LENZ Therapeutics shares surge as FDA review of presbyopia drug on track

Investing.com -- LENZ Therapeutics, Inc. (NASDAQ:LENZ) shares jumped 6.1% premarket after the pre-commercial stage biopharmaceutical company reported its second quarter financial results and confirmed its New Drug Application (NDA) for LNZ100 remains on track for its August 8, 2025 FDA decision date.

The company reported a second quarter loss of -$0.53 per share as it prepares for the potential commercial launch of its aceclidine-based eye drop for presbyopia. LENZ has completed hiring and training its 88-member sales force, positioning itself for immediate commercialization if LNZ100 receives FDA approval. The company ended the quarter with a strong cash position of $209.6 million, which it expects will fund operations through to post-launch positive cash flow.

"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.

The company has secured multiple international licensing agreements for LNZ100, including deals with Lotus Pharmaceutical (TADAWUL:2070) for South Korea and parts of Southeast Asia, and with Laboratoires Théa for Canada. These agreements could bring in over $195 million in upfront and milestone payments, plus double-digit royalties on net sales. Additionally, LENZ’s partner CORXEL has submitted an NDA for LNZ100 in China.

Research and development expenses increased to $9.1 million for the quarter compared to $6.9 million in the same period last year, driven by pre-approval manufacturing activities. Selling, general and administrative expenses rose to $12.8 million from $7.4 million a year ago, reflecting the company’s commercial preparations.

If approved, LNZ100 would be the first aceclidine-based eye drop for treating presbyopia globally.

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