OS Therapies Inc
OS Therapies is a clinical-stage biopharmaceutical company developing treatments for osteosarcoma and other solid tumors, with a focus on cancers affecting children and young adults. Its lead candidate, OST-HER2, is an off-the-shelf immunotherapy made from a weakened, genetically modified Listeria strain that expresses HER2 peptides and is being studied for recurrent osteosarcoma. The company also owns the OST-tADC platform, a preclinical antibody-drug conjugate technology using tunable, pH-sensitive silicone linkers; its lead program targets folate receptor alpha. OS Therapies’ pipeline also includes investigational Listeria-based programs for lung and prostate cancer acquired from Ayala Pharmaceuticals. OS Therapies develops drug candidates for potential human and veterinary use and may pursue partnerships or out-licensing. Its work includes research, preclinical development and clinical trials, with development activities supported by contract research organizations. The company is headquartered in Rockville, Maryland.
No SEC Form 4 filings for $OSTX in the last 30 days.
See all $OSTX insider activity →OS Therapies (OSTX) announced successful requalification of drug substance for its cancer treatment, OST-HER2, allowing submission for early commercial access in the U.K. and Europe. The company plans to update regulatory timelines and focus on U.S., U.K., and Europe. OST-HER2 has received multiple designations from FDA and EMA.
OS Therapies Inc (OSTX) filed an SEC Form 8-K — Entry into a Material Definitive Agreement. Exhibit 99.1 OS Therapies Announces Initial Closing of Warrant Exercise Inducement and Exchange Offer for Initial Gross Proceeds of Approximately $7.2 Million · Proceeds from the initial closing, together with accrued refundable U.K. R&D tax credits, expected to provide operating
OS Therapies Inc. (OSTX) raised $7.2 million from a warrant exercise and exchange offer, with proceeds to fund regulatory filings for Herlystic™, its cancer immunotherapy, in the U.S., U.K., Europe, and Australia. The company plans to submit approval applications in Q4 2026 and expects the funds to support operations through key milestones.
Over the past 7 days, AlphAI's AI scored 2 news stories mentioning OSTX (OS Therapies Inc). Coverage has skewed bullish: 2 bullish, 0 neutral, and 0 bearish.
Recent OSTX coverage spans regulation, corporate actions and financial news.
Stability data removes a key regulatory hurdle, supporting near‑term price appreciation.
The cash infusion should extend runway and support upcoming BLA submissions, likely easing short‑term financing concerns.
Positive trial data and fresh capital improve the company's cash runway and regulatory timeline.
Regulatory feedback creates uncertainty; approval could boost valuation, while delays may pressure the stock.
Positive Phase 2b data may lift the stock on expectations of accelerated approval and future revenue.
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OS Therapies (OSTX) announced successful requalification of drug substance for its cancer treatment, OST-HER2, allowing submission for early commercial access in the U.K. and Europe. The company plans to update regulatory timelines and focus on U.S., U.K., and Europe. OST-HER2 has received multiple designations from FDA and EMA.
OS Therapies Inc (OSTX) filed an SEC Form 8-K — Entry into a Material Definitive Agreement. Exhibit 99.1 OS Therapies Announces Initial Closing of Warrant Exercise Inducement and Exchange Offer for Initial Gross Proceeds of Approximately $7.2 Million · Proceeds from the initial closing, together with accrued refundable U.K. R&D tax credits, expected to provide operating
OS Therapies Inc. (OSTX) raised $7.2 million from a warrant exercise and exchange offer, with proceeds to fund regulatory filings for Herlystic™, its cancer immunotherapy, in the U.S., U.K., Europe, and Australia. The company plans to submit approval applications in Q4 2026 and expects the funds to support operations through key milestones.
OS Therapies (OSTX) received USDA feedback on its OST-HER2 treatment for canine osteosarcoma. The company is reviewing strategic alternatives for its subsidiary, OS Animal Health (OSAH), which plans a crowdfunding campaign. The veterinary oncology market is projected to grow to $4.77B by 2034, according to Towards Healthcare.
OS Therapies reported 72.7% 3-year survival in Phase 2b trial for OST-HER2 vs 45.8% in controls. The company plans regulatory filings and a Phase 3 study. The trial involved 41 patients, with 4 lost to follow-up.
OS Therapies Inc (OSTX) filed an SEC Form 8-K — Entry into a Material Definitive Agreement. Exhibit 99.1 October 1, 2026 OS Therapies Appoints Kerry Clem as Chief Commercial Officer and Frank Knuettel II as Chief Financial Officer Experienced biotech leaders to focus on preparations for U.S., U.K., and European commercial launch of the Company’s lead product candidate H
OS Therapies (NYSE American: OSTX) appointed Kerry Clem as CCO and Frank Knuettel II as CFO. Clem will lead commercialization of Herlystic, their lead immunotherapy for osteosarcoma, with U.S. launch planned post-FDA approval. Knuettel brings financial expertise. The company anticipates regulatory filings in Q4 2026 and has received tax credits for R&D.
OS Therapies (NYSE American: OSTX) announced that the World Health Organization approved 'Herlystic' as the brand name for OST-HER2, a gene-edited cancer immunotherapy. The company plans to initiate regulatory submissions for early market access in the U.K., U.S., Europe, and Australia. OST-HER2 has received multiple designations from the FDA and EMA, and the company aims to file for a Biologics License Application in the U.S. in 2026.
OS Therapies (OSTX) updated its global regulatory coordination for OST-HER2 under Project Orbis. The U.K.'s MHRA will lead the process, with a Phase 3 trial set to begin in mid-2026. The FDA aligned on the study design, and the company aims to submit a CMAA soon. OST-HER2 has received multiple designations from the FDA, EMA, and MHRA.
OS Therapies (OSTX) aligned with the FDA on its Phase 3 trial design for OST-HER2, a treatment for metastatic osteosarcoma. The company will join Project Orbis, a global regulatory initiative, and aims to submit a BLA in Q4 2026. OST-HER2 has received multiple designations from the FDA and EMA, and a successful BLA could make the company eligible for a Priority Review Voucher.
