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 pitavastatin (DSAP): Phase 2 trial initiation (H2 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: QTORIN pitavastatin (DSAP) — Phase 2 trial initiation (H2 2026). 3 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| QTORIN rapamycin (SELVA, completed Ph3) | Microcystic lymphatic malformations | small molecule | Phase 3 |
| QTORIN rapamycin (TOIVA, completed Ph2) | Cutaneous venous malformations | small molecule | Phase 2 |
| QTORIN rapamycin (LOTU Ph2) | Clinically significant angiokeratomas | small molecule | Phase 2 |
| QTORIN pitavastatin | Disseminated superficial actinic porokeratosis (DSAP) | small molecule | Pre-clinical |
Recent results and decisions
- Aug 4, 2026submitted First module of the rolling NDA for QTORIN rapamycin in microcystic LMs submitted to FDA; completion expected 2H 2026.
Submitted the first module of its rolling NDA to the FDA seeking approval of QTORIN™ rapamycin for the treatment of microcystic LMs.
Filing - May 20, 2026positive ISSVA subgroup data from SELVA: ages 6-11 (n=13) mean mLM-IGA +2.46 at Week 24 (p<0.001), 100% much or very much improved.
In participants aged 6–11 years (n=13), QTORIN™ rapamycin demonstrated statistically significant improvement on the Microcystic Lymphatic Malformation Investigator Global Assessment (mLM-IGA) of +2.46 at Week 24 (p<0.001).
Filing - May 7, 2026started First patients dosed in the Phase 2 LOTU trial of QTORIN rapamycin in clinically significant angiokeratomas.
Dosed first patients in the Phase 2 LOTU trial, a single-arm, baseline-controlled clinical trial of QTORIN™ rapamycin administered topically once daily for the treatment of clinically significant angiokeratomas.
Filing
2 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.