Palvella (merger target of Pieris) awarded up to $2.6M FDA grant for Phase 3 rare skin disease trial

PALVELLA THERAPEUTICS, INC.

FDA Office of Orphan Products Development awarded Palvella up to $2.6M over 4 years to support Phase 3 SELVA trial of QTORIN rapamycin gel for microcystic lymphatic malformations.
Program has FDA Breakthrough Therapy and Fast Track designations; trial is single-arm, baseline-controlled.
Grant one of seven awarded out of 51 applications in FY2024; underscores high unmet need in rare genetic skin disease.
Positive development for Palvella, which is being acquired by Pieris Pharmaceuticals via merger announced July 23, 2024.

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