一次情報の記録
重要申請提出
Protara、LMs向けTARA-002のBLA提出を2027年下半期に予定
BTDに基づくFDAとの協議を経て、同社はSTARBORN-1試験のピボタルデータに基づき、リンパ管奇形を対象としたTARA-002のBLA提出を2027年下半期に計画している。FDA審査を支援するため、試験の安全性および有効性データは継続的に提出される。
主要事実
出典の抜粋
EX-99.1 2 ea029923601ex99-1.htm PRESS RELEASE DATED AUGUST 11, 2026, ISSUED BY THE REGISTRANT Exhibit 99.1 Protara Therapeutics Announces Second Quarter 2026 Financial Results and Provides a Business Update Expect to complete enrollment of the BCG-Unresponsive registrational cohort of the ADVANCED-2 trial in 4Q 2026 The ADVANCED-3 trial is being redesigned as an exploratory trial to expand into and accelerate data in high-grade, high-risk BCG-Naïve and BCG-Exposed CIS (± Ta/T1) patients and papillary (Ta/T1) patients across BCG exposures Expect to provide an update and complete enrollment of the STARBORN-1 trial in LMs in 4Q 2026; expect to submit a Biologics License Application for TARA-002 in LMs in 2H 2027 On track to report interim results from THRIVE-3 registrational trial of IV