प्राथमिक स्रोत रिकॉर्ड
महत्वपूर्णPDUFA तारीख़ तय
OS Therapies: OST-HER2 BLA सबमिशन लेट 2026 के लिए टारगेटेड
OS Therapies U.S. Food & Drug Administration (FDA) Type B Statistical Methods और Type B Pre-BLA मीटिंग्स की तैयारी कर रही है ताकि OST-HER2 के लिए रेगुलेटरी अलाइनमेंट हासिल की जा सके। कंपनी लेट 2026 में संभावित अर्ली मार्केट ऑथोराइजेशन का लक्ष्य रखती है और Accelerated Approval Program के तहत Biologics License Application (BLA) सबमिशन को year-end 2026 तक पूरा करने की योजना बना रही है।
मुख्य तथ्य
- फाइल किया गया
- 2 जुल॰ 2026, 08:30 pm
- घटना
- PDUFA तारीख़ तय
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OSTXOS Therapies- स्रोत
- SEC 8-K
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स्रोत का अंश
EX-99.1 6 ea029686801ex99-1.htm PRESS RELEASE ISSUED BY OS THERAPIES INCORPORATED ON JULY 2, 2026 Exhibit 99.1 OS Therapies Appoints Dr. Craig Eagle to Board of Directors ● Company secures $10 million line of credit supported by OS Therapies UK tax credits New York, NY and Rockville, MD, July 2, 2026 – OS Therapies, Inc. (NYSE American: OSTX) (“OS Therapies” or “the Company”) , the world leader in gene-edited, Listeria-based cancer immunotherapies, today announced that it has appointed Dr. Craig Eagle to the Company’s Board of Directors. Dr. Eagle currently serves as the Company’s Chief Medical Advisor. The Company also announced that Karim Galzahr has stepped down from its Board of Directors. “Having enjoyed participating in recent U.S., European and U.K. regulatory meetings as we pr