In contrast to NewLink Genetics, Northwest Biotherapeutics' interim analysis was a boon to the company's investors, as word that its Phase III trial of a personalized cancer vaccine was going according to plan sent its shares up as much as 10%.
After an interim analysis, NewLink Genetics is planning to keep on keeping on with a Phase III study of its cancer vaccine. But that news came as an apparent disappointment to investors, who hoped the drug's promise would result in an early trial termination, and the biotech's shares fell more than 12% on Friday morning.
Incyte CEO Hervé Hoppenot has been telling anyone who'll listen that his biotech is undervalued and underestimated, and now, with promising late-stage results for its lead drug in a rare blood cancer, the company has a shot at blockbuster sales alongside partner Novartis.
Roche's lebrikizumab significantly reduced the rate of asthma attacks in patients with a severe form of the disease, according to mid-stage trial results, lighting the way for a Phase III study on the novel, personalized treatment.
More than two years ago Roche CEO Severin Schwan picked the cancer drug MetMAb out of the pipeline as one of the company's top blockbuster prospects. But on Monday its oncology R&D arm at Genentech was forced to halt a Phase III combo study matching MetMAb with Tarceva in a failed effort to block metastasis in non-small cell lung cancer after an independent monitoring group flagged the attempt for futility.
Framingham, MA-based rEVO Biologics--formerly GTC Biotherapeutics--is planning to put its drug ATryn through a late-stage study for preeclampsia, looking to see if it can help women extend their pregnancy, helping the women as well as their newborns.
Eli Lilly says its closely-watched GLP-1 diabetes drug dulaglutide works as well as the market leading therapy Victoza, but isn't superior to the rival drug. That's going to be good enough for Lilly to claim a big win, though, as analysts were ready to hand it a victory on non-inferiority for a drug now in the hands of regulators.
More than three years after the FDA sent InterMune back to the clinic for another Phase III study of its lung drug pirfenidone--Esbriet--for idiopathic pulmonary fibrosis, the biotech says it scored a win on the primary as well as two secondary endpoints for the lung-scarring treatment. And now InterMune says it's ready to go back to the FDA and lay out the data, hoping for an approval that will greatly expand the market for a drug now sold in Europe.
The New York-based drugmaker is keeping the data under wraps until next month but has revealed the headline results. Primary and secondary objectives were all met.
Investigators at Memorial Sloan Kettering Cancer Center have been pioneering the use of genetically modified T cells to fight cancer. And to underscore the potential of this technology, which they have used to help start up the high-profile Juno Therapeutics, new human data has produced another round of jaw-dropping outcomes from a small but influential study.