Catatan sumber primer
MaterialTanggal PDUFA ditetapkan
OS Therapies: Pengajuan BLA OST-HER2 ditargetkan akhir 2026
OS Therapies sedang mempersiapkan pertemuan Metode Statistik Tipe B dan pertemuan Pra-BLA Tipe B dengan U.S. Food & Drug Administration (FDA) untuk mendapatkan keselarasan regulasi bagi OST-HER2. Perusahaan menargetkan potensi otorisasi pasar awal pada akhir 2026 dan berencana menyelesaikan pengajuan Biologics License Application (BLA) di bawah Accelerated Approval Program pada akhir tahun 2026.
Fakta utama
- Diajukan
- 2 Jul 2026, 20.30
- Peristiwa
- Tanggal PDUFA ditetapkan
- Arah
- Netral
- Perusahaan
OSTXOS Therapies- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
Kutipan sumber
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