Core Insights - Axsome Therapeutics shares experienced a significant increase, closing the year with a rise of over 20% following the announcement of key developments [1] Group 1: FDA Approvals and Designations - The U.S. FDA granted priority review designation for Axsome's AXS-05 drug, aimed at treating agitation in Alzheimer's disease, which addresses a significant unmet medical need [3][4] - AXS-05 is already approved for major depressive disorder (MDD) and has seen a 69% year-over-year sales growth in Q3, contributing to 80% of Axsome's revenue for that quarter [3][8] - The FDA has set a target action date of April 30, 2026, for AXS-05, providing a clear timeline for potential market entry [4] Group 2: Pipeline Developments - Axsome's AXS-12, a drug for treating narcolepsy, is also progressing, with FDA meeting minutes indicating that the regulatory data package is acceptable for a new drug application (NDA) submission expected next month [5][6] - The positive news regarding both AXS-05 and AXS-12 has led to increased investor interest in Axsome stock [6]

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]

Core Viewpoint - The FDA has granted Axsome Therapeutics' AXS-05 a Priority Review designation for the treatment of Alzheimer's disease agitation, with a target action date set for April 30, 2026, indicating a significant step towards addressing an unmet medical need in this area [1][2][3]. 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 other conditions [7][8]. - The company aims to deliver scientific breakthroughs by identifying gaps in care and developing differentiated products that improve patient outcomes [7]. Product Details - AXS-05 is an investigational drug combining dextromethorphan and bupropion, designed to treat agitation in Alzheimer's disease and smoking cessation [6]. - The drug has been granted Breakthrough Therapy designation by the FDA, which is intended to expedite its development and review process due to its potential for significant improvement over existing therapies [3][6]. Clinical Development - The supplemental NDA for AXS-05 is based on a comprehensive clinical development program, including four Phase 3 clinical trials and a long-term safety trial [4]. - Agitation affects up to 76% of Alzheimer's patients, highlighting the critical need for effective treatments in this area [5][3].

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]