PRAX - Praxis Precision gains on late-stage plans for lead asset

2023-06-09 13:01:49 ET

Praxis Precision Medicines ( NASDAQ: PRAX ) added ~4% on Friday after announcing results from an end-of-Phase 2 meeting with the FDA regarding plans to advance its lead candidate ulixacaltamide for Phase 3 development in movement disorder, Essential Tremor (ET).

"Our constructive discussion with the FDA established the path forward towards registration in the U.S. for ulixacaltamide," Chief Executive Officer of Praxis Precision ( PRAX ) Marcio Souza noted.

Highlights of the registrational plan include arrangements to test a single dose of 60 mg across two Phase 3 trials for ulixacaltamide in ET: a 12-week, parallel design study and a 12-week randomized withdrawal study.

There is an agreement to consider Modified Activities of Daily Living 11 (mADL11) as the primary endpoint. According to the company, its Phase 2 Essential 1 study indicated nominally significant results for ulixacaltamide in terms of mADL11.

More on Praxis Precision

• Praxis crashes 42% after mid-stage data for movement disorder candidate
• Praxis Phase 2 Results: Mixed Outcomes Prompt Change In Rating

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