The US FDA Accepts Palvella Therapeutics’ NDA with Priority Review for QTORIN Rapamycin to Treat Microcystic Lymphatic Malformations

Shots: The US FDA has accepted & granted Priority Review to Palvella Therapeutics’ NDA for QTORIN 3.9% rapamycin anhydrous gel to treat microcystic lymphatic malformations (microcystic LMs), with a PDUFA date of Feb 28, 2027 The NDA is supported by the P-III (SELVA) trial, which met all 6 prespecified efficacy endpoints (all p<0.001), with 95% of pts aged ≥6yrs who completed the efficacy evaluation period showing improvement on the mLM-IGA 1EP, along with P-II data; no drug-related SAEs were reported QTORIN rapamycin holds the FDA’s BTD, Fast Track & ODD for microcystic LMs; Palvella is preparing for a potential US launch in H1’27 Ref: GlobeNewswire  |   Image: Palvella Therapeutics  |  Press Release PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com The post The US FDA Accepts Palvella Therapeutics’ NDA with Priority Review for QTORIN Rapamycin to Treat Microcystic Lymphatic Malformations appeared first on PharmaShots.