Investment firm Jefferies has reaffirmed its ‘Buy’ rating for Praxis Precision Medicines (NASDAQ: PRAX) as the U.S. Food and Drug Administration (FDA) reviews the company’s lead drug candidate for rare neurological disorders, according to a research note seen by Investing.com. The stock rose 3.2% in pre-market trading following the report.
Praxis is developing PRAX-628, an experimental treatment for epilepsy and other central nervous system conditions. The FDA is currently evaluating Phase 2 clinical trial data, with a decision expected by Q3 2024. ‘We see compelling efficacy signals in the epilepsy data,’ wrote Jefferies analysts, maintaining their $45 price target.
Industry sources note the FDA’s review comes amid increased scrutiny of neurological drugs following recent controversies over accelerated approvals. However, regulatory experts suggest Praxis’s traditional clinical pathway may avoid such hurdles. ‘The complete dataset appears robust,’ one analyst familiar with the filing told Reuters.
Should PRAX-628 gain approval, Praxis could capture a significant share of the $3.2 billion epilepsy treatment market. Competitors including Neurocrine Biosciences and Jazz Pharmaceuticals are developing rival therapies, setting the stage for potential market disruption in 2025.