Business
Palvella Therapeutics Granted FDA Fast Track Designation for QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Angiokeratomas
Fast Track designation designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and fill an unmet need With Fast Track designation, QTORIN™ rapamycin for angiokeratomas may be eligible for Accelerated Approval and Priority Review in the future, if applicable criteria are met Palvella plans to initiate a Phase 2 trial evaluating QTORIN™ rapamycin for clinically significant angiokeratomas in the second half of 2026 Angiokeratomas are characterized by ly
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":"Fast Track designation designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and fill an unmet need","length":147,"tagName":"p"},{"type":"text","content":"With Fast Track designation, QTORIN™ rapamycin for angiokeratomas may be eligible for Accelerated Approval and Priority Review in the future, if applicable criteria are met","length":172,"tagName":"p"},{"type":"text","content":"Palvella plans to initiate a Phase 2 trial evaluating QTORIN™ rapamycin for clinically significant angiokeratomas in the second half of 2026","length":140,"tagName":"p"},{"type":"text","content":"Angiokeratomas are characterized by lymphatic-derived skin lesions that can persistently bleed and significantly impact quality of life; no FDA-approved therapies exist for the estimated more than 50,000 diagnosed U.S. patients","length":227,"tagName":"p"},{"type":"text","content":"WAYNE, Pa., Dec. 16, 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 the FDA has granted Fast Track Designation to QTORIN™ rapamycin for the treatment of angiokeratomas.","length":484,"tagName":"p"},{"type":"text","content":""We are thrilled that the FDA has granted Fast Track Designation for QTORIN™ rapamycin in angiokeratomas,” said Wes Kaupinen, Founder and CEO of Palvella. “Angiokeratomas are chronic, often debilitating lesions with no FDA-approved therapies. This Fast Track designation underscores the potential of QTORIN™ rapamycin to address this significant unmet need and supports o...