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Praxis Precision Medicines (PRAX) is soaring to fresh multi year highs after announcing this morning that the FDA granted Breakthrough Therapy Designation (BTD) for ulixacaltamide HCl in essential tremor (ET). The designation adds another catalyst to what has already been a remarkable run since October: shares were trading in the low to mid $50s in early October, and are now above $300.

• This momentum began with the Essential3 Phase 3 topline win for ulixacaltamide on October 16, was reinforced by a constructive pre-NDA update in early December, and now gets an added boost from the FDA's expedited designation.
• PRAX also highlighted additional pipeline progress in early December, including EMBOLD results for relutrigine (SCN2A/SCN8A DEEs), where the registrational cohort was stopped early for efficacy, while reiterating plans to file an ulixacaltamide NDA in early 2026.
• BTD is designed to speed development and review for therapies intended to treat serious conditions when early clinical evidence suggests the potential for a meaningful improvement over available options.
• PRAX notes ET is the most common movement disorder, affecting roughly 7 million people in the U.S., and says the current pharmacotherapy landscape is limited, leaving many patients inadequately treated.
• With recent FDA engagement and now BTD in hand, PRAX says it is preparing to submit the ulixacaltamide NDA in early 2026 as the next major catalyst.

Briefing.com Analyst Insight

BTD is a notable headline for PRAX because it helps de-risk the process by supporting a faster, more streamlined path toward an NDA review. It also extends a string of company milestones over the past few months that have fueled a sharp rise in the stock, as investors grow more optimisitc in the potential for near-term launches led by ulixacaltamide and supported by additional pipeline progress, including relutrigine. That said, while BTD can help tighten timelines, it does not de-risk the outcome. The FDA still has to sign off on key parts of the process, including whether the full dataset supports a clear benefit, the safety profile is acceptable, and the final label and manufacturing package are in good shape. Even with those caveats, the steady cadence of clinical and regulatory progress is keeping sentiment constructive and helps explain why PRAX has stayed in a strong uptrend.