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Palvella Therapeutics Completes Enrollment in Phase 3 SELVA Trial of QTORIN™ Rapamycin for Microcystic Lymphatic Malformations, Exceeding Enrollment Target by Over 25%
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. F
About this update from Palvella Therapeutics, Inc.
[{"type":"image","alt":"Palvella Therapeutics Inc.","displaySize":"","headline":null,"caption":"Palvella Therapeutics Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":300,"url":"https://media.zenfs.com/en/globenewswire.com/4b273ae029a5e8cb06a3771e7b41e04d"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/IZ4VZ0Qdm50kE5TTbiIBBg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTQyMDtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/4b273ae029a5e8cb06a3771e7b41e04d","width":300,"height":300}},"lazy":false},{"type":"text","content":"Enrollment of 51 subjects highlights significant unmet need in this serious, lifelong genetic disease which currently has no FDA-approved therapies","length":147,"tagName":"p"},{"type":"text","content":"Top-line data expected in the first quarter of 2026","length":51,"tagName":"p"},{"type":"text","content":"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 Administration (FDA)-approved therapies, today announced the successful completion of SELVA, a Phase 3 trial of QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs). The Phase 3 trial enrolled 51 subjects, exceeding the original target of 40 subjects by over 25%.","length":660,"tagName":"p"},{"type":"text","content":"“The strong demand and over-enrollment in SELVA underscore the high interest within the scientific and clinical communities in establishing a new paradigm of localized, pathogenesis-directed therapy,” said Wes Kaupinen, Founder and Chief Executive Officer of Palvella. “With SELVA now fully enrolled, we remain on track to deliver top-line Phase 3 data in the first quarter of 2026 to support a planned NDA submission for QTORIN™ rapamycin as the first targeted therapy for this chronically debilitating disease.”","length":513,"tagName":"p"},{"type":"text","content":"SELVA is a 24-week, Phase 3, single-arm, baseline-controlled trial evaluating once-daily QTORIN™ rapamycin in individuals aged three years and older with microcystic LMs. Initially designed to enroll 40 subjects, the trial surpassed...