Praxis Precision Medicines (PRAX) is set for "exciting" 2026 after securing a Breakthrough Therapy Designation for ulixacaltamide in essential tremor, Truist Securities said in a note Monday.
The note said securing the label is a positive "surprise" because there is an approved drug for essential tremor, propranolol.
"Therefore, to be granted BTD despite the availability of a commercial drug...implies high unmet need in ET and at least some perception of ulixa's superiority," the report said.
The label is typically granted during earlier stages of drug development, the note said. For ulixa to obtain it after trial results imply that the FDA decision may have been based, at least in part, on the positive trial results, it added.
The report also pointed to indication of FDA's "comfort" with the data and pre-new drug application meeting.
"All of the above de-risk forthcoming NDA submission in early 2026," the note said. Truist kept its high conviction buy rating.
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