WAYNE, PA — Palvella Therapeutics, Inc. (Nasdaq: PVLA) has released its financial results for the first quarter of 2025, along with key updates from its clinical development programs for QTORIN™ 3.9% rapamycin anhydrous gel, which is being evaluated for the treatment of microcystic lymphatic malformations (microcystic LMs) and cutaneous venous malformations (cutaneous VMs).
The Phase 3 SELVA trial for microcystic LMs has exceeded its enrollment target of 40 patients and is expected to close enrollment in June 2025. Top-line results are anticipated in the first quarter of 2026. If approved, QTORIN™ rapamycin would become the first FDA-approved therapy for microcystic LMs, addressing a rare genetic disorder for which no treatments currently exist.
Additionally, the ongoing Phase 2 TOIVA trial is testing QTORIN™ rapamycin for cutaneous VMs across six U.S. sites. This trial, focused on a difficult-to-treat condition, aims to deliver top-line results in the fourth quarter of 2025.
“We are pleased with the strong interest from clinical investigators, trial sites, and participants in our Phase 3 SELVA study, which has allowed us to exceed enrollment targets,” said Wes Kaupinen, Founder and Chief Executive Officer of Palvella Therapeutics. “With a potential first-to-market therapy in the U.S. for microcystic lymphatic malformations and cutaneous venous malformations, QTORIN™ rapamycin represents a significant market opportunity and, more importantly, hope for patients facing these challenging conditions.”
Financially, Palvella reported cash and cash equivalents of $75.6 million as of March 31, 2025, providing a runway to fund operations into the second half of 2027. First-quarter research and development expenses increased to $4.1 million, reflecting increased investment in clinical trials for QTORIN™ rapamycin. General and administrative expenses rose to $3.8 million, including costs associated with new hires and public company operations.
Palvella continues to advance its mission of developing innovative therapies for rare diseases. The company’s strategic pipeline and promising clinical results position it to make a meaningful impact in areas of unmet medical need, potentially transforming the standard of care for patients with microcystic LMs and cutaneous VMs.
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