Expecting to improve its odds of success for the experimental heart drug darapladib, a top drug prospect that failed its first late-stage test, investigators at GlaxoSmithKline have changed up the primary endpoint in the remaining Phase III study that reads out later this quarter.
France's Transgene took a hit this morning after the biotech announced that Novartis had decided to pass on its option for the therapeutic cancer vaccine TG4010. But the CEO says he's laying the groundwork for a late-stage study, confident that he can find another partner.
Late last week, shares of CytoKinetics tanked when it put out the word that its lead drug for Lou Gehrig's disease had missed the primary endpoint. Today, the biotech added that the ALS drug also missed a string of secondary endpoints, as well. There was, though, one bright spot: The drug achieved the secondary endpoint on what's called "slow vital capacity," billed as an important indication of disease prevention.
Last fall, when GlaxoSmithKline decided to bail on Amicus Therapeutics and bowed out of their deal for the late-stage Fabry disease drug migalastat, some investors gave up on the company. After all, the drug had already failed the first step in the first of two Phase III studies, unable to provide a statistically significant improvement over a placebo arm.
Shares of OncoGenex went into meltdown mode this morning after the biotech and its partner Teva put out word that their experimental prostate cancer drug had flunked a long-awaited Phase III study. Shares of OncoGenex immediately shed more than half their value in the reckoning with investors.
Biogen Idec has struck up a far-reaching agreement with CRO giant Quintiles, tapping the contractor to help design, plan and run its Phase II-IV studies.
Cytokinetics has some thinking to do after its lead program missed the mark in a Phase IIb trial, failing to move the efficacy needle in ALS, commonly known as Lou Gehrig's disease.
Amgen is getting aggressive with one of its midstage leukemia drugs. In its earnings call with analysts the big biotech's R&D chief called out blinatumomab, saying that recent Phase II data might warrant an early approval.
A few weeks after Seattle-based Alder Biopharmaceuticals spelled out plans to raise $115 million in an IPO designed to propel them into the ranks of a fully diversified biotech company, the biotech has released some key data points from its proof-of-concept study on its experimental migraine therapy.
After keeping investors on a roller coaster ride of speculation for months, Sarepta says it now plans to shoot for an accelerated approval of its Duchenne muscular dystrophy drug eteplirsen. The biotech says it will file for an early approval by the end of this year after launching a slate of new clinical trials to get the data that the FDA is looking for.