US68764Y2072
© Newsfile
09.12.2025
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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
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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 Typ...
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05.12.2025
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OS Therapies Announces FDA PDUFA Waiver & EMA Grants Union Marketing Authorisation Eligibility
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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 December 8, 2025Scheduled Type C Meeting with United States Food & Drug Administration on December 11, 2025New York, New York--(Newsfile Corp....
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© Newsfile
25.11.2025
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OS Therapies Receives Non-Proprietary Name 'daznelimgene lisbac' for OST-HER2 from World Health Organization
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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 that the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO) approved 'daznelimgene lisbac' for...
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Worth to know
20.10.2025
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21.11.2025
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Stonegate Capital Partners Updates Coverage on OS Therapies Inc. (OSTX) 3Q25
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Dallas, Texas--(Newsfile Corp. - November 21, 2025) - OS Therapies Inc. (NYSE American: OSTX): Stonegate Capital Partners updates their coverage on OS Therapies Inc. (NYSE American: OSTX). OS Therapies advanced key clinical, regulatory, and commercial milestones in 3Q25 as it moves closer to bringing OST-HER2 to patients with recurrent, fully...
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20.10.2025
© Newsfile
20.11.2025
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OS Therapies to Spinoff OS Animal Health into Standalone Public Company
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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 canine and human patients treated with OST-HER2 receives Anthem Award in the 'Documentary or Film under Awareness Categories, Health' categoryC...
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© Newsfile
17.11.2025
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OS Therapies Reports Third Quarter 2025 Financial Results and Provides Business Update
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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, fully-resected pulmonary metastatic osteosarcomaUS Biologics Licensing Application (BLA) and UK MHRA Marketing Authorization Application filings f...
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© Newsfile
22.10.2025
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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
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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 company, today announced additional overall and event free survival data generated from the Company's 41-patient Phase 2b clinical trial...
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© Newsfile
17.10.2025
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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
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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 osteosarcoma dataNew York, New York--(Newsfile Corp. - October 17, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Com...
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© Newsfile
10.10.2025
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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
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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 American: OSTX) ("OS Therapies" or "the Compa...
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© Newsfile
09.10.2025
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OS Therapies Provides Positive EMA Regulatory Update Following Positive Rapporteur Meeting
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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 settings, supported by translational canine data from the University of PennsylvaniaNew York, New York--(Newsfile Corp. - October 9, 2025) - OS Thera...
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© Newsfile
07.10.2025
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OS Therapies to Participate in Fall 2025 Conferences and Events
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Daytime Emmy Awards participation - 2 nomination for 'Shelter Me: Cancer Pioneers' Comparative Oncology documentary that features clinicians, veterinarians and human & canine patients who participated in OST-HER2 clinical trialsNew York, New York--(Newsfile Corp. - October 7, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "t...
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© Newsfile
30.09.2025
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OS Therapies Provides OST-HER2 UK MHRA and US FDA Osteosarcoma Regulatory Update
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Company updates sequence of OST-HER2 regulatory submissions, prioritizing UK MHRA conditional Marketing Authorisation Application (MAA) submission following positive August 2025 Scientific Advice Meeting feedback from UK MHRAIn principle, UK MHRA accepts use of historical control arm to support conditional MAAUK MHRA conditional MAA and US FDA Biol...
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20.10.2025
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19.09.2025
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OS Therapies to Participate in Spotlight Panel at BioFuture 2025 October 13 11:00am EDT
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New York, New York--(Newsfile Corp. - September 19, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced that it has been invited to participate in the "Beyond the Cure: The Brave New World of Revolutionary Cancer T...
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© Newsfile
12.09.2025
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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
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Clinical data from Phase 1b prostate cancer trial to be released in Q4/25Additionally, updated 2-year overall survival data from all 40 patients in the Phase 2b clinical trial of OST-HER2 in the prevention of delay of recurrent, fully resected, pulmonary metastatic osteosarcoma to be released on October 10, 2025New York, New York--(Newsfile Corp. -...
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© Newsfile
08.09.2025
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Stonegate Capital Partners Initiates Coverage on OS Therapies Inc. (OSTX)
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Dallas, Texas--(Newsfile Corp. - September 8, 2025) - OS Therapies Inc. (NYSE American: OSTX): Stonegate Capital Partners initiates their coverage on OS Therapies Inc. (NYSE American: OSTX). OS Therapies advanced meaningful clinical, regulatory, and financial milestones in 2Q25 as it moves closer to bringing OST-HER2 to patients with recu...
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© Newsfile
03.09.2025
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OS Therapies to Participate in Upcoming Investor Conferences in September 2025
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New York, New York--(Newsfile Corp. - September 3, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced that it will participate in the upcoming investor conferences:Cantor Global Healthcare Conference 2025 being he...
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© Newsfile
02.09.2025
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OS Therapies Provides OST-HER2 Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma Program Update Following FDA End of Phase 2 Meeting
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Company on track to begin submission of a rolling Biologics Licensing Application (BLA) request for OST-HER2 to U.S. Food & Drug Administration in September 2025 New York, New York--(Newsfile Corp. - September 2, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody...
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© Newsfile
02.09.2025
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OS Therapies Completes Exercise Inducement and Exchange Offer for All Remaining Outstanding Warrants Issued in Connection with December 2024 Financing
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All remaining holders of outstanding warrants with $1.12 per share exercise price have participated, raising $3.7 million in gross proceeds to be used to accelerate OST-HER2 commercial launch preparationsNew warrants issued have an exercise price of $3.00 per share with a forced exercise provision when the stock trades above $9.00 New York, New Yor...
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© Newsfile
27.08.2025
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OS Therapies to Provide OST-HER2 Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma FDA End of Phase 2 Meeting Update on Tuesday, September 2, 2025
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New York, New York--(Newsfile Corp. - August 27, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced that it will provide stakeholders with a detailed update regarding the Company’s highly constructive Augu...
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© Newsfile
26.08.2025
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OS Therapies Terminates Equity Line of Credit
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New York, New York--(Newsfile Corp. - August 25, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced that it terminated its Equity Purchase Agreement (the "ELOC") with Square Gate Capital Master Fund, LLC — S...
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© Newsfile
19.08.2025
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OS Therapies Reports Second Quarter 2025 Financial Results and Provides Business Update
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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 rec...
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© Newsfile
14.08.2025
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OS Therapies to Report Second Quarter 2025 Financial Results and Provide Business Update on Tuesday, August 19th, 2025
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New York, New York--(Newsfile Corp. - August 14, 2025) - OS Therapies Inc. (NYSE American: 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 th...
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© Newsfile
14.07.2025
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OS Therapies Closes $4.2 Million in Warrant Exercise Inducement and Exchange Offer
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Cash runway extended through 2026, beyond September 30, 2026 sunset date for rare pediatric priority review voucher (PRV) program Additional funding allows Company to advance strategic alternatives for OS Animal Health, close out OST-504 (previously ADXS-504) prostate cancer study and initiate AI-driven next-gen tADC product candidate modelingNew Y...
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© Newsfile
10.07.2025
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OS Therapies Provides Clinical & Global Regulatory Updates
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End of Phase 2 Meeting with FDA scheduled for August 27, 2025 to review OST-HER2 recurrent, pulmonary metastatic osteosarcoma programScientific Advice Meetings confirmed with global regulators in major markets - including the United Kingdom and European UnionAll patients enrolled in its Phase 1 clinical study of OST-504 in second line prostate canc...
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© BusinessWire
03.07.2025
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OS Therapies Granted End of Phase 2 Meeting by US FDA for OST-HER2 Program in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma
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OS Therapies (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced it was granted an End of Phase 2 Meeting by the United States Food & Drug Administration (“FDA”) to review the OST-HER2 program in the prevention or delay of recurrent, fully...
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© BusinessWire
30.06.2025
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OS Therapies Presents Statistically Significantly Positive 1-Year Event Free Survival, Overall Survival and Safety Clinical Data Updates for OST-HER2 at the MIB Agents Factor Osteosarcoma Conference
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OS Therapies (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced positive 1-year event free survival (EFS), overall survival and safety clinical trial data updates from the 40 patient treatment arm of its Phase 2b clinical trial of immunothera...
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© BusinessWire
24.06.2025
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OS Therapies Receives Positive FDA Meeting Feedback on Regulatory Pathway for Accelerated Approval of OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pediatric Lung Metastatic Osteosarcoma
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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 received positive written feedback from the US Food & Drug Administration (“FDA”) Type D Meeting that occurred in mid-June 2025 regarding endpoints required to suppor...
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© BusinessWire
24.06.2025
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OS Therapies Announces Warrant Exercise Inducement & Exchange Offer
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OS Therapies Inc. (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced a warrant exercise inducement and exchange offer to holders of its five-year warrants with a current exercise price of $1.12 per share that were issued in connection with a...
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© BusinessWire
06.06.2025
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OS Therapies Submits Request for Regenerative Medicine Advanced Therapy (RMAT) Designation to U.S. FDA for OST-HER2 in the Prevention of Metastases in Recurrent, Fully-Resected, Lung Metastatic Pediatric Osteosarcoma
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OS Therapies Inc. (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, today announced it has submitted a request for Regenerative Medicine Advanced Therapy (RMAT) Designation to U.S. FDA for OST-HER2 in the prevention of metastases in recurrent, fully-resected,...
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© BusinessWire
16.05.2025
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OS Therapies Reports First Quarter 2025 Financial Results and Provides Business Update
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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 results ended March 31, 2025 and provided a business update.
“The first quarter of 2025 was a crucial execution quarter for OS Therapies, as we ann...
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© BusinessWire
15.05.2025
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OS Therapies Forms Subsidiary OS Animal Health to Commercialize OST-HER2 for Canine Osteosarcoma
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OS Therapies (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced the launch of OS Animal Health, Inc., a wholly owned subsidiary focused on commercializing OST-HER2 for the treatment of canine osteosarcoma.
OST-HER2 market opportunity in can...
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© BusinessWire
07.05.2025
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OS Therapies Announces Issuance of U.S. Patent #12,239,738 Protecting Commercial Manufacturing Market Exclusivity for OST-HER2 in Rare Pediatric Cancer Osteosarcoma and Full Listeria Cancer Immunotherapy Platform into 2040
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OS Therapies (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced the issuance of United States Patent #12,230,738 protecting proprietary commercial manufacturing methods for the Company’s listeria monocytogenes (Lm) cancer immunotherapy platfo...
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© BusinessWire
02.05.2025
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Emmy-Winning Series Debuts Trailer for "Shelter Me: The Cancer Pioneers" Offering A Hopeful Look at Breakthrough Cancer Therapies
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The official trailer for “Shelter Me: The Cancer Pioneers” has just dropped, giving audiences a moving first look at the groundbreaking new documentary that follows the emotional and inspiring journey of dogs helping to pioneer cancer treatments that are saving human lives. The movie will stream through the PBS app and on PBS.org starting on Thurs...
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© BusinessWire
22.04.2025
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OS Therapies FDA Meeting Request Granted
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OS Therapies (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced that the US Food & Drug Administration (“FDA”) granted the Company’s meeting request to gain alignment on the surrogate endpoint to support Breakthrough Therapy Designation &...
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© Newsfile
10.04.2025
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OS Therapies Announces Positive Data for OST-HER2 in the Treatment of Unresected Osteosarcoma in Dogs Opening the Potential for Use as Front-Line Therapy in Humans
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Yet to be published data from clinical study combining OST-HER2 with palliative radiation in dogs with unresected, primary osteosarcoma shows clinical and radiographic arrest of the primary tumor, delayed pulmonary metastases and prolonged overall survival of greater than 500 days in 5 out of 15 dogs.Data from new publication in the journal "Molecu...
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