WAYNE, Pa. — August 14, 2025 — Leads & Copy — Palvella Therapeutics, Inc. (Nasdaq: PVLA), a biopharmaceutical company focused on rare genetic skin diseases, has completed enrollment in its Phase 3 SELVA trial for QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin), exceeding its enrollment target by over 25%. Top-line results are expected in the first quarter of 2026.
The company also reported that top-line results for the Phase 2 TOIVA trial evaluating QTORIN™ rapamycin for cutaneous venous malformations remain on track for the fourth quarter of 2025. Palvella plans to announce a third clinical indication for QTORIN™ rapamycin and a second QTORIN™ platform candidate before year-end 2025. As of June 30, 2025, cash and cash equivalents totaled $70.4 million, expected to fund operations into the second half of 2027.
“We remain on track for two near-term data readouts for QTORIN™ rapamycin,” said Wes Kaupinen, Founder and Chief Executive Officer of Palvella. The company will host a conference call at 8:30 a.m. ET today.
Key research and development highlights include the USPTO issuing patent No. 12,268,673 with claims to QTORIN™ rapamycin for the treatment of microcystic LMs with anticipated patent life extending into 2038. The company also appointed Ashley Kline as Chief Commercial Officer.
Wes Kaupinen, Founder and CEO, Palvella Therapeutics, wes.kaupinen@palvellatx.com; Marcy Nanus, Managing Partner, Trilon Advisors LLC, mnanus@trilonadvisors.com
Source: Palvella Therapeutics, Inc.
