Noticias y eventos de Aclaris Therapeutics, Inc. (ACRS)ACRSAclaris Therapeutics, Inc.

Aclaris Therapeutics Prices Offering of 7,785,714 Shares at $3.50 Each

Aclaris Therapeutics announced the pricing of an underwritten offering of 7,785,714 shares of its common stock at a price of $3.50 per share and, in lieu of shares of common stock to certain investors, pre-funded warrants to purchase 6.5M shares of common stock at a purchase price of $3.49999 per share, which equals the offering price per share of the common stock less the $0.00001 exercise price per share of each pre-funded warrant. All of the shares of common stock and the pre-funded warrants are to be sold by Aclaris. The offering includes participation from TCGX, RA Capital Management, Invus and a large mutual fund. The gross proceeds to Aclaris from the offering are expected to be approximately $50M, before deducting underwriting discounts and commissions and other offering expenses payable by Aclaris. The offering is expected to close on October 28, subject to the satisfaction of customary closing conditions. Leerink Partners, Piper Sandler, Cantor and LifeSci Capital are acting as joint bookrunning managers for the offering.

Aclaris Announces Positive Results for ATI-052 in Dermatitis and Asthma Trials

Aclaris Therapeutics announced positive primary analysis results from the Phase 1b proof-of-concept trials of its anti-TSLP/IL-4R alpha bispecific antibody ATI-052 in atopic dermatitis and asthma. Both trials demonstrated strong proof-of-concept with rapid and broad responses to ATI-052, further validating the additive/synergistic potential of simultaneously targeting TSLP, IL-4, and IL-13 with a bispecific anti-TSLP/IL-4R alpha antibody, and achieved the primary objective, showing a favorable safety profile including no observations of conjunctivitis. Aclaris intends to prioritize Phase 2b development of ATI-052 initially in Eosinophilic Esophagitis or EoE, where the company believes a focused development program is well aligned with its development strategy and capital management. Results demonstrated breadth and rapidity of response to ATI-052 in heterogeneous patient populations; pharmacodynamic results demonstrated potential for additivity and synergy of targeting TSLP and IL-4R alpha. Results showed rapid and durable improvement in skin and itch observed in severe AD population with ATI-052; a single dose rapidly improved airway inflammation and lung function in a diverse asthma population. ATI-052 demonstrated a favorable safety and tolerability profile, including no observations of conjunctivitis. Aclaris will prioritize development in eosinophilic esophagitis, consistent with its development strategy.

Aclaris Receives FDA Fast Track Designation for Moderate to Severe Lichen Planus

Aclaris Therapeutics announced that the U.S. Food and Drug Administration has granted Fast Track Designation for modzatinib for moderate to severe lichen planus including oral erosive LP, cutaneous LP, and lichen planopilaris. Aclaris expects to initiate a phased multi-part Phase 2b trial of modzatinib in LP in the fourth quarter of 2026. Fast Track designation is intended to facilitate the development and expedite the review of investigational therapies that treat serious conditions and fill an unmet medical need. The designation provides for more frequent interactions with the FDA regarding the development plan and clinical trial design, supporting a potentially more efficient path to registration. Fast Track designation also allows for rolling review of a New Drug Application (NDA), meaning completed sections may be submitted and reviewed on an ongoing basis rather than waiting until every section of the NDA is completed before the entire application can be reviewed. "Lichen planus is a serious, clinically concerning disease with debilitating symptoms that can affect the quality of life of patients suffering from this disorder; unfortunately, there are currently no approved therapies," said Dr. Jesse Hall, Chief Medical Officer of Aclaris "This is an important milestone for our company; we look forward to more frequent interactions with the FDA as we move modzatinib into a Phase 2b trial later this year."