Palvella Therapeutics Submits First Module of Rolling New Drug Application to FDA for QTORIN™ Rapamycin for the Treatment of Microcystic Lymphatic Malformations
Palvella Therapeutics has submitted the first module of a rolling New Drug Application to the FDA for QTORIN™ rapamycin for the treatment of microcystic lymphatic malformations. The company remains on track to complete the full NDA submission in the second half of 2026 and is preparing for a potential standalone commercial launch in the first half of 2027. QTORIN™ rapamycin previously received Breakthrough Therapy and Fast Track designations and aims to be the first FDA-approved therapy for the estimated more than 30,000 individuals in the U.S.
Key figures
- Drug Name
- QTORIN™ rapamycin
- Launch target
- first half of 2027
- Target patients us
- more than 30,000
- Nda completion target
- second half of 2026
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