Heurist Finance

Palvella's QTORIN rapamycin gets FDA priority review with Feb 28, 2027 PDUFA date

GlobeNewswire ·
Palvella's QTORIN rapamycin gets FDA priority review with Feb 28, 2027 PDUFA date
  • FDA accepted Palvella's New Drug Application for QTORIN 3.9% rapamycin gel for microcystic lymphatic malformations and granted Priority Review (announced Oct 28, 2026).
  • The PDUFA target action date is February 28, 2027.
  • The Phase 3 SELVA study met all six prespecified efficacy endpoints, each with p<0.001.
  • Palvella is preparing for a potential standalone U.S. commercial launch in H1 2027, subject to FDA approval.

Quotes

“With compelling Phase 3 SELVA results and a February 28, 2027 PDUFA target action date, we believe we are closer than ever to delivering on that mission.”— Wes Kaupinen

Sources