Latest news with #AxsomeTherapeutics
Yahoo
a day ago
- Business
- Yahoo
Axsome Therapeutics to Report Second Quarter 2025 Financial Results on August 4
NEW YORK, July 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 will report its financial results for the second quarter of 2025 on Monday, August 4, 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 update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic) or +1 (201) 389-0851 (international). A live webcast of the conference call can be accessed on the 'Webcasts & Presentations' page of the 'Investors' section of the Company's website at A replay of the conference call will be available on the Company's website for approximately 30 days following the live event. 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@ 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
Hamilton Spectator
3 days ago
- 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
4 days ago
- Business
- Yahoo
Morgan Stanley Assumes Coverage of Axsome Therapeutics (AXSM) with an Overweight Rating
Axsome Therapeutics, Inc. (NASDAQ:AXSM) is one of the 13 Best Pharma Stocks to Buy According to Wall Street Analysts. On July 3, Morgan Stanley analyst Sean Laaman assumed coverage of Axsome Therapeutics, Inc. (NASDAQ:AXSM) with an Overweight rating and a $190 price target. The firm stated that the base case for the rating is the expected on-time supplemental New Drug application Submission for AXS-05 in Alzheimer's Disease Agitation. According to the analyst, it has a high probability of regulatory success and may lead to a potential $900 million in sales by 2030. A pharmacist preparing a prescription for a rapidly absorbed multi-mechanistic medicine. He further stated that the continued launch progress of Auvelity in major depressive disorder is another positive factor for Axsome Therapeutics, Inc. (NASDAQ:AXSM). The analyst told investors in a research note that this growth trajectory is anticipated to continue, supported by market penetration strategies and an expanded sales force. Axsome Therapeutics, Inc. (NASDAQ:AXSM) is a commercial-stage biopharmaceutical company that develops and delivers therapies for central nervous system conditions with limited treatment options. Its two commercial products and development programs include Auvelity and Sunosi. Auvelity treats major depressive disorder (MDD), and Sunosi is an oral medication for the treatment of excessive daytime sleepiness in patients with narcolepsy or obstructive sleep apnea. While we acknowledge the potential of AXSM as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None.
Yahoo
5 days ago
- Business
- Yahoo
Piper Sandler Reaffirms Price Target on Axsome (AXSM) Despite AXS-14 FDA Hurdle
Axsome Therapeutics Inc. (NASDAQ:AXSM) ranks among the 30 stocks expected to beat the market by 20 percentage points this year. Piper Sandler analysts maintained their $148 price target for Axsome Therapeutics Inc. (NASDAQ:AXSM) and reaffirmed their Overweight rating on June 10. This decision comes after the company revealed that the FDA had sent it a Refuse to File (RTF) notice regarding its New Drug Application (NDA) for AXS-14, an oral norepinephrine reuptake inhibitor used to treat fibromyalgia. Although Piper Sandler analysts acknowledged the setback, they stressed that Axsome's shares are not significantly impacted by this incident. Given the lack of new agent approvals in the fibromyalgia sector over the past ten years, the analysts pointed out that the FDA's requested additional study would be useful, and claim that Axsome Therapeutics Inc. (NASDAQ:AXSM) can support the new study with its current commercial infrastructure. Axsome Therapeutics Inc. (NASDAQ:AXSM) is a clinical stage biopharmaceutical company that contributes to the creation of novel therapies for disorders of the central nervous system. While we acknowledge the potential of AXSM as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. Read More: and Disclosure: None.
Yahoo
16-06-2025
- Health
- Yahoo
Axsome Therapeutics Proudly Supports Migraine and Headache Awareness Month Alongside the Association of Migraine Disorders
NEW YORK, June 16, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, is proud to recognize Migraine and Headache Awareness Month alongside the Association of Migraine Disorders. In honor of this year's theme, 'Your Path to Better Days,' Axsome is supporting more than a dozen Miles for Migraine Run, Walk or Relax events across the U.S. throughout the month of June and beyond. Axsome is also sharing resources for patients and their loved ones affected by migraine. 'As someone who lives with migraine, I know how isolating, debilitating, and misunderstood this disease can be,' said, Kylie Gagan, Director of Education at the Association of Migraine Disorders. 'There's a critical need for effective acute treatment options so people can work, attend school, and live their daily lives. Because of the severity and unpredictability of migraine attacks, people often miss out on time with loved ones, work responsibilities, or personal events. The Association of Migraine Disorders is working every day to fund and advance migraine research, educate both patients and providers, and raise awareness about migraine disease worldwide." Migraine is a debilitating condition characterized by recurrent attacks of pulsating, often severe and disabling head pain, accompanied by nausea, sensitivity to light, and/or sensitivity to sound.1 Migraine affects approximately 40 million people in the U.S. and is the second leading cause of disability worldwide.2,3 To help support 'Your Path to Better Days' for individuals affected by migraine, Axsome is sharing the following resources from some of the leading migraine advocacy organizations: American Migraine Foundation Find a Doctor ( is a resource to help patients find medical professionals experienced in migraine and headache care. Association of Migraine Disorders Migraine Explainer Videos ( are educational videos that describe different types of migraines, symptoms, treatments, and pathophysiology. CHAMP Financial Assistance Guides ( outline financial assistance programs operated by pharmaceutical companies and device manufacturers to help patients cover the cost of accessing treatment. National Headache Foundation podcast ( features informative discussions with headache experts on the latest treatment, research, lifestyle recommendations, and personal stories about living with migraine disease and headache disorders. 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: Headache Classification Committee of the International Headache Society (IHS) Cephalagia (2018) American Migraine Foundation (2023), accessed May 2, 2025. Steiner TJ, Stovner LJ, Jensen R, Uluduz D, Katsarava Z. Migraine remains second among the world's causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020 Dec 2;21(1): 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
