Business
LENZ Therapeutics Reports Second Quarter 2025 Financial Results and Recent Corporate Highlights
New Drug Application (NDA) for LNZ100 for treatment of presbyopia on track for PDUFA target action date of August 8, 2025 88-member sales force hired and
About this update from Lenz Therapeutics, Inc.
[{"type":"text","content":"New Drug Application (NDA) for LNZ100 for treatment of presbyopia on track for PDUFA target action date of August 8, 2025 88-member sales force hired and prepared to initiate sales and marketing activities immediately upon approval Executed multiple international license and commercialization agreements for LNZ100 including over $195 million in upfront and milestone payments together with double-digit royalties on net sales Cash, cash equivalents and marketable securities of $209.6 million as of June 30, 2025 SAN DIEGO, July 30, 2025 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a pre-commercial stage 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 reported financial results for the second quarter ended June 30, 2025, and recent corporate highlights. “As our PDUFA target action date is rapidly approaching, we are encouraged by our ongoing engagement with the FDA and are confident that the review of our NDA for LNZ100 is on track,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics. “Additionally, with the recent execution of multiple licensing agreements in key geographies, we look forward to continuing the momentum to position LNZ100 with a global commercial footprint.” Second Quarter 2025 and Recent Corporate Highlights NDA review by U.S. Food and Drug Administration (FDA) for LNZ100 as a treatment for presbyopia remains on track. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 8, 2025 for LNZ100 and noted it is not planning to hold an Advisory Committee Meeting to discuss this application. In May 2025, the late-cycle review meeting and communications were completed, noting no significant review issues and the FDA reiterated it had no plans to request an Advisory Committee Meeting. The Company has not noted any delays or interruptions in the review of its NDA for LNZ100 or changes to the review team. The NDA submission for the treatment of presbyopia is supported by positive data from the pivotal Phase 3 CLARITY study. Aceclidine is a new chemical entity in the United States and, if approved, would mark a global first aceclidine-based eye drop for the treatment of presbyopia. Commer...