Articles from Axsome Therapeutics, Inc.

NEW YORK, March 05, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM) (Axsome), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that it has entered into a settlement agreement with Hikma Pharmaceuticals USA, Inc. (Hikma) resolving patent litigation related to Axsome’s product Sunosi® (solriamfetol). The litigation, which is pending in the United States District Court for the District of New Jersey, resulted from submission by Hikma of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic equivalent of Sunosi in the United States. Under the terms of the settlement agreement, Axsome will grant Hikma a license to sell its generic version of Sunosi beginning on or after September 1, 2040, if pediatric exclusivity is granted for Sunosi, or on or after March 1, 2040, if no pediatric exclusivity is granted, subject to FDA approval and conditions and exceptions customary for agreements of this type.

Supplemental New Drug Application (sNDA) submission anticipated in 3Q 2025

TD Cowen 45th Annual Health Care Conference on March 4 in Boston

SYMBRAVO demonstrated statistically significantly greater migraine treatment response compared to prior treatment with an oral CGRP inhibitor (p<0.001, mTOQ-4 total score, primary endpoint)

Total 4Q and full year 2024 net product revenue of $118.8 million and $385.7 million, respectively, representing 66% and 88% year-over-year growth

NEW YORK, Feb. 10, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM) (Axsome), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that it has entered into a settlement agreement with Teva Pharmaceuticals, Inc. (Teva) resolving all patent litigation related to Axsome’s AUVELITY® (dextromethorphan HBr – bupropion HCl) product. The litigation resulted from submission by Teva of an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of AUVELITY in the United States prior to the expiration of applicable Axsome patents.

NEW YORK, Jan. 31, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, will host a virtual investor event and conference call today at 8:00 AM Eastern Time to discuss the U.S. Food and Drug Administration (FDA) approval of SYMBRAVO®, a novel multi-mechanistic approach to treating migraine that targets multiple pathways underlying a migraine attack.

A single oral dose of SYMBRAVO provided rapid migraine pain freedom and return to normal functioning within 2 hours, and sustained efficacy through 24 and 48 hours

NEW YORK, Jan. 22, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced it will report its financial results for the fourth quarter and full year of 2024 on Tuesday, February 18, 2025, before the opening of the U.S. financial markets. Axsome management will then host a conference call at 8:00 a.m. Eastern Time to discuss these results and provide a business update.

Auvelity preliminary 4Q and full year 2024 net product sales of $92.6 million and $291.4 million, respectively

ACCORD-2 Phase 3 trial in Alzheimer’s disease agitation achieves primary endpoint compared to placebo (p=0.001, time to relapse)

AXS-12 statistically significantly reduced the frequency of cataplexy attacks compared to placebo (p=0.017, primary endpoint)

Total 3Q 2024 net product revenue of $104.8 million, representing 81% year-over-year growth

NEW YORK, Nov. 08, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced eight presentations spanning its innovative portfolio of late-stage products and product candidates in psychiatry and neurology at NEI Congress 2024, being held Nov. 7 - Nov. 10, 2024, in Colorado Springs, Colorado.

NEW YORK, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced seven presentations from across its broad portfolio of innovative neuroscience products and product candidates at Psych Congress 2024, being held Oct. 29 - Nov. 2, 2024, in Boston, Massachusetts.

NEW YORK, Oct. 15, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, will report its financial results for the third quarter of 2024 on Tuesday, November 12, 2024, 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.

Seven presentations highlight the Company’s growing CNS portfolio and commitment to improving treatment outcomes for patients with sleep disorders

FDA sets PDUFA action goal date of January 31, 2025

Morgan Stanley 22nd Annual Global Healthcare Conference on September 4 in New York

NEW YORK, Aug. 21, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system disorders, today announced that it has reached agreement with Sandoz Inc. (Sandoz) to dismiss the patent litigation related to Axsome’s product Sunosi® (solriamfetol). The litigation, which was pending in the United States District Court for the District of New Jersey, resulted from submission by Sandoz of an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration seeking approval to market a generic equivalent of Sunosi in the United States. Sandoz withdrew its ANDA for a generic equivalent of Sunosi, and, as a result, the litigation has been dismissed without prejudice.        

Total 2Q 2024 net product revenue of $87.2 million, representing 87% year-over-year growth

NEW YORK, July 11, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced it will report its financial results for the second quarter of 2024 on Monday, August 5, 2024, before the opening of the U.S. financial markets. Axsome’s management team will host a conference call at 8:00 a.m. Eastern Time on August 5, 2024, to discuss these results and provide a business update.

NEW YORK, June 05, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM) (Axsome), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system disorders, today announced that it has entered into a settlement agreement with Unichem Laboratories Ltd. (Unichem) resolving patent litigation related to Axsome’s product Sunosi® (solriamfetol). The litigation, which is pending in the United States District Court for the District of New Jersey, resulted from submission by Unichem of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic equivalent of Sunosi in the United States. The settlement agreement permits Unichem to begin selling its generic version of Sunosi on June 30, 2042, or earlier under certain circumstances. The June 30, 2042 date is also subject to potential extension for pediatric exclusivity.

NEW YORK, June 04, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, announced today it is joining the migraine advocacy community to raise awareness of unmet patient needs during Migraine & Headache Awareness Month this June.

NEW YORK, June 03, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, announced today it is supporting Alzheimer’s & Brain Awareness Month this June, to help increase awareness and understanding of the challenges Alzheimer’s disease (AD) presents to patients, their caregivers, and their loved ones, and the importance of brain and mental health as cornerstones of overall health.

NEW YORK, May 30, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Axsome will participate in two upcoming investor conferences.

Data on solriamfetol featured in two oral plenary sessions

NEW YORK, May 28, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that data from its industry-leading portfolio of novel products for CNS disorders will be presented at the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, being held May 28-31, 2024, in Miami Beach, Florida.

NEW YORK, May 08, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will participate in two upcoming investor conferences.

Total 1Q 2024 net product revenue of $75.0 million, representing 160% year-over-year growth

NEW YORK, May 01, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today is joining the global community of mental health advocates, including Mental Health America, during May’s Mental Health Month to raise awareness of the importance of mental health as a key element of overall health.

AXS-05 in Alzheimer’s disease agitation data featured in oral plenary session

NEW YORK, April 10, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced it will report its financial results for the first quarter of 2024 on Monday, May 6, 2024, before the opening of the U.S. financial markets. Axsome’s management team will host a conference call at 8:00 a.m. Eastern Time on May 6, 2024, to discuss these results and provide a business update.

NEW YORK, April 01, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, announced the initiation of the ENGAGE Phase 3 trial of solriamfetol, an investigational treatment for binge eating disorder (BED) in adults.

77% of narcolepsy type 1 patients continue to experience cataplexy attacks despite being treated

AXS-12 statistically significantly reduced cataplexy attacks compared to placebo (p=0.018, primary endpoint)

NEW YORK, March 19, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced the first patient has been dosed in the PARADIGM Phase 3 trial of solriamfetol, an investigational treatment for major depressive disorder (MDD).

NEW YORK, March 05, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will participate in a fireside chat at the Leerink Partners Global Biopharma Conference on Wednesday, March 13, at 9:20 a.m. Eastern Time at the Fontainebleau in Miami Beach, Florida.

NEW YORK, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will participate in a fireside chat at the TD Cowen 44th Annual Healthcare Conference on Wednesday, March 6, from 9:50-10:20 a.m. Eastern Time at the Marriott Copley Place in Boston, Massachusetts.

Total 4Q and full year 2023 net product revenue of $71.5 million and $204.9 million, respectively, representing year-over-year growth of 193% and 309%

NEW YORK, Jan. 23, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced it will report its financial results for the fourth quarter and full year of 2023 on Tuesday, Feb. 20, 2024, before the opening of the U.S. financial markets. Axsome’s management team will host a conference call at 8:00 a.m. Eastern Time on Feb. 20, 2024, to discuss these results and provide a business update.

Preliminary total 4Q and full year 2023 net product revenue of $71 million and $204 million, respectively

New data on Auvelity’s impact on quality of life, measured by the Q-LES-Q-SF, in patients who had received at least one prior treatment during their current depressive episode

NEW YORK, Dec. 07, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, is hosting a virtual investor event and conference call today from 8 a.m. – 10 a.m. Eastern Time to provide an update on solriamfetol, a dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) and trace amine-associated receptor 1 (TAAR1) agonist.

NEW YORK, Nov. 22, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that it will host a virtual event on December 7 from 8 a.m. - 10 a.m. Eastern Time to provide investors an update on its development programs for solriamfetol, a dual-acting dopamine and norepinephrine reuptake inhibitor and trace amine-associated receptor 1 (TAAR1) agonist.

NEW YORK, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will participate in a fireside chat at the Piper Sandler 35th Annual Healthcare Conference on Tuesday, Nov. 28, 2023, from 9:30 a.m. - 9:55 a.m. Eastern Time at the Lotte New York Palace in New York City.

Total 3Q 2023 product revenue of $57.8 million, representing 244% year-over-year growth

Axsome’s headquarters to be lit in teal as part of the Alzheimer’s Foundation of America awareness campaign

NEW YORK, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will participate in two upcoming investor conferences in early November. The presentation details are as follows:

NEW YORK, Oct. 24, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced a presentation of data from its ACCORD Phase 3 clinical trial of AXS-05, a novel, oral NMDA receptor antagonist and sigma-1 receptor agonist, in patients with Alzheimer’s disease agitation (ADA), at the 16th Clinical Trials on Alzheimer’s Disease (CTAD) Conference, being held in Boston from Oct. 24-27.

NEW YORK, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Susan Mahony, PhD, has been appointed to Axsome’s board of directors, effective immediately.

Axsome to host conference call and webcast on Monday, Nov. 6, 2023, at 8:00 a.m. Eastern Time

NEW YORK, Oct. 02, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced it is joining patient advocacy organizations, including the National Alliance on Mental Illness (NAMI), to promote awareness of the importance of mental health during Mental Illness Awareness Week (MIAW), recognized on Oct. 1-7, 2023.

NEW YORK, Sept. 21, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced it is joining the global narcolepsy advocacy community, including more than 20 global patient advocacy organizations across six continents, to raise awareness of the impact that narcolepsy has on World Narcolepsy Day, Sept. 22, 2023.

Data presentations explore effects on patient-centric efficacy measures of treatments for patients with depression, and excessive sleepiness associated with obstructive sleep apnea and narcolepsy

NEW YORK, Sept. 05, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will participate in three upcoming investor conferences in September. The presentation details are as follows:

Total 2Q 2023 product revenue of $46.7 million

Axsome to host conference call and webcast on Monday, Aug. 7, 2023, at 8:00 a.m. Eastern Time

NEW YORK, July 07, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that it has dosed the first patient in the FOCUS Phase 3 trial of solriamfetol, an investigational treatment for attention deficit hyperactivity disorder (ADHD) in adults.

NEW YORK, June 30, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM) (“Axsome” or the “Company”), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced the closing of its previously announced underwritten public offering of 3,000,000 shares of its common stock at the public offering price of $75.00 per share. The aggregate gross proceeds to Axsome, before deducting underwriting discounts and commissions and offering expenses, were $225.0 million.

NEW YORK, June 28, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM) (“Axsome” or the “Company”), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced the pricing of an underwritten public offering of 3,000,000 shares of its common stock at a public offering price of $75.00 per share. The proceeds from the offering, before deducting the underwriting discounts and commissions and other offering expenses payable by Axsome, are expected to be $225.0 million. In addition, Axsome has granted the underwriters a 30-day option to purchase up to 450,000 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. The offering is expected to close on or about June 30, 2023, subject to customary closing conditions.

NEW YORK, June 27, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM) (“Axsome” or the “Company”), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that it intends to offer and sell shares of its common stock, subject to market and other conditions, in an underwritten public offering. In addition, Axsome intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering, on the same terms and conditions. All of the shares in the offering are to be sold by Axsome.

Cognitive improvement with Sunosi sustained over eight hours in patients with excessive daytime sleepiness due to obstructive sleep apnea

Data on Auvelity demonstrating improved functioning in major depressive disorder

Auvelity® 1Q 2023 net product sales of $15.7 million

NEW YORK, May 03, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will participate in a fireside chat at the Bank of America Securities 2023 Healthcare Conference being held in Las Vegas, Nevada on Thursday, May 11, 2023, at 12:20 p.m. Eastern Time / 9:20 a.m. Pacific Time.

One World Trade Center to be lit up in green in observance of Mental Health Month

NEW YORK, April 21, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that it will be presenting five abstracts at the upcoming 2023 American Academy of Neurology (AAN) Annual Meeting, being held from April 22-27 in Boston. These presentations include new data from the SHARP study, a randomized, double-blind, placebo-controlled, crossover, multicenter trial in 59 patients with excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA) and impaired cognitive function, from which positive topline results were announced in October 20221.

NEW YORK, April 14, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will participate in a fireside chat at the 22nd Annual Needham Virtual Healthcare Conference on Thursday, April 20, 2023, at 1:30 p.m. Eastern Time.

Axsome to host conference call and webcast on Monday, May 8, 2023, at 8:00 a.m. Eastern Time

NEW YORK, March 01, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will participate in a fireside chat at Cowen’s 43rd Annual Health Care Conference on Wednesday, March 8, 2023, at 2:10 p.m. Eastern Time at the Boston Marriott Copley Place.

Total fourth quarter net product sales of $24.4 million

Axsome to receive an upfront payment of $66 million, and is eligible to receive sales-based and other milestones totaling up to $101 million

NEW YORK, Feb. 07, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQAXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will participate in a fireside chat at the SVB Securities Global Biopharma Conference on Wednesday, Feb. 15, 2023, at 8:40 a.m. Eastern Time.

Axsome to host conference call and webcast on Monday, Feb. 27, 2023, at 8:00 a.m. ET