Shares of Revance Therapeutics Inc. (NASDAQ: RVNC) saw a solid gain early on Tuesday after the company announced positive top-line results from its late-stage trials. Specifically, the firm’s next-generation neuromodulator DaxibotulinumtoxinA for Injection (RT002) delivered positive top-line results in alleviating moderate-to-severe glabellar lines (the frown lines or wrinkles between the brows) in two pivotal Sakura Phase 3 trials.
If approved by the U.S. Food and Drug Administration (FDA), Revance believes RT002 would be the first neuromodulator with a long-acting duration of six months. Currently, marketed neuromodulators have demonstrated duration of three to four months in treating glabellar lines.
Both Sakura 1 and Sakura 2 met the primary composite endpoint by delivering highly statistically significant improvement against placebo in reducing the severity of glabellar lines.
At the same time, all secondary endpoints measuring reduction in severity of glabellar lines with RT002 compared to placebo were highly statistically significant at every time point evaluated to 24 weeks. Also the median duration for patients treated with RT002 to return to baseline wrinkle severity was nearly 27 weeks as assessed by both physicians and patients.
Dan Browne, co-founder, president and CEO of Revance, commented:
We are extremely pleased with these positive SAKURA top-line results, which reinforce the findings from the Belmont Phase 2 active-comparator study. These results demonstrate it is scientifically and clinically possible to create a significantly longer-acting neuromodulator with a duration of six months, compared to three to four months observed with currently available products. We look forward to providing patients and healthcare professionals with what we believe is a new, next-generation, long-acting neuromodulator for the treatment of glabellar lines.
Shares of Revance were last seen up about 28% at $33.60, with a consensus analyst price target of $38.14 and a 52-week range of $15.85 to $35.65.