Stuttgart - Delayed Quote • EUR Axsome Therapeutics Inc (19X.SG) Follow Compare 102.25 -2.10 (-2.01%) At close: January 31 at 9:34:16 PM GMT+1 All News Press Releases SEC Filings All SEC Filings Corporate Changes & Voting Matters Periodic Financial Reports Proxy Statements Tender Offer/Acquisition Reports Offering Registrations Axsome Gets FDA Nod for New Migraine Drug Symbravo, Stock Rises The FDA approves AXSM's Symbravo for the acute treatment of migraine with or without aura in adults. The latest nod diversifies its commercial portfolio. Axsome Therapeutics Hosts SYMBRAVO® FDA Approval Virtual Investor Event with Expert Thought Leader NEW YORK, Jan. 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, will host a virtual investor event and conference call today at 8:00 AM Eastern Time to discuss the U.S. Food and Drug Administration (FDA) approval of SYMBRAVO®, a novel multi-mechanistic approach to treating migraine that targets multiple pathways underlying a migraine attack. Experience the interactive M Axsome Therapeutics Announces FDA Approval of SYMBRAVO® (meloxicam and rizatriptan) for the Acute Treatment of Migraine with or without Aura in Adults A single oral dose of SYMBRAVO provided rapid migraine pain freedom and return to normal functioning within 2 hours, and sustained efficacy through 24 and 48 hours 85% and 77% of patients treated with a single dose of SYMBRAVO did not require migraine rescue medication within 24 hours in two Phase 3 studies SYMBRAVO demonstrated superior efficacy across a broad range of migraine severity (mild, moderate, and severe), and in head-to-head evaluation SYMBRAVO incorporates Axsome’s rapid absorption Axsome Therapeutics to Report Fourth Quarter and Full Year 2024 Financial Results on February 18 NEW YORK, Jan. 22, 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 it will report its financial results for the fourth quarter and full year of 2024 on Tuesday, February 18, 2025, before the opening of the U.S. financial markets. Axsome management will then host a conference call at 8:00 a.m. Eastern Time to discuss these results and provide a business upda BridgeBio, ARS Pharma, Harmony Bio Shine At JPM. But SpringWorks, Beam Take Their Lumps. Biotech stocks put up a split showing at JPM, where names like BridgeBio, ARS and Harmony stood out with strong preliminary reports. Axsome Therapeutics Provides Preliminary Fourth Quarter and Full Year 2024 Net Revenue Auvelity preliminary 4Q and full year 2024 net product sales of $92.6 million and $291.4 million, respectively Sunosi preliminary 4Q and full year 2024 net product revenue of $25.7 million and $93.8 million, respectively NEW YORK, Jan. 13, 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 preliminary net product revenue for the fourth quarter and full year en Axsome Therapeutics, Inc.'s (NASDAQ:AXSM) Profit Outlook Axsome Therapeutics, Inc. ( NASDAQ:AXSM ) is possibly approaching a major achievement in its business, so we would like... Axsome Reveals Data From Alzheimer's Studies, Analyst Sees Hope Despite Mixed Trial Results On Monday, Axsome Therapeutics, Inc. (NASDAQ:AXSM) released data from ACCORD-2, ADVANCE-2, and long-term safety trials AXS-05 (dextromethorphan-bupropion) in Alzheimer's disease agitation. The ACCORD-2 Phase 3 trial achieved the primary endpoint with AXS-05 statistically significantly delaying the time to relapse of agitation, demonstrating a 3.6-fold lower risk of relapse compared to placebo. AXS-05 also met the key secondary endpoint (relapse prevention, p=0.001). Further, AXS-05 reduced the w Axsome Flashes A Bearish Signal On Mixed Results In Alzheimer's Agitation Shares of Axsome Therapeutics dropped Monday on mixed test results for its Alzheimer's disease agitation treatment. Axsome Therapeutics Announces Successful Completion and Results of Phase 3 Clinical Program of AXS-05 in Alzheimer’s Disease Agitation ACCORD-2 Phase 3 trial in Alzheimer’s disease agitation achieves primary endpoint compared to placebo (p=0.001, time to relapse) ACCORD-2 Phase 3 trial achieves key secondary endpoint compared to placebo (p=0.001, prevention of relapse of Alzheimer’s disease agitation) AXS-05 reduced worsening of Alzheimer’s disease overall compared to placebo in ACCORD-2 Phase 3 trial (p<0.001, CGI-S Alzheimer’s disease overall clinical status) ADVANCE-2 trial did not demonstrate statistical significance on pri Why Is Axsome (AXSM) Down 0.1% Since Last Earnings Report? Axsome (AXSM) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues. Axsome Therapeutics' AXS-12 Data For Sleeping Disorder Boosts Confidence In Approval And Market Potential, Analyst Says On Tuesday, Axsome Therapeutics Inc (NASDAQ:AXSM) said AXS-12 statistically significantly reduced the frequency of cataplexy attacks compared to placebo (p=0.017, primary endpoint) in Phase 3 ENCORE trial. AXS-12 was also well tolerated with long-term dosing, and its safety profile was consistent with that observed in previously completed trials. The primary endpoint was achieved with patients randomized to switch to placebo experiencing a mean increase of 10.29 cataplexy attacks per week compar Axsome Therapeutics' (NASDAQ:AXSM) growing losses don't faze investors as the stock ascends 5.5% this past week It might seem bad, but the worst that can happen when you buy a stock (without leverage) is that its share price goes... Axsome Therapeutics Announces AXS-12 Achieves Primary Endpoint in ENCORE Long-Term Phase 3 Trial in Narcolepsy AXS-12 statistically significantly reduced the frequency of cataplexy attacks compared to placebo (p=0.017, primary endpoint) Statistically significant improvement in cognition compared to placebo (p=0.011, NSAQ) Statistically significant improvement in narcolepsy overall compared to placebo (p=0.024, PGI-C) Cataplexy response (≥50% improvement) achieved by 72% of patients at 1 month and 82% at 6 months Improvement in excessive daytime sleepiness (EDS), assessed by the CGI-C, achieved by 84% of Axsome's Q3 Earnings Beat, Auvelity Drives Sales Growth, Stock Up AXSM posts better-than-expected third-quarter results. Stock rises in response to the results and strong sales uptake of Auvelity. Q3 2024 Axsome Therapeutics Inc Earnings Call Q3 2024 Axsome Therapeutics Inc Earnings Call Axsome Therapeutics (AXSM) Q3 2024 Earnings Call Transcript AXSM earnings call for the period ending September 30, 2024. Axsome Hits 52-Week High After Surging Nearly 5%--FDA Milestones Could Fuel Even Bigger Gains Investors rally behind Axsome's explosive growth, with FDA approvals and breakthrough drugs driving momentum. Axsome Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update Total 3Q 2024 net product revenue of $104.8 million, representing 81% year-over-year growth Auvelity® 3Q 2024 net product sales of $80.4 million, representing 113% year-over-year growth Sunosi® 3Q 2024 net product revenue of $24.4 million representing 21% year-over-year growth Second expansion of Auvelity psychiatry sales force planned for 1Q 2025 NDA resubmission for AXS-07 for the treatment of migraine accepted by the FDA with PDUFA goal date of January 31, 2025 Topline results of ADVANCE-2 an Axsome Therapeutics Presents Data from Its Leading Neuroscience Pipeline at NEI Congress 2024 NEW YORK, Nov. 08, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced eight presentations spanning its innovative portfolio of late-stage products and product candidates in psychiatry and neurology at NEI Congress 2024, being held Nov. 7 - Nov. 10, 2024, in Colorado Springs, Colorado. Details for the presentations are as follows: Majo Performance Overview Trailing total returns as of 1/31/2025, which may include dividends or other distributions. Benchmark is S&P 500 Return 19X.SG S&P 500 YTD +24.27% +2.26% 1-Year +22.72% +22.65% 3-Year +365.41% +36.30%