Articles from Palvella Therapeutics Inc.

Co-Founder and former Chief Technical Officer of Arcutis Biotherapeutics brings extensive topical product development experience, including track record of translating science into commercially available therapies

WAYNE, Pa., Aug. 28, 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 Food and Drug Administration-approved therapies, today announced that Wes Kaupinen, Founder and Chief Executive Officer of Palvella, will present at two upcoming healthcare investor conferences. The details are as follows:

Phase 3 SELVA trial evaluating QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for microcystic lymphatic malformations completed enrollment, exceeding enrollment target by over 25%; top-line results on track for the first quarter of 2026

WAYNE, Pa., Aug. 07, 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 second quarter 2025 financial results on Thursday, August 14, 2025.

WAYNE, Pa., Aug. 05, 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 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 Canaccord Genuity 45th Annual Growth Conference on Tuesday, August 12, 2025, at 1:00 p.m. ET.

WAYNE, Pa., June 30, 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 it has been added to the broad-market Russell 3000® Index and the Russell 2000® Index, effective after the U.S. market opens on June 30, as part of the 2025 Russell indexes reconstitution.

Enrollment of 51 subjects highlights significant unmet need in this serious, lifelong genetic disease which currently has no FDA-approved therapies

New intellectual property builds on Palvella’s multi-layered exclusivity strategy

FDA Orphan Products Grants are awarded based on rigorous scientific and technical review by rare disease and regulatory experts

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

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

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.

WAYNE, Pa., May 05, 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 genetic skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, announced today that the Company will ring the opening bell at the Nasdaq Stock Market (Nasdaq) on Monday, May 12, 2025 in New York City.

Quantitative analysis of medical claims indicates an estimated 44,553 to 92,967 diagnosed U.S. patients with lymphatic malformations (LMs) with cutaneous involvement

Fifth issued patent in the U.S. for QTORIN™ rapamycin with anticipated patent life extending into 2038

Presentation highlighted the recent expansion of the Phase 3 SELVA trial to include children 3 to 5 years old

WAYNE, Pa., April 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 genetic skin diseases for which there are no 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 Jones Healthcare and Technology Innovation Conference on Wednesday, April 9, 2025, at 2:00 p.m. PT.

Presentation to highlight SELVA, a 24-week, Phase 3, single-arm, baseline-controlled clinical trial of QTORIN™ rapamycin 3.9% anhydrous gel for the treatment of microcystic lymphatic malformations

Upon close of merger and $78.9mm concurrent private placement from a syndicate of leading healthcare-dedicated investors, completed transformation to a publicly traded rare disease biopharmaceutical company advancing a late clinical-stage pipeline and a platform for treating serious, rare genetic skin diseases

WAYNE, Pa., March 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 FDA-approved therapies, today announced that it will report its full year 2024 financial results on Monday, March 31, 2025.

WAYNE, Pa., Feb. 25, 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 its management team will present at the TD Cowen 45th Annual Healthcare Conference on Tuesday March 4, 2025, at 2:30 p.m. ET.

Expansion reflects Palvella's commitment to serving all patients affected by microcystic lymphatic malformations (microcystic LMs)

Publication reports 100% of participants were either “Much Improved” or “Very Much Improved” as rated by the Clinician Global Impression of Change following 12-weeks of QTORIN™ rapamycin

Phase 2 single-arm, baseline-controlled trial evaluating QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of cutaneous venous malformations (cutaneous VMs) to enroll approximately 15 subjects at leading vascular anomaly centers across the U.S.

        Palvella Therapeutics to debut on Nasdaq under the ticker symbol “PVLA” as a publicly traded rare disease biopharmaceutical company advancing a late clinical-stage pipeline and a platform for treating serious, rare genetic diseases