Dyne at ‘attractive entry point’ following pullback, says Chardan

Chardan notes Dyne Therapeutics (DYN) announced updates for its DYNE-101 program for myotonic dystrophy type 1, which included an update on regulatory alignment with the FDA regarding an accelerated approval pathway and updated data, out to 12-months, for the 6.8 mg/kg dose from the ACHIEVE trial. An accelerated approval pathway for DYNE-101 targeting DM1 requires the company to revise the protocol for the registrational expansion cohort of the ACHIEVE trial, switching to video hand opening time as the primary endpoint, notes the analyst, who believes that the confirmation by the FDA of an accelerated approval pathway “more than offsets” what could be a six month delay from prior estimates of a BLA submission. The firm, which maintains its Buy rating and 12-month price target of $50 on Dyne shares, argues that with the stock having declined 41% year-to-date at yesterday’s close that the current stock price “represents an attractive entry point.”