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Revance’s Neuromodulator Injection Positive in Phase III


Revance Therapeutics, Inc. RVNC shares surged more than 33% on Dec 5 after the company announced positive top-line results from two pivotal phase III studies, evaluating its next-generation neuromodulator, RT002 (daxibotulinumtoxin), for reducing wrinkles that lies between the brows (glabellar lines).

Both the phase III studies, SAKURA 1 and SAKURA 2, met their primary and secondary endpoints, demonstrating highly statistically significant improvement in severity of glabellar lines with RT002 against placebo. Data from the study showed that RT002 delivered substantial reduction in severity of glabellar lines for a long-acting duration of six months. The candidate was generally well tolerated in both the trials.

Notably, the duration achieved by RT002 in treating glabellar lines is better than any other marketed neuromodulators which demonstrates a duration of three-four months. It is important to note that Allergan’s AGN shares dropped almost 2% following the news release as RT002 is considered a potential threat to the company’s lead drug, Botox, which is marketed for the same indication. RT002 has a longer duration compared with Allergan’s Botox of five months.

Revance’s shares have significantly outperformed the industry year to date. The stock has soared 66.4% compared with the industry’s gain of 0.9% in the same time frame.

Notably, the company is conducting a long-term safety trial, SAKURA 3, on RT002 that already enrolled more than 2,500 patients across 66 sites in the United States and Canada. The study is expected to complete in the second half of 2018. If the study is successful, plans are afoot to submit regulatory applications to the FDA in the first half of 2019 with a potential launch in 2020. Per the company, RT002 will be the first neuromodulator with a long-acting duration of six months, if approved.

Per the data from Global Industry Analysts, the global aesthetic market represented revenues of about $1.6 billion in 2016 for treatments with neuromodulators. Moreover, patients and physicians consider the effect of treatment duration as the most significant component for any injectable neuromodulator. Hence, approval of the candidate is expected to cater to the hugely unmet needs of patients preferring longer duration for treatment of glabellar lines.

We remind investors that RT002 is also being evaluated in other clinical programs for different indications. Revance plans to initiate a phase III study on RT002 for treating cervical dystonia (a neurological muscle movement disorder) in 2018. RT002 was recently granted an orphan drug designation for cervical dystonia indication in the United States. Moreover, it also plans to release results from a phase II study, evaluating RT002 for management of plantar fasciitis by this year-end.

Revance Therapeutics, Inc. Price

Revance Therapeutics, Inc. Price | Revance Therapeutics, Inc. Quote

Zacks Rank & Key Picks

Revance carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the health care sector are Corcept Therapeutics Incorporated CORT and Achillion Pharmaceuticals, Inc. ACHN, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Corcept’s earnings per share estimates have moved up from 77 cents to 88 cents for 2018 over the last 60 days. The company delivered positive earnings surprises in two of the trailing four quarters with an average beat of 14.32%. Share price of the company has skyrocketed 127.3% year to date.

Achillion’s loss per share estimates has narrowed from 66 cents to 63 cents for 2017 and from 75 cents to 67 cents for 2018 over the last 60 days. The company came up with positive earnings surprises in two of the trailing four quarters with an average beat of 4.51%.

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