Pieris Pharmaceuticals, Inc. Stock News

Brings expertise in cutaneous vascular anomalies, including microcystic lymphatic malformations, venous malformations and angiokeratomas

QTORIN™ rapamycin has the potential to become the first FDA-approved therapy and establish a new standard of care for an estimated more than 30,000 pediatric and adult patients living with microcystic lymphatic malformations in the U.S.

WAYNE, Pa., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the “Company”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies for serious, rare skin diseases and vascular malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, announced today that Wes Kaupinen, F...

First module of the rolling NDA for QTORIN™ rapamycin for microcystic lymphatic malformations submitted to FDA, with completion of the NDA submission on track for the second half of 2026 Preparing for a planned standalone U.S. commercial launch of QTORIN™ rapamycin for microcystic lymphatic malformations in the first half of 2027, if approved Initiation of Phase 3 trial of QTORIN™ rapamycin for...

Brings more than 25 years of experience advancing and commercializing high-impact therapies for serious diseases, including those with limited or no approved treatment options

FDA's rolling review process is intended to facilitate expedited review, enabling FDA to begin evaluating completed modules of the NDA before the full application is submitted

FDA's rolling review process is intended to facilitate expedited review, enabling FDA to begin evaluating completed sections of the NDA before the full application is submitted