Already occupying the top five spots among non-leveraged sector exchange traded funds this year, biotech ETFs could end 2014 with a bang if a spate of expected decisions by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) bring positive news.
Several important new application (NDA), supplemental new drug applications (SNDA) and related announcements are expected this month, starting with Incyte’s (INCY) SNDA “for ruxolitinib as a potential treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea” on Friday Dec. 5, reports Jon Ogg for 24/7 Wall Street.
December 21 Prescription Drug User Fee Act (PDUFA) date Cubist Pharmaceuticals (CBST), which “is seeking FDA approval of ceftolozane/tazobactam for the treatment of complicated urinary tract infections and complicated intra-abdominal infections,” according to 24/7 Wall Street.
Incyte is the largest holding in the First Trust NYSE Arca Biotechnology Index Fund (FBT) at 4.3% of the ETF’s weight. The $2 billion FBT also allocates 3.4% of its weight to Cubist, according to issuer data.
Up more than 43% this year, FBT is not only the top-performing health care, but the top-performing non-leveraged sector ETF of any variety. The potential for FBT and its rivals to add to 2014 gains this month does not end with Cubist and Incyte. [Behind the Dominance of Health Care ETFs]
As 24/7 Wall Street reports, big news is expected from BioCryst Pharmaceuticals (BCRX) on Dec. 23, Vertex Pharmaceuticals (VRTX) on Dec. 30 and Pozen (POZN) on Dec. 30. Vertex also accounts for about 3.4% of FBT’s weight.
Another biotech ETF to consider this month is the SPDR S&P Biotech ETF (XBI) . Although XBI is an equal-weight ETF that allocates no more than 2.5% of its weight to any of its 84 holdings, the fund has proven on multiple occasions this year that a huge day for just one of its holdings can translate into a big day for the ETF.
Just look at how XBI surged in July when Puma Biotechnology (PBYI) said its experimental breast cancer treatment, neratinib, proved successful in a Phase III trial, how the fund soared in June on news of Merck’s (MRK) of purchase of Idenix Pharmaceuticals (IDIX) and how XBI thrilled investors in January, surging more than 7% in one day after shares of Intercept Pharmaceuticals (ICPT) nearly quadrupled after trials for the company’s liver disease treatment proved successful. [Intercept Lifts This Biotech ETF]
XBI is up nearly 38% this year, making it the second-best biotech and sector ETF overall behind FBT.
SPDR S&P Biotech ETF