Aclaris Therapeutics, Inc.
- Company Name
- Aclaris Therapeutics, Inc.
- Stock Symbol
- Class Period
- May 8, 2018 to June 20, 2019
- Motion Deadline
- September 28, 2019
- Southern District of New York
The complaint charges Aclaris and certain of its officers with violations of the Securities Exchange Act of 1934. Aclaris is a biopharmaceutical company that identifies, develops, and commercializes therapies to address unmet needs in medical and aesthetic dermatology and immunology. The Company’s lead product is Eskata, a hydrogen peroxide solution to treat raised seborrheic keratosis, a common non-malignant tumor.
The complaint alleges that throughout the Class Period, defendants made materially false and misleading statements and/or failed to disclose material adverse facts about the Company’s business and prospects. Specifically, defendants failed to disclose that the Company’s advertising materials minimized the risks and overstated the efficacy of Eskata, and that, as a result, the Company was reasonably likely to face regulatory scrutiny regarding its lead product. As a result of this information being withheld from the market, Aclaris securities traded at artificially inflated prices during the Class Period, with its stock price reaching a high of more than $20 per share.
On June 20, 2019, a letter from the U.S. Food & Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) was widely publicized. In the letter the OPDP stated that an advertisement for Eskata “makes false or misleading claims” regarding the product’s risks and efficacy. Specifically, “a direct-to-consumer video of an interview featuring a paid Aclaris spokesperson” was “especially concerning . . . because it fails to include information regarding the serious risks associated with Eskata, which bears warnings and precautions related to the risks of serious eye disorders . . . in the case of exposure to the eye and severe skin reactions including scarring.” In addition, the letter stated that on March 29, 2018, the OPDP had “addressed draft Aclaris presentations for Eskata with certain similarities to the video” and had “recommended that Aclaris revise proposed presentations so that they did not omit material information regarding risks associated with Eskata or otherwise misrepresent important information,” including the “efficacy of Eskata.” In conclusion, the OPDP stated it was “concerned that Aclaris is promoting Eskata in a manner that fails to adequately present the serious risks of the drug or describe the efficacy of the drug in a truthful and non-misleading manner despite this direction from OPDP.” On this news, the price of Aclaris stock fell $0.57 per share, or more than 11%, over the next two trading sessions to close at $4.54 per share on June 21, 2019.