PVLA biotech catalysts & pipeline

PALVELLA THERAPEUTICS INC · Data as of 2026-10-25

Upcoming catalysts

sirolimus (QTORIN rapamycin) — Rolling 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 2026

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

sirolimus (QTORIN rapamycin) — PDUFA

Q2 2027

APPROVAL TARGET Q2 2027

Source 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 2027

Source filing

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