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| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 4/2/2025 | $19.00 | Buy | Lake Street |
Lake Street initiated coverage of OS Therapies with a rating of Buy and set a new price target of $19.00
Company finalizing preparations for end of January 2026 U.S. FDA Biologics License Application (BLA) submission for OST-HER2 program in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma (Metastatic Osteosarcoma Program) under Accelerated Approval ProgramBiomarker data from Phase 2b Metastatic Osteosarcoma Program human clinical trial expected to be released during week of J.P. Morgan Healthcare Conference 2026UK and EU Marketing Authorisation Application (MAA) submissions for conditional approval expected by end of February 2026 and March 2026, respectivelyCompany expects to participate in multiple H1 2026 meetings with U.S. FDA, U.K. MHRA and Europe's E
FDA confirmed that data from single-arm studies in rare diseases, such as in ultra-rare deadly pediatric cancer osteosarcoma, could support a Biologics Licensing Application (BLA) under Accelerated Approval Program pathway, as stated in FDA guidance documentsFDA proposed confirmatory study design include additional osteosarcoma disease settings such as prevention of recurrence following primary tumor resection, where a randomized controlled study may be feasible and that the confirmatory study would have to be underway prior to granting a BLAFDA indicated that the use of canine data to support confirmation that pre-specified immune biomarker activation is correlated with treatment-emergent h
Alignment achieved on all key points surrounding non-clinical, CMC and post-market authorization confirmatory study designBiomarker data advanced as key pre-specified surrogate clinical efficacy endpoint, with pending analysis awaiting alignment with US FDA on biomarker statistical analysis plan to be discussed at upcoming December 11, 2025 FDA Type C MeetingCompany reiterates end of January 2026 timeline for MAA submissionNew York, New York--(Newsfile Corp. - December 9, 2025) - OS Therapies Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced that it held a successful pre-Marketing Authorisation Application (MAA) wit
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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
75% of OST-HER2 treated patients achieved 2-year overall survival compared with 40% in the historical control group (p < 0.0001)100% of patients who achieved 12 month event free survival achieved 2 year overall survivalNew York, New York--(Newsfile Corp. - October 10, 2025) - OS Therapies Inc. (NYSE:OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced statistically significant positive final 2-year overall survival data from the Company's Phase 2b trial of off-the-shelf immunotherapy candidate OST-HER2 in the prevention or delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma (the "Fu
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
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