Biotech Stocks Facing FDA Decision In June

(RTTNews) - The bench to bedside journey of drugs is fraught with challenges. It is estimated that only 5 in 5,000 compounds that enter preclinical testing make it to human testing, and out of those 5, only 1 may pass through all the regulatory hurdles needed to reach pharmacy shelves.

There is hardly a week left for the month of June, and so far this year, 21 novel drugs have already been approved. Given the fact that for the whole of 2016, only 22 novel drugs were approved, this figure is certainly encouraging.

Novel drugs are new molecular entities (NMEs) having chemical structures that have never been approved before.

In May, as of this writing, 3 novel drugs were approved by the FDA namely, AstraZeneca's Imfinzi for previously treated patients with advanced bladder cancer; Mitsubishi Tanabe Pharma's Radicava to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig's disease, and Sanofi/Regeneron's Kevzara to treat moderately to severely active rheumatoid arthritis in adult patients.

Another FDA approval of the month that merits mention is Roche's subcutaneous Actemra to treat adults with giant cell arteritis, which becomes the first FDA-approved therapy, specific to this type of vasculitis. (Actemra is not an NME).

So that's all that happened in May on the regulatory front.

On a more official front, Dr. Scott Gottlieb was sworn in as the 23rd Commissioner of the FDA on May 11, 2017, succeeding Robert Califf.

June is certainly going to be busy month for the FDA, with over 10 drug candidates looking forward to knowing their fate.

Let's take a look at some of the biotech stocks awaiting FDA decision in June.