Editas gets Australian clearance to start Strive trial of EDIT-401, reports Q3 2026 results
Editas said it received ethics and regulatory clearance to begin its Phase 1/2 Strive study of EDIT-401 in Australia, with dosing expected by year-end and initial safety data due in early 2027.
Editas Medicine said on November 9, 2026 that it received Human Research Ethics Committee approval and completed the Clinical Trial Notification process with Australia's Therapeutic Goods Administration to begin the Phase 1/2 Strive study of EDIT-401 in patients with Heterozygous Familial Hypercholesterolemia in Australia.1 The company said it remains on track to begin patient dosing this year and report initial safety and tolerability data in the first quarter of 2027.1 It also said it expects to finish enrolling Part 1 of the Strive study, with topline safety and efficacy data from that portion available in the second half of 2027.1
Editas also presented new preclinical data on EDIT-401 at the American Heart Association Scientific Sessions in November. The company reported that LDL-C reduction of at least 90 percent with EDIT-401 was maintained over 10 months in an ongoing non-human primate study.1 It further reported that EDIT-401 achieved roughly 90 percent mean Lp(a) and ApoB reductions, sustained over three months in an ongoing NHP study.1 On safety, the company described the preclinical profile in a presentation titled "Consistent safety profile with targeted delivery to the liver, transient elevations in LFTs, no histopathologic findings, and no evidence of genotoxicity in relevant primary human cells."
On the collaboration side, Editas said that under its agreement with Bristol Myers Squibb, a second IND/CTA was accepted for an alpha-beta T cell medicine, which triggered a milestone payment to Editas.1 The company noted that BMS will advance this product, BMS-986527, a CD70 healthy-donor allogeneic CAR-T therapy, in a Phase 1 study evaluating safety and tolerability in patients with clear cell renal cell carcinoma.1 Editas developed the Cas12a gene editing technology used to engineer the CAR-T cells.1
On finances, Editas reported cash, cash equivalents, and marketable securities of $190.2 million as of September 30, 2026, compared with $146.6 million at the end of 2025.1 The company said it expects these resources to fund operations into the second half of 2028.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.