Nagsumite ang Palvella ng unang module ng rolling NDA para sa QTORIN rapamycin

Sinimulan ng Palvella ang rolling NDA submission nito para sa QTORIN rapamycin sa microcystic lymphatic malformations sa pamamagitan ng pag-file ng unang module sa FDA. Nananatili ang kumpanya sa track para makumpleto ang buong NDA submission sa ikalawang kalahati ng 2026 sa ilalim ng Rolling Review na ibinigay pagkatapos ng pre-NDA meeting.

Mahahalagang fact

Na-file: Ago 4, 2026, 11:30 AM
Kaganapan: Naisumite ang aplikasyon
Direksyon: Neutral
Kumpanya: PVLAPalvella
Asset: QTORIN rapamycin
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa source

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

SEC 8-K