Palvella Therapeutics Completes Enrollment for Pivotal Phase 3 Trial of QTORIN Rapamycin

Palvella Therapeutics Inc. (NASDAQ:PVLA) is one of the best-performing NASDAQ stocks according to analysts. On June 23, Palvella Therapeutics announced the successful completion of enrollment for its Phase 3 SELVA trial. The trial is evaluating QTORIN 3.9% rapamycin anhydrous gel (QTORIN rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs).

The trial exceeded its initial enrollment target of 40 subjects by over 25%, successfully enrolling 51 subjects at leading US vascular anomaly centers. This over-enrollment highlights the significant unmet need for treatments for this serious and lifelong genetic disease, for which no FDA-approved therapies currently exist.

The SELVA trial is a 24-week, Phase 3, single-arm, and baseline-controlled study designed to evaluate once-daily QTORIN rapamycin in individuals aged 3 years and older with microcystic LMs. QTORIN rapamycin has received several significant designations from the FDA for the treatment of microcystic LMs, such as Breakthrough Therapy, Orphan Drug, and Fast Track designations. If approved, QTORIN rapamycin is expected to qualify for 7 years of orphan drug market exclusivity in the US.

Palvella Therapeutics Inc. (NASDAQ:PVLA) is a clinical-stage biopharmaceutical company that develops and commercializes novel therapies to treat patients with serious and rare genetic skin diseases.

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Disclosure: None. This article is originally published at Insider Monkey.