Core Viewpoint - The FDA has accepted Axsome Therapeutics Inc.'s supplemental New Drug Application for AXS-05 for Alzheimer's disease agitation, granting it Priority Review status with a target action date of April 30, 2026 [1][2]. Group 1: AXS-05 Development - The supplemental NDA is based on a comprehensive clinical development program, which includes four randomized, double-blind, controlled Phase 3 clinical trials and a long-term safety trial [3]. - A Priority Review designation means the FDA aims to act on the application within 6 months, compared to 10 months under standard review [2]. Group 2: AXS-12 Regulatory Update - Axsome received formal pre-NDA meeting minutes from the FDA, supporting an NDA submission for AXS-12 in narcolepsy, a chronic neurological condition [4][5]. - The company anticipates completing the NDA submission for AXS-12 in January 2026, with the acceptance of the final NDA subject to FDA review [6]. - AXS-12's clinical development program includes three controlled efficacy trials and a completed long-term safety trial [6]. Group 3: Market Reaction - Axsome Therapeutics shares increased by 18.18% to $175.84, reaching a new 52-week high [7]. - Needham has maintained a Buy rating on Axsome Therapeutics and raised the price forecast from $154 to $169 [6].

Core Insights - Shares of Praxis Precision Medicines (PRAX) have increased by 519.5% over the past three months, driven by positive data from late-stage studies of ulixacaltamide for essential tremor [1][6] - The stock has surged 272.6% in the past year, significantly outperforming the industry growth of 9.2% [5] Study Results - The Phase III Essential3 program demonstrated strong efficacy for ulixacaltamide, meeting all primary endpoints and most key secondary measures [2] - In Study 1, ulixacaltamide showed a statistically significant 4.3-point improvement in the Modified Activities of Daily Living 11 (mADL11) score at Week 8, with effects observed as early as Week 2 [2][3] - Study 2 confirmed the treatment's effectiveness, with 55% of responders maintaining their response after an additional four weeks of ulixacaltamide compared to 33% for placebo [4] Safety and Tolerability - Ulixacaltamide was generally well tolerated, with treatment-related adverse events mostly mild in severity, consistent with previous studies [7] Regulatory Progress - Praxis completed a pre-NDA meeting with the FDA, aligning on the content for the upcoming NDA submission for ulixacaltamide, expected in early 2026 [8] - This regulatory progress is seen as a key factor contributing to the recent stock price rally [8] Additional Catalysts - Positive results from the EMBOLD study for relutrigine, another late-stage asset, have also contributed to the stock's upward momentum, with interim analysis showing significant efficacy [9] - The FDA has confirmed a meeting to discuss the regulatory path for relutrigine, providing clarity on next steps [10] Future Opportunities - The ongoing registrational EMERALD study for relutrigine could support a supplemental NDA by 2027 if successful, expanding its market potential [12]