Catalysts / PVLA
Upcoming FDA decisions and readouts we track for Palvella Therapeutics, each with the filing that announced it.
FreeBioList tracks 3 catalysts for Palvella Therapeutics (PVLA, listed on Nasdaq): 2 upcoming and 1 decided. All of them concern QTORIN rapamycin (Microcystic lymphatic malformations; Clinically significant angiokeratomas).
First on the list: the FDA decision expected for QTORIN rapamycin (Microcystic lymphatic malformations), guided by the company to H1 2027. By stage, the upcoming rows are 1 Phase 2 readout and 1 FDA decision expected.
Decided and on record:
Each outcome links to the filing or notice that reported it in the table below.
Of the 3 rows, 2 link to SEC filings (8-K or 6-K) and 1 to a company press release. 2 have been verified by a person reading the filing itself, most recently on 12 Sep 2026. 1 still needs confirming against the company's own filing. The methodology page explains each status.
Background reading: NDA vs BLA: the two kinds of US drug application; What a PDUFA date is, and why the FDA doesn't publish them; Clinical trial phases explained: Phase 1 to Phase 4.
| Company ▾ | Drug ▾ | Effect / indication | Next catalyst ▾ | Phase / type ▾ | Status ▾ | Source | Options |
|---|---|---|---|---|---|---|---|
| Palvella Therapeutics PVLA · Nasdaq | QTORIN rapamycin | Microcystic lymphatic malformations | H2 2026 secondary source |
Regulatory submission | Reported | Press release ↗ | Yes |
| Palvella Therapeutics PVLA · Nasdaq | QTORIN rapamycin | Microcystic lymphatic malformations | H1 2027 company guidance |
FDA decision expected | Verified | 8-K exhibit 99.1 ↗ | Yes |
| Palvella Therapeutics PVLA · Nasdaq | QTORIN rapamycin | Clinically significant angiokeratomas | H2 2027 company guidance |
Phase 2 readout | Verified | 8-K exhibit 99.1 ↗ | Yes |
FreeBioList