Primärquellen-Eintrag
WesentlichPDUFA-Termin festgelegt
OS Therapies: OST-HER2 BLA-Einreichung für Ende 2026 geplant
OS Therapies bereitet sich auf Type-B-Statistikmethoden- und Type-B-Pre-BLA-Meetings mit der U.S. Food & Drug Administration (FDA) vor, um regulatorische Abstimmung für OST-HER2 zu erreichen. Das Unternehmen strebt potenzielle frühe Marktzulassungen Ende 2026 an und plant, die Einreichung der Biologics License Application (BLA) im Rahmen des Accelerated Approval Program bis Ende 2026 abzuschließen.
Kernfakten
- Eingereicht
- 2. Juli 2026, 20:30
- Ereignis
- PDUFA-Termin festgelegt
- Richtung
- Neutral
- Unternehmen
OSTXOS Therapies- Quelle
- SEC 8-K
- Belegstatus
- Belegt
Auszug aus der Quelle
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