On October 13, 2025, Palvella Therapeutics announced that it has received the second year of funding under its FDA Office of Orphan Products Development grant, providing up to $2.6 million in non‑dilutive funding over the grant’s four‑year term.
The grant directly supports Palvella’s Phase 3 SELVA trial of QTORIN™ 3.9 % rapamycin anhydrous gel for microcystic lymphatic malformations. The SELVA study is a 24‑week, single‑arm, baseline‑controlled trial that enrolled 51 subjects, exceeding its 40‑patient target, and is scheduled to report top‑line results in the first quarter of 2026.
By securing this second‑year funding, Palvella reduces its cash burn and demonstrates continued FDA confidence in its clinical program. The grant strengthens the company’s financial runway as it moves toward a potential NDA submission in the second half of 2026, positioning QTORIN™ rapamycin for a rare disease market with no approved therapies.
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