On July 2, Praxis Precision Medicines fell 5.15% in regular trading, trading at approximately $318.22/share, with turnover of $84.89 million.

The decline was triggered by the FDA announcing an extension of the review period for the company's core drug Relutrigine by three months. The New Drug Application (NDA) covers the treatment of SCN2A and SCN8A-related developmental and epileptic encephalopathies. The FDA had previously set a PDUFA target action date of September 27, meaning the potential approval timeline is now pushed further out, pressuring market expectations for the company's commercialization progress.

Praxis had originally planned to submit the Relutrigine NDA by mid-February and received the September PDUFA date in late March. The company's pipeline also includes Vormatrigine, which showed favorable tolerability with discontinuation rates below 10%, and Elsunersen, which reported positive Phase A results in the Embrave trial for SCN2A early-onset developmental epileptic encephalopathy. However, the delay in Relutrigine — the most advanced commercial candidate — weighs on near-term sentiment.

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