Aclaris Therapeutics, Inc. (ACRS) SEC Filing 10-K Annual report for the fiscal year ending Saturday, December 31, 2016

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Aclaris Therapeutics, Inc.
Ticker: ACRS CIK: 1557746

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Aclaris Therapeutics Reports Fourth Quarter and Full Year 2016 Financial Results and Provides Corporate Update

-- Provides Update on Clinical and Other Developments

-- Initiates Financial Guidance for Full Year 2017

-- Management to Host Conference Call at 8:00 a.m. ET today

Malvern, PA – March 15, 2017 (GLOBE NEWSWIRE) –

Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biotechnology company, today announced financial results for the fourth quarter and year ended December 31, 2016 and provided an update on its clinical development programs.

“The year was a transformational year as we continued to make progress toward our goal of becoming a fully integrated biotechnology company. In November 2016, we reported that two pivotal Phase 3 trials of our lead product candidate A-101 40% Topical Solution met all primary and secondary endpoints of each trial, achieving clinically and statistically significant clearance of seborrheic keratosis (SK) lesions. In February 2017, we submitted a New Drug Application (NDA) for A-101 40% Topical Solution for the treatment of SK to the U.S. Food and Drug Administration (FDA),” said Dr. Neal Walker, President and Chief Executive Officer of Aclaris. “During 2016 we also reported positive data from a Phase 2 trial of A-101 45% Topical Solution for the treatment of common warts. Finally, we recently completed a Phase 1 clinical trial of ATI-50001, our investigational Janus Kinase (JAK) inhibitor, for the treatment of alopecia totalis and alopecia universalis.”

Clinical Pipeline Update

A-101 40% Topical Solution

In November 2016, reported positive data from two pivotal Phase 3 trials, SEBK-301 and SEBK-302, in which A-101 40% Topical Solution achieved statistically significant and clinically meaningful results on all primary and secondary endpoints. SEBK-301 and SEBK-302 enrolled 937 patients in total and were conducted at 34 investigational centers in the United States.

There were no treatment-related serious adverse events among patients treated with A-101 40% Topical Solution, and local skin reactions (LSR), if present, were predominantly classified as mild. The rates of hypopigmentation, hyperpigmentation, and scarring classified as greater than mild were less than one percent in all groups in both trials

In February 2017, submitted an NDA to the FDA for A-101 40% Topical Solution as a treatment for SK.

Plan to submit a marketing authorization application (MAA) for A-101 40% Topical Solution in the European Union in the second half of 2017.

The following information was filed by Aclaris Therapeutics, Inc. (ACRS) on Wednesday, March 15, 2017 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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