Palvella: FDA Grants Fast Track Designation For QTORIN Rapamycin In Angiokeratomas

(RTTNews) - Palvella Therapeutics ((PVLA) announced that the FDA has granted Fast Track Designation to QTORIN rapamycin for the treatment of angiokeratomas. The company noted that, if relevant criteria are met, programs with Fast Track designation can become eligible for accelerated approval and priority review.

In September 2025, Palvella announced the expansion of QTORIN rapamycin development program into clinically significant angiokeratomas. The company plans to meet with the FDA in the first half of 2026 to discuss the proposed design of a Phase 2 study of approximately 1020 patients, with study initiation expected in the second half of 2026.

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