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

Ayon sa press release, balak ng kumpanya na magsumite ng BLA para sa TARA-002 sa LMs batay sa pivotal STARBORN-1 trial sa ikalawang kalahati ng 2027. Inilipat ng FDA ang pagsusuri ng TARA-002 mula sa Office of Vaccines Research and Review patungo sa Office of Therapeutic Products. Patuloy na magsusumite ang kumpanya ng data sa kaligtasan at bisa mula sa trial upang suportahan ang pagsusuri ng FDA.

Mahahalagang fact

Na-file
May 13, 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 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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