On September 24, 2025, Palvella Therapeutics, Inc. (NASDAQ: PVLA) announced that it is expanding the development of its QTORIN™ 3.9% rapamycin anhydrous gel into clinically significant angiokeratomas, a rare lymphatic skin disease that currently has no FDA‑approved therapies and affects more than 50,000 U.S. patients.
The company stated that the expansion aligns with its strategy of targeting serious, rare skin diseases where it can introduce the first FDA‑approved therapy. Palvella’s QTORIN™ platform is already being evaluated in Phase 3 SELVA for microcystic lymphatic malformations and Phase 2 TOIVA for cutaneous venous malformations, and the new indication adds a third potential market to the pipeline.
CEO Wes Kaupinen said, “Based on scientific discoveries and published case studies on off‑label rapamycin, we are excited to expand QTORIN™ rapamycin into this chronically debilitating disease, which represents our third target clinical indication and aligns with Palvella’s strategy of selecting serious, rare skin diseases in which we have the opportunity to introduce the first FDA‑approved therapy.”
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