On Tuesday, shares of Revance Therapeutics Inc. (NASDAQ:RVNC) are plummeting, down over 22% in morning trading after the company reported disappointing results from its REALISE 1 Phase 3 trial of DaxibotulinumtoxinA Topical Gel (RT001) to treat patients with moderate to severe lateral canthal lines, or crow's feet.
The treatment did not achieve its co-primary and other endpoints, which were composite measurements of 2-point or greater or 1-point or greater improvements in crow’s feet between the baseline and 28 days after treatment.
RT001 topical generally appeared to be well-tolerated in this study.
"We are disappointed with the results of the REALISE 1 trial. The data was unambiguous, and we do not plan to continue development of RT001 topical for crow's feet. Based on these results, we have also decided not to pursue the current clinical development plan for RT001 in axillary hyperhidrosis. We are grateful to all the patients and investigators for their participation in the REALISE 1 trial," said Dan Browne, President and Chief Executive Officer at Revance.
Mr. Browne continued, "Looking ahead to the second half of this year, we remain on track to initiate RT002 injectable Phase 3 clinical trials for glabellar lines and report interim Phase 2 results in cervical dystonia. We recently held an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding our RT002 injectable program for glabellar lines. We believe the meeting was informative and productive.
Revance is a biopharmaceutical company which focuses on the development, manufacturing, and commercialization of novel botulinum toxin products for various aesthetic and therapeutic applications.
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