WAYNE, PA — Palvella Therapeutics, Inc. has been awarded up to $2.6 million by the FDA’s Office of Orphan Products Development to support its Phase 3 SELVA trial. This trial investigates QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) as a treatment for microcystic lymphatic malformations (microcystic LMs), a rare and debilitating genetic condition.
“We are pleased to receive this grant from the FDA which will support the advancement of SELVA, our ongoing single arm, baseline-controlled Phase 3 trial of QTORIN rapamycin for the treatment of microcystic LMs,” stated Wes Kaupinen, Founder and CEO of Palvella. He emphasized that the grant highlights the urgent need for treatments for this condition and the potential of QTORIN rapamycin to become the first approved therapy in the U.S.
Among 51 applications, Palvella’s trial was one of only seven selected for funding. The FDA Orphan Products Grants Program, which supports the development of treatments for rare diseases, has contributed to the approval of over 85 products since its inception. This funding marks a critical step toward addressing an unmet medical need, offering hope for patients with microcystic LMs through targeted therapy.
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