OS Therapies provides first half 2026 corporate outlook [Seeking Alpha]
OS Therapies Incorporated (OSTX)
Company Research
Source: Seeking Alpha
The outlook highlights planned submissions to seek regulatory approval for the its lead candidate OST-HER2 in the U.S., U.K. and Europe, the expected release of Phase 2b biomarker data Quick Insights OS Therapies plans BLA submission to FDA by January 2026, MAA submissions to U.K. MHRA and EMA by February and March 2026, and expects possible approvals in the U.K., U.S., and Europe throughout 2026. OST-HER2's Orphan, Fast Track, and Rare Pediatric Disease designations make the company eligible for a Priority Review Voucher worth as much as $160M if approval is secured by September 2026, with intentions to sell the voucher. The company will advance clinical development for OST-503 (NSCLC) and OST-504 (prostate cancer) with key upcoming FDA meetings in 2026 and delayed clinical data release for OST-504 in Q1 2026. Recommended For You More Trending News
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News
- OS Therapies Enters into Warrant Inducement Agreements [Yahoo! Finance]Yahoo! Finance
- 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
- Stonegate Capital Partners Updates Coverage on OS Therapies Inc. (OSTX) 3Q25 [Yahoo! Finance]Yahoo! Finance
OSTX
Earnings
- 11/17/25 - Miss
OSTX
Sec Filings
- 1/12/26 - Form 8-K
- 12/19/25 - Form 4
- 12/19/25 - Form 4
- OSTX's page on the SEC website