Axsome Therapeutics Inc. ($AXSM) has multiple catalysts coming up in the near future as it has two main drug candidates under Phase 3 testing for multiple conditions. One of its drug candidate recently received the FDA Fast Track designation while the other already has this designation for both the indications. The stock has shown strength as it gained over 12 percent in the past one month.
The company recently announced that the FDA has conferred Fast Track designation for its AXS-05 designed for the treatment of agitation in patients with Alzheimer’s disease. There is currently no approved treatment for this condition, increasing the potential of this drug to boost the company’s liquidity position. The company CEO stated that agitation is faced by nearly half of Alzheimer’s patients. The Fast Track designation will considerably cut down the approval process for the drug, making it more cost effective.
AXS-05 is one of the drugs currently being developed by Axsome. Another drug candidate for the company is AXS-02, which is under test for treating osteoarthritis of the knee with associated bone marrow lesions. The interim data is expected by the third quarter. The drug is currently in the Phase 3 for Complex Regional Pain Syndrome (CRPS) as well and the company expects the data to be released by the fourth quarter. It has fast track designation for both the indications.
The company is currently running several studies simultaneously, which may put strain on its liquidity position. It recently announced its net loss for the first quarter at $8 million, up from $5.9 million in loss it had reported for the corresponding quarter of the previous year. Its R&D expenses also jumped to $6 million in the quarter. Any delay in the studies may cause serious liquidity issue for the company. However, the latest news of Fast Track designation is expected to take a lot of pressure off the company by reducing its approval time.
The company has several catalysts coming up as it gears to report top line data for AXS-02 in the third quarter as well as in the fourth quarter again. The drug has Orphan designation for CRPS.
Herriot Tabuteau, MD
Chief Executive Officer
Dr. Tabuteau has served as the founder, Chief Executive Officer, and Chairman of the board of directors since the founding in January 2012. Prior to founding this company, Dr. Tabuteau was a Senior Analyst and Partner at Healthco/S.A.C. Capital (now known as HealthCor) where he was responsible for the biotechnology, genomics, and instrumentation portfolios.
Vice President, Finance
Ms. Ames has served as the Vice President, Finance since February 2015. Ms. Ames joined the company from Keryx Biopharmaceuticals, Inc., which she joined in 2010, where she served most recently as Senior Director, Finance and Accounting.