OS Therapies Incorporated
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- OS Therapies Incorporated (NYSE American: OSTX) is a clinical-stage biopharmaceutical company focused on the identification, development, and commercialization of innovative immunotherapies and targeted drug conjugates for osteosarcoma and other HER2-expressing solid tumors, including breast, colorectal, esophageal, lung, ovarian, and pancreatic cancers. The company's lead product candidate, OST-HER2, comprises an off-the-shelf, attenuated bioengineered Listeria monocytogenes-based immunotherapy that expresses HER2 peptides to activate T cells and stimulate the immune system against cancer cells and metastases; its pipeline also features OST-tADC (tunable antibody-drug conjugate), a plug-and-play platform utilizing pH-sensitive silicone dioxide linkers (SiLinkers) to deliver cell-penetrating payloads selectively into solid tumors via a bystander effect while minimizing toxicity to healthy tissue. Incorporated in 2018 and headquartered in Rockville, Maryland, OS Therapies operates primarily in the United States, conducting clinical trials at multiple sites across 18 states targeting pediatric and adult patients with rare and aggressive cancers that lack new FDA-approved treatments in over 40 years. In January 2025, the company agreed to acquire full rights to all Listeria monocytogenes-based immunotherapies from Ayala Pharmaceuticals, eliminating near-term milestone payments, reducing future royalty obligations on OST-HER2, and enhancing financial prospects ahead of planned regulatory submission; this followed a $7.1 million financing round in late 2024 at $4.00 per share, providing cash runway into 2026, and a September 2025 warrant exchange that raised approximately $3.7 million for commercialization efforts. OST-HER2 received U.S. FDA orphan drug, rare pediatric disease, and fast track designations, with Phase IIb trial enrollment ongoing as of late 2024 showing promising event-free and overall survival data in osteosarcoma.
OS Therapies Accepts New FDA Meeting Request to Review Biomarker Data as Part of BEST Program
OS Therapies Third Quarter 2026 Corporate Outlook
OS Therapies Appoints Dr. Craig Eagle to Board of Directors
OS Therapies Provides U.S. Regulatory Update
OS Animal Health Announces Peer-Reviewed Publication of Clinical Trial Data for OST-HER2 Plus Palliative Radiation as Frontline Treatment in Canine Osteosarcoma
OS Therapies Achieves Global Regulatory Alignment on Design of Phase 3 Trial of OST-HER2 in Fully Resected, Pulmonary Metastatic Osteosarcoma
OS Therapies Says New Bone Cancer Data Strengthens Case For Regulatory Filings
OS Therapies Achieves Statistically Significant 2.5-Year Overall Survival in Phase 2b Trial of OST-HER2 in Fully Resected Pulmonary Metastatic Osteosarcoma
OS Therapies Announces the Publication of Four Articles on OST-HER2 and Osteosarcoma in Drug Discovery World
OS Therapies to Attend Upcoming Medical, Financial and Industry Conferences
OS Therapies Reports First Quarter 2026 Financials and Provides Business Update
OS Therapies to Announce First Quarter 2026 Financials on Monday, May 18, 2026
OS Therapies Appoints Industry Leader Dr. Craig Eagle as Chief Medical Advisor
Stonegate Capital Partners Updates Coverage on OS Therapies Inc. (OSTX)
OS Therapies Announces EMA Initiates Rolling Review of Conditional Marketing Authorization Application for OST-HER2 in the Prevention or Delay of Recurrence in Fully Resected Pulmonary Metastatic Osteosarcoma
OS Therapies Schedules OST-HER2 Pharmacodynamic Response Biomarker Conference Call on April 30, 2026 at 8:30am ET
OS Therapies Files New Patent Application Covering Biomarkers of the Immune Response to Listeria Monocytogenes
OS Therapies Appoints Biotech Industry Luminary Robert "Bob" S. Langer, PhD as Strategic Advisor
OS Therapies Investor News: Rosen Law Firm Encourages OS Therapies Incorporated Investors to Inquire About Securities Class Action Investigation – OSTX
Rosen Law Firm Encourages OS Therapies Incorporated Investors to Inquire About Securities Class Action Investigation – OSTX