OS Therapies Provides Clinical & Global Regulatory Updates
OS Therapies (NYSE American: OSTX) announced significant regulatory progress for its oncology programs. The company has scheduled an End of Phase 2 Meeting with FDA on August 27, 2025 to review its OST-HER2 program for recurrent, pulmonary metastatic osteosarcoma, aiming to begin a rolling BLA submission under Accelerated Approval.
The company has secured Scientific Advice Meetings with European regulators, including EMA and MHRA, pursuing marketing authorizations across Europe and the UK. Additionally, all patients in the Phase 1 clinical study of OST-504 for second-line prostate cancer have completed treatment, with data expected in H2 2025.
OS Therapies aims to obtain regulatory approval for OST-HER2 before the rare pediatric disease priority review voucher (PRV) program expires, planning to use potential PRV sale proceeds for commercialization and pipeline advancement.
OS Therapies (NYSE American: OSTX) ha annunciato importanti progressi regolatori per i suoi programmi oncologici. L'azienda ha programmato un Incontro di Fine Fase 2 con la FDA il 27 agosto 2025 per esaminare il suo programma OST-HER2 per osteosarcoma metastatico polmonare ricorrente, con l'obiettivo di avviare una sottomissione BLA progressiva sotto l'Accelerated Approval.
La societ脿 ha ottenuto incontri di Consulenza Scientifica con i regolatori europei, inclusi EMA e MHRA, perseguendo autorizzazioni di commercializzazione in tutta Europa e nel Regno Unito. Inoltre, tutti i pazienti nello studio clinico di Fase 1 di OST-504 per il cancro alla prostata in seconda linea hanno completato il trattamento, con dati attesi nella seconda met脿 del 2025.
OS Therapies punta a ottenere l'approvazione regolatoria per OST-HER2 prima della scadenza del programma di voucher di revisione prioritaria per malattie pediatriche rare (PRV), pianificando di utilizzare i potenziali proventi della vendita del PRV per la commercializzazione e l'avanzamento della pipeline.
OS Therapies (NYSE American: OSTX) anunci贸 avances regulatorios significativos para sus programas oncol贸gicos. La compa帽铆a ha programado una Reuni贸n de Fin de Fase 2 con la FDA para el 27 de agosto de 2025 para revisar su programa OST-HER2 para osteosarcoma metast谩sico pulmonar recurrente, con el objetivo de comenzar una presentaci贸n BLA continua bajo la Aprobaci贸n Acelerada.
La empresa ha asegurado reuniones de Asesoramiento Cient铆fico con los reguladores europeos, incluyendo EMA y MHRA, buscando autorizaciones de comercializaci贸n en Europa y el Reino Unido. Adem谩s, todos los pacientes en el estudio cl铆nico de Fase 1 de OST-504 para c谩ncer de pr贸stata en segunda l铆nea han completado el tratamiento, con datos esperados en la segunda mitad de 2025.
OS Therapies pretende obtener la aprobaci贸n regulatoria para OST-HER2 antes de que expire el programa de vales de revisi贸n prioritaria para enfermedades pedi谩tricas raras (PRV), planeando utilizar los posibles ingresos de la venta del PRV para la comercializaci贸n y el avance de la cartera de productos.
OS Therapies (NYSE American: OSTX)電� 鞛愳偓鞚� 膦呾枒頃� 頂勲攴鸽灗鞐� 雽�頃� 欷戩殧頃� 攴滌牅 歆勳爠鞚� 氚滍憸頄堨姷雼堧嫟. 須岇偓電� 鞛皽靹� 韽� 鞝勳澊靹� 瓿湣膦呾潉 鞙勴暅 OST-HER2 頂勲攴鸽灗鞚� 瓴�韱犿晿旮� 鞙勴暣 2025雲� 8鞗� 27鞚� FDA鞕�鞚� 2靸� 膦呺 氙疙寘鞚� 鞓堨爼頃橁碃 鞛堨溂氅�, 臧�靻� 鞀轨澑 頃橃棎 靾滌皑鞝� BLA 鞝滌稖鞚� 鞁滌瀾頃� 瓿勴殟鞛呺媹雼�.
須岇偓電� EMA鞕� MHRA毳� 韽暔頃� 鞙犽熃 攴滌牅 雼龟淡瓿� 瓿柬暀 鞛愲 氙疙寘鞚� 頇曤炒頄堨溂氅�, 鞙犽熃 氚� 鞓侁淡 鞝勳棴鞐愳劀 毵堨紑韺� 鞀轨澑 須嶋摑鞚� 於旍 欷戩瀰雼堧嫟. 霕愴暅, 2彀� 旃橂鞖� 鞝勲靹犾晹鞐� 雽�頃� OST-504 1靸� 鞛勳儊鞁滍棙鞚� 氇摖 頇橃瀽臧� 旃橂毳� 鞕勲頄堨溂氅�, 雿办澊韯半姅 2025雲� 頃橂皹旮办棎 瓿店皽霅� 鞓堨爼鞛呺媹雼�.
OS Therapies電� 頋穩 靻岇晞 歆堩櫂 鞖办劆 鞁偓 氚旍毎觳�(PRV) 頂勲攴鸽灗鞚� 毵岆霅橁赴 鞝勳棎 OST-HER2鞐� 雽�頃� 攴滌牅 鞀轨澑鞚� 鞏浑姅 瓴冹潉 氇╉憸搿� 頃橂┌, PRV 韺愲Г 靾橃澋鞚� 靸侅梾頇� 氚� 韺岇澊頂勲澕鞚� 歆勳爠鞐� 靷毄頃� 瓿勴殟鞛呺媹雼�.
OS Therapies (NYSE American : OSTX) a annonc茅 des avanc茅es r茅glementaires significatives pour ses programmes en oncologie. La soci茅t茅 a programm茅 une r茅union de fin de phase 2 avec la FDA le 27 ao没t 2025 afin d'examiner son programme OST-HER2 pour l'ost茅osarcome m茅tastatique pulmonaire r茅cidivant, dans le but de commencer un d茅p么t BLA progressif sous l'Acc茅l茅ration d'Approbation.
La soci茅t茅 a obtenu des r茅unions de conseil scientifique avec les autorit茅s europ茅ennes, y compris l'EMA et la MHRA, visant des autorisations de mise sur le march茅 en Europe et au Royaume-Uni. De plus, tous les patients de l'茅tude clinique de phase 1 d'OST-504 pour le cancer de la prostate en deuxi猫me ligne ont termin茅 leur traitement, avec des donn茅es attendues au second semestre 2025.
OS Therapies vise 脿 obtenir l'approbation r茅glementaire pour OST-HER2 avant l'expiration du programme de bon de r茅vision prioritaire pour les maladies p茅diatriques rares (PRV), pr茅voyant d'utiliser les 茅ventuels revenus de la vente du PRV pour la commercialisation et le d茅veloppement du pipeline.
OS Therapies (NYSE American: OSTX) meldete bedeutende regulatorische Fortschritte f眉r seine Onkologieprogramme. Das Unternehmen hat ein Ende der Phase-2-Sitzung mit der FDA am 27. August 2025 angesetzt, um sein OST-HER2-Programm f眉r rezidivierenden, pulmonal metastasierten Osteosarkom zu 眉berpr眉fen und strebt an, eine fortlaufende BLA-Einreichung unter Accelerated Approval zu beginnen.
Das Unternehmen hat wissenschaftliche Beratungsgespr盲che mit europ盲ischen Regulierungsbeh枚rden wie EMA und MHRA gesichert und verfolgt Zulassungen f眉r den europ盲ischen und britischen Markt. Zudem haben alle Patienten in der Phase-1-Studie von OST-504 f眉r das Prostatakarzinom in der Zweitlinientherapie die Behandlung abgeschlossen; Daten werden f眉r das zweite Halbjahr 2025 erwartet.
OS Therapies strebt an, die Zulassung f眉r OST-HER2 vor Ablauf des Priority Review Voucher (PRV)-Programms f眉r seltene p盲diatrische Erkrankungen zu erhalten und plant, m枚gliche Erl枚se aus dem PRV-Verkauf f眉r die Kommerzialisierung und Weiterentwicklung der Pipeline zu verwenden.
- Secured End of Phase 2 Meeting with FDA for OST-HER2 program
- Confirmed Scientific Advice Meetings with EMA and MHRA for European and UK market access
- Completed patient treatment in Phase 1 trial of OST-504 for prostate cancer
- Potential to receive non-dilutive funding through Priority Review Voucher sale
- Company limiting capital deployment and clinical studies pending OST-HER2 approval
- Operating under time pressure due to upcoming expiration of rare pediatric disease PRV program
Insights
OS Therapies progressing towards regulatory approvals for two oncology programs with multiple global regulatory meetings scheduled.
This update represents meaningful advancement in OS Therapies' regulatory strategy for both its lead programs. The scheduled FDA End of Phase 2 meeting on August 27th for OST-HER2 is particularly significant as it could potentially lead to a rolling BLA submission under the Accelerated Approval pathway. This expedited process would substantially reduce the time to market for their osteosarcoma treatment.
The confirmation of Scientific Advice Meetings with both the EMA and MHRA demonstrates a sophisticated global regulatory approach, pursuing parallel approval pathways in major markets. The UK's Innovative Licensing and Access Pathway (ILAP) mentioned could further accelerate commercialization in that market.
Regarding the company's second program, the completion of patient treatment in the OST-504 Phase 1 prostate cancer trial represents a critical milestone, with data readout expected in H2 2025. The technology platform leveraging Listeria monocytogenes as an immunotherapy vector has shown promise in both human and canine applications.
Management's focus on obtaining the rare pediatric disease priority review voucher (PRV) is strategically sound, as these vouchers have historically sold for
This is a pivotal period for OS Therapies as they transition from clinical development toward regulatory approval stages for multiple programs across different indications, while maintaining disciplined capital allocation focused on their lead asset.
- End of Phase 2 Meeting with FDA scheduled for August 27, 2025 to review OST-HER2 recurrent, pulmonary metastatic osteosarcoma program
- Scientific Advice Meetings confirmed with global regulators in major markets - including the United Kingdom and European Union
- All patients enrolled in its Phase 1 clinical study of OST-504 in second line prostate cancer have completed treatment, with data expected to be announced later in 2025
New York, New York--(Newsfile Corp. - July 10, 2025) - OS Therapies (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today provided a clinical and global regulatory update on its currently active clinical-stage oncology programs. The Company announced that the End of Phase 2 Meeting granted by the US Food & Drug Administration ("FDA") to review the from its OST-HER2 recurrent, pulmonary metastatic osteosarcoma program is scheduled for August 27, 2025, during which the Company expects to seek alignment with FDA to begin a rolling review Biologics Licensing Application ("BLA") submission to FDA under its Accelerated Approval Program ("Accelerated Approval").
Further, the Company announced that it has a confirmed a Scientific Advice Meeting ("SAM") with a European Medicines Agency ("EMA") rapporteur with respect to the OST-HER2 osteosarcoma program. This milestone is a critical step in the EMA's Centralized Procedure, providing a single Marketing Authorization valid across all European Member States. The Company also announced that it intends to pursue a Conditional Marketing Authorization ("CMA") in the United Kingdom via the Medicines and Health products Regulatory Agency's ("MHRA") Innovative Licensing and Access Pathway ("ILAP") in the event of a successful previously disclosed July 31st, 2025 UK SAM Meeting. Biolacuna has been appointed by OS Therapies as advisors for all global regulatory affairs efforts.
In addition, the Company reported that all patients enrolled in the have completed treatment, with updated clinical data expected to be reported in the second half of 2025.
"We are making significant progress towards our primary objective of obtaining regulatory approval for OST-HER2 in recurrent, pulmonary metastatic osteosarcoma prior to the sunsetting of the rare pediatric disease priority review voucher ("PRV") program," said Paul Romness, MPH, Chairman & CEO of OS Therapies. "If successful, we expect to receive significant non-dilutive funding from the sale of the PRV which we would then be able to deploy in commercializing OST-HER2 osteosarcoma and other HER2 expressing cancers, as well as advance the other clinical candidates in our pipeline, including OST-504 in prostate cancer. We strongly believe in the promise of the listeria immunotherapy platform to help prevent and treat cancer, and intend to judiciously deploy our capital to focus on the OST-HER2 approval while advancing our other clinical programs without deploying significant capital or running other clinical studies while we wait for the OST-HER2 approval and related PRV sale."
OST-HER2, an immunotherapy for osteosarcoma that uses a HER2-bioengineered form of the bacterium Listeria monocytogenes to trigger a strong immune response against HER2-expressing cancer cells, is featured in the movie Shelter Me: The Cancer Pioneers. The movie offers a look into canine comparative oncology, a field that compares treatment of cancers in dogs to those in people and covers developing treatments for rare forms of cancer. The movie is available via streaming on .
The most recent data updated regarding the OST-HER2 canine osteosarcoma program is available at this . The Company has formed the subsidiary OS Animal Health to advance the canine osteosarcoma program.
OST-504 is a prostate cancer-specific listeria-based immunotherapy targeting multiple common prostate cancer-specific antigens such as PSA, certain cancer-testis antigens and certain standard-of-care treatment resistance mutations.
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 US Food & Drug Administration and Fast-Track and Orphan Drug designations from the US FDA and European Medicines Agency. The Company 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 US 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 .
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 news 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 US FDA and other risks and uncertainties described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's most recent Annual Report on Form 10-K 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:
Jack Doll
410.297.7793
[email protected]
To view the source version of this press release, please visit
FAQ
When is OS Therapies' (OSTX) End of Phase 2 Meeting with FDA for OST-HER2?
What are the regulatory pathways OS Therapies is pursuing for OST-HER2 in different regions?
When will OS Therapies (OSTX) release Phase 1 data for OST-504 in prostate cancer?
What is OST-HER2 and how does it work?
How does OS Therapies plan to fund OST-HER2 commercialization?
