Palvella Therapeutics

PVLA

Market cap $1.25B

Phase 3 SELVA study evaluating QTORIN™ rapamycin 3.9% anhydrous gel (QTORIN™ rapamycin) for microcystic lymphatic malformations (microcystic LMs) remains on track, with topline results anticipated in March 2026; pending positive results, an NDA submission is planned for the second half of 2026

Seasoned dermatology and immunology executive brings more than 25 years of experience advancing and launching innovative therapies, including OPZELURA ® , povorcitinib, ILUMYA®, ODOMZO ® , REMICADE ® , and STELARA ®

Palvella Therapeutics offers a compelling risk/reward profile, underpinned by strong Phase 2 data and a pivotal Phase 3 catalyst in Q1 2026. Palvella's QTORIN rapamycin platform demonstrates high local efficacy with minimal systemic exposure, validated across multiple rare skin disease indications. With $63.6M in cash and a recent $80M raise, Palvella is well-capitalized to reach key data readouts and NDA preparation, minimizing financing risk.

Fast Track designation designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and fill an unmet need

73% of trial participants (11/15 participants) improved on the Overall Cutaneous Venous Malformations Investigator Global Assessment (Overall cVM-IGA) at Week 12; 67% of trial participants (10/15 participants) rated as “Much Improved” (+2) or “Very Much Improved” (+3) on the Overall cVM-IGA at Week 12

Palvella's recently expanded rare disease pipeline now comprises QTORIN™-derived product candidates advancing in four serious, rare skin diseases that currently have no FDA-approved therapies

WAYNE, Pa., Nov. 06, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: PVLA) Palvella Therapeutics, Inc. (Palvella or “the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases 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 present at the Stifel 2025 Healthcare Conference on Wednesday, November 12, 2025, at 4:00 p.m. ET.

DSAP is a premalignant, progressive disease characterized by numerous expanding lesions which significantly impact quality-of-life; no FDA-approved therapies exist for the estimated more than 50,000 diagnosed U.S. patients

WAYNE, Pa., Nov. 04, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: PVLA) Palvella Therapeutics, Inc. (Palvella), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases for which there are no FDA-approved therapies, today announced that it will report its third quarter 2025 financial results before market open on Tuesday, November 11, 2025. Palvella management will host a conference call for investors at 8:30 a.m. ET on that same day to discuss the results and provide a corporate update.

Second year proceeds granted following FDA review of annual performance progress report on Phase 3 SELVA single-arm, baseline-controlled trial; up to $2.6 million in non-dilutive funding anticipated over the grant period