PVLA

Announcements

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Daily updates

• Palvella Therapeutics secured a third year of FDA Orphan Products grant funding to advance QTORIN rapamycin following positive Phase 3 SELVA results, with all six efficacy endpoints showing statistically significant improvements.Sep 28, 2026

FDA designations

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News

• FDA awards additional funding to support QTORIN Rapamycin development for microcystic lymphatic malformationsSep 28, 2026
• Palvella Therapeutics completed the rolling NDA submission to the FDA for QTORIN Rapamycin in microcystic lymphatic malformationsAug 31, 2026
• Palvella Therapeutics submitted the first module of its rolling NDA for QTORIN Rapamycin to the FDAJun 29, 2026
• Palvella Therapeutics completed its FDA pre-NDA meeting for QTORIN RapamycinJun 3, 2026
• Palvella Therapeutics dosed the first patients in the Phase 2 LOTU trial of QTORIN RapamycinMay 4, 2026