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Stock impact report

LENZ Therapeutics Announces FDA Acceptance of New Drug Application for LNZ100 for the Treatment of Presbyopia

LENZ Therapeutics, Inc. (LENZ) 
Company Research Source: GlobeNewswire
SAN 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, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for LNZ100 for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025 for LNZ100. The FDA noted that it is not planning to hold an advisory committee meeting to discuss this application. “With the acceptance of our New Drug Application for LNZ100, we are pleased to be one step closer towards potential approval and look forward to continuing to collaborate with the FDA to deliver the first on Show less Read more
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