原始出處紀錄
重大申請已送件
Protara 預計 TARA-002 針對 LMs 的 BLA 提交將於 2027 年下半年進行
在 BTD 下的 FDA 互動後，該公司計劃根據 STARBORN-1 關鍵試驗的結果，在 2027 年下半年提交 TARA-002 用於淋巴管畸形的 BLA。試驗的持續安全性與療效數據將持續提交以支持 FDA 審查。
關鍵事實
來源摘錄
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