FDA Accepts Palvella’s QTORIN NDA for Priority Review
The FDA set February 28, 2027, as the PDUFA target action date for QTORIN rapamycin.
Story updates
11:34:21 AM UTC
SquawkNews
Palvella said the FDA accepted and granted Priority Review to its NDA for QTORIN 3.9% rapamycin gel for microcystic LMs, with a Feb 28, 2027 PDUFA target action date. Phase 3 SELVA met all six endpoints (all p<0.001).Material DetailsContext by AI AnalystThis marks a late-stage regulatory step follo…
11:34:50 AM UTC
SquawkNews
QTORIN™ rapamycin could become the first FDA-approved therapy for microcystic lymphatic malformations, a serious, lifelong rare disease affecting an estimated more than 30,000 diagnosed children and adults in the U.S.Phase 3 SELVA study achieved highly statistically significant results across all s…