With the SPDR S&P Biotech Index up 37% over the trailing-12-month period, it's evident that investment dollars are willingly flowing into the biotech sector. Keeping that in mind, let's have a look at some of the rulings, studies, and companies that made waves in the sector last week.
As always, let's start off with some of the positive stories we witnessed this week.
Supernus Pharmaceuticals (SUPN +2.16%) soared as much as 27% on Monday after announcing the approval of extended-release epilepsy drug, Trokendi XR, by the Food and Drug Administration. The clearly good news here is that Trokendi is approved in patients as young as six years of age, with Supernus being granted a waiver on certain pediatric study requirements. With Trokendi XR and Oxtellar XR now approved for the treatment of epilepsy, Supernus projects it'll be breakeven on a cash flow basis by the end of next year. While certainly good news, quarterly losses will continue in the interim and, given that reality, shareholders wound up giving back nearly all of its early week gains by the end of the week.
In a similar instance of great news, Incyte (INCY +0.81%) shares skyrocketed after announcing positive proof-of-concept data from a phase 2a clinical study of ruxolitinib in cases of refractory metastatic pancreatic cancer. The data from the study in which ruxolitinib (the scientific name for Jakafi, Incyte's FDA-approved myelofibrosis drug) was combined with Roche's Xeloda demonstrated six-month survival of 42% for the ruxolitinib arm as compared to just 11% for the placebo. In addition, only the ruxolitinib arm showed any durable tumor response and significant improvement in body weight.
Not to be lost on this news, either, is Novartis (NVS +0.78%) which is the global licensing holder to ruxolitinib outside the United States. Novartis recently lost patent exclusivity to its best-selling hypertensive drug, Diovan, and is definitely looking for ways to bolster its product pipeline. If ruxolitinib, a JAK1 and JAK 2 inhibitor, continues to show progress in trials, I wouldn't be shocked to see Novartis simply snatch up Incyte and keep 100% of sales. Shares of Incyte gained 30% this week while Novartis' shares added 4%.
Rounding out the good news this week with a solid gain of 20% was Pain Therapeutics (NASDAQ: PTIE), which rallied after Pfizer announced that it would indeed be running another clinical trial for painkiller Remoxy. The Remoxy saga, which was developed by Pain Therapeutics, is licensed to Pfizer and incorporates DURECT's gel-capsule technology, seems to be right up there next to Days of Our Lives for longest running daytime drama. Remoxy has been rejected twice by the FDA with the original new drug application having been filed all the way back in June 2008. Not to count my chickens before they're hatched, but I'm not going to hold my breath on the outcome of this new trial.
And then there was GTx (NASDAQ: GTXI), this week's disaster du jour. GTx shares fell a whopping 65% on the week after a late-stage study of its lead drug enobosarm failed to meet either of its primary endpoints of improving body mass and physical function for non-small cell lung cancer patients. GTx did note an improvement in lean body mass in one of its two trials, but it wasn't enough to meet the primary endpoint of significance in either of its cancer-induced muscle wasting trials. With both of GTx's lead drugs failing to be approved since 2010, GTx's options are quickly running out.
