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Axsome Therapeutics to Report Second Quarter 2020 Financial Results on August 10, 2020

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Axsome Therapeutics (NASDAQ: AXSM) will report its Q2 2020 financial results on August 10, 2020, prior to the U.S. market opening. A management conference call will follow at 8:00 AM ET to discuss the results and provide a business update. The company is focused on developing therapies for central nervous system disorders, with five product candidates including AXS-05 for major depressive disorder and AXS-07 for migraine treatment. All candidates are investigational drugs and not FDA-approved.

Positive
  • Diverse pipeline with five investigational therapies targeting CNS disorders.
  • Potential for accelerated development timeline and market approval of AXS-05 and AXS-07.
Negative
  • Dependence on successful clinical trial outcomes for future growth.
  • Risks related to FDA approval processes and potential delays.

Axsome to host conference call and webcast on Monday, August 10, 2020 at 8:00 AM Eastern Time

NEW YORK, July 30, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that it will report its financial results for the second quarter of 2020 on Monday, August 10, 2020 before the opening of the U.S. financial markets. Axsome’s management team will host a conference call at 8:00 AM Eastern Time on August 10, 2020 to discuss these results and provide a business update.

To participate in the live conference call, please dial (844) 698-4029 (toll-free domestic) or (647) 253-8660 (international), and use the conference ID 4876676. 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 www.axsome.com. A recording of the conference call will be available on the Company’s website for approximately 30 days following the live event.

About Axsome Therapeutics, Inc.

Axsome Therapeutics, Inc. is a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders for which there are limited treatment options. For the many people facing unsatisfactory treatments for CNS disorders, Axsome accelerates the invention and adoption of life changing medicines. Axsome’s core CNS product candidate portfolio includes five candidates, AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14. AXS-05 is being developed for major depressive disorder (MDD), treatment resistant depression (TRD), Alzheimer’s disease (AD) agitation and as treatment for smoking cessation. AXS-07 is being developed for the acute treatment of migraine. AXS-12 is being developed for the treatment of narcolepsy. AXS-14 is being developed for fibromyalgia. AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14 are investigational drug products not approved by the FDA. For more information, please visit the Company’s website at axsome.com. The Company may occasionally disseminate material, nonpublic information on the company website.

Forward Looking Statements

Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. 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 success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of our current product candidates; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, our product candidates (including, but not limited to, FDA’s agreement with the Company’s discontinuation of the bupropion treatment arm of the ADVANCE-1 study in accordance with the independent data monitoring committee’s recommendations); the potential for the MOMENTUM clinical trial to provide a basis for approval of AXS-07 for the acute treatment of migraine in adults with or without aura, pursuant to our special protocol assessment; the potential for the ASCEND clinical trial, combined with the GEMINI clinical trial results, to provide a basis for approval of AXS-05 for the treatment of major depressive disorder and accelerate its development timeline and commercial path to patients; the 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 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 product candidates, if approved; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway; unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19; and other factors, including general economic conditions and regulatory developments, not within the 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 circumstance.

Axsome Contact:
Mark Jacobson
Chief Operating Officer
Axsome Therapeutics, Inc.
22 Cortlandt, 16th Floor
New York, NY 10007
Tel: 212-332-3243
Email: mjacobson@axsome.com
www.axsome.com

 


FAQ

What is Axsome Therapeutics' Q2 2020 earnings release date?

Axsome Therapeutics will release its Q2 2020 financial results on August 10, 2020.

What time is the Axsome conference call scheduled for?

The conference call is scheduled for 8:00 AM Eastern Time on August 10, 2020.

What product candidates is Axsome developing?

Axsome is developing AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14 for various CNS disorders.

Is AXS-05 approved by the FDA?

No, AXS-05 is an investigational drug and is not approved by the FDA.

What are the key risks mentioned in Axsome's press release?

Key risks include the success and timing of clinical trials and the potential for regulatory delays.

Axsome Therapeutics, Inc

NASDAQ:AXSM

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Biotechnology
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United States of America
NEW YORK