Palvella Therapeutics

PVLA

Market cap $2.12B

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

4,302 common shares were exercised and sold on June 17, 2026, for $476,000 at a weighted average price of around $110.73 per share. This was a derivative transaction involving the exercise and immediate sale of options.

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

Palvella Therapeutics, Inc. (PVLA) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript

Palvella Therapeutics is now a much more credible bet on QTORIN after their positive mLM data. They've also received some FDA feedback, which bodes well for their upcoming NDA submission. PVLA is now targeting a 2H2026 NDA submission for QTORIN rapamycin in mLM.

Palvella remains on track to submit an NDA in the second half of 2026 Microcystic lymphatic malformations are serious, chronic, lifelong vascular malformations that can cause persistent leaking, bleeding, infection, functional impairment, and significant daily burden for patients and families QTORIN™ rapamycin has the potential to become the first FDA-approved therapy and standard of care for the estimated more than 30,000 individuals with microcystic lymphatic malformations in the U.S. WAYNE, Pa., June 03, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the “Company”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced completion of its pre-New Drug Application (NDA) meeting with FDA for QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) in microcystic lymphatic malformations (microcystic LMs).

WAYNE, Pa., June 02, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the “Company”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced that Wes Kaupinen, Founder and Chief Executive Officer of Palvella, will participate in a fireside chat at the Goldman Sachs 47th Annual Global Healthcare Conference 2026 on Tuesday, June 9, 2026 at 8:40 a.m. ET.

Yale-licensed U.S. patent provides broad protection for topical mevalonate pathway inhibition in porokeratosis, including disseminated superficial actinic porokeratosis (DSAP)

WAYNE, Pa., May 21, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or “the Company”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced it has been named the Healthcare & Life Sciences Company of the Year at the 2026 Philadelphia Alliance for Capital and Technologies (PACT) Ecosystem Awards. “We are incredibly honored to be recognized by PACT as Healthcare & Life Sciences Company of the Year,” said Wes Kaupinen, Founder and Chief Executive Officer of Palvella.