Palvella Therapeutics

PVLA

Market cap $819M

Second year proceeds granted following FDA review of annual performance progress report on Phase 3 SELVA single-arm, baseline-controlled trial; up to $2.6 million in non-dilutive funding anticipated over the grant period

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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 venous malformations and lack of FDA-approved pharmacologic options while advocating for an FDA-approved targeted topical formulation of rapamycin for patients with cutaneous venous malformations WAYNE, Pa., Sept. 17, 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 publication of a manuscript in Lymphatic Research and Biology which summarizes a systematic literature review of rapamycin for the treatment of venous malformations (VMs).

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 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. Palvella management will host a conference call for investors at 8:30 a.m.