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Blog Coverage: Axsome Received Fast Track Designation for its Treatment of Agitation in Patients with Alzheimer's Disease

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LONDON, UK / ACCESSWIRE / May 9, 2017 / Active Wall St. blog coverage looks at the headline from Axsome Therapeutics, Inc. (NASDAQ: AXSM) as the biopharmaceutical Company announced on May 08, 2017, that it has received Fast Track designation from the US Food and Drug Administration (FDA) for its investigational AXS-05 drug for the treatment of agitation in patients with Alzheimer's disease (AD). Register with us now for your free membership and blog access at:


One of Axsome Therapeutics' competitors within the Biotechnology space, Bioverativ Inc. (NASDAQ: BIVV), reported on May 04, 2017, its financial results for Q1 2017. AWS will be initiating a research report on Bioverativ in the coming days.

Today, AWS is promoting its blog coverage on AXSM; touching on BIVV. Get all of our free blog coverage and more by clicking on the link below:


What is AXS-05?

Axsome Therapeutics' AXS-05 is a novel, oral, investigational drug product under development for the treatment of central nervous system (CNS) disorders. AXS-05 utilizes Axsome Therapeutics' technology of combining bupropion and dextromethorphan. Dextromethorphan is an NMDA receptor antagonist, sigma-1 receptor agonist, and inhibitor of the serotonin and norepinephrine transporters. Bupropion serves to increase the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist. Axsome Therapeutics previously received Investigational New Drug Application (IND) clearance from the FDA to proceed with a Phase 2/3 trial of AXS-05 in this indication.

"Agitation is reported in nearly half of individuals living with Alzheimer's disease, results in distress to patients and caregivers, and has significant consequences including early nursing home placement and increased mortality," said Herriot Tabuteau, M.D., CEO of Axsome Therapeutics. "The receipt of Fast Track designation from the FDA highlights the serious nature of this condition, the lack of FDA-approved treatments, and the potential of AXS-05 to address this high unmet medical need."

How is Fast Track Designation Important?

The FDA's Fast Track designation program is designed to aid in the development and expedite the review of drugs that are intended to treat serious or life-threatening conditions. In order to receive Fast Track designation, a product must also demonstrate the potential to address an unmet medical need. Fast Track designation will provide Axsome Therapeutics greater access to, and more frequent communication with, the FDA throughout the entire drug development and review process, with the goal of getting important new drugs to patients more rapidly. It also provides the Company with an opportunity to submit sections of a New Drug Application (NDA) on a rolling basis, where the FDA may review portions of the NDA as they are received instead of waiting for the entire NDA submission.

Alzheimer's Disease Agitation

Alzheimer's disease (AD) is a progressive neurodegenerative disorder that manifests initially as forgetfulness advancing to severe cognitive impairment and memory loss. As per the press release, the disease affects an estimated 5 million individuals in the United States; a number that is anticipated to increase to approximately 14 million by 2050. Agitation is characterized by emotional distress, aggressive behaviors, disruptive irritability, and disinhibition. Agitation in patients with AD has been associated with increased caregiver burden, decreased functioning, earlier nursing home placement, and increased mortality. There are currently no therapies approved by the FDA for the treatment of agitation in patients with AD.

Stock Performance

At the close of trading session on Monday, May 08, 2017, following the announcement, Axsome Therapeutics' stock price rose 7.69% to end the day at $4.20. A total volume of 2.44 million shares were exchanged during the session, which was above the 3-month average volume of 174.31 thousand shares. The Company's share price has gained 18.31% in the past one month. The stock currently has a market cap of $97.86 million.

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SOURCE: Active Wall Street