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OS Therapies Incorporated Common Stock (NY:OSTX)

1.391 -0.019 (-1.35%)
Streaming Delayed Price Updated: 2:34 PM EDT, Apr 1, 2026 Add to My Watchlist
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All News about OS Therapies Incorporated Common Stock

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OS Therapies Completes Submission of Biomarker & Clinical Data for U.S. FDA Pre-BLA Meeting, Reports Full Year 2025 Financial Results and Provides Business Update
December 2025 Type C Meeting confirmed immune biomarkers suitability to establish surrogate clinical efficacy that could support BLA under Accelerated... 
Via Newsfile
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OS Therapies Granted Meetings with U.S. FDA, U.K. MHRA, EMA and Australian Therapeutic Goods Administration to Review Global Confirmatory Phase 3 Trial for OST-HER2 in Metastatic Osteosarcoma
Meetings with all four regulatory agencies scheduled to occur in the second quarter of 2026, with expected Phase 3 commencement... 
Via Newsfile
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OS Therapies Granted EMA's Advanced Therapy Medicinal Product (ATMP) Designation for OST-HER2 in the Treatment of Pulmonary Recurrence in Resected Osteosarcoma
ATMP benefits include access to the Conditional Marketing Authorisation accelerated market access pathway in Europe, significantly reduced user fees for... 
Via Newsfile
Get insights into the top gainers and losers of Thursday's after-hours session. ↗
Via Chartmill
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OS Therapies Announces FDA OST-HER2 Type D Meeting Elevated to Type B Pre-BLA Meeting
FDA's elevated meeting status signals transition from biomarker data discussions to Accelerated Approval discussionsOS Therapies on track to complete clinical... 
Via Newsfile
Topics Intellectual Property
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OS Therapies Provides Global Regulatory Update for OST-HER2 in Recurrent, Fully Resected, Pulmonary Metstatic Osteosarcoma ↗
Additional forthcoming biomarker data from human trial expected to further characterize immune pathway activation and its relationship to clinical outcomesU.S.,... 
Via Newsfile
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OS Therapies Applauds Reauthorization of Pediatric Priority Review Voucher Program to Advance Breakthrough Osteosarcoma Immunotherapies
New York, New York--(Newsfile Corp. - February 4, 2026) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or... 
Via Newsfile
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OS Therapies Initiates US FDA BLA Filing for OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma
Request for FDA Rolling Review submitted to FDA on January 30, 2026Non-Clinical and CMC BLA modules submitted to FDAAt FDA's... 
Via Newsfile
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OS Therapies Announces Positive Biomarker Data from Phase 2b Clinical Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma
Activation of immune blood biomarkers from interferon gamma pathway distinguished long term survivors (>=2 years) from short-term survivors (<1year)Pre-specified pathway... 
Via Newsfile
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OS Therapies Announces Filing Form S-1 of OS Animal Health Subsidiary
OS Animal Health (OSAH), a wholly-owned subsidiary of OS Therapies (OSTX), targeting Initial Public Offering (IPO) on NYSE American or... 
Via Newsfile
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OS Therapies Enters into Warrant Inducement Agreements
$7.53M gross proceeds raised from pre-existing investors, providing capital runway into 2027All nine investors that were offered agreed to participateNet... 
Via Newsfile
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OS Therapies Provides First Half 2026 Corporate Outlook
Company finalizing preparations for end of January 2026 U.S. FDA Biologics License Application (BLA) submission for OST-HER2 program in the... 
Via Newsfile
Topics Regulatory Compliance
Market Signals Highlight Next Wave of Immunotherapy Growth (OSTX, IBRX)
Via AB Newswire
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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
FDA confirmed that data from single-arm studies in rare diseases, such as in ultra-rare deadly pediatric cancer osteosarcoma, could support... 
Via Newsfile
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OS Therapies Announces Successful pre-Marketing Authorisation Application Meeting with UK MHRA Regarding the Phase 2b Clinical Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma
Alignment achieved on all key points surrounding non-clinical, CMC and post-market authorization confirmatory study designBiomarker data advanced as key pre-specified... 
Via Newsfile
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OS Therapies Announces FDA PDUFA Waiver & EMA Grants Union Marketing Authorisation Eligibility
U.S. FDA grants waiver of application fee for BLA Filing of OST-HER2Scheduled pre-Marketing Authorisation Application meeting with United Kingdom's Medicines... 
Via Newsfile
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OS Therapies Receives Non-Proprietary Name 'daznelimgene lisbac' for OST-HER2 from World Health Organization
New York, New York--(Newsfile Corp. - November 25, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the... 
Via Newsfile
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Stonegate Capital Partners Updates Coverage on OS Therapies Inc. (OSTX) 3Q25
Dallas, Texas--(Newsfile Corp. - November 21, 2025) - OS Therapies Inc. (NYSE American: OSTX): Stonegate Capital Partners updates their coverage... 
Via Newsfile
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OS Therapies to Spinoff OS Animal Health into Standalone Public Company
Successful preliminary discussion with NYSE representatives and potential investorsOS Therapies shareholders to receive direct equity participation in new listing'Shelter Me:... 
Via Newsfile
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OS Therapies Reports Third Quarter 2025 Financial Results and Provides Business Update
Type C Meeting with US FDA set for December 11, 2025 to address key items following August 27, 2025 End... 
Via Newsfile
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Why Quantum Computing Shares Are Trading Higher By Over 23%; Here Are 20 Stocks Moving Premarket ↗
 
Via Benzinga
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OS Therapies Announces Overall and Event Free Survival Key Subgroup Data for OST-HER2 in Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma
New York, New York--(Newsfile Corp. - October 22, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the... 
Via Newsfile
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OS Therapies Granted Final Type C Meeting by U.S. FDA and pre-MAA Meeting by U.K. MHRA for OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma
Final FDA Type C Meeting December 11, 2025 - biomarker data to be availableOctober 10, 2025 FDA/Osteosarcoma Institute Workshop narrows... 
Via Newsfile
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OS Therapies Reports Strong 2-Year Survival Data For Bone Cancer Immunotherapy Candidate ↗
OS Therapies reports 75% two-year survival in osteosarcoma trial, plans regulatory filings with the FDA, EMA, and MHRA following positive Phase 2b results. 
Via Benzinga
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OS Therapies Announces Statistically Significant Positive Final 2-Year Overall Survival Data from Phase 2b Trial of OST-HER2 in the Prevention or Delay of Recurrent, Fully-Resected, Pulmonary Metastatic Osteosarcoma
75% of OST-HER2 treated patients achieved 2-year overall survival compared with 40% in the historical control group (p < 0.0001)100%... 
Via Newsfile
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OS Therapies Provides Positive EMA Regulatory Update Following Positive Rapporteur Meeting
Overall survival recognized as key efficacy endpoint in osteosarcoma, where no standard of care existsRapporteur highlights potential broader benefits of... 
Via Newsfile
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OS Therapies to Participate in Fall 2025 Conferences and Events
Daytime Emmy Awards participation - 2 nomination for 'Shelter Me: Cancer Pioneers' Comparative Oncology documentary that features clinicians, veterinarians and... 
Via Newsfile
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OS Therapies Provides OST-HER2 UK MHRA and US FDA Osteosarcoma Regulatory Update
Company updates sequence of OST-HER2 regulatory submissions, prioritizing UK MHRA conditional Marketing Authorisation Application (MAA) submission following positive August 2025... 
Via Newsfile
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OS Therapies to Participate in Spotlight Panel at BioFuture 2025 October 13 11:00am EDT
New York, New York--(Newsfile Corp. - September 19, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the... 
Via Newsfile
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OS Therapies Announces Last Patient Enrolled in OST-504 (previously ADXS-504) Phase 1b Prostate Cancer Clinical Trial Completes Last Visit
Clinical data from Phase 1b prostate cancer trial to be released in Q4/25Additionally, updated 2-year overall survival data from all... 
Via Newsfile
Topics Death
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