Editas Medicine receives approval to start Phase 1/2 trial of gene‑editing therapy EDIT‑401 in Australia
Editas Medicine announced that the Australian Therapeutic Goods Administration and a Human Research Ethics Committee have approved the Strive Phase 1/2 trial of its in‑vivo gene‑editing therapy EDIT‑401 for heterozygous familial hypercholesterolemia. The company plans to begin dosing patients later in 2026 and expects first‑in‑human safety and tolerability data in the first quarter of 2027. New preclinical data showing about a 90 % LDL‑C reduction sustained for up to ten months will be presented at the American Heart Association Scientific Sessions in November 2026.
Why it matters
Editas says the regulatory clearance allows the company to move into human testing and target a large hyperlipidemia market, with initial safety data slated for Q1 2027. Analysts at TipRanks note a $5.00 price target and a Buy rating, while Wells Fargo upgraded the stock to Overweight, indicating potential upside from the milestone.
Key facts
- 1Human Research Ethics Committee approval and Therapeutic Goods Administration Clinical Trial Notification were obtained for the Strive trial in Australia. globenewswire.com
- 2The trial will also be submitted for review in New Zealand. globenewswire.com
- 3Editas expects to begin patient dosing later in 2026. globenewswire.com
- 4Initial safety and tolerability data are expected in the first quarter of 2027. globenewswire.com
- 5Preclinical studies showed approximately 90 % mean reduction in LDL‑C, Lp(a) and ApoB in non‑human primates, with the LDL‑C reduction maintained for about ten months. globenewswire.com
- 6Five clinical trial sites have been selected across Australia and New Zealand. globenewswire.com
Summary written by AlphAI from 6 of 6 sources. Not investment advice. Figures are as stated by the linked sources.