Palvella Therapeutics, Inc. PVLA

NDA submission completed following positive Phase 3 SELVA results; potential U.S. commercial launch in the first half of 2027, if approved 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., Sept. 28, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or the “Company”) (Nasdaq: PVLA), a cli

Brings expertise in cutaneous vascular anomalies, including microcystic lymphatic malformations, venous malformations and angiokeratomas Leader in pediatric dermatology with nearly 20 years of distinguished clinical, research, and academic experience Longstanding Palvella clinical collaborator and QTORIN™ trial investigator brings deep understanding of the unmet needs in serious, rare skin diseases including vascular anomalies Dr. Treat to lead medical strategy as Palvella moves QTORIN™ rapamyci

WAYNE, Pa., Sept. 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 for 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 two upcoming healthcare investor c

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. FDA previously granted Breakthrough Therapy and Fast Track designations; QTORIN™ rapamycin has also received Orphan Drug designation Accelerating U.S. launch readiness for a potential commercial launch of QTORIN™ rapamycin in the first half of 2027, if approved W

Ligand Pharmaceuticals (NASDAQ:LGND) outlined its royalty-focused growth strategy, recent XOMA acquisition and portfolio catalysts during a company presentation, highlighting a larger commercial-stage asset base and planned investment capacity. Chief Financial Officer Tavo Espinoza said Ligand has

Palvella Therapeutics stock has delivered a very strong 285.7% return over the past year, yet the latest valuation checks and stretched market multiples suggest the current price may already be baking in a lot of optimism. Palvella Therapeutics has returned 285.7% over the last 12 months, which puts extra focus on whether recent gains are supported by the fundamentals. Progress on the QTORIN rapamycin program, including the rolling New Drug Application and plans for a potential commercial...

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, Founder and Chief Executive Officer of Palvella, will participate in a fireside chat at the Canaccord Ge

Moby summary of Palvella Therapeutics, Inc.'s Q2 2026 earnings call

Palvella Therapeutics Inc (PVLA) reports robust QTORIN rapamycin results, a successful $230M capital raise, and on-track NDA submission for microcystic lymphatic malformations.

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 the treatment of cutaneous venous malformations planned for the fourth quarter of 2026 Initiation of P

Hybrid public meeting on August 5th will explore approaches to selecting and prioritizing promising FDA-approved drugs for repurposing, with the potential to accelerate patient access to effective therapies for significant unmet medical needs Dr. Martini to discuss evidence frameworks and regulatory approaches for advancing repurposed therapies for patients with serious, rare diseases Meeting builds on FDA’s May 2026 drug repurposing initiative focused on advancing new uses for approved medicine

Palvella Therapeutics Inc. (NASDAQ:PVLA) is one of the 10 affordable biotech stocks to buy right now. On June 29, Palvella Therapeutics Inc. (NASDAQ:PVLA) disclosed that it filed the initial module of its New Drug Application with the FDA for approval of QTORIN 3.9% rapamycin anhydrous gel. QTORIN is used to treat microcystic lymphatic malformations. The […]

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 Extensive public company and rare disease experience, including executive and Board roles at Savara Inc. (Nasdaq: SVRA), Soleno Therapeutics (formerly Nasdaq: SLNO), Strongbridge Biopharma (formerly Nasdaq: SBBP) and Insmed Incorporated (Nasdaq: INSM) WAYNE, Pa., June 30, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc