LENZ Therapeutics (LENZ) announced that the U.S. Food and Drug Administration, FDA, has accepted the Company’s New Drug Application, NDA,

FDA sets Prescription Drug User Fee Act (PDUFA) target date of August 8, 2025SAN DIEGO, Oct. 21, 2024 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a pre-commercial biopharmaceutical company focused on the development and commercialization of the first and only aceclidine-based eye drop to improve near vision in people with presbyopia,

LENZ Therapeutics said the submission for the treatment of presbyopia is supported by the positive data results from a Phase 3 study. Aceclidine is a new chemical entity in the U.S. and isn't approved for the treatment of presbyopia in any country.

(RTTNews) - LENZ Therapeutics, Inc. (LENZ) Monday said that the Food and Drug Administration (FDA) has accepted the company's new drug application for LNZ100 for the treatment of presbyopia. Prescription Drug User Fee Act (PDUFA) target action date or a decision from the regulator is expected on August 8, 2025.