1차 출처 기록
결정급자문위원회 일정 확정
MoonLake, sonelokimab HS BLA 패키지를 위한 FDA Type B 미팅 일정 확정
MoonLake는 2025년 12월 15일 FDA와 Type B 미팅을 확정하여 VELA-1 및 VELA-2 시험의 현재 임상 증거 패키지가 hidradenitis suppurativa에 대한 sonelokimab의 BLA 제출을 지원하기에 충분한지 논의할 예정입니다. 미팅 결과는 2026년 3분기/4분기 예정 BLA 제출의 규제 경로와 시기를 결정할 것입니다.
핵심 사실
출처 발췌
EX-99.1 2 moonlake-pressreleasexq320.htm EX-99.1 Document MoonLake Immunotherapeutics Reports Third Quarter 2025 Financial Results and Announces New Data from Clinical Trials of its Nanobody® Sonelokimab • Ended the third quarter with $380.5 million in cash, cash equivalents and short-term marketable debt securities which, together with funds from a previously announced debt-facility, are expected to provide runway into the second half of 2027 • Reported results of its Phase 2 LEDA clinical trial in Palmoplantar Pustulosis (PPP) where sonelokimab (SLK) demonstrated clinically meaningful and statistically significant benefit • Reported an interim analysis of the long-term data from the VELA-1 and VELA-2 clinical trials in adults with Hidradenitis Suppurativa (HS), as well as an interim a