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.
The NDA submission is supported by positive data from Phase 3 CLARITY study.
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