Dec. 5 at 4:51 PM
OS Therapies (NYSE American:
$OSTX ) announced that the U.S. Food & Drug Administration has granted a waiver of the application fee for BLA 125867 for OST-HER2. The European Medicines Agency’s Committee for Medicinal Products for Human Use has also granted Union Marketing Authorization eligibility 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.
These regulatory developments remove the BLA application fee burden, advance OST-HER2 into the European Union-wide Centralised Procedure, and support the company’s planned submissions across multiple geographies. Specifically, the press release noted:
• The FDA has waived the application fee for BLA 125867 for OST-HER2.
• EMA CHMP has requested an accelerated MAA submission for the Metastatic Osteosarcoma Program by February 28, 2026.
• OS Therapies has completed pre-meeting submissions for its UK MHRA pre-MAA meeting on December 8 and its FDA Type C Meeting on December 11. These discussions will address commercial CMC, non-clinical considerations, and the proposed global confirmatory study design intended to support conditional approval pathways.
See the announcement at: https://ir.ostherapies.com/news-events/press-releases/detail/91/os-therapies-announces-fda-pdufa-waiver-ema-grants-union
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.
