OS Therapies Initiates US FDA BLA Filing for OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma [Yahoo! Finance]
OS Therapies Incorporated (OSTX)
Company Research
Source: Yahoo! Finance
At FDA's request, Type D Meeting expected in March 2026 to review Comparative Oncology biomarker data from patients treated in OST-HER2 Phase 2b human clinical trial and OST-HER2 trial in spontaneous osteosarcoma in canines Final BLA clinical module expected to be submitted to FDA by end of March 2026 after Type D Meeting Regenerative Medicine Advanced Therapy (RMAT) designation requests update submitted to FDA with recent biomarker data Company remains on track to be eligible to receive Priority Review Voucher under Rare Pediatric Disease Designation (RPDD) with approval anticipated by September 30, 2026 New York, New York--(Newsfile Corp. - February 2, 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 formally initiated a Biologics License Application (BLA) submission to the U.S. Food & Drug Administration (FDA) for OST-HER2 in the prevention or delay of r
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OSTX
News
- 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
- OS Therapies Announces Successful Type C Meeting with US FDA Regarding Phase 2b Clinical Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma [Yahoo! Finance]Yahoo! Finance
OSTX
Earnings
- 11/17/25 - Miss
OSTX
Sec Filings
- 1/20/26 - Form D
- 1/12/26 - Form 8-K
- 12/19/25 - Form 4
- OSTX's page on the SEC website