OS Therapies: Presentación de la BLA de OST-HER2 prevista para finales de 2026

OS Therapies se está preparando para las reuniones Tipo B de Métodos Estadísticos y Tipo B Pre-BLA de la Administración de Alimentos y Medicamentos de EE.UU. (FDA) para obtener alineación regulatoria para OST-HER2. La compañía apunta a posibles autorizaciones de mercado tempranas a finales de 2026 y planea completar la presentación de la Solicitud de Licencia de Biológicos (BLA) bajo el Programa de Aprobación Acelerada para finales de 2026.

Datos clave

Presentado: 2 jul 2026, 20:30
Evento: Fecha PDUFA fijada
Dirección: Neutral
Empresa: OSTXOS Therapies
Fuente: SEC 8-K
Confianza: Con fuente

Extracto de la fuente

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

SEC 8-K