PRAX - Praxis: 2nd Half 2024 ET Readout Could Lead To U.S. Regulatory Filing

2024-03-26 13:34:38 ET

Summary

• Praxis Precision Medicines, Inc. results from the phase 3 Essential3 program, using ulixacaltamide for the treatment of patients with essential tremor, expected in the 2nd half of 2024.
• Company believes that the essential tremor U.S. market opportunity could be $4 billion.
• Positive data achieved in phase 2 study, using PRAX-628 for focal epilepsy; Phase 2b study targeting this very same patient population to be initiated 2nd half of 2024.
• With cash on hand, plus underwritten public offering that brought in $161.7 million in cash, Praxis Precision Medicines believes it can fund its operations into 2026.

Praxis Precision Medicines, Inc. ( PRAX ) is gearing up to have several catalysts with respect to one of its lead programs in its pipeline, which is the use of ulixacaltamide for the treatment of patients with essential tremor [ET]. This would be with respect to the advancement of the phase 3 Essential3 study, which is using this drug to treat this specific patient population. The first catalyst of which is going to be the completed enrollment of this late-stage study, expected in the 1st half of 2024. Upon completion of recruitment, it is expected that topline results from the phase 3 Essential3 study are going to be released in the 2nd half of 2024. Lastly, if the primary endpoint is met, then the company will be in a position to file a New Drug Application [NDA] to the FDA of ulixacaltamide in 2025....

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