Anavex Life Sciences Corp (AVXL)

[nidan7500]

https://finance.yahoo.com/news/why-multiple-sclerosis-promising-risky-151203400.html

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Meanwhile, in the past, seizures were known side-effects of another MS drug, Ampyra. Seizure risk was seen to increase with higher blood levels of the drug. As a result, the FDA had to update Ampyra’s label to clarify recommendations that kidney function should be checked in patients before starting Ampyra and monitored at least annually while Ampyra treatment continues.
Nevertheless, the risks associated with the drugs have not deterred newer entrants which claim better formulations with lesser side effects. Consequently, the market has become too crowded.
In March 2017, the FDA approved Roche’s (RHHBY) Ocrevus to treat adults with relapsing forms of MS and primary progressive multiple sclerosis. However, there were questions if Ocrevus was a new innovation or a reformulation of Roche’s older drug Rituxan. The drug sales aren’t that impressive yet either.
The FDA recently issued Refusal to File letter to Celgene’s CELG New Drug Application (NDA) for ozanimod, which is in development for the treatment of patients with relapsing forms of multiple sclerosis. The FDA determined that the nonclinical and clinical pharmacology sections in the NDA were insufficient to permit a complete review. Hence, the company is now gearing up to meet the FDA and determine the future course of action. While there haven’t been any safety issues reports, the delay will definitely open up avenues for competition.
Given that so much is happening in this space, we expect investors to remain glued for further updates.