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What: Aralez Pharmaceuticals (NASDAQ: ARLZ) is up 14% at 3:30 p.m. ET. While there was no obvious news today, investors are likely buying in anticipation of Food and Drug Administration news in the coming month.
So what: The FDA is scheduled to make a decision about Aralez Pharmaceuticals' Yosprala by Sept. 14. That date, called the Prescription Drug User Fee Act (PDUFA) date, is only a goal. The FDA can make a decision before the PDUFA date, so investors are likely jumping in now in anticipation of a decision.
Yosprala is a combination of aspirin and the active ingredient in Procter & Gamble's Prilosec. Aralez Pharmaceuticals is trying to get the combination approved for the "secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers." In other words, patients who should be taking aspirin for their heart, but can't because the aspirin gives them stomach ulcers.
Now what: Aralez has been trading near its 52-week lows, so an increase based on sentiment, rather than news, shouldn't be too surprising.
Aralez is scheduled to report second-quarter earnings next week, but with sales of its current products relatively low -- first-quarter revenue was only $8.1 million -- Aralez will likely continue to trade on sentiment until an FDA decision on Yosprala is revealed.
