Dyne wins regulatory nod to start trial for myotonic dystrophy candidate

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• Dyne Therapeutics (NASDAQ:DYN), a clinical-stage biotech focused on muscular diseases, said on Tuesday that health authorities in New Zealand cleared a clinical trial application to start a Phase 1/2 for DYNE-101, an experimental therapy for myotonic dystrophy type 1 (DM1).
• DM1 is a rare genetic disease characterized by its impact on skeletal, cardiac, and smooth muscle.
• The multiple ascending dose trial is expected to start dosing patients in mid-2022, the company said, noting that more countries could greenlight DYNE-101 as the trial expands globally, targeting about 60 to 70 adult patients with DM1
• The decision from the New Zealand Medicines and Medical Devices Safety Authority marks the “first regulatory clearance for DYNE-101, an important milestone in our efforts to execute our planned global clinical trial for people living with DM1,” Chief Executive of Dyne (DYN) Joshua Brumm said.

• Wall Street stands strongly behind the prospects of Dyne (DYN) with four Buy ratings and no Hold or Sell ratings.