Articles from LENZ Therapeutics, Inc.

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New Drug Application (NDA) for LNZ100 for treatment of presbyopia on track for PDUFA target action date of August 8, 2025

SAN DIEGO, May 06, 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 announced that company management will participate in a fireside chat and one-on-one meetings at the BofA Securities 2025 Health Care Conference taking place May 13- 15, 2025 in Las Vegas, NV.

SAN DIEGO, April 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 announced it will host a webcast on Wednesday, May 7th, 2025, at 4:30 p.m. EDT to report its 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

SAN DIEGO, March 11, 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 announced it will host a webcast on Wednesday, March 19, 2025, at 4:30 p.m. EST to report its fourth quarter and full year 2024 financial results and recent corporate highlights.

Event to highlight the commercialization strategy and progress towards the potential approval of LNZ100 for the treatment of presbyopia

SAN DIEGO, Feb. 24, 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 announced that company management will participate in the following upcoming investor conferences:

SAN DIEGO, Nov. 12, 2024 (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 announced that company management will participate in the following upcoming investor conferences:

New Drug Application (NDA) for LNZ100 for treatment of presbyopia accepted for review by the U.S. Food and Drug Administration (FDA); PDUFA target action date of August 8, 2025

SAN DIEGO, Oct. 30, 2024 (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 announced it will host a webcast on Wednesday, November 6, 2024 at 8:00 a.m. EST to report its third quarter 2024 financial results and provide a business update.

Primary endpoint was met with 74% of participants dosed with LNZ100 achieving three-lines or greater improvement at 3 hours post treatment，and maintaining their optimal distance visual acuity (i.e., not losing 5 or more letters). The difference in efficacy was statistically significant in the LNZ100 treatment group compared to the vehicle group (p<0.0001)

FDA sets Prescription Drug User Fee Act (PDUFA) target date of August 8, 2025

SAN DIEGO, Sept. 30, 2024 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a late clinical-stage biopharmaceutical company focused on developing the first and only aceclidine-based eye drop to improve near vision in people with presbyopia, today announced presentations featuring LNZ100 at multiple upcoming ophthalmology and optometry medical conferences, including Eyecelerator at the 2024 American Academy of Ophthalmology (AAO) Annual Meeting on October 17, 2024 and Academy 2024 Indianapolis, presented by the American Academy of Optometry on November 6–9, 2024.

SAN DIEGO, Aug. 27, 2024 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a late clinical-stage biopharmaceutical company focused on developing the first and only aceclidine-based eye drop that has been shown to improve near vision in people with presbyopia, today announced that company management will participate in the following upcoming investor conferences:

Submitted New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for LNZ100 for the treatment of presbyopia

SAN DIEGO, Aug. 12, 2024 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a late clinical-stage biopharmaceutical company focused on developing the first and only aceclidine-based eye drop to improve near vision in people with presbyopia, today announced that the Company has submitted a New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for LNZ100 (an aceclidine-based ophthalmic solution) for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally and 128 million people in the United States.

SAN DIEGO, Aug. 07, 2024 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a late clinical-stage biopharmaceutical company focused on developing the first aceclidine-based eye to improve near vision in people with presbyopia, today announced it will host a webcast on Wednesday, August 14, 2024 at 4:30 p.m. ET to report its second quarter 2024 financial results and provide a business update.

SAN DIEGO, July 15, 2024 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a late clinical-stage biopharmaceutical company focused on developing the first aceclidine-based eye drop to improve near vision in people with presbyopia, today announced that it has entered into a stock purchase agreement with Ridgeback Capital Investments L.P. (“Ridgeback Capital”) for a $30 million private investment in public equity (“PIPE”) common stock financing.

Capstone data from Phase 3 CLARITY study to be presented

SAN DIEGO, May 30, 2024 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a late clinical-stage biopharmaceutical company focused on developing the first aceclidine-based eye drop that has been shown to improve near vision in people with presbyopia, today announced that Eef Schimmelpennink, President and Chief Executive Officer, will present and company management will participate in one-on-one meetings at the Jefferies Global Healthcare Conference being held from June 5th- 6th, 2024 in New York City.

Reported positive topline data from Phase 3 CLARITY study for presbyopia; selected LNZ100 as lead candidate; New Drug Application submission anticipated in mid-2024

SAN DIEGO, May 01, 2024 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a late clinical-stage biopharmaceutical company focused on developing the first aceclidine-based eye drop that has been shown to improve near vision in people with presbyopia, today announced it will host a webcast on Wednesday, May 8, 2024 at 4:30 p.m. ET to report its first quarter 2024 financial results and provide a business update.

LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a late clinical-stage biopharmaceutical company focused on developing the first aceclidine-based eye drop to improve near vision in people with presbyopia, today announced positive topline results from its Phase 3 CLARITY study of two investigational formulations of aceclidine, LNZ100 and LNZ101, for the treatment of presbyopia, the inevitable loss of near vision that impacts the daily lives of nearly all people over 45.

LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a late clinical-stage biopharmaceutical company focused on developing the first aceclidine-based eye drop that has been shown to improve near vision in people with presbyopia, today announced that the Company will host a conference call and webcast on Wednesday, April 3, 2024, at 8:00 a.m. ET to discuss the topline results from its Phase 3 CLARITY study, a group of three multi-center, double-masked, randomized active and vehicle-controlled clinical trials evaluating the efficacy and safety of two investigational formulations of aceclidine, LNZ100 and LNZ101, for the treatment of presbyopia.

LENZ Therapeutics, Inc. (Nasdaq: LENZ) (LENZ or the Company), a late clinical-stage biopharmaceutical company focused on developing the first aceclidine-based eye drop that has been shown to improve near vision in people with presbyopia, today announced the completion of its previously announced merger with Graphite Bio, Inc. (previously trading on Nasdaq under the ticker symbol “GRPH”) (“Graphite Bio”). The new combined company will operate under the name LENZ Therapeutics, Inc. and will commence trading on Nasdaq under the ticker symbol “LENZ” on March 22, 2024.