Editas Wins Approval to Start First-In-Human Trial of Gene-Editing Therapy EDIT-401
EDIT sits 64% above its 52-week low of $1.66.
Summary
Editas Medicine received regulatory and ethics approval in Australia to begin the Phase 1/2 Strive trial of EDIT-401, its in vivo gene editing therapy for heterozygous familial hypercholesterolemia (HeFH). The trial has completed the Clinical Trial Notification process with Australia's TGA and has been submitted for review in New Zealand. The company also announced new preclinical data showing ~90% LDL-C reduction maintained over 10 months in non-human primates, to be presented at AHA Scientific Sessions on November 8. Editas expects to begin patient dosing this year and report initial safety and tolerability data in Q1 2027. This is a significant milestone for a company with a market cap around $422 million, as it moves its lead pipeline asset into the clinic. The approval follows the 8-K filed earlier today, which first disclosed the Australian approval and new preclinical data.
Updates
· SEC 8-K — The 8-K confirms the approval and adds that the trial has been submitted for review in New Zealand, with five clinical trial sites selected across Australia and New Zealand.
At the time of this announcement, EDIT was trading at $2.73 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $422.3M. The 52-week trading range was $1.66 to $4.54. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.