OS Therapies to Provide OST-HER2 Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma FDA End of Phase 2 Meeting Update on Tuesday, September 2, 2025
OS Therapies (NYSE American: OSTX), a clinical-stage biotechnology company focused on cancer immunotherapy and antibody drug conjugates, has announced plans to provide a comprehensive update following their End of Phase 2 Meeting with the FDA regarding OST-HER2. The update, scheduled for September 2, 2025, will detail the regulatory pathway for potential approval of OST-HER2 in treating recurrent, fully resected, pulmonary metastatic osteosarcoma.
The company described their August 27 meeting with the FDA as "highly constructive," suggesting positive developments in their clinical program for this rare cancer treatment.
OS Therapies (NYSE American: OSTX), una società biotecnologica in fase clinica focalizzata sull'immunoterapia oncologica e sugli anticorpi coniugati, ha annunciato l'intenzione di fornire un aggiornamento completo a seguito del loro End of Phase 2 Meeting con la FDA relativo a OST-HER2. L'aggiornamento, previsto per il 2 settembre 2025, illustrerà il percorso regolatorio per la possibile approvazione di OST-HER2 nel trattamento dell'osteosarcoma polmonare metastatico ricorrente completamente asportato.
La società ha definito l'incontro del 27 agosto con la FDA "altamente costruttivo", lasciando intendere sviluppi positivi nel loro programma clinico per questo trattamento di una malattia rara.
OS Therapies (NYSE American: OSTX), una compañía biotecnológica en fase clínica centrada en la inmunoterapia contra el cáncer y en los anticuerpos conjugados, ha anunciado que ofrecerá una actualización completa tras su End of Phase 2 Meeting con la FDA sobre OST-HER2. La actualización, programada para el 2 de septiembre de 2025, detallará la vía regulatoria para la posible aprobación de OST-HER2 en el tratamiento del osteosarcoma metastásico pulmonar recurrente completamente resecado.
La compañía describió la reunión del 27 de agosto con la FDA como "altamente constructiva", lo que sugiere avances positivos en su programa clínico para este tratamiento de una enfermedad rara.
OS Therapies (NYSE American: OSTX)는 암 면역치료제와 항체 약물 접합체(ADC)에 중점을 둔 임상 단계의 바이오텍 회사로, OST-HER2와 관련한 End of Phase 2 Meeting with the FDA 이후 포괄적인 업데이트를 제공할 계획이라고 발표했습니다. 해당 업데이트는 2025년 9월 2일에 예정되어 있으며, 재발한 완전 절제된 폐 전이성 골육종 치료에 대한 OST-HER2의 잠재적 승인에 관한 규제 경로를 상세히 설명할 예정입니다.
회사는 8월 27일 FDA와의 회의를 "매우 건설적이었다"고 평가하며, 이 희귀 암 치료제 임상 프로그램에 긍정적인 진전이 있었음을 시사했습니다.
OS Therapies (NYSE American: OSTX), une société biotechnologique en phase clinique axée sur l'immunothérapie anticancéreuse et les conjugués anticorps-médicaments, a annoncé son intention de fournir une mise à jour complète à la suite de son End of Phase 2 Meeting avec la FDA concernant OST-HER2. La mise à jour, prévue pour le 2 septembre 2025, détaillera la voie réglementaire en vue d'une approbation potentielle d'OST-HER2 pour le traitement de l'ostéosarcome pulmonaire métastatique récidivant totalement réséqué.
La société a qualifié sa réunion du 27 août avec la FDA de « très constructive », suggérant des développements positifs dans son programme clinique pour ce traitement d'une maladie rare.
OS Therapies (NYSE American: OSTX), ein biotechnologisches Unternehmen in der klinischen Phase mit Schwerpunkt auf Krebsimmuntherapie und Antikörper-Wirkstoff-Konjugaten, hat angekündigt, ein umfassendes Update nach ihrem End of Phase 2 Meeting mit der FDA zu OST-HER2 zu geben. Das Update, geplant für den 2. September 2025, wird den regulatorischen Weg für eine mögliche Zulassung von OST-HER2 zur Behandlung des rezidivierenden, vollständig resezierten, pulmonalen metastasierten Osteosarkoms darlegen.
Das Unternehmen bezeichnete das Treffen mit der FDA am 27. August als „sehr konstruktiv“, was auf positive Entwicklungen in ihrem klinischen Programm für diese seltene Krebserkrankung hindeutet.
- None.
- None.
New York, New York--(Newsfile Corp. - August 27, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced that it will provide stakeholders with a detailed update regarding the Company’s highly constructive August 27, 2025 End of Phase 2 Meeting with the US Food & Drug Administration ("FDA") discussing the regulatory path forward towards approval for OST-HER2 in recurrent, fully resected, pulmonary metastatic osteosarcoma on Tuesday, September 2, 2025.
About OS Therapies
OS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. OST-HER2, the Company's lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initiate a strong immune response targeting the HER2 protein. OST-HER2 has received Rare Pediatric Disease Designation (RPDD) from the U.S. Food & Drug Administration and Fast-Track and Orphan Drug designations from the U.S. FDA and European Medicines Agency. The Company reported positive data in its Phase 2b clinical trial of OST-HER2 in recurrent, fully resected, lung metastatic osteosarcoma, demonstrating statistically significant benefit in the 12-month event free survival (EFS) primary endpoint of the study. The Company anticipates submitting a Biologics Licensing Application (BLA) to the U.S. FDA for OST-HER2 in osteosarcoma in 2025 and, if approved, would become eligible to receive a Priority Review Voucher that it could then sell. OST-HER2 has completed a Phase 1 clinical study primarily in breast cancer patients, in addition to showing preclinical efficacy data in various models of breast cancer. OST-HER2 has been conditionally approved by the U.S. Department of Agriculture for the treatment of canines with osteosarcoma.
In addition, OS Therapies is advancing its next-generation Antibody Drug Conjugate (ADC) and Drug Conjugates (DC), known as tunable ADC (tADC), which features tunable, tailored antibody-linker-payload candidates. This platform leverages the Company's proprietary silicone Si-Linker and Conditionally Active Payload (CAP) technology, enabling the delivery of multiple payloads per linker. For more information, please visit www.ostherapies.com.
Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of the federal securities laws. These forward-looking statements and terms such as "anticipate," "expect," "intend," "may," "will," "should" or other comparable terms involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Those statements include statements regarding the intent, belief or current expectations of OS Therapies and members of its management, as well as the assumptions on which such statements are based. OS Therapies cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to the approval of OST-HER2 by the U.S. FDA and other risks and uncertainties described in "Risk Factors" in the Company's most recent Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and other subsequent documents the Company files with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by the federal securities laws, OS Therapies specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
OS Therapies Contact Information:
Investor Relations
Harrison Seidner, PhD
WaterSeid Partners
OSTX@waterseid.com
Public Relations
Stephanie Chen
Elev8 New Media
stephanie@elev8newmedia.com
https://x.com/OSTherapies
https://www.instagram.com/ostherapies/
https://www.facebook.com/OSTherapies/
https://www.linkedin.com/company/os-therapies/
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/264171
FAQ
When will OS Therapies (OSTX) provide the FDA End of Phase 2 Meeting update for OST-HER2?
What is the purpose of OS Therapies' FDA End of Phase 2 Meeting for OST-HER2?
What type of treatment is OST-HER2 being developed for by OS Therapies (OSTX)?
What is OS Therapies' (OSTX) main business focus?
