Palvella Therapeutics Inc., a clinical-stage biopharmaceutical company, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for its investigational drug QTORIN™ rapamycin for the treatment of angiokeratomas. This designation is intended to facilitate the development and expedite the review of drugs addressing serious conditions with unmet medical needs. Currently, there are no FDA-approved therapies for angiokeratomas, which affect over 50,000 diagnosed patients in the U.S. Palvella plans to initiate a Phase 2 clinical trial for QTORIN™ rapamycin in the second half of 2026. No other organizations were mentioned as recipients of this regulatory milestone.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Palvella Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9602825-en) on December 16, 2025, and is solely responsible for the information contained therein.
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