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Protara planeja submissão de BLA para TARA-002 em LMs no 2S 2027

O comunicado à imprensa afirma que a empresa pretende submeter um BLA para TARA-002 em LMs com base no ensaio pivotal STARBORN-1 no segundo semestre de 2027. A FDA transferiu a análise de TARA-002 do Office of Vaccines Research and Review para o Office of Therapeutic Products. A empresa continuará a submeter dados de segurança e eficácia do ensaio de forma contínua para apoiar a avaliação da FDA.

Fatos principais

Arquivado
13 de mai. de 2026, 12:05
Evento
Pedido submetido
Direção
Neutro
Empresa
TARAProtara
Ativo
TARA-002
Fonte
SEC 8-K
Confiança
Com fonte

Trecho da fonte

EX-99.1 2 ea028858101ex99-1.htm PRESS RELEASE DATED MAY 13, 2026, ISSUED BY THE REGISTRANT Exhibit 99.1 Protara Therapeutics Announces First Quarter 2026 Financial Results and Provides a Business Update The Company intends to submit a Biologics License Application (BLA) for TARA-002 in Lymphatic Malformations (LMs) in 2H 2027 Hosting virtual investor webinar discussing LMs program with key opinion leader (KOL) perspectives on May 19, 2026 at 4:30 pm ET Interim safety and durability data from STARBORN-1 trial of TARA-002 in LMs to be presented at the International Society for the Study of Vascular Anomalies (ISSVA) World Congress 2026 in May Company expects to complete enrollment of the BCG-Unresponsive registrational cohort of the ADVANCED-2 trial and initiate the ADVANCED-3 regist

SEC 8-K

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