Biotech Stocks Facing FDA Decision In October

(RTTNews) - The biotech space is not for the faint hearted, given the ebbs and flows in terms of the returns from investing in it. However, for one who perseveres and astutely devises strategies with full cognizance of key regulatory events coming up, the probability of drug candidates getting FDA's blessings and sympathy plays in the space, it provide a sea of opportunity and huge upside prospects.

The case in point is Sarepta Therapeutics (SRPT), which has soared over 121 percent, in the 8 trading sessions following the company's announcement of getting accelerated approval for its Duchenne muscular dystrophy drug Exondys 51. That said, the approval did come as a surprise to some analysts.

PTC Therapeutics (PTCT), a sympathy play, is up about 29 percent during the period. The company's DMD drug Translarna, which was given conditional approval in the European Union in 2014, is knocking strongly at the doors of the FDA. In February of this year, the FDA refused to accept the NDA for Translarna for review, stating that the application was not sufficiently complete to permit a substantive review.

Granted the space is volatile, it still had enough fuel in it to outperform the broader markets in September. Thus far into September, the NYSE Arca Biotechnology Index has added 5.7 percent compared to a nearly flat performance by the S&P 500 Index and a 2.02 percent gain for the tech-heavy Nasdaq Composite Index.

The FDA has had its hands full this month - with a number of noteworthy regulatory events taking place.

Though Sarepta found favor with the FDA, pain drug candidate Remoxy ER of Pain Therapeutics Inc. (PTIE) and Durect Corp. (DRRX) failed to pass the muster even on its third try, with the FDA seeking more data in order to approve the drug. On the contrary, the third time proved to be a charm for Aralez Pharmaceuticals Inc.'s (ARLZ) Yosprala, as the regulatory agency greenlighted its proposed indication i.e., the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers, this time.

The month also saw FDA giving nod to the first Humira biosimilar namely, Amgen's (AMGN) Amjevita. Given that a biosimilar applicant is required to give 180 days' pre-marketing notice period to the reference product sponsor, the launch of Amjevita is not going to happen until at least March of 2017. However, AbbVie, which claims that Humira has patent protection until at least 2022, has already filed a patent infringement lawsuit against Amgen.

Click on to know more about the biotech companies awaiting FDA rulings in October.