Biotech Stocks Facing FDA Decision In March

(RTTNews) - The month of February saw the FDA approve the second drug for Duchenne muscular dystrophy namely Emflaza, which is also a novel drug. A novel drug refers to a new molecular entity that has never before been approved anywhere in the world. Developed by privately held Marathon Pharmaceuticals, Emflaza is also the first drug in the United States approved for use by patients who are 5 years or older with Duchenne muscular dystrophy (DMD), regardless of genetic mutation. As you may know, the first FDA-approved treatment for DMD is Exondys 51, manufactured by Sarepta Therapeutics Inc. (SRPT). Approved last September, Exondys 51 is specifically indicated for patients who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping, which affects about 13 percent of the population with DMD.

Besides Emflaza, two other novel drugs - Amgen Inc.'s (AMGN) Parsabiv for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on haemodialysis, and Valeant Pharmaceuticals' (VRX) Siliq for adult patients with moderate-to-severe plaque psoriasis, also passed FDA muster in February.

Now, let's take a look at the biotech stocks awaiting FDA decision in March.