As I mentioned previously in Part 1, it was an incredibly busy week for the biotech sector. A PDUFA decision, as well as three FDA panel reviews/findings provided the impetus for some big moves; however, that was only part of the story.
Four other biotech companies released clinical-stage data that certainly moved the needle for shareholders. Here’s a look at those four key stories.
No company stole the show more than Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) , which skyrocketed 62% on Friday after the combination of VX-661 and Kalydeco, its already FDA-approved cystic fibrosis treatment, delivered results far and above anyone’s expectations in mid-stage trials. Of the four dosing levels being tested, the two highest doses delivered an FEV-1 improvement (a test that measures the amount of air a person can exhale within the first second) of 9% and 7.5%, respectively. By comparison, the placebo delivered just a 3% improvement in FEV-1. Considering that the treatment was well tolerated, Vertex may have found its next area of clinical dominance in cystic fibrosis.
This is also crucial, because Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX)’s Incivek, an intravenous hepatitis-C treatment, is projected to face heavy competition from Gilead Sciences, Inc. (NASDAQ:GILD)‘ oral hep-C treatment known as Sofosbuvir. Gilead Sciences, Inc. (NASDAQ:GILD)’s drug flew through all four late-stage trials, has been filed with the FDA as a new drug applicant, and could revolutionize hep-c treatments with fewer side effects. With multiple revenue sources, Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) shareholders can definitely rest easier with VX661 and Kalydeco performing well in trials.
Not wanting to be outdone, Alkermes Plc (NASDAQ:ALKS) shares surged 25% on the week as well, following positive mid-stage results for its major depressive disorder drug, Alkermes Plc (NASDAQ:ALKS)-5461. The oral ALKS-5461 met its primary endpoint of changing the baseline in depressive symptoms over the four-week period of the trial as defined by the Hamilton Depression Rating Scale. While the Street seems hopeful that this news should expedite ALKS-5461 into the next stage of development, I remain concerned that as an opioid-modulating drug, it could be construed in some way as addictive even though Alkermes Plc (NASDAQ:ALKS) labels it as a non-addictive drug. This is one case I’d stay away from until (if it makes it that far) the FDA panel has its say.