Palvella Therapeutics, Inc. PVLA
Palvella Therapeutics, Inc. (Nasdaq: PVLA) is a dermatology drug developer. Its lead program, QTORIN 3.9% rapamycin anhydrous gel, is in Phase 3 for microcystic lymphatic malformations. Its next catalyst on record is QTORIN rapamycin for microcystic LMs: FDA PDUFA action date (February 2027).
Upcoming catalysts
- February 2027QTORIN rapamycin for microcystic LMs — FDA PDUFA action date
The FDA assigned a Prescription Drug User Fee Act ('PDUFA') target action date of February 28, 2027.
Next further out: QTORIN rapamycin for cutaneous VMs — Phase 3 pivotal study commencement (Q4 2026). 4 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| QTORIN rapamycin | microcystic lymphatic malformations | small molecule | Phase 3 |
| QTORIN rapamycin | cutaneous venous malformations | small molecule | Phase 2 |
| QTORIN rapamycin | clinically significant angiokeratomas | small molecule | Phase 2 |
| QTORIN pitavastatin | disseminated superficial actinic porokeratosis (DSAP) | small molecule | Pre-clinical |
Recent results and decisions
- Oct 31, 2026accepted FDA accepted the NDA for QTORIN rapamycin for microcystic lymphatic malformations and granted Priority Review with a PDUFA date of February 28, 2027.
Completed the NDA submission for QTORIN™ rapamycin, which was accepted by the FDA with a February 28, 2027 PDUFA target action date.
Filing - Oct 28, 2026accepted FDA accepts NDA for QTORIN™ rapamycin for microcystic lymphatic malformations, grants Priority Review with February 28, 2027 PDUFA target action date.
The FDA has accepted for filing and granted Priority Review to the Company's New Drug Application (NDA) for QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs).
Filing - Oct 28, 2026accepted FDA accepts NDA for QTORIN™ rapamycin for microcystic lymphatic malformations and grants Priority Review with PDUFA date of February 28, 2027.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2027.
Filing
5 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 dermatology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.