Company Overview - Palvella Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies for serious, rare genetic skin diseases that lack FDA-approved treatments [4] - The company is developing a pipeline of product candidates based on its patented QTORIN™ platform, with its lead product candidate being QTORIN™ 3.9% rapamycin anhydrous gel, currently in Phase 3 and Phase 2 clinical trials [4] Market Position - Palvella has been added to the Russell 3000 Index and the Russell 2000 Index, effective June 30, 2025, as part of the annual Russell indexes reconstitution [1][2] - Membership in the Russell 3000 Index indicates automatic inclusion in the large-cap Russell 1000 Index or small-cap Russell 2000 Index, which is significant for market visibility and investment opportunities [2] Industry Context - The Russell indexes are widely utilized by investment managers and institutional investors for index funds and as benchmarks for active investment strategies, with approximately $10.6 trillion in assets benchmarked against these indexes as of June 2024 [3]

Enrollment of 51 subjects highlights significant unmet need in this serious, lifelong genetic disease which currently has no FDA-approved therapies Top-line data expected in the first quarter of 2026 WAYNE, Pa., June 23, 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 genetic skin diseases for which there are no U.S. Food and Drug ...

New intellectual property builds on Palvella's multi-layered exclusivity strategy Patent term expected through at least 2038 WAYNE, Pa., June 18, 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 genetic skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced that the United S ...

FDA Orphan Products Grants are awarded based on rigorous scientific and technical review by rare disease and regulatory experts Up to $2.6 million in non-dilutive funding anticipated over the grant period Top-line data from SELVA expected in the first quarter of 2026 WAYNE, Pa., June 09, 2025 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Nasdaq: PVLA), a clinical-stage biopharmaceutical company developing and commercializing novel therapies for serious, rare genetic skin diseases with no U.S. Food and Dr ...

Ms. Kline to lead Palvella’s commercial buildout for planned standalone U.S. launch of QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for microcystic lymphatic malformations, a serious, rare, and lifelong genetic disease affecting an estimated more than 30,0000 patients in the U.S., if approved Under Kline’s leadership at Dompé, Oxervate®, a first-in-disease topical therapy for rare disease neurotrophic keratitis, scaled to over $500 million in annual U.S. sales while achieving early profitability ...

Phase 3 SELVA trial evaluating QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs) has exceeded enrollment target of 40 patients; enrollment expected to close in June 2025 Phase 3 SELVA trial top-line results anticipated in the first quarter of 2026 Phase 2 TOIVA trial evaluating QTORIN™ rapamycin for the treatment of cutaneous venous malformations top-line results on track for the fourth quarter of 2025 QTORIN™ rapamycin has th ...

WAYNE, Pa., May 08, 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 genetic skin diseases for which there are no FDA-approved therapies, today announced that it will report its first quarter 2025 financial results on Thursday, May 15, 2025. Palvella management will host a conference call for investors at 8:30 a.m. ET on Thursday, ...

Core Viewpoint - Palvella Therapeutics, Inc. is set to ring the opening bell at the Nasdaq Stock Market on May 12, 2025, marking a significant milestone for the company as it aims to become a leading biopharmaceutical entity focused on rare genetic skin diseases [1][3]. Company Overview - Palvella Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapies for serious, rare genetic skin diseases that currently lack FDA-approved treatments [4]. - The company is led by veterans in rare disease drug development and is advancing a pipeline of product candidates based on its patented QTORIN™ platform [4]. - The lead product candidate, QTORIN 3.9% rapamycin anhydrous gel, is undergoing evaluation in Phase 3 and Phase 2 clinical trials for specific conditions [4]. Leadership and Ceremony - Wes Kaupinen, the Founder and CEO, will be joined by the management team, Board of Directors, investors, and guests during the opening bell ceremony [2]. - The event will be live-streamed from the Nasdaq MarketSite Tower and is intended to showcase Palvella's vision and achievements [3].