Palvella Therapeutics (PVLA) announced it has received the second year of funding under its FDA Office of Orphan Products Development, OPD, grant. The grant provides up to $2.6 million in non-dilutive funding over its full 4-year term and supports Palvella’s ongoing Phase 3 SELVA trial of QTORIN 3.9% rapamycin anhydrous gel for the treatment of microcystic lymphatic malformations. “We are deeply appreciative of the FDA’s continued support of our Phase 3 program, which reflects the urgency and importance of addressing the significant unmet need faced by the estimated more than 30,000 individuals in the U.S. living with microcystic lymphatic malformations,” said Jeff Martini, Ph.D., Chief Scientific Officer of Palvella. “Exceeding our enrollment goal and maintaining momentum toward top-line data in early 2026 demonstrates the strength of our clinical program and our unwavering commitment to bringing QTORIN(TM) rapamycin to patients who currently have no FDA-approved therapies.”
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