1차 출처 기록
중대신청 제출
Palvella, QTORIN rapamycin에 대한 rolling NDA 첫 번째 모듈 제출
Palvella는 microcystic lymphatic malformations 치료를 위한 QTORIN rapamycin의 rolling NDA 제출을 시작했으며, FDA에 첫 번째 모듈을 제출했습니다. 회사는 pre-NDA 미팅 후 부여된 Rolling Review에 따라 2026년 하반기에 전체 NDA 제출을 완료할 예정입니다.
핵심 사실
출처 발췌
EX-99.1 2 pvla-ex99_1.htm EX-99.1 EX-99.1 Palvella Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update First module of the rolling NDA for QTORIN™ rapamycin for microcystic lymphatic malformations submitted to FDA, with completion of the NDA submission on track for the second half of 2026 Preparing for a planned standalone U.S. commercial launch of QTORIN™ rapamycin for microcystic lymphatic malformations in the first half of 2027, if approved Initiation of Phase 3 trial of QTORIN™ rapamycin for the treatment of cutaneous venous malformations planned for the fourth quarter of 2026 Initiation of Phase 2 trial of QTORIN™ pitavastatin for the treatment of disseminated superficial actinic porokeratosis planned for the second half of 2026 Topline resu