WAYNE, PA — Palvella Therapeutics, Inc. (Nasdaq: PVLA) said the U.S. Food and Drug Administration has granted Fast Track designation to QTORIN™ rapamycin for the treatment of angiokeratomas, a rare and chronic skin condition with no approved therapies.
The designation is intended to speed development and review of drugs that target serious diseases and address unmet medical needs. For Palvella, it opens the door to closer and more frequent engagement with regulators and could make the program eligible for accelerated approval or priority review if future criteria are met.
Angiokeratomas are lymphatic-derived skin lesions that can bleed persistently, cause pain, and impair daily function. The condition affects an estimated more than 50,000 diagnosed patients in the United States and has no FDA-approved treatments. Care today is largely limited to procedural interventions that can be painful, leave scars, and carry a high risk of recurrence.
Palvella plans to advance QTORIN™ rapamycin into a Phase 2 clinical study for clinically significant angiokeratomas, with trial initiation targeted for the second half of 2026. The company expects to meet with the FDA in the first half of 2026 to discuss study design, which is expected to enroll approximately 10 to 20 patients.
QTORIN™ rapamycin is a topical formulation designed to deliver localized therapy while limiting systemic exposure. The drug is already being evaluated in other rare vascular and skin conditions, forming the backbone of Palvella’s broader development strategy.
The FDA’s Fast Track program is designed to shorten timelines by resolving regulatory questions earlier in development and streamlining the review process. For investors and patients alike, the designation signals regulatory recognition of both the seriousness of angiokeratomas and the potential role of QTORIN™ rapamycin in addressing a long-standing treatment gap.
Palvella is a clinical-stage biopharmaceutical company focused on developing therapies for serious, rare skin diseases where approved treatment options remain limited or nonexistent.
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