Revance Therapeutics Drops on Missed Late Stage Results

Revance Therapeutics Inc. (NASDAQ: RVNC) hit a new 52-week low in Tuesday’s session following the release of its late stage trial results. The reported results were 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.

Unfortunately, DaxibotulinumtoxinA Topical Gel (RT001) did not achieve its co-primary and other endpoints. The co-primary efficacy endpoints in the trial were composite measurements of two-point or greater and one-point or greater improvement in lateral canthal lines between baseline and 28 days after treatment. Overall, RT001 topical generally appeared to be well-tolerated in this study.

Considering the path going forward in the second half of this year, Revance remains on track to initiate its RT002 injectable Phase 3 clinical trials for glabellar lines and report interim Phase 2 results in cervical dystonia.

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Separately, the company held an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding its RT002 injectable program for glabellar lines. Management believes the meeting was “informative and productive.”

Dan Browne, president and CEO of Revance, commented:

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. Given the positive results in our recent Phase 2 BELMONT active comparator trial, we will focus our future development efforts and financial resources on DaxibotulinumtoxinA for Injection (RT002).

At the end of March 2016, the company had cash and investments totaling $236.6 million. Revance expects this to fund its operations through the second quarter of 2018.

Shares of Revance were trading down about 22% at $14.34 on Tuesday, with a 52-week trading range of $13.21 to $42.41.

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