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Axsome Therapeutics, Inc. (AXSM) Q1 2021 Earnings Call Transcript


Good morning, and welcome to the Axsome Therapeutics Conference Call. [Operator Instructions]
I would now like to turn the conference over to your host, Mark Jacobson, Chief Operating Officer at Axsome Therapeutics. Please go ahead.
Mark Jacobson
Chief Operating Officer
Thank you, operator. Good morning, and thank you all for joining us on today s conference call. Our earnings press release providing a corporate update and details of the company s financial results for the first quarter of 2021 crossed the wire a short time ago and is available on our website at axsome.com.
During today s call, we will be making certain forward-looking statements. These statements may include statements regarding, among other things, the efficacy, safety and intended utilization of our investigational agents, our clinical and non-clinical plans, our plans to present or report additional data, the anticipated conduct in the source of future clinical trials, regulatory plans, ....

United States , Chris Howerton Jefferies , Herriot Tabuteau , Matt Kaplan , Joe Thome , Charles Duncan , Nick Pizzie , Ram Selvaraju , Joon Lee Truist , Charles Duncan Cantor Fitzgerald , Joseph Thome Cowen , Yatin Suneja Guggenheim , Marc Goodman , Lori Englebert , Joon Lee , Roanna Ruiz , Matt Kaplan Ladenburg Thalmann , Chris Howerton , Cedric Ogorman , Amanda Jones , Yatin Suneja , Mark Jacobson , American Psychiatric Association , Axsome Therapeutics Inc , Ladenburg Thalmann , Vamil Divan Mizuho Securities United States ,

Axsome Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update


Published: May 10, 2021
NEW YORK, May 10, 2021 (GLOBE NEWSWIRE)
Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today reported financial results for the first quarter ended March 31, 2021.
“We continued to make significant strides in the quarter toward becoming a premier biopharmaceutical company focused on delivering potentially life-changing medicines to people living with serious CNS conditions. We successfully filed our NDA for AXS-05 for the treatment of MDD with the FDA, which was granted Priority Review, and are on track to file our NDA for AXS-07 for the acute treatment of migraine this quarter,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “Pre-commercial activities are intensifying as planned to ensure launch readiness assuming FDA approval. The rest of our pipeline continues to progress with the anticipated initiation ....

New York , United States , Herriot Tabuteau , Mark Jacobson , Centers For Disease , Axsome Therapeutics Inc , International Society For Pharmacoeconomics , Drug Administration , Mental Health America , Outcomes Research , American Society For Clinical Psychopharmacology , Mental Health Month , American Headache Society , Bofa Health Care Conference , Duke University , Priority Review , Chief Executive Officer , Disease Control , Breakthrough Therapy , New Drug Application , Prescription Drug User Fee Act , Digital Centric Commercialization , Trial Readouts , Trial Initiations , Clinical Psychopharmacology , Headache Society ,

Axsome Therapeutics Reports First Quarter 2021 Financial


AXS-07 for migraine, NDA submission (2Q 2021)
AXS-05 for smoking cessation, FDA meeting (3Q 2021)
AXS-05 for MDD, commercial launch, if approved (2H 2021)
Clinical Trial Readouts:
Clinical Trial Initiations:
Upcoming Scientific Conferences
International Society for Pharmacoeconomics and Outcomes Research (ISPOR) annual meeting, May 17-20, 2021
American Society for Clinical Psychopharmacology (ASCP) annual meeting, June 1-4, 2021
American Headache Society (AHS) annual meeting, June 3-6, 2021
Upcoming Investor Conferences
BofA Health Care Conference, May 11, 2021 (to be webcast)
RBC Capital Markets Global Healthcare Conference, May 18, 2021 (to be webcast)
UBS Global Healthcare Virtual Conference, May 24, 2021 (to be webcast)
William Blair Growth Stock Conference, June 3, 2021 (to be webcast)
First Quarter 2021 Financial Results ....

New York , United States , Herriot Tabuteau , Mark Jacobson , Centers For Disease , Axsome Therapeutics Inc , International Society For Pharmacoeconomics , Drug Administration , Mental Health America , Outcomes Research , American Society For Clinical Psychopharmacology , Mental Health Month , American Headache Society , Bofa Health Care Conference , Duke University , Priority Review , Chief Executive Officer , Disease Control , Breakthrough Therapy , New Drug Application , Prescription Drug User Fee Act , Digital Centric Commercialization , Trial Readouts , Trial Initiations , Clinical Psychopharmacology , Headache Society ,