Core Insights - Axsome Therapeutics Inc's stock is experiencing significant gains, rising 19% to $177.13 after the FDA granted priority review for its Alzheimer's disease agitation drug AXS-05 [1] - Analysts from Needham and TD Cowen have reiterated "buy" ratings, with Needham increasing its price target from $154 to $169 [1] - The stock is on track for its largest single-day percentage gain since February, reaching a record peak of $178.99 [2] Stock Performance - If current gains are maintained, Axsome Therapeutics is projected to finish 2025 with over 100% year-to-date gain [2] - The options market has seen a surge, with AXSM's options volume reaching ten times its average daily volume, particularly in the January 2026 185-strike call [2] Short Interest - A portion of the stock's increase may be due to short covering, as short interest accounts for 6.8% of the stock's available float [3] - It would take over five days for short sellers to buy back their borrowed shares based on the stock's average trading pace [3]

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 Viewpoint - Axsome Therapeutics has received priority review designation from the FDA for its supplemental new drug application to expand the indication of AXS-05 for the treatment of agitation associated with Alzheimer's disease [1][2] Group 1: Company Developments - Axsome Therapeutics announced that the FDA has set a target review completion date of April 30, 2026, for the supplemental new drug application for AXS-05 [1] - Following the announcement, Axsome's stock rose over 7% in pre-market trading [1] - AXS-05 was previously approved by the FDA in 2022 for the treatment of major depressive disorder in adults [1] Group 2: Drug Mechanism and Potential - AXS-05 is an oral NMDA receptor antagonist, sigma-1 agonist, and CYP2D6 inhibitor, combining dextromethorphan and bupropion in a patented formulation [2] - The drug aims to improve symptoms characterized by emotional distress, verbal and physical aggression, irritability, and disinhibition in Alzheimer's disease agitation [2] - The CEO of Axsome expressed optimism about the FDA's acceptance and priority review designation, indicating a commitment to collaborate with the FDA during the review process [2]

FDA grants AXS-05 Priority Review designation and sets PDUFA action goal date of April 30, 2026 NEW YORK, Dec. 31, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s supplemental New Drug Application (NDA) for AXS-05 (dextromethorphan HBr and bupropion HCl) for the treatment of Alzheime ...

Core Viewpoint - Axsome Therapeutics is on track to submit a New Drug Application (NDA) for AXS-12, a treatment for cataplexy in narcolepsy, by January 2026, following positive feedback from the FDA regarding the regulatory data package [2][3][4]. Company Overview - Axsome Therapeutics is a biopharmaceutical company focused on developing treatments for central nervous system (CNS) disorders, with a portfolio that includes FDA-approved therapies for major depressive disorder and excessive daytime sleepiness associated with narcolepsy [8]. Product Details - AXS-12 (reboxetine) is a selective norepinephrine reuptake inhibitor and cortical dopamine modulator, aimed at treating narcolepsy by promoting wakefulness and enhancing cognition [7]. - AXS-12 has received Orphan Drug Designation from the FDA, which may provide seven years of marketing exclusivity upon approval and a waiver of application user fees [5]. Clinical Development - The clinical development program for AXS-12 includes three controlled efficacy trials and a completed long-term safety trial, indicating a robust approach to validating the drug's effectiveness and safety [4]. Market Context - Narcolepsy is a serious neurological condition affecting the sleep-wake cycle, characterized by excessive daytime sleepiness and cataplexy, which impacts cognitive and social functioning and is associated with a higher mortality rate [6].

Company Strategy - Axsome Therapeutics aims for differentiated outcomes by avoiding conventional approaches [1] Leadership - Herriot Tabuteau, 57, CEO of Axsome Therapeutics, gave his first interview about the company [1]

Core Insights - Axsome Therapeutics, Inc. is focused on developing therapies for central nervous system disorders, particularly in treating depression and migraines, highlighting its commitment to addressing unmet medical needs in the healthcare sector [1] Company Developments - On December 4, 2025, CEO Herriot Tabuteau sold 10,558 shares of Axsome's common stock at $148.18 each, retaining 7,229 shares post-sale, indicating continued vested interest in the company's future [2] - Axsome showcased its progress at the Piper Sandler 37th Annual Healthcare Conference, emphasizing its active engagement with the healthcare community and providing a platform to highlight recent developments [3] Market Performance - AXSM's stock is currently priced at $148.04, reflecting a slight increase of 0.16% from the previous session, with fluctuations between a low of $147.56 and a high of $149.59 today [4] - The company's market capitalization stands at approximately $7.46 billion, indicating its substantial size within the biopharmaceutical industry, with a trading volume of 351,301 shares on NASDAQ, showcasing active investor interest [5]

Core Viewpoint - Vodacom Group has announced the acquisition of a strategic stake in Safaricom, highlighting its commitment to expanding its presence in the telecommunications market [1][2]. Group 1: Acquisition Details - The announcement regarding the acquisition was made on the Johannesburg Stock Exchange, indicating a significant move in the telecommunications sector [2]. - A presentation related to the acquisition has been made available on Vodacom's website, providing further details for stakeholders [2]. Group 2: Management Involvement - The call includes participation from both Vodacom and Safaricom management teams, showcasing collaboration between the two companies [3]. - Key executives from Vodacom, including Shameel and Raisibe, along with Sean Bennett, Chief Officer of M&A and Business Development, are present to discuss the acquisition [3].

Core Insights - The company is currently awaiting an important decision regarding the filing for Auvelity and its application for AD agitation, which is a significant topic for stakeholders [1] - The company confirmed that a supplemental New Drug Application (sNDA) was submitted, and they are now waiting to provide further updates on this matter [1] - The expectation is that if the sNDA is accepted, it will undergo a standard review due to the current resource constraints and bandwidth considerations at the FDA, which are independent of the submitted package [2]

Axsome Therapeutics FY Conference Summary Company Overview - **Company**: Axsome Therapeutics (NasdaqGM:AXSM) - **Event**: FY Conference on December 03, 2025 Key Points Industry and Product Updates - **Auvelity and Alzheimer's Disease (AD) Agitation**: - Axsome is awaiting an acceptance decision for the supplemental new drug application (SNDA) for Auvelity in AD agitation, which was submitted in early November [3][5][10] - The expectation is for a standard review due to FDA resource constraints, despite having three positive trials and breakthrough therapy designation [10][11] - The company believes the trial package is robust, consisting of one randomized parallel group study and two randomized withdrawal studies [10][12][22] Commercialization Strategy - **Sales Force Expansion**: - Currently, Axsome has approximately 300 sales representatives detailing for Major Depressive Disorder (MDD) and plans to expand the team upon approval for AD agitation [24][26] - The peak sales opportunity for AD agitation is estimated between $1.5 billion and $3 billion, while MDD is estimated at $1 billion to $3 billion, totaling $2.5 billion to $6 billion [30][32] - A discrete field force team will be established for long-term care facilities, recognizing the comorbidity between MDD and AD agitation [32][34] Market Access and Coverage - **Access to Auvelity**: - Currently, there is 100% access in the government channel and 75% in the commercial channel, leading to an overall 85% total covered lives [47][47] - The majority of prescriptions are expected to come from the government channel, with high-quality access anticipated for the AD agitation indication [47][123] Direct-to-Consumer (DTC) Campaign - **DTC Campaign for Auvelity**: - A national TV DTC campaign launched in September has shown positive results, with new prescriptions (NBRXs) increasing from 2,000 to over 2,800 per week [75][78] - The campaign is expected to continue through 2026, with adjustments made based on market conditions [79][100] Product Performance and Market Position - **Auvelity in MDD**: - Over 50% of prescriptions are now for monotherapy, with 15% first-line and 35% second-line usage [103][108] - The gross-to-net (GTN) improved from mid-50s% in Q1 and Q2 to high 40s% in Q3, with expectations for a slight uptick in Q4 [122][123] Pipeline Developments - **Solriamfetol**: - Axsome is excited about the potential of Solriamfetol in various CNS settings, with studies underway for ADHD, MDD with excessive daytime sleepiness, and binge eating disorder [159][161][186] - The company anticipates starting a pediatric ADHD study this quarter and expects top-line results for binge eating disorder next year [174][190] New Product Development - **GABA-A Alpha 2/3 Modulator**: - Axsome is exploring the value proposition of a new GABA-A modulator for epilepsy and psychiatric indications, with preclinical work already underway [200][206] - The company is taking an opportunistic approach to expand its early-stage pipeline [211][220] Conclusion - Axsome Therapeutics is strategically positioned with a robust pipeline and commercialization plans, focusing on expanding its market presence in both existing and new indications while maintaining a strong emphasis on data-driven decision-making and market access strategies.