Inaasahan ng Protara ang pagsusumite ng TARA-002 BLA para sa LMs sa 2H 2027

Kasunod ng pakikipag-ugnayan sa FDA sa ilalim ng BTD, plano ng kumpanya na magsumite ng BLA para sa TARA-002 sa mga lymphatic malformations batay sa pivotal STARBORN-1 trial sa ikalawang kalahati ng 2027. Patuloy na isusumite ang data ng kaligtasan at bisa mula sa trial upang suportahan ang pagsusuri ng FDA.

Mahahalagang fact

Na-file: Ago 11, 2026, 12:05 PM
Kaganapan: Naisumite ang aplikasyon
Direksyon: Neutral
Kumpanya: TARAProtara
Asset: TARA-002
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa source

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

SEC 8-K

Higit pa tungkol sa asset na ito

Materyal

May 13, 2026

12:05 PM

TARAProtara

Plano ng Protara na magsumite ng TARA-002 BLA para sa LMs sa 2H 2027

Naisumite ang aplikasyonSEC 8-K Buksan ang record