June 14, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Newark, California-based Revance Therapeutics (RVNC) announced yesterday that its DaxibotulinumtoxinA Topical Gel (RT001) failed to meet its co-primary and other endpoints. RT001 was being tested to treat patients with moderate to severe lateral canthal lines, otherwise known as crow’s feet.
The study’s endpoints were composite measurements of 2-point or greater and 1-point or greater improvement in crow’s feet between baseline and 28 days.
“We are disappointed with the results of the REALISE 1 trial,” said Dan Browne, president and chief executive officer of Revance, in a statement. “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 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 II BELMONT active comparator trial, we will focus our future development efforts and financial resources on DaxibotulinumtoxinA for Injection (RT002).”
Axillary hyperhidrosis is underarm sweating. RT002 is being developed to treat frown lines.
Revance was one of the companies floated as a possible acquisition target by Dublin-based Allergan (AGN). After the Pfizer-Allergan merger fell through, both companies have shown an inclination for acquisitions. With Allergan’s strong presence in the dermatology market as the manufacturer of Botox, Revance would make sense.
And the company’s (stock price is down at the moment. Shares traded for $40.78 on Nov. 11, 2015, dropped to $17.12 on Feb. 9, 2016, and rose only slightly to $20.67 on June 7 before falling to its current price of $14.44.
TheStreet Ratings gave the company a “sell” rating with a score of D, saying, “This is driven by multiple weaknesses, which can be seen in multiple areas, such as its weak operating cash flow, generally disappointing historical performance in the stock itself and feeble growth in its earnings per share.
At the end of March 2016, the company had $236.6 million in cash and investments. Based on its plans and assets, the company indicates it has enough money to fund operations into the second quarter of 2018.
“Looking ahead to the second half of this year, we remain on track to initiate RT002 injectable Phase III clinical trials for glabellar lines and report interim Phase II results in cervical dystonia,” said Browne in a statement. “We recently held an End-of-Phase II 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. Meeting minutes are in process, and consistent with company and industry practice, we look forward to providing further updates when we have final minutes from the FDA.”