Latest news with #AxsomeTherapeutics
Yahoo
5 days ago
- 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
Yahoo
12-06-2025
- Business
- Yahoo
Axsome's AXS-14 Gets Regulatory Setback with RTF, says Morgan Stanley
Axsome Therapeutics, Inc. (NASDAQ:AXSM) is one of the 13 Biotech Stocks with Huge Upside Potential. The FDA's Division of Anesthesiology, Addiction Medicine, and Pain Medicine has issued a Refusal to File letter for Axsome Therapeutics, Inc. (NASDAQ:AXSM) AXS-14 new drug application. A pharmacist preparing a prescription for a rapidly absorbed multi-mechanistic medicine. The submission was deemed incomplete by the agency due to the use of an 8-week primary endpoint in one of the two supporting trials and a flexible-dose schedule. Vikram Purohit, an analyst at Morgan Stanley, stated that Axsome Therapeutics, Inc. (NASDAQ:AXSM) intends to start a fresh 12-week primary endpoint trial with a fixed dose in Q4. The stock is still rated as overweight by Morgan Stanley, which has set a price target of $190. AXS-14's regulatory setback is viewed as a temporary setback. The regulatory development of AXS-05 for Alzheimer's disease agitation and the commercial success of Auvelity in major depressive disorder are seen by Morgan Stanley as Axsome Therapeutics, Inc. (NASDAQ:AXSM)'s primary 2025 value drivers. The company is nevertheless optimistic about Axsome Therapeutics, Inc. (NASDAQ:AXSM)'s overall pipeline momentum and prospects for near-term revenue growth despite the AXS-14 filing struggle. Axsome Therapeutics, Inc. (NASDAQ:AXSM) is a biopharmaceutical business in the clinical stage. It is involved in the development of new treatments for conditions of the central nervous system or CNS, for which there are few available options. The business is among the stocks with the biggest upside. 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: 10 High-Growth EV Stocks to Invest In and 13 Best Car Stocks to Buy in 2025. Disclosure. None. Sign in to access your portfolio
Hamilton Spectator
11-06-2025
- Health
- Hamilton Spectator
Axsome Therapeutics Showcases Innovation in Sleep Medicine with Multiple Presentations for AXS-12 and Solriamfetol at SLEEP 2025
NEW YORK, June 11, 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 seven presentations, including two featured oral plenary sessions, on AXS-12 and solriamfetol, at SLEEP 2025, the 39th annual meeting of the Associated Professional Sleep Societies (APSS), being held June 8-11, 2025, in Seattle, Washington. Details for the presentations are as follows: AXS-12 Title: ENCORE: Topline Results of a Phase 3 Open-Label Extension and Randomized-Withdrawal Trial of AXS-12 in Narcolepsy Lead Author: Richard Bogan, MD, FCCP, FAASM, Associate Clinical Professor at the University of South Carolina School of Medicine in Columbia, SC Poster Presentation Date and Time: Wednesday, June 11, 10 - 11:45 a.m. PT Poster Session: P-51 Poster Number: 405 Title: Impact of AXS-12 on Symptom Severity and Functional Impairment in Narcolepsy: Results from the Phase 3 SYMPHONY Trial Lead Author: Michael Thorpy, MD, Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center and Professor of Neurology at Albert Einstein College of Medicine, New York, NY Oral Presentation Date and Time: Wednesday, June 11, 3:45 - 4 p.m. PT Oral Session: O-24 Poster Presentation Date and Time: Wednesday, June 11, 10 - 11:45 a.m. PT Poster Session: P-51 Poster Number: 390 Title: Residual Symptom Burden in Patients with Narcolepsy Satisfied with Treatment: Subgroup Analysis from the CRESCENDO Survey Lead Author: Michael Thorpy, MD, Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center and Professor of Neurology at Albert Einstein College of Medicine, New York, NY Oral Presentation Date and Time: Wednesday, June 11, 4 - 4:15 p.m. PT Oral Session: O-24 Poster Presentation Date and Time: Wednesday, June 11, 10 - 11:45 a.m. PT Poster Session: P-51 Poster Number: 391 Solriamfetol Title: Effects of Solriamfetol on Neuropsychological Outcomes in Patients with Obstructive Sleep Apnea in the Real-World SURWEY Study Lead Author: Yaroslav Winter, MD, Mainz Comprehensive Epilepsy and Sleep Medicine Center, Department of Neurology, Johannes Gutenberg-University, Mainz, Germany Poster Presentation Date and Time: Wednesday, June 11, 10 - 11:45 a.m. PT Poster Session: P-50 Poster Number: 366 Title: Real-World Use of Solriamfetol for Excessive Daytime Sleepiness in Patients with Obstructive Sleep Apnea in the US Lead Author: Yang Zhao, PhD, Axsome Therapeutics Poster Presentation Date and Time: Wednesday, June 11, 10 - 11:45 a.m. PT Poster Session: P-50 Poster Number: 369 About AXS-12 AXS-12 (reboxetine) is a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator under development for the treatment of narcolepsy. AXS-12 is thought to modulate noradrenergic activity to promote maintain tone during wakefulness, and noradrenergic and cortical dopamine signaling to promote wakefulness and enhance cognition. AXS-12 has been granted U.S. Food and Drug Administration (FDA) Orphan Drug Designation for the treatment of narcolepsy. AXS-12 is covered by issued patents providing protection to at least 2039. AXS-12 is an investigational drug product not approved by the FDA. About Solriamfetol Solriamfetol is a dopamine and norepinephrine reuptake inhibitor (DNRI), TAAR1 agonist, and 5-HT1A agonist being developed for the treatment of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD), binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD). 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@
Hamilton Spectator
28-05-2025
- Health
- Hamilton Spectator
Axsome Therapeutics Presents Data from Three of Its Innovative Neuroscience Programs at the American Society of Clinical Psychopharmacology (ASCP) 2025 Annual Meeting
NEW YORK, May 28, 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 presentations from three of its innovative neuroscience programs at the American Society of Clinical Psychopharmacology (ASCP) 2025 Annual Meeting, being held from May 27-30 in Scottsdale, Arizona. Details of the presentations are as follows: AUVELITY Title: Initiating Dextromethorphan 45 mg - Bupropion 105 mg (AUVELITY®) in Patients with Major Depressive Disorder (MDD): Expert Panel Consensus Recommendations Lead Author: Anita Clayton, MD, Wilford W. Spradlin Professor and Chair of Psychiatry & Neurobehavioral Sciences and Professor of Clinical Obstetrics & Gynecology at the University of Virginia Presentation Date and Time: Wednesday, May 28, 11:15 a.m. - 1 p.m. Mountain Standard Time Session Name: Poster Session I Poster Number: W25 AXS-05 Title: Efficacy and Safety of AXS-05 in Alzheimer's Disease Agitation: A Phase 3 Randomized-Withdrawal Double-Blind Placebo-Controlled Study Lead Author: Jeffrey Cummings, MD, ScD, Vice Chair of Research, UNLV Department of Brain Health Presentation Date and Time: Thursday, May 29, 11:30 a.m. - 1 p.m. Mountain Standard Time Session Name: Poster Session II Poster Number: T16 Solriamfetol Title: Solriamfetol for Excessive Daytime Sleepiness in Patients with Narcolepsy and OSA Reporting Anxiety and Depression in the Real-World SURWEY Study Lead Author: Ulf Kallweit, MD, Assistant Professor of Neurology at Witten/Herdecke University, Germany Presentation Date and Time: Thursday, May 29, 11:30 a.m. - 1 p.m. Mountain Standard Time Session Name: Poster Session II Poster Number: T15 About AUVELITY® AUVELITY is a novel, oral, NMDA receptor antagonist with multimodal activity approved for the treatment of MDD in adults. AUVELITY is a proprietary extended-release oral tablet containing dextromethorphan HBr (45 mg) and bupropion HCl (105 mg). The dextromethorphan component of AUVELITY is an antagonist of the NMDA receptor (an ionotropic glutamate receptor) and a sigma-1 receptor agonist. These actions are thought to modulate glutamatergic neurotransmission. The bupropion component of AUVELITY is an aminoketone and CYP2D6 inhibitor which serves to increase and prolong the blood levels of dextromethorphan. The exact mechanism of action of AUVELITY in the treatment of depression is unclear. AUVELITY received Breakthrough Therapy designation from the FDA for the treatment of MDD. INDICATION AND IMPORTANT SAFETY INFORMATION WHAT IS AUVELITY (aw-VEHL-ah-tee)? It is a prescription oral medicine used to treat adults with major depressive disorder (MDD). It is not known if AUVELITY is safe and effective for use in children. AUVELITY is not approved for uses other than the treatment of MDD. The ingredients in AUVELITY, bupropion and dextromethorphan, are the same ingredients found in some other medicines approved for other uses. WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT AUVELITY? AUVELITY and other antidepressant medicines may increase suicidal thoughts and actions in some children, adolescents, and young adults, especially within the first few months of treatment or when the dose is changed. AUVELITY is not for use in children. You should pay close attention to any new or sudden changes in mood, behavior, thoughts, or feelings or if you develop suicidal thoughts or actions. This is very important when starting or changing the dose of an antidepressant medicine. Call your healthcare provider (HCP) or get emergency help right away if you or your loved one have any of the following symptoms, especially if they are new, worse, or worry you: Do not take AUVELITY if you: AUVELITY may cause serious side effects. Ask your HCP how to recognize the serious side effects below and what to do if you think you have one: Seizures. There is a risk of seizures during treatment with AUVELITY. The risk is higher if you take higher doses of AUVELITY, have certain medical problems, or take AUVELITY with certain other medicines. Do not take AUVELITY with other medicines unless your healthcare provider tells you to. If you have a seizure during treatment with AUVELITY, stop taking AUVELITY and call your HCP right away. Do not take AUVELITY again if you have a seizure. Increases in blood pressure (hypertension). Some people may get high blood pressure during treatment with AUVELITY. Your HCP should check your blood pressure before you start taking and during treatment with AUVELITY. Manic episodes. Manic episodes may happen in people with bipolar disorder who take AUVELITY. Symptoms may include: Unusual thoughts or behaviors. One of the ingredients in AUVELITY (bupropion) can cause unusual thoughts or behaviors, including delusions (believing you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your HCP. Eye problems (angle-closure glaucoma). AUVELITY may cause a type of eye problem called angle-closure glaucoma in people with certain other eye conditions. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your HCP if you have eye pain, changes in your vision, or swelling or redness in or around the eye. Dizziness. AUVELITY may cause dizziness which may increase your risk for falls. Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take AUVELITY with certain other medicines. Call your HCP or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms: COMMON SIDE EFFECTS The most common side effects of AUVELITY include dizziness, headache, diarrhea, feeling sleepy, dry mouth, sexual function problems, and excessive sweating. These are not all the possible side effects of AUVELITY. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or . BEFORE USING Tell your HCP about all your medical conditions, including if you: Review the list below with your HCP. AUVELITY may not be right for you if: HOW TO TAKE LEARN MORE For more information about AUVELITY, call 866-496-2976 or visit . This summary provides basic information about AUVELITY but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other HCP about AUVELITY and how to take it. Your HCP is the best person to help you decide if AUVELITY is right for you. AUV CON BS 10/2022 Please see full Prescribing Information , including Boxed Warning for suicidal thoughts and behaviors, and Medication Guide . 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@
Business Insider
19-05-2025
- Business
- Business Insider
Analysts Conflicted on These Healthcare Names: Axsome Therapeutics (AXSM), Waters (WAT) and Cingulate Inc (CING)
Analysts have been eager to weigh in on the Healthcare sector with new ratings on Axsome Therapeutics (AXSM – Research Report), Waters (WAT – Research Report) and Cingulate Inc (CING – Research Report). Confident Investing Starts Here: Axsome Therapeutics (AXSM) In a report issued on May 16, Vikram Purohit from Morgan Stanley maintained a Buy rating on Axsome Therapeutics, with a price target of $190.00. The company's shares closed last Friday at $107.53. According to Purohit 's ranking currently consits of 0 on a 0-5 ranking scale, with an average return of -7.5% and a 30.9% success rate. Purohit covers the Healthcare sector, focusing on stocks such as Recursion Pharmaceuticals, BioMarin Pharmaceutical, and Arcutis Biotherapeutics. Currently, the analyst consensus on Axsome Therapeutics is a Strong Buy with an average price target of $177.85, a 66.6% upside from current levels. In a report issued on May 1, Mizuho Securities also maintained a Buy rating on the stock with a $210.00 price target. Waters (WAT) Bank of America Securities analyst Michael Ryskin reiterated a Hold rating on Waters yesterday and set a price target of $370.00. The company's shares closed last Friday at $359.48. According to Ryskin is a 2-star analyst with an average return of 0.2% and a 45.0% success rate. Ryskin covers the Healthcare sector, focusing on stocks such as Maravai Lifesciences Holdings, West Pharmaceutical Services, and Fortrea Holdings Inc. The word on The Street in general, suggests a Moderate Buy analyst consensus rating for Waters with a $393.77 average price target, representing an 11.9% upside. In a report issued on May 6, TD Cowen also maintained a Hold rating on the stock with a $375.00 price target. Cingulate Inc (CING) In a report released yesterday, Boobalan Pachaiyappan from Roth MKM reiterated a Buy rating on Cingulate Inc, with a price target of $11.00. The company's shares closed last Friday at $3.82, close to its 52-week low of $1.80. According to Pachaiyappan has 0 stars on 0-5 stars ranking scale with an average return of -9.8% and a 31.5% success rate. Pachaiyappan covers the Healthcare sector, focusing on stocks such as Reviva Pharmaceuticals Holdings, Entrada Therapeutics Inc, and Gain Therapeutics.
