Breakthrough designation gives Praxis ‘notable FDA validation,’ says Jefferies

After Praxis Precision (PRAX) Medicines announced that the FDA has granted Breakthrough Therapy Designation for ulixacaltamide for the treatment of patients with essential tremor, Jefferies analyst Andrew Tsai calls the news “fundamentally de-risking” as well as “notable FDA validation” since it can be inferred that the FDA has vetted the data package that includes two positive Phase 3 studies. The firm, which notes that programs receiving BTD have a high 73% approval rate, raises its view of the odds off success of ulixacaltamide in essential tremor to 80%-90% from 70% previously. Jefferies has a Buy rating and $450 price target on Praxis shares.