Biotech Stocks Facing FDA Decision In November

(RTTNews) - It looks like 2016 is going to be a relatively lackluster year in terms of new drug approvals. Only 19 new molecular entity drugs have been approved year-to-date compared to 32 approved during the same time frame last year.

For the uninitiated, a new molecular entity, or NME in short, is an active ingredient that has never before been marketed in the United States in any form.

Stock market showing of biotech stocks in October isn't inspiring. The NYSE Arca Biotechnology Index has slid 10.81 percent thus far this year compared to a more modest 1.16 percent drop by the broader S&P 500 Index and a 0.5 percent slippage by the Nasdaq Composite Index.

In October, only 2 new molecular entity drugs were greenlighted by the FDA. The two lucky novel drugs are Eli Lilly & Co.'s (LLY) Lartruvo and Merck's (MRK) Zinplava. Lartruvo is approved for use with chemotherapy drug doxorubicin in adults with certain types of soft tissue sarcoma while Zinplava is approved to reduce recurrence of Clostridium difficile infection.

However, Nicox and Egalet Corp. (EGLT), which faced the FDA in October, were not so lucky. The regulator turned down Nicox's application seeking approval of AC-170 for the treatment of ocular itching associated with allergic conjunctivitis while it sought more time to review Egalet's abuse-deterrent opioid medicine Arymo ER, extending the deadline of October 14, 2016.

As we head into November, it's time to take a look at the upcoming FDA decisions of the month.