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Os Therapies Incorporated (OSTX)

Os Therapies Incorporated (OSTX)
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OS Therapies Announces FDA PDUFA Waiver & EMA Grants Union Marketing Authorisation Eligibility Newsfile - Fri Dec 5, 7:04AM CST

U.S. FDA grants waiver of application fee for BLA Filing of OST-HER2Scheduled pre-Marketing Authorisation Application meeting with United Kingdom's Medicines and Healthcare products Regulatory Agency on...

OSTX : 1.9200 (+5.49%)
OS Therapies Receives Non-Proprietary Name 'daznelimgene lisbac' for OST-HER2 from World Health Organization Newsfile - Tue Nov 25, 8:24AM CST

New York, New York--(Newsfile Corp. - November 25, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced...

OSTX : 1.9200 (+5.49%)
OS Therapies to Spinoff OS Animal Health into Standalone Public Company Newsfile - Thu Nov 20, 6:48AM CST

Successful preliminary discussion with NYSE representatives and potential investorsOS Therapies shareholders to receive direct equity participation in new listing'Shelter Me: Cancer Pioneers' film featuring...

OSTX : 1.9200 (+5.49%)
OS Therapies Reports Third Quarter 2025 Financial Results and Provides Business Update Newsfile - Mon Nov 17, 5:12AM CST

Type C Meeting with US FDA set for December 11, 2025 to address key items following August 27, 2025 End of Phase 2 Meeting regarding Phase 2b clinical trial of OST-HER2: prevention or delay of recurrent,...

OSTX : 1.9200 (+5.49%)
OS Therapies Announces Overall and Event Free Survival Key Subgroup Data for OST-HER2 in Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma Newsfile - Wed Oct 22, 8:30AM CDT

New York, New York--(Newsfile Corp. - October 22, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology...

OSTX : 1.9200 (+5.49%)
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 Newsfile - Fri Oct 17, 8:28AM CDT

Final FDA Type C Meeting December 11, 2025 - biomarker data to be availableOctober 10, 2025 FDA/Osteosarcoma Institute Workshop narrows focus for OST-HER2 overall survival, biomarker correlation & canine...

OSTX : 1.9200 (+5.49%)
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 Newsfile - Fri Oct 10, 5:14AM CDT

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...

OSTX : 1.9200 (+5.49%)
OS Therapies Provides Positive EMA Regulatory Update Following Positive Rapporteur Meeting Newsfile - Thu Oct 9, 6:50AM CDT

Overall survival recognized as key efficacy endpoint in osteosarcoma, where no standard of care existsRapporteur highlights potential broader benefits of OST-HER2 in pulmonary and primary osteosarcoma...

OSTX : 1.9200 (+5.49%)
OS Therapies to Participate in Fall 2025 Conferences and Events Newsfile - Tue Oct 7, 10:50AM CDT

Daytime Emmy Awards participation - 2 nomination for 'Shelter Me: Cancer Pioneers' Comparative Oncology documentary that features clinicians, veterinarians and human & canine patients who participated...

OSTX : 1.9200 (+5.49%)
OS Therapies Provides OST-HER2 UK MHRA and US FDA Osteosarcoma Regulatory Update Newsfile - Tue Sep 30, 6:48AM CDT

Company updates sequence of OST-HER2 regulatory submissions, prioritizing UK MHRA conditional Marketing Authorisation Application (MAA) submission following positive August 2025 Scientific Advice Meeting...

OSTX : 1.9200 (+5.49%)

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