Evergreen Therapeutics Receives FDA Fast Track Designation for EG-501 Cognitive Impairment Associated with Neuropsychiatric SLE

BETHESDA, Md., Oct. 13, 2026 /PRNewswire/ -- Evergreen Therapeutics, Inc., a Maryland based clinical-stage biotechnology company leveraging artificial intelligence (AI) to address unmet medical needs, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to EG-501, its investigational drug candidate for the treatment of cognitive impairment in adult patients with neuropsychiatric systemic lupus erythematosus (NPSLE-CI).

The designation was supported by positive data from the Phase II ClearMEMory study, a 12-week, multicenter, randomized, placebo-controlled trial that demonstrated clinically meaningful improvements in objective neuropsychological function among patients with NPSLE-CI.

"We are very pleased to receive Fast Track designation for our EG-501 program, which underscores the urgent need to advance new treatment options for the NPSLE-CI community," said Tom Du, M.D., Ph.D., Chief Executive Officer of Evergreen Therapeutics. "We look forward to working closely with the FDA as we advance the clinical development of EG-501 and strive to bring this potential therapy to patients as quickly as possible."

Fast Track designation is granted to investigational therapies intended to treat serious or life-threatening conditions and that have the potential to address significant unmet medical needs. The designation is designed to facilitate the expedited development and review of eligible therapies.

About NPSLE-CI

Systemic lupus erythematosus (SLE) is a chronic autoimmune condition that can affect multiple organ systems, with cognitive impairment representing a significant clinical manifestation. Pharmacology experiments demonstrated that SLE may cause neuron damage in animal models. Current epidemiological estimates suggest a substantial portion of patients may experience cognitive deficits, which can include memory difficulties and concentration issues. There remains a lack of approved therapies specifically for cognitive impairment associated with neuropsychiatric systemic lupus erythematosus (NPSLE-CI).

Forward-Looking Statements

This press release contains forward-looking statements regarding the future development of EG-501, planned clinical activities, and potential therapeutic uses. These statements are subject to risks and uncertainties, including clinical trial outcomes and regulatory feedback, which could cause actual results to differ materially.

For more information please contact: Evergreen Therapeutics, Inc., [email protected]

SOURCE Evergreen Therapeutics, Inc.