RegulatoryCompany release

Praxis Sets Up Two FDA Decisions as Relutrigine and Ulixacaltamide NDAs Enter Review

🇺🇸 Praxis Precision Medicines, Inc. (PRAX) · Mon 09 Nov 2026

Praxis Precision Medicines reported Q3 2026 results, with FDA decisions on relutrigine and ulixacaltamide due by 27 December 2026 and 29 January 2027 respectively.

Praxis Precision Medicines gave a corporate update on 9 November 2026 alongside its third-quarter results. The US company said the FDA is reviewing new drug applications for two of its candidates, relutrigine and ulixacaltamide, and that target action dates are now set.

Relutrigine is under review for developmental and epileptic encephalopathies linked to SCN2A and SCN8A. The FDA's PDUFA goal date for that application is 27 December 2026.

Ulixacaltamide is being assessed for essential tremor, with a PDUFA date of 29 January 2027. A PDUFA date is the date by which the agency aims to complete its review of an application under the Prescription Drug User Fee Act.

On finances, Praxis reported about $1.3 billion in cash and said this gives it a runway into 2028. It also expects topline data from the EMERALD study in the fourth quarter of 2026, and has scheduled an Investor Day for 12 November.

What it means for your team

  • Two FDA action dates fall within about five weeks of each other (27 December 2026 and 29 January 2027), so regulatory and market-access teams tracking these indications should plan around both.
  • Relutrigine targets SCN2A and SCN8A developmental and epileptic encephalopathies, a rare-disease setting where a decision could reshape the treatment landscape.
  • EMERALD topline data are expected in Q4 2026, before or around the first FDA decision, so further information may emerge during the review period.

Company's press release (SEC filing): Praxis Precision Medicines, Inc. ↗

Article written by VigiEye from the official source (Praxis Precision Medicines, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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