OS Therapies Incorporated

OS Animal Health Receives USDA Feedback on Regulatory Pathway for OST-HER2 in Canine Osteosarcoma

OS Therapies' subsidiary OS Animal Health received USDA feedback on its conditional licensure pathway for OST-HER2 in canine osteosarcoma, covering efficacy, safety, non-clinical, and CMC requirements. OSAH plans to seek conditional licensure on existing clinical data and hopes for a 2027 U.S. commercial launch, though full licensure will require additional studies. The company is also evaluating strategic and capital alternatives for OSAH, including a Q4 2026 crowdfunding intended to help the subsidiary meet U.S. exchange listing standards.

•19d ago

OS Therapies Achieves Statistically Significant Final Three-Year Overall Survival Benefit for Herlystic(TM)-Treated Patients in Phase 2b Pulmonary Metastatic Osteosarcoma Trial

OS Therapies reported final three-year overall survival data from its Phase 2b trial of OST-HER2 (Herlystic) in fully resected pulmonary metastatic osteosarcoma: 72.7% survival versus 45.8% for a combined published historical control (p=0.0006). The company is preparing regulatory submissions for early market access in the U.S., U.K., Europe and Australia, with BLA and Conditional Marketing Authorization Applications targeted for Q4 2026; a U.K. CTA for the confirmatory Phase 3 trial will be submitted first. OST-HER2 holds FDA Orphan Drug, Fast Track and Rare Pediatric Disease designations, and a BLA approval would make OS Therapies eligible for a Priority Review Voucher -- the most recent PRV sold for $220 million in August 2026, though the company cautions future sales may not realize comparable value.

•20d ago

OS Therapies Completes FDA Type C Statistical Methods Meeting and Provides Update on Global Regulatory Coordination for OST-HER2 Under Project Orbis

OS Therapies completed an FDA Type C Statistical Methods Meeting with alignment on the amended adaptive design of its pending confirmatory Phase 3 study of OST-HER2 in fully resected, pulmonary metastatic osteosarcoma. The UK MHRA has accepted the lead regulatory role under Project Orbis for early market access and confirmed it will accept the company's Conditional Marketing Authorisation Application, expected in the coming weeks, with the UK Phase 3 portion set to begin mid Q4 2026 following Phase 2b drug product requalification. MHRA also granted access to the UK Clinical Practice Research Datalink national patient registry to strengthen comparator data while Phase 3 is ongoing. On the US track, the BLA initiated in Q1 2026 remains on track for Q4 2026 completion under the Accelerated Approval Program, with FDA decisions pending on RMAT, Rolling Review and CNPV requests. A comparable Priority Review Voucher sold for $220 million in August 2026, though the company cautions there is no assurance of realizing comparable value from any future PRV sale. Separately, a patient previously reported as lost to follow-up in the Phase 2b study has been confirmed to be alive.

•1mo ago

OS Therapies Achieves Incremental Alignment With FDA and Accepts Project Orbis Invitation From MHRA on OST-HER2 Metastatic Osteosarcoma Program

OS Therapies said the FDA aligned with the U.K.'s MHRA and Europe's EMA on the adaptive design for the pending Phase 3 trial of OST-HER2 in fully resected, pulmonary metastatic osteosarcoma, with the trial expected to commence in the fourth quarter of 2026. The company also accepted an MHRA request to become its representative to Project Orbis, the FDA-launched reciprocal oncology review initiative, following a successful Statistical Methods Scientific Advice Meeting; FDA's CBER recently re-opened the program to foreign-sponsored U.S. companies. Management plans to complete the BLA filing initiated in January 2026 by submitting the clinical section with 3-year overall survival data, hold an invited Type B Pre-BLA meeting in Q4 2026, and seek Accelerated Approval in the U.S. plus Conditional Marketing Authorization Applications in Europe, the U.K. and Australia. If the BLA is granted, OST-HER2's Rare Pediatric Disease Designation makes the company eligible for a Priority Review Voucher it intends to sell; the most recent PRV sold for $220 million in August 2026, though management cautions there is no assurance of comparable value from any future sale.

•1mo ago

OS Therapies Announces Full Alignment with UK MHRA and EU EMA for Conditional Marketing Authorisation Application Filing

OS Therapies achieved full alignment with the UK MHRA on its pending Conditional Marketing Authorisation Application for OST-HER2 in fully resected, pulmonary metastatic osteosarcoma, with MHRA accepting the use of comparable historical control data in the orphan indication. The company also secured full alignment on the design of its confirmatory Phase 3 trial, which must commence before a CMAA can be granted; OS Therapies expects to complete the CMAA submission in coming weeks, start the Phase 3 in Q4 2026, and noted EMA advice aligned via the pan-European Centralised Procedure. In the US, the FDA is considering the BLA submitted in January 2026 under the Accelerated Approval Program, with Rolling Review to be requested after a mid-September Type C meeting; BLA approval would make the company eligible for a Priority Review Voucher -- the most recent PRV sold for $220 million in August 2026, though management cautions no comparable value is assured.

•1mo ago

OS Therapies Achieves Statistically Significant Benefit for OST-HER2-Treated Patients in Interim 3-Year Overall Survival Analysis of Phase 2b Pulmonary Metastatic Osteosarcoma Trial

OS Therapies reported interim 3-year overall survival of 71.2% for OST-HER2-treated patients versus 45.8% in a combined published historical control (p = 0.002) in its Phase 2b trial of fully resected pulmonary metastatic osteosarcoma. The company expects to complete the final data analysis within a month and intends to file for a BLA under the FDA Accelerated Approval Program plus CMAAs with the MHRA, EMA and TGA in the months ahead, targeting commercial availability in 2027; a mid-September FDA Type C meeting and a Rolling Review request are next steps. Concurrently, OS Therapies received $3.15 million in UK VAT refunds into subsidiary OS Therapies UK, Ltd. and confirmed eligibility for at least $7.2 million more in VAT and R&D tax credits, funds earmarked to start the confirmatory Phase 3 trial in the U.K., which must be initiated before an FDA BLA decision.

•1mo ago

OS Therapies Provides OST-HER2 Metastatic Osteosarcoma Program Update and Announces Upcoming Conference Attendance

OS Therapies laid out a dense regulatory calendar for OST-HER2 in metastatic osteosarcoma: interim 3-year overall survival data plus an FDA Type C Statistical Methods meeting and an MHRA Statistical Methods Scientific Advice meeting are all expected in September 2026. RMAT and Rolling Review decisions are expected to follow the FDA meeting, with final 3-year overall survival data, a Pre-BLA meeting, a U.S. BLA submission under the Accelerated Approval Program, and CMAA submissions in Europe, the U.K., and Australia slated for Q4 2026. CEO Paul Romness called the coming months a pivotal moment, citing over 20 years and $300 million invested in the Listeria-based immunotherapy platform, with a first commercial product expected to reach patients in 2027. The company cited its August 2026 Priority Review Voucher sale for $220 million as a benchmark while cautioning that future PRV sales may not realize comparable value; subsidiary OS Animal Health is also seeking a USDA meeting to reinstate conditional approval of OST-HER2 in canine osteosarcoma.

•1mo ago

OS Therapies Reports Second Quarter 2026 Financials and Provides Business and Regulatory Updates

OS Therapies reported a Q2 net loss of $8.6 million, or $0.20 per share, compared to a loss of $4.8 million in the prior period. To fund operations into 2027, the company secured a $10 million debt facility backed by U.K. VAT refunds and R&D tax credits, with $5 million already funded. Operationally, the company announced statistically significant 2.5-year overall survival data for OST-HER2 (75% vs 47%, p=0.003) and scheduled a Type C Statistical Methods Meeting with the FDA for mid-September. Management remains on track to submit a Biologics License Application (BLA) under the Accelerated Approval Program in the second half of 2026. Regulatory progress included the MHRA waiving the Pediatric Investigation Plan requirement and the EMA granting Advanced Therapy Medicinal Product designation. The company also expects to receive over $4 million in R&D tax credits by the end of Q3 and appointed Dr. Craig Eagle to the Board of Directors.

•2mo ago

OS Therapies Granted U.S. FDA Type C Statistical Methods Meeting to Review 2.5-Year Overall Survival Data for OST-HER2 in the Prevention or Delay of Recurrence in Fully Resected, Pulmonary Metastatic Osteosarcoma

OS Therapies announced that the FDA has granted a Type C Statistical Methods meeting to review the 2.5-year overall survival data from the Phase 2b trial of OST-HER2, with the meeting expected in mid-September 2026. Parallel to this, the U.K. MHRA has granted a Scientific Advice Meeting to review statistical methods for the company's pending Conditional Marketing Authorisation application. Management noted that overall survival at the 2.5-year timepoint remained unchanged from the 2-year mark and expects interim 3-year data in early September to support RMAT designation and a potential BLA submission by year-end 2026.

•2mo ago

OSTX: 8-K · material agreement

OS Therapies Incorporated has terminated its At Market Issuance Sales Agreement with B. Riley Securities and JonesTrading Institutional Services, effective July 28, 2026. The agreement, originally established in August 2025, allowed for the sale of up to $18 million in common stock, but only $530,162 in gross proceeds was raised prior to termination. By terminating the agreement, the company has eliminated approximately $17.47 million in potential future dilution that was authorized under the sales agreement. The termination was executed without any fees or penalties required from either party.

SEC 8-K•2mo ago

OS Therapies Accepts New FDA Meeting Request to Review Biomarker Data as Part of BEST Program

OS Therapies accepted a meeting request from the FDA's Center for Drug Evaluation and Research to review biomarker data for OST-HER2, scheduled alongside a separate meeting with the Center for Biologics Evaluation and Research to discuss 2.5-year overall survival data. Alignment between these FDA centers facilitates the preparation for a Biologics License Application under the Accelerated Approval Program, which the company expects to submit in early Fall 2026. The company plans to announce interim 3-year overall survival data in summer 2026 and targets a BLA submission by year-end 2026, supported by OST-HER2's Orphan Drug, Fast Track, and Rare Pediatric Disease designations.

•3mo ago

OS Therapies Third Quarter 2026 Corporate Outlook

OS Therapies achieved full regulatory alignment with EMA, MHRA, and TGA for Conditional Marketing Authorisation, targeting early market access using 3-year overall survival data and biomarkers. The company plans to initiate a confirmatory Phase 3 study in Australia by the end of Q3 2026 and expects a pivotal FDA meeting to align on the Biologics License Application for Accelerated Approval. Financially, the company secured a $10 million line of credit backed by tax credits, extending its cash runway into 2027 while significantly reducing quarterly expenses.

•3mo ago

OS Therapies Appoints Dr. Craig Eagle to Board of Directors

OS Therapies appointed Dr. Craig Eagle, former Chief Medical Officer of Guardant Health, to its Board of Directors and secured a $10 million line of credit backed by UK tax credits. The company confirmed consensus on key regulatory items for OST-HER2, targeting potential early market authorization in late 2026 and a Phase 3 initiation in late Q3. Management reiterated that cash resources will extend into 2027, supported by the initial $1.6 million draw and expected total tax credits of $10.2 million by year-end.

•3mo ago

OS Animal Health Announces Peer-Reviewed Publication of Clinical Trial Data for OST-HER2 Plus Palliative Radiation as Frontline Treatment in Canine Osteosarcoma

OS Therapies' subsidiary OS Animal Health published peer-reviewed Phase 2 data showing OST-HER2 combined with palliative radiation significantly improved survival in dogs with osteosarcoma. Treated dogs achieved a 20% survival rate at two years compared to 1% in the control group, with median overall survival extending to 159 days from 124 days. Management intends to meet with the USDA in Q3 2026 to align on a regulatory path for conditional approval, while reiterating plans to distribute OS Animal Health shares to OS Therapies shareholders. The subsidiary is also initiating a Regulation Crowdfunding campaign in Q3 to expand its shareholder base to meet U.S. national exchange listing standards. With over 15,000 dogs diagnosed annually in the U.S., the study indicates OST-HER2 could become a new standard of care that helps avoid amputation. The authors noted that the clinical success in dogs supports the platform's potential for translation into human oncology.

•4mo ago

OS Therapies Achieves Global Regulatory Alignment on Design of Phase 3 Trial of OST-HER2 in Fully Resected, Pulmonary Metastatic Osteosarcoma

OS Therapies secured full regulatory alignment with the FDA, EMA, MHRA, and TGA on the design of its Phase 3 trial for OST-HER2 in pulmonary metastatic osteosarcoma. The confirmatory trial is expected to commence in late Q3 2026 in Australia, utilizing existing Phase 2b drug product to minimize costs and accelerate timelines. This alignment positions the company for potential regulatory decisions in Q4 2026 and patient access in 2027, with a BLA filing already underway in the U.S. and rolling review initiated by the EMA.

•4mo ago

OS Therapies Achieves Statistically Significant 2.5-Year Overall Survival in Phase 2b Trial of OST-HER2 in Fully Resected Pulmonary Metastatic Osteosarcoma

OS Therapies reported statistically significant 2.5-year overall survival data for its lead asset OST-HER2 in metastatic osteosarcoma, showing 75% survival versus 47% in pooled historical controls (p=0.003). No new patient deaths were reported in the treatment group between the 2-year and 2.5-year timepoints, suggesting durability of the clinical benefit. The company is updating regulatory dossiers for early market access in the U.S., U.K., Europe, and Australia, with a confirmatory Phase 3 trial expected to initiate in late Q3 2026.

•4mo ago

OS Therapies Announces the Publication of Four Articles on OST-HER2 and Osteosarcoma in Drug Discovery World

OS Therapies will present 2.5-year overall survival data from its Phase 2b clinical trial of OST-HER2 at the ASCO Annual Meeting in late May 2026. The company reiterated its plan to submit a Biologics License Application (BLA) for OST-HER2 in osteosarcoma in the second half of 2026, leveraging its Orphan Drug, Fast Track, and Rare Pediatric Disease designations. Approval under the Accelerated Approval Program would make the company eligible for a Priority Review Voucher, which it intends to sell, while also pursuing Conditional Marketing Authorizations in Europe, the UK, and Australia.

•4mo ago

OS Therapies Reports First Quarter 2026 Financials and Provides Business Update

OS Therapies reported a Q1 2026 net operating loss of $10.4 million, driven by R&D and regulatory expenses, but confirmed a cash runway into 2027 following $11.2 million in recent financings and expected non-dilutive tax credits. Regulatory momentum is accelerating: the EMA has initiated rolling review of the conditional Marketing Authorization Application (MAA) for OST-HER2, and the company has aligned with the FDA, EMA, and ATGA on the design of the confirmatory Phase 3 trial required for approval. The company is targeting a BLA submission in H2 2026 under the Accelerated Approval Program, with potential eligibility for a Priority Review Voucher (PRV) that could be sold for significant value, referencing a recent $195 million PRV sale.

•5mo ago

OS Therapies Appoints Industry Leader Dr. Craig Eagle as Chief Medical Advisor

OS Therapies has appointed Dr. Craig Eagle as Chief Medical Advisor, strengthening the company's medical, regulatory, and commercial leadership. The appointment is in preparation for potential early market access decisions from regulators in the U.S., U.K., Europe, and Australia for OST-HER2, expected by year-end 2026. Dr. Eagle brings extensive experience from his roles at Guardant Health, Genentech, and Pfizer, and is working closely with the regulatory team on commercialization and reimbursement preparations.

•5mo ago

OS Therapies Announces EMA Initiates Rolling Review of Conditional Marketing Authorization Application for OST-HER2 in the Prevention or Delay of Recurrence in Fully Resected Pulmonary Metastatic Osteosarcoma

OS Therapies announced that the EMA has initiated a rolling review of the Conditional Marketing Authorization request for OST-HER2 in osteosarcoma, while the UK MHRA granted Advanced Therapy Medicinal Product designation. Regulatory alignment has been achieved on using 3-year overall survival as the primary efficacy endpoint for confirmatory Phase 3 trials, which are planned to initiate in Q3 2026. Management forecasts peak European sales exceeding $300 million, with over $50 million in sales expected in 2027, pending regulatory approvals in the U.S., Europe, and Australia.

•5mo ago