Aclaris Therapeutics (ACRS) Accused of Making Misleading Claims in Video Advertisement

According to the complaint, in May 2018, Aclaris 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. In its subsequent filings with the SEC, Aclaris touted its revenue from its sale of ESKATA and consistently assured that there were no material changes in its risk factors. However, in reality, Aclaris' advertising materials for ESKATA minimized its risks and overstated its efficacy, leaving the company vulnerable to regulatory scrutiny. This reality was realized on June 20, 2019, when the FDA issued a letter in response to a direct-to-consumer video interview with a paid Aclaris spokesperson, stating that Aclaris' advertisement for ESKATA " false or misleading claims" about the product's risks and efficacy by failing to mention risk of serious eye disorders or severe skin reactions. Since this news, Aclaris' share price has fallen $3.99, almost 80%.