Palvella Therapeutics (PVLA) announced the expansion of its QTORIN 3.9% rapamycin anhydrous gel development program into Clinically Significant Angiokeratomas. Palvella plans to meet with the FDA in the first half of 2026 to discuss the proposed design of a Phase 2 study of approximately 10-20 patients to evaluate QTORIN rapamycin for the treatment of clinically significant angiokeratomas. Study initiation is anticipated in the second half of 2026. Additionally, QTORIN rapamycin is currently being evaluated for microcystic lymphatic malformations in the Phase 3 SELVA study and cutaneous venous malformations in the Phase 2 TOIVA study. SELVA top-line results are anticipated in the first quarter of 2026 and TOIVA top-line results are expected in mid-December 2025.
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