OS Therapies Granted Meetings with U.S. FDA, U.K. MHRA, EMA and Australian Therapeutic Goods Administration to Review Global Confirmatory Phase 3 Trial for OST-HER2 in Metastatic Osteosarc...
OS Therapies Incorporated (OSTX)
Company Research
Source: Yahoo! Finance
Commencing the Phase 3 confirmatory study is a pre-requisite to being granted a Biologics License Application (BLA) under the Accelerated Approval Program in the U.S. and Conditional Marketing Authorisations (CMAs) in the U.K. & Europe New York, New York--(Newsfile Corp. - March 27, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced that it has been granted meetings with the U.S. Food & Drug Administration (FDA), the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), the European Medicines Agency (EMA) and the Australian Therapeutic Goods Administration (TGA) to review the design of the proposed global confirmatory Phase 3 trial for OST-HER2 in metastatic osteosarcoma. Meetings with each of these four regulatory agencies are expected to occur in the second quarter of 2026, with trial enrollment expected to begin in the third quarter of 2026 initially in Australi
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News
- OS Therapies Initiates US FDA BLA Filing for OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma [Yahoo! Finance]Yahoo! Finance
- OS Therapies Enters into Warrant Inducement Agreements [Yahoo! Finance]Yahoo! Finance
- OS Therapies provides first half 2026 corporate outlook [Seeking Alpha]Seeking Alpha
- SHAREHOLDER ALERT: Purcell & Lefkowitz LLP Announces Shareholder Investigation of OS Therapies Incorporated (NYSE American: OSTX)PR Newswire
- OS Therapies Provides First Half 2026 Corporate Outlook [Yahoo! Finance]Yahoo! Finance
OSTX
Earnings
- 3/31/26 - Miss
OSTX
Sec Filings
- 4/2/26 - Form 8-K
- 4/2/26 - Form 424B5
- 3/31/26 - Form 8-K
- OSTX's page on the SEC website