Palvella Therapeutics, Inc. (PVLA) is set to present topline results from its pivotal Phase 3 SELVA clinical trial evaluating QTORIN 3.9% rapamycin anhydrous gel (QTORIN rapamycin) for the treatment of microcystic lymphatic malformations today.
The company will host a conference call today, February 24, 20206, at 8:00 am, where the data will be discussed in detail. PVLA shares have already moved higher in overnight trading, rising more than 5% ahead of the anticipated data release.
Microcystic lymphatic malformations are rare, lifelong vascular malformations characterized by clusters of fluid-filled cysts that can cause pain, swelling, recurrent infections, and significant impairment in quality of life. There are currently no FDA-approved therapies for this condition, underscoring the unmet medical need.
The Phase 3 SELVA trial evaluated the efficacy and safety of QTORIN rapamycin, a topical formulation designed using Palvella's patented QTORIN platform to deliver rapamycin directly to affected skin and vascular tissues. The company plans to issue the topline results at approximately 6:30 am ET, ahead of the scheduled call.
Palvella, a clinical-stage biopharmaceutical company focused on serious, rare skin diseases and vascular malformations, is also advancing additional QTORIN-based candidates, including QTORIN Pitavastatin for disseminated superficial actinic porokeratosis.
PVLA closed Monday's session at $87.84, up 2.54%, and in overnight trading climbed to $93.01, a 5% gain, ahead of the Phase 3 data announcement.
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