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Palvella Therapeutics: other events

Form 8-K filed Oct 28, 2026 · items 8.01

FDA decisionsPalvella Announces FDA Acceptance and Priority Review of QTORIN™ Rapamycin NDA; February 28, 2027 PDUFA Target Action Date Set

What the filing says

QTORIN™ rapamycin could become the first FDA-approved therapy for microcystic lymphatic malformations, a serious, lifelong rare disease affecting an estimated more than 30,000 diagnosed children and adults in the U.S. Phase 3 SELVA study achieved highly statistically significant results across all six prespecified effi

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What usually followsAcross 44,881 8-Ks reporting Item 8.01 (other events) in our universe, the stock's median move the next session was +0.1% (typical size ±1.5%, up 52% of the time); over the following 21 sessions, +1.1%. Every item ranked →

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