OS Therapies Provides Regulatory Update on Rare Pediatric Cancer Immunotherapy Candidate OST-HER2 for Human Osteosarcoma
OS Therapies Incorporated (OSTX)
Company Research
Source: Business Wire
Dialogue open with FDA in preparation for End of Phase 2 Meeting requestNew canine elite responder biomarkers added to human biomarker strategy NEW YORK--(BUSINESS WIRE)--OS Therapies (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today provided a regulatory update for its OST-HER2 listeria monocytogenes (Lm) immunotherapeutic cancer biologic drug candidate in the prevention or delay of fully-resected, recurrent, lung metastatic osteosarcoma.“We are making rapid progress in putting together an appropriate data package to achieve accelerated approval for OST-HER2 given the feedback we’ve received to date from the FDA,” said Paul Romness, MHP, Chairman & CEO of OS Therapies. “We know one of the US government’s stated priorities is to treat deadly childhood cancers, and we believe that OST-HER2 for osteosarcoma aligns well with that mission.”Regulatory TimelinesThe Company initiated regulato
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News
- 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
- OS Therapies to spin off OS Animal Health into a standalone public company [Seeking Alpha]Seeking Alpha
- OS Therapies to Spinoff OS Animal Health into Standalone Public Company [Yahoo! Finance]Yahoo! Finance
- OS Therapies GAAP EPS of -$0.21 misses by $0.08 [Seeking Alpha]Seeking Alpha
OSTX
Earnings
- 11/17/25 - Miss
OSTX
Sec Filings
- 12/19/25 - Form 4
- 12/19/25 - Form 4
- 12/19/25 - Form 4
- OSTX's page on the SEC website