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Investigations  /  11.27.2019

Investigation of Aclaris Therapeutics

Aclaris Therapeutics (ACRS) Accused of Making Misleading Claims Regarding its ESKATA Drug

According to the complaint against the company’s officers and directors for breaches of fiduciary duties, unjust enrichment, abuse of control, gross mismanagement, waste of corporate assets, and alleged violations of the Securities Exchange Act of 1934 from May 8, 2018 through the present, Aclaris Therapeutics (ACRS) announced the launch of ESKATA, touting the product as the “first and only FDA-approved topical treatment for seborrheic keratosis.” Despite positive expectations, Aclaris acknowledged in its 2017 10-K that ESKATA was subject to post-marketing restrictions and that failure to comply with regulations could lead to penalties. Despite these warnings, Aclaris’ officers and directors allowed advertisements for ESKATA that exaggerated the drug’s efficacy and understated its risks. Consequently, on June 20, 2019, the FDA issued a letter expressing concern over misleading statements and omissions in Aclaris’ advertising regarding ESKATA’s efficacy and risk of harmful side effects, noting that the company was previously warned about the consequences of these advertising defects prior to publishing. As a result of Aclaris’ officers and directors’ failure to prevent the dissemination of false information, Aclaris, its CEO, and its CFO have been named in two federal securities class actions, which could further deplete the company’s assets. Since this news, Aclaris’ share price has fallen $3.41, an almost 67% decline from its June 19, 2019 closing price of $5.11.

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