EDIT News & Events

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).

Reports Q3 revenue $7.54M, consensus $4.94M. "We are incredibly excited by the progress we made in the third quarter advancing our lead in vivo development candidate, EDIT-401, an experimental, potential best-in-class, one-time therapy designed to significantly reduce LDL cholesterol levels. We recently presented data at AHA and ESGCT demonstrating the ability of EDIT-401 to reduce mean LDL cholesterol levels by over 90 percent in non-human primates," said Gilmore O'Neill, M.B., M.M.Sc., President and Chief Executive Officer of Editas Medicine. "In addition, we have extended our cash runway into the third quarter of 2027 and remain on track to submit an investigational new drug or clinical trial application for EDIT-401 by mid-2026, with the goal of achieving in vivo human proof-of-concept data by the end of 2026."