SEC Form PRE 14A filed by OS Therapies Incorporated
$OSTX
Biotechnology: Pharmaceutical Preparations
Health Care
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| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 4/2/2025 | $19.00 | Buy | Lake Street |
U.S. FDA ("FDA") confirms OST-HER2 meets biological definition of Regenerative Medicine Advanced Therapy (RMAT) FDA issues OST-HER2 BLA number in preparation for Accelerated Approval submission following End of Phase 2 MeetingFDA End of Phase 2 Meeting scheduled for August 27, 2025 to review Phase 2b clinical trial in the prevention or delay of recurrent, pulmonary metastatic osteosarcomaStatistically significant 12-month Event Free Survival and interim 2-year Overall Survival and strong safety data in Phase 2b trial drives global accelerated/conditional approval pathwaysCommercial partnership with Eversana positions OST-HER2 for possible U.S. launch in first half of 2026$4.2 million capital
New York, New York--(Newsfile Corp. - August 14, 2025) - OS Therapies Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced that it will report second quarter 2025 financial results ended June 30, 2025 and provide a business update on the morning of Tuesday, August 19, 2025.About OS TherapiesOS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. OST-HER2, the Company's lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initia
66.6% of OST-HER2 treated patients achieved 2-year overall survival compared with 40% in the historical control group (p = 0.0046)FDA issues Biologics Licensing Application (BLA) number for OST-HER2 in preparation for anticipated BLA filing for the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma following August 27, 2025 End of Phase 2 MeetingCompany responds to FDA correspondences seeking to align approval metrics for Regenerative Medicine Advanced Therapy (RMAT) designation, Breakthrough Therapy designation (BTD) and Biologics Licensing Application via Accelerated Approval ProgramCompany's NYSE American listing included in the Russell Microcap, Russell M
4 - OS Therapies Inc (0001795091) (Issuer)
4 - OS Therapies Inc (0001795091) (Issuer)
4 - OS Therapies Inc (0001795091) (Issuer)
8-K - OS Therapies Inc (0001795091) (Filer)
10-Q - OS Therapies Inc (0001795091) (Filer)
PRE 14A - OS Therapies Inc (0001795091) (Filer)
Lake Street initiated coverage of OS Therapies with a rating of Buy and set a new price target of $19.00
USA News Group News CommentaryIssued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, June 26, 2025 /PRNewswire/ -- USA News Group News Commentary – With analysts forecasting the global oncology drug market to surpass US$900 billion by 2034, investor interest in cancer-focused biotechs is rapidly intensifying. ResearchAndMarkets and Vision Research Reports both point to strong double-digit growth, citing surging demand for next-gen diagnostics and immunotherapies. Yet even as market potential grows, the U.S. public health sector is facing potential setbacks. Budget proposals suggest National Cancer Institute (NCI) funding could be slashed by up to 40%, while Bloomberg highlights concerns
Consolidates ownership of listeria monocytogenes-based immunotherapy IP Eliminates milestone payments and reduces future royalty obligations relating to OST-HER2 for osteosarcoma and other HER2-related indications Capital allocation focus remains on regulatory approval, priority review voucher (PRV) issuance and commercialization of OST-HER2 in osteosarcoma Previously disclosed $7.1M funding for OS therapies priced at $4.00/share provides cash runway into 2026 & precludes raises below $12.00 for 6 months Karim Galzahr appointed to OS Therapies Board of Directors OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company advancing immunotherapies and targeted d
Concurrently, the Company accepted the resignations of Dr. Colin Goddard and Mr. Joacim Borg OS Therapies (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate biopharmaceutical company, today announced the appointments of Avril McKean Dieser, MA, JD and Olivier R. Jarry, MS, MBA as independent members of the Company's Board of Directors. Collectively, Ms. McKean Dieser and Mr. Jarry bring over 50 years of biopharmaceutical executive decision-making experience to the Company, with a specific focus in commercializing biologic products. "OS Therapies is thrilled to welcome Ms. McKean Dieser and Mr. Jarry to our Board of Directors," sa
New York, New York--(Newsfile Corp. - August 14, 2025) - OS Therapies Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced that it will report second quarter 2025 financial results ended June 30, 2025 and provide a business update on the morning of Tuesday, August 19, 2025.About OS TherapiesOS Therapies is a clinical stage oncology company focused on the identification, development, and commercialization of treatments for Osteosarcoma (OS) and other solid tumors. OST-HER2, the Company's lead asset, is an immunotherapy leveraging the immune-stimulatory effects of Listeria bacteria to initia
Feedback from Type D FDA Meeting expected by mid-June 2025 to confirm statistical analysis methods to support pending Accelerated Approval, Regenerative Medicine Advanced Therapy & Breakthrough Therapy designation requests Completed Phase 2b trial data analysis using methods agreed to by FDA to be presented at MIB Factor on June 28, 2025 Company remains on track for Q3 2025 BLA filing for OST-HER2 in the prevention of recurrent, fully resected, lung metastatic pediatric osteosarcoma OS Therapies Inc. (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today reported first quarter 2025 financial res
Company now listeria-based cancer immunotherapy world leader Expands clinical pipeline with 3 new cancer immunotherapy candidates 8 pre-clinical immunotherapy candidates targeting 30+ cancers added OS Therapies (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that it has completed the acquisition of the listeria-based cancer immunotherapy assets of Advaxis Immunotherapies from Ayala Pharmaceuticals. The Company is now positioned as the world leader in listeria-based cancer immunotherapies, poised to become a new commercial category of immunotherapy in oncology upon approval of
SC 13G - OS Therapies Inc (0001795091) (Subject)