What happened
In response to the company's strong results from two pivotal phase 3 trials, shares of Revance Therapeutics (RVNC +0.00%), a clinical-stage biotech focused on aesthetics, rose 36% as of 11:10 a.m. EST on Tuesday.
So what
Revance announced top-line results from its two Sakura phase 3 trials. These studies were designed to evaluate a compound called RT002 as a treatment for glabellar lines, which are the short vertical lines found between the eyebrows.
Both phase 3 trials met their primary endpoint, which was defined as a statistically significant improvement in reducing the severity of glabellar lines when compared to a placebo.
Image source: Getty Images.
Specifically, the percent of patients who reported had an improvement from baseline were 73.6% in Sakura 1 trial and 74% in Sakura 2 trial at week 4. Both results were statistically significant. What's more, 88% of 91% of patients from Sakura 1 and Sakura 2, respectively, reported that they were "very satisfied" or "satisfied" with their treatment experience.
RT002 was all generally shown to be safe and well tolerated in both studies.
Revance CEO Dan Browne offered investors the following commentary:
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.
Given the upbeat results, it is easy to understand why shares are flying high today.
Now what
If RT002 can win Food and Drug Administration approval, it would be the first glabellar lines treatment that offers patients a long-acting duration time of six months. That would likely be viewed as a welcome improvement over currently available treatments that have demonstrated a duration time of roughly three to four months.
The aesthetics market is large and management estimates that global sales for neuromodulator injectibles currently top $3.6 billion globally. Treatments for glabellar lines currently account for about a third of that figure. If RT002 can win approval, it could easily drive meaningful financial results for Revance.
From here, Revance is launching a long-term safety trial called Sakura 3. The study is fully enrolled and is expected to be completed in the second half of 2018. If all goes well, the company plans to submit RT002 for review in 2019 and will launch the drug in 2020.
Will RT002 be able to produce replicate these exciting clinical results in its Sakura 3 trial? That question is still up in the air, but given its performance in Sakura 1 and 2, investors have every reason to feel optimistic.
