QTORIN rapamycin - (SELVA)

June 22, 2026: Palvella Therapeutics, Inc. (NASDAQ: PVLA) said the FDA granted rolling review for its New Drug Application (NDA) for QTORIN™ rapamycin (QTORIN™ 3.9% rapamycin anhydrous gel) to treat microcystic lymphatic malformations (microcystic LMs). The company stated it remains on track to complete the NDA submission in the second half of 2026, and that rolling review will allow it to submit completed NDA sections as they become available while FDA begins reviewing them. Palvella noted QTORIN™ rapamycin has received FDA Breakthrough Therapy, Fast Track, and Orphan Drug designations for microcystic LMs, and referenced positive Phase 3 SELVA results (no data provided in the text). The release also notes QTORIN™ rapamycin is being developed for cutaneous venous malformations and clinically significant angiokeratomas, and QTORIN™ pitavastatin is being developed for disseminated superficial actinic porokeratosis.