Praxis receives FDA alignment on ulixacaltamide NDA submission plans

Praxis Precision Medicines Inc. (NASDAQ: PRAX) completed a pre-New Drug Application meeting with the FDA regarding ulixacaltamide for essential tremor treatment, the company announced. The biopharmaceutical company received written feedback and participated in an in-person meeting with the agency.

The FDA provided alignment on the content requirements for the NDA submission. Praxis expects to submit its first NDA in early 2026 based on the regulatory feedback received.

"We are very pleased with the collaborative discussions we recently had with the FDA and remain on track to submit Praxis' first NDA in early 2026," said Marcio Souza, president and chief executive officer.

Ulixacaltamide is designed as a selective small molecule inhibitor of T-type calcium channels intended to block abnormal neuronal burst firing in brain circuits associated with tremor activity. The drug candidate previously demonstrated statistically significant improvements in daily functioning in the company's Essential3 clinical program.

Essential tremor affects approximately seven million people in the United States and represents the most common movement disorder. The condition causes involuntary rhythmic movements primarily in the upper limbs and can progressively worsen over time. Currently, propranolol is the only FDA-approved pharmacotherapy for essential tremor, though it offers limited efficacy and tolerability issues.

The Boston-based company focuses on developing therapies for central nervous system disorders characterized by neuronal excitation-inhibition imbalance. Praxis operates two proprietary platforms: Cerebrum for small molecules and Solidus for antisense oligonucleotides.

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