PRAX Stock Drops 12% After Hours On Trial Setback — Retail Eyes FDA Approval Of Other Pipeline Candidates

• Vormatrigine was generally well-tolerated, with adverse event-related discontinuations below 10%, the firm said. 
• Praxis said it is pausing enrollment in the POWER2 study to reassess the overall vormatrigine program and evaluate potential modifications.
• No immediate changes were announced for other ongoing trials or regulatory timelines.

Praxis Precision Medicines (PRAX) shares plunged nearly 12% in after-hours trading on Monday after the company reported that its vormatrigine candidate failed to reduce the monthly frequency of focal onset seizures in certain patients in a trial, prompting a pause in enrollment of a second registrational study.

Vormatrigine is a once-daily oral therapy targeting hyperexcitable sodium channels in the brain. It has been viewed as a key pipeline asset alongside the company’s more advanced candidates relutrigine and ulixacaltamide.

In the POWER1 Phase 2/3 registrational study, patients with focal onset seizures who were already taking one to three anti-seizure medications were randomized to once-daily vormatrigine or placebo for 12 weeks. The trial did not meet its primary endpoint of percent change in monthly seizure frequency from baseline.

However, it did meet a key secondary endpoint — the 50% responder rate — and seizure reduction was more pronounced during the second half of the study on the higher 30 mg dose. Vormatrigine was generally well-tolerated, with adverse event-related discontinuations below 10%.

Praxis said it is pausing enrollment in the POWER2 study to reassess the overall vormatrigine program and evaluate potential modifications. No immediate changes were announced for other ongoing trials or regulatory timelines.

“While the results for POWER1 were not what we hoped for, we are encouraged by the signal we saw on the higher dose arm, the low discontinuation rate and solid safety profile,” said Marcio Souza, president and chief executive officer of Praxis. “We will take some time to review these results to ensure we have the best path forward for developing vormatrigine and the ongoing POWER2 study.”

Praxis also reiterated that it remains on track with preparations for commercial launches of its other late-stage candidates, relutrigine and ulixacaltamide, while continuing to advance its broader precision neuroscience pipeline.

How Did PRAX Retail Traders React?

On Stocktwits, retail sentiment around PRAX stock jumped from ‘neutral’ to ‘bullish’ territory over the past 24 hours, while message volume remained at ‘high’ levels.

A Stocktwits user said that vormatrigine accounts for only a fraction of Praxis’s valuation.

Another opined that investors would regret selling PRAX, highlighting upcoming catalysts.

While the U.S. Food and Drug Administration is slated to decide on Praxis’s application for relutrigine in the treatment of developmental and epileptic encephalopathies by September, the agency is expected to decide on ulixacaltamide’s application for the treatment of essential tremor (ET) in adults by January 2027.

PRAX stock has gained nearly 742% over the past 12 months. 

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