$OSTX

OS Therapies Inc

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Med

OS Therapies Gains EMA Rolling Review for OST-HER2

OS Therapies has announced that the European Medicines Agency (EMA) has initiated a rolling review for its OST-HER2 conditional marketing authorization application for osteosarcoma. The company has also achieved alignment with European and Australian regulators on key efficacy endpoints and expects a potential EMA decision in late 2026. Despite a "Neutral" rating from TipRanks' AI Analyst due to weak financial performance, OS Therapies is advancing its oncology pipeline programs.

OS Therapies Announces Filing Form S-1 of OS Animal Health Subsidiary

OS Therapies Inc. (NYSE American: OSTX) announced that its wholly-owned subsidiary, OS Animal Health Corp (OSAH), has filed a Form S-1 with the SEC for an Initial Public Offering, targeting a listing on NYSE American or Nasdaq Capital Markets in the first half of 2026. OS Therapies shareholders are expected to receive one share of OSAH for every ten shares of OS Therapies owned. OSAH will focus on re-establishing and commercializing OST-HER2 for canine osteosarcoma and other HER2-positive cancers, a treatment that has shown improved patient outcomes in canine studies.

OS Therapies Enters into Warrant Inducement Agreements

OS Therapies announced it raised $7.53 million in gross proceeds from pre-existing investors through warrant exercise inducement and exchange offers. This capital provides runway into 2027 and will fund regulatory approval submissions for OST-HER2, commercial preparation activities, and preparations for an OS Animal Health spinoff. The company aims for regulatory approval of OST-HER2 in the US, UK, and EU in 2026 and plans to file a Biologics Licensing Application with the U.S. FDA by January 2026.