Welcome to our dedicated page for OS THERAPIES INCORPORATED news (Ticker: OSTX), a resource for investors and traders seeking the latest updates and insights on OS THERAPIES INCORPORATED stock.
OS Therapies Incorporated (NYSE American: OSTX) is a clinical-stage oncology and biopharmaceutical company focused on osteosarcoma and other solid tumors. News about OS Therapies centers on its listeria-based cancer immunotherapy programs, regulatory interactions, capital markets activity, and the planned spin-off of its veterinary oncology subsidiary, OS Animal Health.
A major theme in OSTX news flow is the progress of OST-HER2 (daznelene lisbac), the company’s lead listeria-based immunotherapy targeting the HER2 protein. Press releases highlight positive Phase 2b data in recurrent, fully resected, pulmonary metastatic osteosarcoma, including statistically significant benefit in 12-month event free survival and reported 2-year overall survival outcomes. The company also reports immune biomarker analyses from its human metastatic osteosarcoma trial and related canine osteosarcoma studies, emphasizing the role of Comparative Oncology and interferon gamma pathway biomarkers as potential surrogate markers of clinical efficacy.
Investors following OSTX news will see regular updates on regulatory milestones, such as FDA Type C and other meetings, waiver of the BLA application fee for OST-HER2, EMA Union Marketing Authorisation eligibility, and preparations for Biologics License Application and Marketing Authorisation Application submissions in the United States, United Kingdom, and European Union. Company outlook releases describe anticipated timelines for regulatory submissions, potential conditional approvals, and planned interactions with FDA, MHRA, and EMA.
OS Therapies also issues news on capital raising and corporate transactions, including warrant exercise inducement agreements, gross proceeds from warrant exercises, and the intended use of proceeds to fund OST-HER2 regulatory and commercial preparation activities and the proposed OS Animal Health spin-off. Additional news items cover the veterinary oncology strategy for canine osteosarcoma, recognition of OST-HER2 in documentaries and awards, and the development of the company’s tunable ADC (tADC) platform.
For readers tracking OSTX, this news feed provides a consolidated view of clinical trial updates, biomarker findings, regulatory developments, financing events, and the evolution of both the human and animal health franchises. Regular visits can help investors and observers monitor how OS Therapies advances OST-HER2 and its broader oncology pipeline through key clinical and regulatory inflection points.
OS Therapies (NYSE: OSTX) announced that the EMA has initiated a rolling review of OST-HER2 for prevention of recurrence in fully resected pulmonary metastatic osteosarcoma and selected the company for EMA's Raw Data Pilot.
EMA, Australian TGA and UK MHRA/ATGA aligned on 3-year overall survival as the approvable efficacy endpoint and on seroconversion as a surrogate; Phase 3 initiation is planned in Australia in Q3 2026. OST-HER2 holds multiple orphan/accelerated designations and the company forecasts >$300M peak European sales and >$50M in 2027.
OS Therapies (NYSE American: OSTX) will host a conference call on April 30, 2026 at 8:30 AM ET to review data behind a Patent Cooperation Treaty application for an OST-HER2 pharmacodynamic biomarker (the OST-HER2 Immune Signature) proposed as a surrogate efficacy endpoint.
Company plans include filing a BLA under Accelerated Approval in H2 2026 in the U.S. for osteosarcoma, seeking CMAs in Europe, the U.K. and Australia, and pursuing regulatory meetings with FDA, EMA, MHRA and TGA. The company noted recent designations including ODD, FTD and RPDD, and referenced a publicly reported PRV sale value of $205 million in February 2026.
OS Therapies (NYSE American: OSTX) filed a patent application covering a treatment-emergent immune signature tied to Listeria-based OST-HER2 therapy in its Phase 2b trial for preventing or delaying recurrent, fully‑resected pulmonary metastatic osteosarcoma.
The company says the biomarker met FDA BEST pharmacodynamic/response criteria as a surrogate for 1‑year event‑free survival and 2‑year overall survival, will host an April 2026 call, will file to EMA on April 30, 2026, and aims for a BLA under Accelerated Approval in H2‑2026.
OS Therapies (NYSE: OSTX) appointed Dr. Robert "Bob" S. Langer as a strategic advisor to support listeria oncology pipeline prioritization, combination strategies and tADC candidate selection.
The company is pursuing a BLA under Accelerated Approval for OST-HER2 in H2 2026 and holds multiple FDA and EMA designations, potentially qualifying for a Priority Review Voucher.
OS Therapies (NYSE:OSTX) appointed Craig Eagle, MD, to its newly formed strategic advisory board on April 8, 2026. Dr. Eagle will advise on osteosarcoma regulatory execution and help prioritize the company’s oncology pipeline, leveraging his clinical, biomarker and commercial experience.
The board aims to refine regulatory strategy using Phase 2b biomarker insights and to prioritize clinical-stage assets across multiple cancer indications.
OS Therapies (NYSE: OSTX) completed a $5.25 million registered direct offering on April 2, 2026, issuing common stock (or pre-funded warrants) and accompanying warrants at a $1.40 per-share exercise/purchase price.
The company expects approximately $4 million of additional non-dilutive VAT refunds and R&D tax credits via its U.K. subsidiary in 2Q-26 and 2H-26, and says proceeds plus those funds are expected to provide cash runway into 2027 while it pursues H2-2026 regulatory interactions and potential approvals for OST-HER2.
OS Therapies (NYSE: OSTX) submitted Phase 2b clinical and biomarker data to the U.S. FDA for a Pre-BLA meeting and reported full-year 2025 results. The company reported a $28.75M net operating loss for 2025 and expects to seek Accelerated Approval in the U.S. and CMAs in Europe and the U.K. in 2H/26. Key operational items include acquisition of listeria platform assets, positive Phase 2b EFS and OS results, patent extensions to 2040, and plans to initiate a confirmatory Phase 3 trial in Australia in 3Q/26.
OS Therapies (NYSE: OSTX) secured meetings with the U.S. FDA, U.K. MHRA, EMA and Australian TGA to review a global confirmatory Phase 3 design for OST-HER2 in metastatic osteosarcoma.
Meetings are expected in Q2 2026, with Phase 3 enrollment planned to begin in Q3 2026 (initially Australia). The company is seeking a BLA and CMAs in H2 2026 and completed requested FDA data delivery by end-Q1 2026. OST-HER2 holds multiple regulatory designations and the company cited a recent PRV transaction of $205M.
OS Therapies (NYSE American: OSTX) announced that the EMA Committee for Advanced Therapies granted OST-HER2 ATMP designation for treatment of pulmonary recurrence in resected osteosarcoma at the March 18–20, 2026 meeting.
ATMP status opens the Conditional Marketing Authorisation pathway, reduced SME fees, tailored CAT assessment and improved reimbursement routes. The company is finalizing a CMA submission and plans BLA filing under Accelerated Approval in H2 2026, with potential revenues projected to begin in 2027.
OS Therapies (NYSE: OSTX) said the FDA elevated its Type D biomarker meeting for OST-HER2 to a Type B pre-BLA meeting, shifting discussions toward Accelerated Approval. The company is targeting completion of its clinical data submission by end of Q1 2026 and seeks Accelerated Approval in H2 2026.
OST-HER2 holds FDA Orphan Drug, Fast Track, and Rare Pediatric Disease designations; a Priority Review Voucher sale comparable transaction was reported at $205 million in February 2026.