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
Globenewswire·2025-10-13 11:30
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 focused on de ...