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Clinically significant 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
Palvella's QTORIN rapamycin is its main value driver. This candidate is in Phase 3 trials for mLM. Management anticipates its top-line data by Q1 2026, with a potential NDA planned by 2H2026. If approved, QTORIN would be a potential first-in-disease medication, which would give it solid competitive prospects.
Recent advances in understanding venous malformation disease pathogenesis highlight the PI3K/AKT/mTOR pathway as a key driver of disease proliferation, spurring real-world off-label use of systemic rapamycin (sirolimus) Publication includes a systematic review of 26 studies evaluating the use of rapamycin for the treatment of venous malformations Study authors highlight unmet clinical need for ...
Phase 2 TOIVA trial successfully met recruitment target, enrolling 16 subjects at leading vascular anomaly centers; top-line data expected in mid-December 2025
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 E...
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
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