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U.S. Food and Drug Administration Awards Year Two Proceeds from Orphan Products Grant Supporting Palvella Therapeutics’ Phase 3 SELVA Trial of QTORIN™ Rapamycin for Microcystic Lymphatic Malformations

Second year proceeds granted following FDA review of annual performance progress report on Phase 3 SELVA single-arm, baseline-controlled trial; up to $2.6 million in non-dilutive funding anticipated over the grant period Top-line data from SELVA expected in the first quarter of 2026; New Drug Application (NDA) submission planned for second half of 2026 WAYNE, Pa., Oct. 13, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: PVLA) Palvella Therapeutics, Inc. (Palvella), a clinical-stage biopharmaceutical company f

articlePalvella Therapeutics, Inc.October 13, 20257/company/palvella-therapeutics-inc/news/u-food-drug-administration-awards-113000185
U.S. Food and Drug Administration Awards Year Two Proceeds from Orphan Products Grant Supporting Palvella Therapeutics’ Phase 3 SELVA Trial of QTORIN™ Rapamycin for Microcystic Lymphatic Malformations

About this update from Palvella Therapeutics, Inc.

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More updates from Palvella Therapeutics, Inc.

rare skin diseasesPalvella Therapeutics, IncFDAclinical trialPalvella TherapeuticsSELVAFDA-approved therapiesU.S. Food and Drug Administration Orphan Products