• LNZ100 NDA on track for August 8, 2025 PDUFA target action date.
• 88-member sales force hired for immediate sales and marketing.
• International license and commercialization agreements for LNZ100.
• $195 million in upfront and milestone payments, double-digit royalties.
• Cash, cash equivalents and marketable securities of $209.6 million as of June 30, 2025.
LENZ Therapeutics, Inc. (Nasdaq: LENZ) has made significant strides in its quest to develop a global therapy for presbyopia, with a notable milestone achieved in the submission of its New Drug Application (NDA) for LNZ100 in China. The NDA submission by CORXEL Pharmaceuticals to the National Medical Products Administration (NMPA) of the People’s Republic of China (PRC) marks a crucial step in LENZ's development and commercialization plans for LNZ100 [1].
The submission of the NDA for LNZ100, a preservative-free, single-use, once-daily eye drop containing aceclidine, was supported by positive data from the Phase 3 JX07001 clinical trial in China. The trial demonstrated statistically significant improvements in Best Corrected Distance Visual Acuity (BCDVA) at near, without compromising distance vision [1]. This achievement underscores LENZ's commitment to enhancing vision for individuals with presbyopia.
LENZ Therapeutics has also announced the hiring of an 88-member sales force to drive immediate sales and marketing efforts for LNZ100. This strategic move aims to capitalize on the growing market demand for innovative solutions in eye care [1]. Additionally, LENZ has entered into international license and commercialization agreements for LNZ100, further expanding its reach and potential market penetration.
Financial highlights include a substantial upfront payment and milestone payments totaling $195 million, as well as double-digit royalties on net sales. These financial arrangements are poised to significantly bolster LENZ's cash position, with the company reporting $209.6 million in cash, cash equivalents, and marketable securities as of June 30, 2025 [1].
LENZ's partnership with Laboratoires Théa for Canadian commercialization further underscores the potential of LNZ100 as a global presbyopia therapy. The company's strategic focus on international markets and strong financial backing position it favorably for future growth and market expansion [1].
References:
[1] https://finance.yahoo.com/news/lenz-therapeutics-announces-nmpa-submission-120000440.html
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