Registro de fonte primária
RelevanteData PDUFA definida
OS Therapies: Submissão do BLA para OST-HER2 prevista para o final de 2026
OS Therapies está se preparando para reuniões Tipo B de Métodos Estatísticos e Tipo B Pré-BLA com a U.S. Food & Drug Administration (FDA) para obter alinhamento regulatório para OST-HER2. A empresa visa potenciais autorizações de mercado antecipadas no final de 2026 e planeja concluir a submissão do Biologics License Application (BLA) sob o Programa de Aprovação Acelerada até o final de 2026.
Fatos principais
- Arquivado
- 2 de jul. de 2026, 20:30
- Evento
- Data PDUFA definida
- Direção
- Neutro
- Empresa
OSTXOS Therapies- Fonte
- SEC 8-K
- Confiança
- Com fonte
Trecho da fonte
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