Allogene Gets FDA Fast Track Designations for ALLO-329 in Autoimmune Diseases

MT Newswires Live2025-04-07

Allogene Therapeutics (ALLO) said Monday that the US Food and Drug Administration granted three fast track designations for ALLO-329, which the company is developing to treat autoimmune diseases.

The designations cover the treatment of adult patients with active refractory moderate-to-severe systemic lupus erythematous, active severe or refractory idiopathic inflammatory myopathy, and active refractory diffuse systemic sclerosis (Scleroderma), according to the company.

Allogene said FDA's fast track designation is intended to expedite the development and review of therapies that address serious or life-threatening conditions and demonstrate the potential to meet unmet medical needs.

The company said it plans to start a phase 1 trial of ALLO-329 in the diseases covered by the three fast track designations in mid-2025, with proof-of-concept from the trial expected by the end of the year.

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