Matribhumi Samachar English
Alignment achieved on all key points surrounding non-clinical, CMC and post-market authorization confirmatory study design Biomarker 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 Meeting …
Read More »OS Therapies Receives Positive Feedback from UK MHRA Scientific Advice Meeting and Submits Innovative Licensing and Access Pathway (ILAP) Request for OST-HER2 in the Prevention or Delay of Recurrent, Fully Resected, Pulmonary Metastatic Osteosarcoma
MHRA seeks to harmonize UK & US regulatory review via Project Orbis EMA Rapporteur Scientific Advice Meeting scheduled for October 2025 New York, New York–(Newsfile Corp. – August 7, 2025) – OS Therapies (NYSE American: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical …
Read More »OS Therapies Closes $4.2 Million in Warrant Exercise Inducement and Exchange Offer
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 modeling New York, New …
Read More »OS Therapies Provides Clinical & Global Regulatory Updates
End of Phase 2 Meeting with FDA scheduled for August 27, 2025 to review OST-HER2 recurrent, pulmonary metastatic osteosarcoma program Scientific Advice Meetings confirmed with global regulators in major markets – including the United Kingdom and European Union All patients enrolled in its Phase 1 clinical study of OST-504 in …
Read More »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
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 …
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