Latest news with #Axsome
Yahoo
30-07-2025
- Business
- Yahoo
2 Growth Stocks Wall Street Predicts Will Soar 74% to 159%
In the highly competitive biotech industry, only a few standout companies attract Wall Street's attention. Among them, two high-growth biotech stocks, Axsome Therapeutics (AXSM) and Viking Therapeutics (VKTX), have analysts predicting massive upside ahead. These companies not only promise breakthroughs in neuroscience and metabolic disease, but they may also help deliver massive returns to investors who are willing to ride the wave. Let's find out why Wall Street is so bullish. Growth Stock #1: Axsome Therapeutics Valued at $4.9 billion, Axsome Therapeutics is a commercial-stage biotech company focused on developing new treatments for complex central nervous system (CNS) disorders. These include depression, Alzheimer's disease symptoms, narcolepsy, and other areas where few other companies have succeeded. More News from Barchart Here's What Happened the Last Time Novo Nordisk Stock Was This Oversold Earnings Will Be 'Worse Than Expected' for UnitedHealth. How Should You Play UNH Stock Here? As SoFi Raises 2025 Guidance, Should You Buy, Sell, or Hold SOFI Stock Here? Our exclusive Barchart Brief newsletter is your FREE midday guide to what's moving stocks, sectors, and investor sentiment - delivered right when you need the info most. Subscribe today! Axsome stock has gained 19.3% year-to-date, outperforming the broader market's 8.5% gain. Currently, Axsome has three approved products on the market. The U.S. Food and Drug Administration (FDA) approved Auvelity in 2022 for major depressive disorder (MDD) in adults, and it is unique in that it suppresses hallucinogenic effects while providing antidepressant benefits. The second approved drug is Sunosi (solriamfetol), which Axsome purchased from Jazz Pharmaceuticals (JAZZ) in 2022. It is used for the treatment of excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea. The third one is Symbravo (AXS 07), a combination of meloxicam and rizatriptan for the acute treatment of migraine with or without aura in adults, which the FDA approved in January 2025. The drug is now commercially available in the U.S. In the first quarter, total net product revenue increased 62% year over year (YoY) to $121.5 million, driven by an 80% increase in Auvelity sales to $96.2 million. Auvelity has also received favorable reimbursement coverage, with over 78% of covered lives having access, showing both its unique mechanism and real-world efficacy. Sunosi also generated net product revenue of $25.2 million, up 17% year on year, with 83% reimbursement coverage. Despite significant revenue growth, the company has yet to report a profit. Furthermore, Axsome's pipeline is rich, with multiple programs already in or nearing Phase 3, as well as several FDA-designated Breakthrough Therapies. These include AXS-05 for Alzheimer's disease agitation and smoking cessation, AXS-12 for narcolepsy, and AXS-14 for fibromyalgia. Axsome is also expanding Auvelity, Sunosi, and Symbravo's labels into new CNS indications such as ADHD, shift work disorder, binge eating disorder, and depression-related fatigue, all of which could significantly increase its market potential over the next five years, bringing it close to profitability. Analysts predict the company will turn a profit by 2026. Despite aggressive clinical expansion and commercial build-out, the company's balance sheet remains robust, with cash and cash equivalents totaling $300.9 million. On Wall Street, overall, Axsome stock is a 'Strong Buy.' Out of the 19 analysts that cover the stock, 17 rate it a 'Strong Buy,' and two say it is a 'Moderate Buy.' The average target price of $175.61 is 74.1% above current levels. The high price estimate of $210 implies 108.3% upside over the next 12 months. Growth Stock #2: Viking Therapeutics Valued at $3.9 billion, Viking Therapeutics is a clinical-stage biotech company focused on metabolic and endocrine disorders. Obesity, non-alcoholic steatohepatitis (NASH/MASH), and rare metabolic diseases are among the company's primary focus areas. Viking stock has dropped 16.2% year-to-date, compared to the broader market gain. The company currently has no commercially approved products, but a few of its candidates are in late-stage clinical trials. VK2735 is a dual GLP-1/GIP receptor agonist available in subcutaneous (Phase 3 trial) and oral (Phase 2 trial) formulations for the treatment of obesity and other metabolic disorders. VK2809, a selective thyroid hormone receptor β agonist, has completed Phase 2b in biopsy-confirmed NASH/fibrosis. Its pipeline also includes VK0214 for X-ALD (a genetic disorder affecting the nervous system and adrenal glands) and an Amylin agonist, which targets obesity. Viking has also signed a $150 million manufacturing agreement with CordenPharma, which guarantees large-scale production readiness for both oral and injectable VK2735 forms. The agreement solved a significant commercial challenge for the company by supplying up to 100 million autoinjectors and over 1 billion oral tablets annually. As a clinical-stage company, it generates no revenue. However, Viking's cash-rich balance sheet, which hovers around $808 million, gives it a runway that extends until late 2026 and reduces immediate dilution risk. Viking is a high-risk, high-reward biotech investment, with a large cash reserve and candidates in the late stages of development. On Wall Street, overall, Viking stock is a 'Strong Buy.' Out of the 18 analysts that cover the stock, 16 rate it a 'Strong Buy,' and two rate it a 'Hold.' The average target price of $89.18 is 159% above current levels. The high price estimate of $125 implies 263.2% upside over the next 12 months. On the date of publication, Sushree Mohanty did not have (either directly or indirectly) positions in any of the securities mentioned in this article. All information and data in this article is solely for informational purposes. This article was originally published on Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Toronto Star
21-07-2025
- Business
- Toronto Star
Axsome Therapeutics to Ring the NASDAQ Stock Market Opening Bell Today
NEW YORK, July 21, 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 Herriot Tabuteau, MD, Axsome's Chief Executive Officer, along with the rest of the management team, and other Axsome team members, will ring the opening bell of the NASDAQ Stock Market today, Monday, July 21, 2025, in connection with its Frontiers in Brain Health R&D Day event being held today. Herriot Tabuteau, MD, Chief Executive Officer of Axsome said, 'We are thrilled to ring NASDAQ's opening bell in connection with our Frontiers in Brain Health R&D Day today, showcasing our pioneering work across our pipeline of innovative, late-stage CNS product candidates, and commemorating the recent availability of SYMBRAVO® by prescription in the U.S. With our growing portfolio of differentiated on-market medicines, and our pipeline of potentially transformative investigational medicines, Axsome is defining the future of clinical practice in brain health to improve the lives of the millions of patients living with serious and difficult-to-treat CNS conditions.'
Hamilton Spectator
21-07-2025
- Business
- Hamilton Spectator
Axsome Therapeutics to Ring the NASDAQ Stock Market Opening Bell Today
NEW YORK, July 21, 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 Herriot Tabuteau, MD, Axsome's Chief Executive Officer, along with the rest of the management team, and other Axsome team members, will ring the opening bell of the NASDAQ Stock Market today, Monday, July 21, 2025, in connection with its Frontiers in Brain Health R&D Day event being held today. Herriot Tabuteau, MD, Chief Executive Officer of Axsome said, 'We are thrilled to ring NASDAQ's opening bell in connection with our Frontiers in Brain Health R&D Day today, showcasing our pioneering work across our pipeline of innovative, late-stage CNS product candidates, and commemorating the recent availability of SYMBRAVO® by prescription in the U.S. With our growing portfolio of differentiated on-market medicines, and our pipeline of potentially transformative investigational medicines, Axsome is defining the future of clinical practice in brain health to improve the lives of the millions of patients living with serious and difficult-to-treat CNS conditions.' The opening bell ceremony will take place at the Nasdaq MarketSite located in Times Square, New York, NY. The live ceremonies will begin at 9:20 a.m. Eastern Time and can be viewed at . About Axsome Therapeutics Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit us at and follow us on LinkedIn and X . Forward Looking Statements Certain matters discussed in this press release are 'forward-looking statements'. The Company 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. In particular, the Company's statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company's SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company's efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company's ability to maintain and expand payer coverage; the success, timing and cost of the Company's ongoing clinical trials and anticipated clinical trials for the Company's current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company's ability to fully fund the Company's disclosed clinical trials, which assumes no material changes to the Company's currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company's ongoing clinical trials, and/or data readouts, 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 the Company's current product candidates; the Company's ability to fund additional clinical trials to continue the advancement of the Company's product candidates; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration ('FDA') or other regulatory authority approval of, or other action with respect to, the Company's product candidates, including statements regarding the timing of any NDA submission; the Company's ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company's ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company's research and development programs and collaborations; the success of the Company's license agreements; the acceptance by the market of the Company's products and product candidates, if approved; the Company's anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company's commercial launch of its other product candidates, if approved, and the potential impact on the Company's anticipated cash runway; the Company's ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company's control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. Investors: Mark Jacobson Chief Operating Officer (212) 332-3243 mjacobson@ Media: Darren Opland Director, Corporate Communications (929) 837-1065 dopland@ Nasdaq MarketSite Media Contact: Sophia Weiss (646) 483-6960
Hamilton Spectator
07-07-2025
- Business
- Hamilton Spectator
Axsome Therapeutics to Showcase Its Innovative CNS Pipeline at Upcoming Frontiers in Brain Health R&D Day in New York City on July 21
NEW YORK, July 07, 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 it will host its Frontiers in Brain Health R&D Day on July 21, 2025, starting at 11:00 a.m. Eastern Time in New York City. The event will highlight Axsome's singular, innovative late-stage CNS pipeline. At the event, physician key opinion leaders will discuss the company's current indications in neurology and psychiatry. Members of the Axsome management team will provide an overview of the clinical development programs. The presenters will be available to answer questions at the end of the presentations. This event is intended for institutional investors and sell-side analysts. To attend, please RSVP by emailing ir@ , as space is limited. To register for the live webcast, please click here . The live webcast and a replay of the event will also be publicly available on the 'Webcasts & Presentations' page of the 'Investors' section of the Company's website at . About Axsome Therapeutics Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit us at and follow us on LinkedIn and X . Forward Looking Statements Certain matters discussed in this press release are 'forward-looking statements'. The Company 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. In particular, the Company's statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company's SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company's efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company's ability to maintain and expand payer coverage; the success, timing and cost of the Company's ongoing clinical trials and anticipated clinical trials for the Company's current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company's ability to fully fund the Company's disclosed clinical trials, which assumes no material changes to the Company's currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company's ongoing clinical trials, and/or data readouts, 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 the Company's current product candidates; the Company's ability to fund additional clinical trials to continue the advancement of the Company's product candidates; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration ('FDA') or other regulatory authority approval of, or other action with respect to, the Company's product candidates, including statements regarding the timing of any NDA submission; the Company's ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company's ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company's research and development programs and collaborations; the success of the Company's license agreements; the acceptance by the market of the Company's products and product candidates, if approved; the Company's anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company's commercial launch of its other product candidates, if approved, and the potential impact on the Company's anticipated cash runway; the Company's ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company's control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. Investors: Mark Jacobson Chief Operating Officer (212) 332-3243 mjacobson@ Media: Darren Opland Director, Corporate Communications (929) 837-1065 dopland@
Yahoo
09-06-2025
- Business
- Yahoo
Axsome Therapeutics Provides Update on the New Drug Application (NDA) for AXS-14 for the Management of Fibromyalgia
NEW YORK, June 09, 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 has received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for AXS-14 (esreboxetine) for the management of fibromyalgia. The FDA states that upon preliminary review, it found that the NDA was not sufficiently complete to permit a substantive review. Specifically, the FDA does not consider the second of the two placebo-controlled trials in the submission to be adequate and well-controlled because its primary endpoint was at 8 weeks and it used a flexible-dose paradigm. The FDA indicated that the first of the two placebo-controlled trials in the submission, which utilized a 12-week endpoint and a fixed-dose paradigm, is adequate and well-controlled. The FDA did not raise any questions relating to the positive results of the studies, both of which met their primary endpoints. To address the FDA's feedback, Axsome will conduct an additional controlled trial, which will use a fixed-dose paradigm and a 12-week primary endpoint as requested by the FDA. Axsome anticipates initiating this trial in the fourth quarter of 2025. 'The clear feedback provided by the FDA's Division of Anesthesiology, Addiction Medicine, and Pain Medicine allows us to move expeditiously with the continued development of this important investigational medicine for the approximately 17 million patients in the U.S. living with fibromyalgia. We are well positioned to initiate a new controlled trial that will incorporate the FDA's feedback by the end of 2025,' said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. 'As highlighted in the FDA's Patient-Focused Drug Development Initiative report The Voice of the Patient: Fibromyalgia, patients with fibromyalgia experience debilitating widespread pain, fatigue, and functional impairment, and report living with constant stigmatization, anxiety, depression, and fear of ongoing or worsening symptoms. We are excited and motivated by the potential for AXS-14 to address this high unmet medical need for patients, as evidenced by the consistent efficacy demonstrated to date across a broad range of fibromyalgia symptoms, including significant improvements in pain, function, and fatigue, in the completed trials.' About AXS-14 AXS-14 (esreboxetine) is a highly selective and potent norepinephrine reuptake inhibitor for the management of fibromyalgia and other conditions. Esreboxetine, the SS-enantiomer of reboxetine, is more potent and selective than racemic reboxetine. AXS-14 is an investigational drug product not approved by the FDA. About Fibromyalgia Fibromyalgia is a chronic debilitating disorder characterized by widespread pain, fatigue, disturbed sleep, depression, and cognitive impairment.1 Other symptoms of this disorder can include tingling in the hands and feet and headaches.1 Fibromyalgia has considerable detrimental effects on physical, emotional, social, and day-to-day functioning.1 Fibromyalgia is considered to be mediated mainly in the central nervous system. Approximately 17 million Americans, 90% of whom are women, are estimated to suffer from fibromyalgia.2 Treatment options for fibromyalgia are limited with only three pharmacologic treatments currently approved by the FDA. About Axsome Therapeutics Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit us at and follow us on LinkedIn and X. Forward Looking Statements Certain matters discussed in this press release are 'forward-looking statements'. The Company 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. In particular, the Company's statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company's SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company's efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company's ability to maintain and expand payer coverage; the success, timing and cost of the Company's ongoing clinical trials and anticipated clinical trials for the Company's current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company's ability to fully fund the Company's disclosed clinical trials, which assumes no material changes to the Company's currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company's ongoing clinical trials, and/or data readouts, 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 the Company's current product candidates; the Company's ability to fund additional clinical trials to continue the advancement of the Company's product candidates; the timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration ('FDA') or other regulatory authority approval of, or other action with respect to, the Company's product candidates, including statements regarding the timing of any NDA submission; the Company's ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company's ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company's research and development programs and collaborations; the success of the Company's license agreements; the acceptance by the market of the Company's products and product candidates, if approved; the Company's anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company's commercial launch of its other product candidates, if approved, and the potential impact on the Company's anticipated cash runway; the Company's ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company's control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. Investors:Mark JacobsonChief Operating Officer(212) 332-3243mjacobson@ Media:Darren OplandDirector, Corporate Communications(929) 837-1065dopland@ References: Matthew J. Bair, Erin E. Krebs. Fibromyalgia. Ann Intern Med. 2020;172:ITC33-ITC48. doi:10.7326/AITC202003030 Vincent A, et al. Prevalence of fibromyalgia: a population-based study in Olmsted County, Minnesota, utilizing the Rochester Epidemiology Project. Arthritis Care Res (Hoboken). 2013 May;65(5):786-92. doi: 10.1002/ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
