the Trump administration, has enabled the Netanyahu government to commit crimes against humanity and became complicit in the unfathomably horrific disaster that is being inflicted on the Palestinians in Gaza

The war in Gaza has crossed many red lines, rendering Palestinian lives worthless, trivial, and of no consequence. Much of the horrific crimes against humanity being committed against the Palestinians in Gaza by the Netanyahu government could have been prevented had it not been for the nearly unconditional and continuing political, economic, and military support of Western powers, led by the US.

If this does not constitute complicity in war crimes perpetrated against tens of thousands of innocent Palestinians, then I don’t know what does.

Western powers’ claims of high moral grounds seemed to have withered completely, as evidenced by the fact that even though most of Gaza lies in utter ruin, and over 59,000 people have been killed, Western support remains shamelessly unabated.

And while the majority of the 2.1 million Palestinians are starving to death, the supplies of killing machines continue to flow, while the suppliers pay less than lip service to the intensifying human cataclysm on the entire population of Gaza.

Before I elaborate on the US’ indispensable role in ending the war in Gaza, a brief review of what other Western powers have failed to do is in order.

Children in Gaza wait in the hope of receiving food. Credit: UN News

France, the UK, and Germany’s Dereliction

The Western powers, especially the UK, France, and Germany, have consistently supported Israel’s onslaught on Gaza, claiming Israel’s right to defend itself. Only during the past few weeks have they started to contemplate addressing the horrific humanitarian crisis in Gaza. They have considered measures— from suspending trade and imposing sanctions to public criticisms and diplomatic efforts—to force Netanyahu’s hand.

In addition, recently the UK, France, and Canada issued a joint statement threatening “concrete reactions,” including targeted sanctions, if Israel fails to end its renewed offensive and allow unhindered humanitarian aid, and insisting on immediate improvements in humanitarian access. The UK and France have also co-hosted international conferences to advance a ceasefire and a two-state solution, and pledged diplomatic and financial support for peace initiatives.

Sadly, Western threats and limited actions fall far short of what is critically needed to end these mind-boggling war crimes being committed by Netanyahu and his government. They must impose an immediate embargo on all supplies of military equipment and spare parts, and, being the largest trading partners, they must freeze all trade with Israel where it hurts. Only by taking these measures can Netanyahu and his corrupt government realize the magnitude of the European ire.

US Complicity in Netanyahu’s Crimes Against Humanity

The US can wield far greater pressure on Israel than what other Western powers can exercise combined. Sadly, though, neither the Biden nor the Trump administrations have used their immense leverage to force Netanyahu to end the horrific war that is on the verge of destroying what’s left of Gaza and devastating nearly entirely its inhabitants.

The US commitment to Israel’s national security has been a given since Israel’s establishment in 1948. But then, even though successive American administrations have and continue to adhere to this commitment, 77 years later, Israel does not feel secure due to the continuing conflict with the Palestinians.

That is, if the US cares about Israel’s national security, which it does, it should have mitigated the source of Israel’s sense of insecurity by relentlessly pushing Israel to reach a peace agreement with the Palestinians, where Israel’s ultimate national security rests.

For decades, successive American presidents, including Trump, have championed the notion of a two-state solution. Although they have made repeated efforts over several decades to forge peace between the two sides, they have never taken concrete steps to pressure both sides to accept the only realistic outcome that they have been advocating, which could have ended the Israeli-Palestinian conflict.

Not once have the Biden and the Trump administrations threatened, let alone imposed, sanctions on Israel, to stop the indiscriminate bombing of Gaza and the deliberate chokehold on the supplies of food, medicine, and water, which is causing mass starvation and even famine. To the contrary, both continued to supply Israel with the weapons and munitions it was asking for with no reservations.

Military aid to Israel

According to the Costs of War Project, which tracks US military aid and expenditure, since the war began in October 2023, the US has provided Israel $22.76 billion in military assistance. In January 2025, Trump authorized the release of 1,800 MK-84 bombs (2,000-lb weapons) that the Biden administration had previously withheld as a protest against Israel’s actions in Rafah.

Instead of realizing that this heinous Gaza war only reinforces the idea that only a two-state solution would end the Israeli-Palestinian conflict, Trump offered to take over Gaza and build a ‘luxury riviera’, which would only perpetuate the deadly Israeli-Palestinian conflict for another generation.

Instead of disabusing Netanyahu and his government of the notion of planning to rebuild new Jewish settlements in Gaza, Trump has been pushing the idea of relocating the Palestinians to a third country. This is nothing but music to Netanyahu’s ear, praising Trump for his “ingenuity” because nothing will quench Netanyahu and his government’s appetite more than seizing more Palestinian land and getting rid of the Palestinians once and for all.

Instead of insisting on an immediate ceasefire and developing a clear exit strategy from Gaza, Trump is still tiptoeing around, careful not to antagonize his political base, especially the evangelicals. For these religiously devout Christians, Israel can do no wrong, even though thousands of innocent women and children have been killed and hundreds more are added weekly to the roster of the dead, while Netanyahu is destroying what’s left of Gaza’s infrastructure to render it unlivable.

Now, the Netanyahu government is forcibly displacing the Palestinians in Gaza to the south and building a concentration camp on top of the ruins of Rafah. From there, the government is planning to commit a total ethnic cleansing by exiling the Palestinians to a third country. Yes, another Nakba (catastrophe), à la 1948, is in the making.

Trump Can End the War If He Wills It

Trump’s focus on a ceasefire as a first step is imperative and immediately needed, but it must only be a first step. He must make it unequivocally clear to Netanyahu that, during the cessation of hostilities, he must develop and submit an exit strategy from Gaza. The war must stop and cannot be resumed under any circumstances, and the flow of humanitarian assistance must begin immediately in sufficient quantities to prevent mass starvation.

Yes, given Israel’s dependence on the US on a host of issues, including political cover, economic assistance, and military aid, Trump is in a position not to ask but to demand that Netanyahu adhere to the US’ demand to end this horrifying war, the ultimate consequences of which are hard even to imagine.

Trump, who is clamoring to win a Nobel Peace Prize, is facing a crossroad. At the first road, remaining silent in the face of this pending catastrophe. He will be complicit, before the law, in the war crimes being committed in Gaza. The other road could potentially help him to realize his dream by ending the war in Gaza and beginning an Israeli-Palestinian peace process that would lead to the only viable solution—a two-state solution.

Will he rise to the occasion and do what all of his predecessors failed to achieve?

Dr. Alon Ben-Meir is a retired professor of international relations, most recently at the Center for Global Affairs, at New York University (NYU). He taught courses on international negotiation and Middle Eastern studies.
[email protected] Web: www.alonben-meir.com

IPS UN Bureau

 


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COMMENTARY: Trump National Monument at Mount Rushmore

Demonstration against Trump-era policies in Seattle, May 1, 2025. Credit: Peter Constantini

By Peter Costantini
SEATTLE, USA, Jul 28 2025 – President Donald Trump reportedly wants to add his own head to Mount Rushmore National Memorial. But the National Park Service says there’s no room next to the four current presidents: George Washington, Thomas Jefferson, Abraham Lincoln and Theodore Roosevelt. [Branch & White 6/27/2025] Here’s an innovative proposal for how to immortalize him right there in the Black Hills of South Dakota.

On the backside of the same rocky bluff where the monument is located, the President will unveil a full-body statue of himself. His combover is made of gold-plated carbon fiber that scintillates in the breeze. He bestrides an imposing masonry wall fronted by a moat filled with alligators and poisonous snakes, an idea that he purportedly floated during his first term. [Shear & Davis 10/2/2019]

The statue is as dynamic as its subject. Starting at dawn, Trump’s nose gradually grows out all day into a long, Pinocchio-like proboscis.

The soundtrack features the greatest hits from the President’s vast playlist of falsehoods – the Washington Post counted 30,573 false or misleading claims over his first term, around 20 per day. [Kessler et al 1/24/2021]. And veteran White House correspondent Peter Baker has analyzed them extensively in the New York Times. [Baker 2/23/2025] The nose grows proportionately to the magnitude and creativity of each whopper. Then it retracts at night.

The grand finale comes at sundown, when the President’s pants suddenly catch fire. In honor of his “Drill, Baby, Drill” energy policy, we’re not talking an LED or laser light show here. This has got to be something with a respectable carbon footprint, like methane. The blaze illuminates the whole monument and can be seen from outer space.

At this point, you may be wondering whether the President would embrace this sort of monument to his mendacity. Well, don’t underestimate his passion for inspired grifting (for example, see his pardon of Steve Bannon). [Costantini 10/4/2021]

As one pundit put it: “His superpower is his shamelessness.” [The 11th Hour 5/22/2025] The President once notoriously joked that “I could stand in the middle of Fifth Avenue and shoot somebody, and I wouldn’t lose any voters, OK?” [Dwyer 1/23/2016]

The Supreme Court later backed his boast with a king-size get-our-of-jail-free card in Trump v. United States, in which it ruled that presidents are immune from criminal prosecution for official acts taken while in office. [Congressional Research Office 7/5/2024]

Why would he not take equal pride in his ability to pull the most brazen prevarications out of his ample posterior and watch some of his base worship them as gospel, while others just revel in “owning the libs”.

Don’t miss the other entertaining features. Every couple of hours during the day, one of Trump’s arms extends out, the palm of his massive hand facing upward. A drone tricked out as a model of his new Air Force One 747 lands on it like a falcon, accompanied by fireworks and martial music. Look! The plane has a new name emblazoned on it: “The Emperor of Emoluments”!

At alternate hours, Trump’s other arm rises up with the palm facing down, sporting a gold-plated ring with giant zirconium jewels. Actors impersonating public figures approach, kiss the ring, and tell him their troubles.

He agrees to help, adding: “I’d like you to do me a favor, though.” Somber music from The Godfather amps up the gravitas. On Tuesdays and Thursdays, visitors can ask for pardons and other favors on a cell-phone app. An AI Trump entity reads the petitions and responds with appropriate noblesse oblige or scorn. But if he asks if you’re a public employee, beware: if you say “Yes”, his favorite reply is “You’re fired.”

Below the statue, a small herd of human heads on toad bodies greets visitors. These are talking robots representing Trump’s toadies: cabinet members, advisors, political allies, business partners, even tech bros. They sing extravagant praises of the President with quotes from his North Korea-style cabinet meetings. One group asks guests to sign a petition to award the President the Nobel Peace Prize. [CNN 7/7/2025]

On some evenings the lighting changes, and Trump’s statue is costumed as Czar Donald the Impaler. If you’re very lucky, you may catch a glimpse of a shadowy Stephen Miller whispering in his ear, cosplaying in monk drag as his Mini-Rasputin. He’s just a hologram, too.

However, someone did recruit a special force of live ICE agents who roam the monument in plain-clothes packs. As long as you don’t “look foreign”, you have nothing to fear from them. If you do “look foreign”, you could win an all-expenses-paid open-ended vacation to El Salvador or South Sudan.

Looking for fun for the kids? Saddle up for an immigration rodeo. Holograms of immigrant families climb over the wall and try to cross the moat.

Players mounted on robot horses can “shoot them in the legs” with laser tags, as Trump suggested, and then herd them into two virtual concentration camps bristling with razor wire: one for kids, one for parents. [Shear & Davis 10/2/2019]

The more families you separate, the more points you earn. You can also bump your score up by denying the captives water or medical care. Then you can use your accumulated points to score Trump merch like golden watches, golden sneakers, and Holy Bibles.

But the fun is not just for kids. For adult fans of Trumponomics, there’s the Tariff Shoot. Who knew that tariffs are not really economic policies? As Trump has demonstrated, they are weapons you can use to blast countries you just don’t like.

For example, even though virtually no fentanyl enters the U.S. through Canada, the Big Guy has imposed crippling tariffs on our northern neighbor until they end all fentanyl smuggling. [Zahn 7/11/2025] The Tariff Shoot turns this boring trade tool into a dope game.

You shoot virtual tariff arrows from an electronic bow at a rotating holographic globe. When you hit a country, your game controller shows what goods you can put tariffs on and how much you can raise prices. You can also loot mineral rights and expropriate territory for your own private virtual country.

If you bankrupt a country, you can acquire outright ownership. Then at the end, you receive your winnings in Trump-backed cryptocurrency tokens. Best of all, if you hit the capital of a country, say Ottawa or Mexico City, you win a kewpie doll of Canadian Prime Minister Mark Carney or Mexican President Claudia Sheinbaum.

And then there are other kinds of fun after the sun goes down. Away from the plebeian hurly-burly, there’s a secret part of the Trump monument open only to very rich men. It’s concealed behind a stone door located somewhere on a neighboring bluff. You have to buy the GPS coordinates and entry codes for a price starting well over seven figures.

And security? Let’s just say word on the Dark Web is that Erik Prince’s mercenaries enforce the non-disclosure agreement. Once you find it and enter the codes, the hidden door opens briefly and then slams shut behind you with a metallic clang. You’ve just gained entry into a virtual re-creation of Jeffrey Epstein’s private island. We’ll leave the rest to your imagination. But hey, big spender, not to worry. Counsel advises that it is not legally possible for holograms to be underage.

As magnificent as it will be, the Trump Monument at Mount Rushmore is just the opening play. It will serve as the spearhead of a much broader blitzkrieg to disrupt Big Park. A revamped DOGE will be called in to root out inefficiencies and corruption from national parks and monuments and finally to sell them off to private equity.

Plans are hatching to redevelop the tired old presidential faces. Move over, El Capitan: imagine rock climbing up Honest Abe’s nose. Join the kids hurtling down the bomb water slide in the gap between OG Washington and TJeff. And Trump’s real estate hounds are sniffing out a site to build a 50-story hotel on top of one of the surrounding bluffs.

Picture the majestic Trump Golden Calf Resort and Casino, featuring crossover themes from the Old West and the Old Testament. It will enforce the signature Trump policy of pay-to-play: if you want access to the premium features of the Trump Monument, why wouldn’t you want to stay at the premium lodging on-site?

And did someone mention links? If you’re looking for Trump-class golfing during your stay, plans are afoot to turn a nearby patch of the Black Hills into valleys full of putting greens.

Some may call it tacky totalitarianism, but the markets are jonesing at the prospect of an Orlando of the Prairies.

A final word to the wise: President Trump will decree that birthright citizenship does not apply on the grounds of his national monument. So don’t forget to bring birth certificates for the whole family. And for their moms.

 

See also

Peter Baker. “Trump Uses Lies to Lay the Groundwork for Radical Change”. New York Times, February 23, 2025.
https://nytimes.com/2025/02/23/us/politics/trump-alternative-reality.html

Peter Baker. “Trump’s Wild Claims, Conspiracies and Falsehoods Redefine Presidential Bounds”. November 3, 2024.
https://nytimes.com/2025/02/23/us/politics/trump-alternative-reality.html

Congressional Research Office. “Presidential Immunity from Criminal Prosecution in Trump v. United States”. Washington, DC: July 5, 2024.
https://congress.gov/crs_external_products/LSB/PDF/LSB11194/LSB11194.2.pdf

Peter Costantini. “The Roadrunner and the Wall”. Ciudad de México: Americas Migration, October 4, 2021.
https://americasmigration.blogspot.com/2021/10/the-roadrunner-and-wall.html

John Branch & Jeremy White. “Room for One More on Mount Rushmore? (The President Wants to Know.)”. New York Times, June 27, 2025.
https://nytimes.com/interactive/2025/06/27/us/mount-rushmore-trump.html

CNN. “’It’s a great honor’: Trump receives Nobel Peace Prize nomination from Netanyahu”. CNN Politics, July 7, 2025.
https://cnn.com/2025/07/07/politics/video/trump-netanyahu-nobel-nomination-letter-digvid

Colin Dwyer. “Donald Trump: ‘I Could … Shoot Somebody, And I Wouldn’t Lose Any Voters’”. National Public Radio, The Two-Way, January 23, 2016.
https://npr.org/sections/thetwo-way/2016/01/23/464129029/donald-trump-i-could-shoot-somebody-and-i-wouldnt-lose-any-voters

Glenn Kessler, Salvador Rizzo & Meg Kelly. “Trump’s false or misleading claims total 30,573 over 4 years”. Washington Post, January 24, 2021.
https://washingtonpost.com/politics/2021/01/24/trumps-false-or-misleading-claims-total-30573-over-four-years

Michael D. Shear & Julie Hirschfeld Davis. “Shoot Migrants Legs, Build Alligator Moat: Behind Trumps Ideas for Border”. New York Times, October 2, 2019.
https://nytimes.com/2019/10/01/us/politics/trump-border-wars.html

The 11th Hour. “’His superpower is his shamelessness’: A look at Trump’s crypto dinner” (interview with Salman Rushdie). MSNBC, May 22, 2025.
https://msnbc.com/11th-hour/watch/-his-superpower-is-his-shamelessness-a-look-at-trump-s-crypto-dinner-240173637966

Max Zahn. “What to know about Trump’s new tariffs on Canada”. ABC News, July 11, 2025.
https://abcnews.go.com/Business/trumps-new-tariffs-canada/story?id=123678621