
PRAX
Praxis Precision Medicines is a clinical-stage biopharmaceutical company developing drug candidates, though the specific therapeutic areas and modalities are not detailed in this excerpt. The firm is in early development phases and faces typical biotech risks including the need for FDA approval, uncertain clinical trial outcomes, and dependence on future capital raises to fund its programs.
Pipeline
Catalyst Calendar
“The Company expects to complete Part A and disclose the topline results in the first half of 2026.”
“The FDA has set a target action date under the Prescription Drug User Fee Act of September 27, 2026.”
“The FDA has set a target action date under the Prescription Drug User Fee Act of January 29, 2027”
“On September 3, 2024, the Company announced topline results from the EMBOLD study evaluating relutrigine (PRAX-562) in SCN2A and SCN8A developmental and epileptic encephalopathy (DEE) patients.”
“the FDA granted a Type B meeting to take place in the fourth quarter of 2025”
“On October 16, 2025, the Company announced positive topline results for the Phase 3 Essential3 program of ulixacaltamide in essential tremor ("ET").”
“The Company also submitted a late-breaker abstract to present the full RADIANT study results at the American Epilepsy Society Annual Meeting in December 2025 in Atlanta, Georgia.”
“the confirmation to file a New Drug Application for relutrigine in SCN2A and SCN8A DEEs in early 2026.”
“The Company has submitted a pre-NDA meeting request to the FDA with plans to submit the NDA by early 2026, upon agreement with the agency.”