Palvella nag-ulat ng positibong Phase 3 SELVA topline para sa QTORIN rapamycin sa microcystic LMs

Phase 3 SELVA ay nakamit ang pangunahing endpoint nito (mean mLM-IGA change +2.13, p<0.001) at lahat ng secondary endpoints (lahat ng p<0.001) sa microcystic lymphatic malformations. Plano ng Palvella na magsumite ng NDA sa H2 2026, na may potensyal na unang pag-apruba sa U.S. sa H1 2027. Ang QTORIN rapamycin ay mahusay na tinanggap nang walang seryosong masamang pangyayari na may kaugnayan sa gamot.

Mahahalagang fact

Na-file: Peb 24, 2026, 11:30 AM
Kaganapan: Topline na resulta
Direksyon: Positibo
Kumpanya: PVLAPalvella
Asset: QTORIN rapamycin
Pinagmulan: SEC 8-K
Kumpiyansa: May source
kaligtasan: walang gamot-nauugnay na SAEs; systemic levels <2 ng/mL
mLM-IGA pagbabago: +2.13 (p<0.001)
pagpapabuti rate: 95%
Pangalawahing sukatan ng resulta: lahat p<0.001
Malaki hanggang napakalaking pagbuti: 86%

Sipi mula sa source

EX-99.1 2 pvla-ex99_1.htm PRESS RELEASE ISSUED BY PALVELLA THERAPEUTICS, INC. ON FEBRUARY 24, 2026 EX-99.1 Palvella Therapeutics Announces Positive Topline Results from Phase 3 SELVA Clinical Study of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) in Microcystic Lymphatic Malformations Primary endpoint met with statistically significant improvement (mean change of +2.13; p<0.001) on the Microcystic Lymphatic Malformation Investigator Global Assessment (mLM-IGA) Achieved statistical significance on pre-specified key secondary endpoint (p<0.001) and all four secondary efficacy endpoints (all p<0.001) 95% of trial participants aged ≥ 6 who completed the efficacy evaluation period improved on the mLM-IGA at Week 24 86% of trial participants aged ≥ 6 who completed the efficacy e

SEC 8-K