QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) — NDA/BLA submission
2H 2026
First module of rolling NDA submitted in Q2 2026; completed NDA submission on track for 2H 2026Source filing
PVLA biotech catalysts & pipeline
PALVELLA THERAPEUTICS INC · Data as of 2026-09-08
Upcoming catalysts
sirolimus (QTORIN rapamycin) — NDA/BLA submission
H2 2026
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 2026Source filing
QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) — Regulatory decision
H1 2027
Based on these results, Palvella plans to submit a New Drug Application (NDA) to FDA for QTORIN™ rapamycin for patients with microcystic LMs in the second half of 2026, with potential U.S. approval for QTORIN™ rapamycin in the first half of 2027.Source filing
sirolimus (QTORIN rapamycin) — Regulatory decision
H1 2027
We remain on track to file our NDA in the second half of 2026 for microcystic lymphatic malformations, with potential approval targeted in the first half of 2027.Source filing
QTORIN(TM) rapamycin — PDUFA
Q2 2027
APPROVAL TARGET Q2 2027Source filing
sirolimus (QTORIN rapamycin) — Topline data
H2 2027
Topline results from the Phase 2 LOTU trial of QTORIN™ rapamycin for clinically significant angiokeratomas expected in the second half of 2027Source filing