OS THERAPIES INCORPORATED Stock Price, News & Analysis

OS Therapies (NYSE: OSTX) reported a positive regulatory update after an October 6, 2025 meeting with the EMA rapporteur (MEB). The rapporteur indicated that overall survival (OS) with statistically significant, final two-year results may serve as a primary endpoint for a conditional marketing authorization (CMA). The rapporteur viewed safety, non-clinical, and CMC data as sufficient to support a CMA submission. The meeting advances formal EMA Scientific Advice expected in December 2025 and established a pathway for a confirmatory randomized program and potential label expansion. The UK MHRA granted an expedited Market Access Scientific Advice meeting to support the MAA process.

OS Therapies (NYSE: OSTX) announced participation in multiple October–November 2025 conferences and events to present corporate updates, engage in partnering and one-on-one meetings, and meet investors and stakeholders.

Key activities include: Cell and Gene Meeting on the Mesa (Oct 6-8, Phoenix) with CEO Paul Romness; Roth Healthcare (Oct 9, New York) with CBO Gerald Commissiong; an FDA/OSI osteosarcoma workshop (Oct 10, Washington, DC) with management and regulatory team; BIOFuture spotlight (Oct 13-15, New York); Daytime Emmy Awards attendance (Oct 17, Pasadena) for the documentary featuring OST-HER2 clinical trial participants; Maxim Growth Summit presentation (Oct 22, New York); and BIO-Europe partnering (Nov 3-5, Vienna).

OS Therapies (NYSE American: OSTX) has announced updates to its regulatory submission strategy for OST-HER2, targeting osteosarcoma treatment. The company plans to prioritize its UK MHRA conditional Marketing Authorisation Application (MAA) submission in December 2025, followed by the US FDA Biologics Licensing Application (BLA) in January 2026.

Following positive feedback from the UK MHRA's August 2025 Scientific Advice Meeting, the agency has accepted the use of historical control arm data. For the FDA submission, the company will propose using immune activation biomarker coupled with overall survival data as surrogate efficacy endpoints for Accelerated Approval, following positive End of Phase 2 Meeting outcomes.

The submissions are based on data from the completed Phase 2b clinical trial, currently in long-term follow-up phase, for OST-HER2 in preventing recurrent, fully resected, pulmonary metastatic osteosarcoma.

OS Therapies (NYSE American: OSTX), a clinical-stage biotech company, will participate in BioFuture 2025's Cancer Spotlight Panel on October 13, 2025 in New York City. The company plans to submit a Biologics Licensing Application (BLA) for OST-HER2 to the FDA in Q4 2025.

If approved before September 30, 2026, OS Therapies could receive a priority review voucher (PRV), which it plans to sell to fund further development of OST-HER2 for osteosarcoma and other HER2-positive cancers. The company has leveraged over $300 million in invested capital into its Listeria Platform technology, aiming to launch the first new osteosarcoma treatment in over 40 years.

The company's pipeline includes OST-504 for prostate cancer and OST-503 for non-small cell lung cancer and other solid tumors.

OS Therapies (NYSE American: OSTX) announced the completion of the last patient visit in its OST-504 Phase 1b clinical trial for biochemically recurrent prostate cancer. The trial enrolled 7 patients, with data expected in Q4 2025.

Additionally, the company will release updated 2-year overall survival data from its Phase 2b trial of OST-HER2 in osteosarcoma on October 10, 2025. OS Therapies is preparing to initiate a rolling submission for a Biologics Licensing Application (BLA) for OST-HER2 in the coming weeks.

The company sees significant potential for OST-504 in prostate cancer treatment, noting that 1 in 8 men are diagnosed with prostate cancer, making it the second leading cause of male cancer deaths after lung cancer.

OS Therapies (NYSE American: OSTX) has achieved significant milestones in its development of OST-HER2 for treating recurrent, fully resected, pulmonary metastatic osteosarcoma. The FDA has confirmed OST-HER2's qualification as a Regenerative Medicine Advanced Therapy (RMAT) and issued a BLA number for Accelerated Approval submission.

The company's Phase 2b trial demonstrated statistically significant improvements with 35% vs. 20% in 12-month Event Free Survival and 66.6% vs. 40% in interim 2-year Overall Survival. OSTX has secured a U.S. commercial partnership with Eversana and raised $7.9M through warrant exchange financings, extending its cash runway into 2027. The company is preparing for potential U.S. launch in H1 2026.

OS Therapies (NYSE American: OSTX), a clinical-stage cancer immunotherapy and antibody drug conjugate biotech company, has announced its participation in three major investor conferences in September 2025. The company will attend the Cantor Global Healthcare Conference (Sept 3-5), the H.C. Wainwright Global Investment Conference (Sept 8-10), and the Lake Street Capital Markets BIG9 Conference (Sept 11).

Management will be available for meetings with institutional investors and brokers at all events, with a pre-recorded presentation available for H.C. Wainwright conference participants.

OS Therapies (NYSE:OSTX) has provided a significant update following its End of Phase 2 Meeting with the FDA regarding OST-HER2 for recurrent, fully resected, pulmonary metastatic osteosarcoma. The company plans to begin a rolling Biologics Licensing Application (BLA) submission in September 2025.

Key achievements include positive clinical data with statistically significant 12-month Event Free Survival (p=0.0197) and interim 2-year overall survival data (p=0.0046) from its 40-patient Phase 2b trial. The FDA identified no significant safety concerns and agreed on non-clinical and CMC-related matters. The company is awaiting FDA guidance on efficacy endpoints and statistical analysis plans that would support either Accelerated Approval or full marketing authorization.

A crucial FDA/OSI public meeting is scheduled for October 10, 2025, focusing on advancing osteosarcoma drug development pathways. The company is also developing the OST-400 database to potentially support a synthetic control arm for the trial.

OS Therapies (NYSE American: OSTX) has successfully completed a warrant exchange offer with holders of outstanding warrants originally issued in December 2024. The transaction raised $3.7 million in gross proceeds through the exercise of warrants with a $1.12 per share exercise price.

The new warrants issued have an exercise price of $3.00 per share with a forced exercise provision triggered when the stock trades above $9.00. The proceeds will primarily fund commercial preparations for OST-HER2, targeting prevention of recurrent pulmonary metastatic osteosarcoma. The company now has funding extended into 2027, with potential for additional $20 million if the forced exercise provision is triggered.