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If you are a U.S. Healthcare Professional and would like to receive more information please click here. Fact Sheets: Depression. In 2020, another tiny biotech, Novavax (NASDAQ:NVAX), came out of nowhere to stomp the stock market, with its share price skyrocketing by 2,700%. For the many people facing unsatisfactory treatments for CNS disorders, Axsome accelerates the invention and adoption of . NeuroRx, Inc. is a clinical stage, small molecule pharmaceutical company developing novel therapeutics for the treatment of central nervous system disorders. If I Could Only Buy 1 Stock Right Now, This Would Be It, Bitcoin prices just got smashed, but this crypto insider still sees $160,000, These jobs are offering lucrative sign-on bonuses of up to $100,000 amid shortage of candidates, The Ownership Structure of Palantir Technologies (NYSE:PLTR) is a Double Edged Sword for the Stock. Description . The FDA did not request additional information from the Company, and the review of the application is ongoing. In 2019, tiny Axsome Therapeutics (NASDAQ:AXSM) emerged from micro-cap obscurity to become the best-performing stock in the market, rising by an amazing 3,600% in a year. New York, NY 10007. Additionally, the Company has released its Q2 2021 Financial Results and provided a business update. By now, you've probably heard of someone who has gotten COVID despite being fully vaccinated. Axsome Therapeutics Inc said on Monday the U.S. Food and Drug Administration did not ask for additional information on the company's drug to treat depression as the agency continues to review it, sending shares of the drug developer surging 44% before the bell. It is engaged in developing novel therapies for the management of the central nervous system, or CNS, disorders for which there are limited treatment options. Neurolixis was founded in 2011 by highly experienced pharmaceutical industry professionals, with a world-class track record of CNS drug discovery, drug development, clinical trials, and company management. Axsome Therapeutics snagged a speedy review for its depression treatment on Monday, leading Axsome stock to gap higher.. X. The stock market was having a generally weak session on Wednesday, with all three major averages in the red throughout the morning. A new drug application (NDA) for AXS-05 for the treatment of major depressive disorder is under review by the FDA. Found insideThis book presents, at a non-technical level, several approaches for the analysis of correlated data: mixed models for continuous and categorical outcomes, nonparametric methods for repeated measures and growth mixture models for Axsome Therapeutics. Its pipeline products include AXS-05, AXS-07, AXS-12, and others. President Biden blamed the coronavirus delta variant. Beta is used in the capital asset pricing model (CAPM), which describes the relationship between systematic risk and expected return for assets (usually stocks). Overview. LinkedIn Description . Axsome is located in New York City, New York. Found insideThis greatly expanded third edition provides a comprehensive overview of clinical psychopharmacology, incorporating the major advances in the field since the previous edition's publication. The Dow Jones Industrial Average dropped 150 points Wednesday, as Tesla stock reversed lower amid China sales. Nevertheless, it may feel like they're happening more often than you had hoped. For the many people facing unsatisfactory treatments for CNS disorders, Axsome accelerates the invention and adoption of . I interviewed at Axsome Therapeutics (New York, NY) Went through all the interview process, landed an in-person interview and was flown out to their HQ in NY. The forward-looking statements include risks and uncertainties, including, but not limited to, the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials, and the number or type of studies or nature of results necessary to support the filing of a new drug application (NDA) for any of our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration (FDA) or other regulatory authority approval of, or other action with respect to, our product candidates (including, but not limited to, whether potential filing issues or issues identified by FDA during the substantive review may impact the potential approvability of the Companys NDA submission for AXS-05 in MDD or the timing of such approval, and whether the FDA will agree with the Companys discontinuation of the bupropion treatment arm of the ADVANCE study in accordance with the independent data monitoring committees recommendations); the acceptance and approval by the FDA of an NDA for AXS-07 for the acute treatment of migraine in adults with or without aura, pursuant to our special protocol assessment for the MOMENTUM clinical trial; the potential for the ASCEND clinical trial, combined with the GEMINI clinical trial results, to provide a basis for approval of AXS-05 for the treatment of major depressive disorder and accelerate its development timeline and commercial path to patients; the Companys ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Companys research and development programs and collaborations; the success of the Companys license agreements; the acceptance by the market of the Companys product candidates, if approved; the Companys anticipated capital requirements, including the amount of capital required for the Companys commercial launch of its product candidates, and the potential impact on the Companys anticipated cash runway; unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19; and other factors, including general economic conditions and regulatory developments, not within the Companys control. First Name. The Company may occasionally disseminate material, nonpublic information on the company website. Zogenix' lead product, needle free delivery of sumatriptan, is approved in the US and Europe for the treatment of cluster headaches and migraine. Associated sectors: Neurobiology; Small Molecule Pharmaceuticals; NeurolixisUSAn/aNeurolixis is an early-stage biopharmaceutical company focused on the discovery and development of novel drugs for the treatment of human central nervous system disorders including Parkinson's disease, Rett syndrome, depression and schizophrenia. Rush AJ, et al. As it turned out, Smartsheet lost only $0.05 per share, and its sales beat expectations, rising 44% year over year to $131.7 million. The company said the FDA did not request additional information, adding. Axsome Contact: Mark Jacobson Chief Operating Officer Axsome Therapeutics, Inc. 22 Cortlandt Street, 16^th Floor New York, NY 10007 Tel: 212-332-3243 Email: mjacobson@axsome.com www.axsome.com . Investors are still upset . On August 9, 2021, Axsome Therapeutics, Inc. shares tumbled in response to a disappointing regulatory update for AXS-05 as a potential treatment for major depressive disorder (MDD). Aptinyx has a platform for discovery of novel compounds that work through a unique mechanism to modulaterather than block or over-activateNMDA receptors and enhance synaptic plasticity, the foundation of neural cell communication. Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders for which there are limited treatment options. Contact and general information about Axsome Therapeutics, Inc. company, headquarter location in New York, United States. Percentage. 2 days ago. jdoe@axsome.com) being used 90.9% of the time. NEW YORK (AP) _ Axsome Therapeutics Inc. (AXSM) on Monday reported a loss of $32.3 million in its second quarter. Feb 2005 - Mar 20061 year 2 months. Axsome Therapeutics, Inc. engages in the development of novel therapies for the management of central nervous system disorders. This could lead to some big price moves if either group is proved right or wrong on the company. Get an in-depth profile of Axsome Therapeutics Inc, including a general overview of the company's business and key management, as well as employee data and location and contact information. Biomedical Products. Neurolixis was founded in 2011 by highly experienced pharmaceutical industry professionals, with a world-class track record of CNS drug discovery, drug development, clinical trials, and company management. Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders for which there are limited treatment options. The Company is engaged in developing therapies for the management of central nervous system (CNS) disorders, including pain. | Investors in Axsome Therapeutics Inc (Symbol: AXSM) saw new options become available this week, for the March 2022 expiration. For the many people facing unsatisfactory treatments for C. Let's review three reasons to buy AT&T -- as well as one reason to sell it -- to see if it's a contrarian play. Getting an even larger dividend payment this year. Zogenix' lead product, needle free delivery of sumatriptan, is approved in the US and Europe for the treatment of cluster headaches and migraine. Labaton Sucharow LLP is one of the world's leading complex litigation firms representing clients in securities, antitrust, corporate governance and shareholder rights, and consumer cybersecurity and data privacy litigation. is Investigating Axsome Therapeutics, Inc. on Behalf of Axsome Stockholders and Encourages Investors to Contact the Firm Posted on 08/11/2021 8078 Email: mjacobson@axsome.com Today. Axsome Therapeutics, Inc. ClinicalTrials.gov Identifier: NCT04947553 Other Study ID Numbers: AXS-05-AD-303 : First Posted: July 1, 2021 Key Record Dates: Last Update Posted: July 29, 2021 Last Verified: July 2021 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: No Found insideThe American Psychiatric Association Practice Guideline on the Use of Antipsychotics to Treat Agitation or Psychosis in Patients With Dementia seeks to fulfill this need to improve the care of patients with dementia who are exhibiting Certain matters discussed in this press release are forward-looking statements. There are some situations where a financial interest may constitute a prohibited financial interest in an SRO, even if it . Found insideShedding light on the debilitating disorders themselves as well as their everyday realities, this book is a much-needed resource for anyone caring for another person suffering from Alzheimers disease and other neurocognitive disorders. Trademark registration by Axsome Therapeutics, Inc. for the trademark MYVELO. Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company. Found inside Axsome Therapeutics Inc & NASDAQ Axsome Therapeutics beta ( AXSM Beta) is a measure of the volatilityor systematic riskof Axsome Therapeutics compared to the market as a whole. If the high-water price target for each of the following five stocks were to come to fruition, shareholders would be looking at gains ranging from a low of 195% to as much as 467%. Axsome Therapeutics USA n/a Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders for which there are limited treatment options. Glutamate-Related Biomarkers in Drug Development for Disorders of the Nervous System: Workshop Summary investigates promising current and emerging technologies, and outlines strategies to procure resources and tools to advance drug The Canadian energy infrastructure giant agreed to acquire privately held Moda Midstream Operating for $3 billion in cash. AXS-05 is being developed for major depressive disorder (MDD), Alzheimers disease (AD) agitation, and as a treatment for smoking cessation. 2.Vesting. The Company is engaged in developing therapies for the management of central nervous system (CNS) disorders, including pain. Found insideIn this "must-read" guide (Lonnie Ali), four leading doctors and advocates offer a bold action plan to prevent, care for, and treat Parkinson's disease-one of the great health challenges of our time. Learn about our pipeline Axsome focuses on CNS conditions including depression, Alzheimer's disease agitation, migraine, narcolepsy and fibromyalgia. If you're "only" looking to triple your money, analyst Amit Dayal of H.C. Wainwright would suggest putting it to work in hydrogen fuel-cell solutions company Plug Power (NASDAQ: PLUG). Rather, they create and sustain a culture where innovation is allowed to happen again and againan environment where people are both willing and able to do the hard work that innovative problem solving requires. Contact Us Checked in with them after 2 weeks and never heard back. ANNEX A . Axsome Therapeutics, Inc. (NASDAQ: AXSM) uses its chiral chemistry and formulation capabilities to identify, isolate and stabilize chirally pure enantiomers for developing drug candidates for the treatment of central nervous system (CNS) disorders with large unmet needs. Save Job. Specifically, Axsome revealed during its 2021 second-quarter earnings release that the U.S. Food and Drug Administration (FDA) had notified the company on July 30, 2021 that it has identified deficiencies within the drug's regulatory application that preclude discussion of labeling and post-marketing requirements at this time. Axsome Therapeutics. Never heard anything afterwards. If I hold a one-stock portfolio, the qualities I am looking for are a diversified business, sustainability, and a fair price. Managed staff consisting of 3 employees. NEW YORK, May 26, 2020 (GLOBE NEWSWIRE) - Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced the Company's 2020 Annual Meeting of Stockholders will now be held in a virtual-only . Location. The New . NIO Inc. (NYSE:NIO): Are Analysts Optimistic? We may, in some cases, use terms such as predicts, believes, potential, continue, estimates, anticipates, expects, plans, intends, may, could, might, will, should or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. A report by transparency market research predicts that the global market for Alzheimer's will reach US$6.4 billion by 2025, growing at a CAGR of 7.5%, from US$3.6 billion in 2017. The dextromethorphan component of AXS-05 is also a sigma-1 receptor agonist. Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for central nervous system (CNS) conditions that have limited treatment options. 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