EDIT News & Events

Reports Q4 revenue $24.741M vs $30.604M last year. "We achieved notable progress in the fourth quarter of 2025 as we advanced our mission and strategy to become a leader in in vivo gene editing," said Gilmore O'Neill, M.B., M.M.Sc., President and Chief Executive Officer of Editas Medicine. "We continue to advance our lead in vivo development candidate, EDIT-401, an experimental, potential best-in-class, one-time therapy, which demonstrated significantly reduced mean LDL cholesterol levels of over 90 percent in preclinical studies. With cash runway into the third quarter of 2027, we are in a strong position to drive EDIT-401 toward upcoming milestones and look forward to submitting an IND/CTA by mid-2026 and initiating our first-in-human trial of EDIT-401 in patients living with heterozygous familial hypercholesterolemia later this year."

The U.S. Department of Health and Human Services and the U.S. Food and Drug Administration announced that Richard Pazdur, M.D., has been appointed director of the Center for Drug Evaluation and Research. "Pazdur is a 26-year veteran of the FDA and the founding director of its Oncology Center of Excellence. A renowned regulatory innovator, Dr. Pazdur developed an integrated approach for cross-center coordination of oncology product review to expedite the development of novel cancer therapies. He also led the agency's launch of a series of initiatives that streamlined oncology drug approvals, access, and labeling: Project Orbis to provide a framework for concurrent submission and review of oncology products among international partners, Project Facilitate to support oncology professionals in completing expanded access requests for cancer patients, and Project Renewal to update the prescribing information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date," the FDA stated. Publicly traded large-cap drugmakers include AstraZeneca (AZN), Bristol Myers (BMY), Eli Lilly (LLY), GSK (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Companies working on gene therapies include Sarepta (SRPT), Capricor Therapeutics (CAPR), Taysha Gene Therapies (TSHA), MeiraGTx (MGTX), Crispr Therapeutics (CRSP), Editas Medicine (EDIT), Beam Therapeutics (BEAM), Caribou Biosciences (CRBU) and Intellia Therapeutics (NTLA).