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FDA grants rolling review for Palvella's QTORIN™ rapamycin NDA for rare microcystic lymphatic malformations

Market News
22 Jun 2026
GlobeNewsWire
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Bullish
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The FDA has granted rolling review for Palvella Therapeutics' New Drug Application (NDA) for QTORIN™ rapamycin, aimed at treating microcystic lymphatic malformations (LMs), a rare and serious disease with no approved therapies. This expedited review allows the FDA to evaluate sections of the application as they are completed, speeding up the approval process. Palvella plans to submit the full NDA in the second half of 2026 and aims for QTORIN™ rapamycin to become the first FDA-approved treatment for over 30,000 U.S. patients affected by this chronic condition. The drug targets the disease mechanism locally to minimize side effects, offering hope for a condition that currently has limited treatment options.

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