Business
LENZ Therapeutics Reports First 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 Cash, cash equivalents 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 Cash, cash equivalents and marketable securities of $194.1 million as of March 31, 2025 Upwardly revised anticipated cash balance at PDUFA to over $185.0 million; cash runway anticipated to extend to post-launch positive operating cash flow Company to host a conference call today at 4:30 p.m. EDT SAN DIEGO, May 07, 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 first quarter ended March 31, 2025, and recent corporate highlights. “The first quarter of 2025 and recent period have continued to be extremely productive as we near our August 8, 2025 PDUFA and the potential launch of LNZ100 in the United States. We have been very pleased by the ongoing engagement with the FDA and are confident the review of our NDA is on track,” said Eef Schimmelpennink, President and Chief Executive Officer of LENZ Therapeutics. “As you would have seen from our successful Commercial Day in April, we continue to make tremendous progress on our pre-launch commercial planning and feel prepared for a successful launch.” First Quarter 2025 and Recent Corporate Highlights New Drug Application (NDA) review by U.S. Food and Drug Administration (FDA) for LNZ100 as a treatment for presbyopia on track. In October 2024, the Company announced that the FDA accepted the NDA for LNZ100 for the treatment of presbyopia. 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 January 2025, the mid-cycle review meeting and communications were completed, noting no significant review issues. In the mid-cycle review communications, 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 review timelines remain on track with the late-cycle review meeting moved forward and scheduled...