Feb. 2 at 6:52 PM
OS Therapies Inc. (NYSE American:
$OSTX ) announced that it has formally initiated a Biologics License Application submission to the US FDA for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma.
OS Therapies is a B2i Digital Featured Company. View their comprehensive profile at https://b2idigital.com/os-therapies-1.
A request for Rolling Review was submitted on January 30, 2026, along with the Non-Clinical and CMC (chemistry, manufacturing, and controls) modules of the BLA. Following a December 2025 Type C meeting, FDA invited OS Therapies to request a Type D meeting, now expected in March 2026, to review Comparative Oncology biomarker data from both the Phase 2b human clinical trial and a similar trial in spontaneous osteosarcoma in canines. The final clinical BLA module is expected to be submitted by end of March 2026 after that meeting.
In a concurrent filing, OS Therapies updated its Regenerative Medicine Advanced Therapy (RMAT) designation request to FDA with recent biomarker data. RMAT designation, if granted, would shorten the BLA review timeline and expedite patient access.
Approval is anticipated by September 30, 2026, which would make OS Therapies eligible to receive a Priority Review Voucher under the Rare Pediatric Disease Designation program. The most recent PRV sale, in January 2026, was valued at
$200 million.
Paul Romness, MPH, Chairman & CEO noted: “We are delighted in the FDA’s interest in reviewing OST-HER2 Comparative Oncology Data. There is strong demand for compassionate use of OST-HER2 from the patient community, underscoring the urgent need for new therapies in Human Metastatic Osteosarcoma. We remain committed to bringing OST-HER2 to market as expeditiously as possible and are grateful for FDA’s engagement as we finalize the biomarker data package that will be submitted as part of Type D meeting preparations to support our request for a BLA under the Accelerated Approval Program.”
See the announcement at: https://ir.ostherapies.com/news-events/press-releases/detail/98/os-therapies-initiates-us-fda-bla-filing-for-ost-her2-in
Led by CEO Paul Romness and an executive team that includes Christopher Acevedo (CFO), Robert Petit (Chief Medical and Scientific Officer), Jack Doll (Chief of Staff), and Gerald Commissiong (Chief Business Officer), OS Therapies is focused on advancing immunotherapies for osteosarcoma and other solid tumors.
Learn more at https://www.ostherapies.com and visit B2i Digital for updates. For investor-related questions, please see OS Therapies’ Investor Relations page or email
[email protected].
Disclosure: David Shapiro, CEO of B2i Digital, personally purchased in the open market and currently owns shares of unrestricted OSTX stock. B2i Digital, Inc. is not a broker-dealer or investment adviser. This post is for informational purposes only and is not an offer to sell or a solicitation to buy any security. Investors should conduct their own research and consult with a qualified financial adviser before making any investment decisions. See the complete disclosure in the Risks and Disclosures section of https://b2idigital.com/disclaimer.
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