Dyne Therapeutics pivot on primary endpoint will ‘raise questions,’ says Stifel

Stifel analyst Paul Matteis expects the essence of Dyne Therapeutics (DYN)’ myotonic dystrophy type 1 regulatory update to be “debated by investors” after the company announced that following a Type C meeting with FDA, they’ve elected to change the primary endpoint of the registrational cohort for DYNE-101 in DM1 to change from baseline in middle finger myotonia as measured by vHOT at six months from splicing. The pivot to vHOT as the primary outcome for the DYNE-101 registrational cohort “represents a meaningful shift” that “comes as a surprise” and will “raise questions,” but there’s also a case that it offers an “easier path,” says the analyst, who maintains a Buy rating on Dyne shares. The stock is down $2.69, or 19%, to $11.13 in pre-market trading.