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Palvella Therapeutics Announces Completion of FDA Pre-NDA Meeting for QTORIN™ Rapamycin in Microcystic Lymphatic Malformations

$PVLAPress releaseJun 3, 2026, 7:30 AM ETRead the release

Palvella Therapeutics completed its pre-NDA meeting with the FDA for QTORIN™ rapamycin in microcystic lymphatic malformations. The company confirmed it remains on track to submit the New Drug Application in the second half of 2026, in line with prior guidance.

Key figures

Drug Name
QTORIN™ rapamycin
Phase Of Trial
Phase 3
Target population us
30,000
Nda submission window
H2 2026

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