Biotech Stocks Facing FDA Decision In January

(RTTNews) - The journey of new drugs from lab to market is a long and expensive one. Some drugs pass the FDA muster easily while some face a host of hurdles before getting the official stamp of approval.

The biotech stocks could soar or slump depending upon the FDA decision. Also, usually the stocks experience a run-up going into the scheduled decision/review dates. So, having prior knowledge of the catalysts goes a long way toward maximizing profit or minimizing loss while trading volatile biotech stocks.

The following are the biotech stocks with FDA decision dates coming up in January of 2017.

Tesaro Inc. (TSRO)

The FDA decision on Tesaro's intravenous formulation of Rolapitant, developed for the prevention of chemotherapy-induced nausea and vomiting, is scheduled for January 11, 2017.

An oral formulation of Rolapitant was approved by the FDA under brand name Varubi on September 1st, 2015, and has been available in the U.S. since last November. Sales of Varubi totaled $4.41 million in the first nine months of 2016.

The intravenous formulation of Rolapitant is meant to provide oncologists additional flexibility in their choice of antiemetic regimens.

Tesaro obtained an exclusive, royalty bearing, sublicensable worldwide license, to research, develop, manufacture, market and sell Rolapitant from Opko Health Inc. (OPK) in December 2010.

TSRO closed Wednesday's trading at $134.86, down 1.32%.

Incyte Corp. (INCY)

Eli Lilly and Co. (LLY) and Incyte Corp. (INCY) await the FDA decision on oral once-daily Baricitinib, proposed for the treatment of moderately-to-severely active rheumatoid arthritis, which is slated for January 19, 2017.

The two companies have a deal in place for the development and commercialization of Baricitinib that was signed in December 2009.

The NDA for Baricitinib was submitted to the FDA on January 19, 2016, following which Incyte received a milestone payment of $35 million from Lilly. If Baricitinib gets the FDA nod, Incyte will receive a milestone payment of $100 million from Lilly, and could earn additional global regulatory as well as sales-based milestone payments and royalties on global net sales of the drug.

Cowen & Co analyst Eric Schmidt foresees peak annual sales of Baricitinib to hit nearly $1.5 billion.

INCY closed Wednesday's trading at $101.10, down 1.39%.

Synergy Pharmaceuticals Inc. (SGYP)

Synergy Pharma will find out by January 29, 2017, whether or not its drug candidate Plecanatide, a once-daily tablet, proposed for use in chronic idiopathic constipation wins the FDA nod.

Plecanatide has also been investigated as a potential treatment for irritable bowel syndrome with constipation (IBS-C). The company plans to seek expanded approval of Plecanatide in IBS-C in the first quarter of 2017.

If approved, Plecanatide is expected to rake in sales of over $400 million by 2020, according to BTIG analyst Timothy Chiang.

SGYP closed Wednesday's trading at $5.92, down 0.17%.