Record mula sa primary source
MateryalNaitakda ang petsa ng PDUFA
OS Therapies: OST-HER2 BLA submission na naka-target para sa huling bahagi ng 2026
OS Therapies ay naghahanda para sa U.S. Food & Drug Administration (FDA) Type B Statistical Methods at Type B Pre-BLA meetings upang makakuha ng regulatory alignment para sa OST-HER2. Ang kumpanya ay naglalayon para sa potensyal na maagang market authorizations sa late 2026 at plano na kumpletuhin ang Biologics License Application (BLA) submission sa ilalim ng Accelerated Approval Program sa pagtatapos ng 2026.
Mahahalagang fact
- Na-file
- Hul 2, 2026, 08:30 PM
- Kaganapan
- Naitakda ang petsa ng PDUFA
- Direksyon
- Neutral
- Kumpanya
OSTXOS Therapies- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
Sipi mula sa source
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