At first glance, you might suspect that Gene Signal's Phase III study of its lead drug for a rare eye disease was a roaring success. But if you dig down into its release today, you'll find that the drug flunked its primary endpoint--an inconvenient truth that is dismissed as a mere triviality.
Isis says its lead diabetes drug scored a success in a Phase II study, with both doses of ISIS-GCGR spurring a significant drop in blood glucose levels after 13 weeks of therapy in a group of treatment-resistant patients. And the antisense therapy hit its marks on HbA1c without spurring some of the troubling side effects that may hinder rival therapies in the pipeline.
GlaxoSmithKline's last-minute gambit to switch the primary endpoint in its remaining Phase III study of the heart drug darapladib failed to pay off. The pharma giant says that its top cardio prospect flunked the second big trial just as it had the first, leaving the pharma giant staring at a likely writeoff of a one-time megablockbuster hopeful.
Rolapitant, Tesaro's experimental therapy for preventing some nasty side effects of chemo, has hit all the primary and secondary goals, helping boost the company's stock today and leaving it on track to deliver an NDA to the FDA in the next few months.
Last March, Pfizer announced it would file for approval for its meningitis B candidate. Now, it has positive results from a pair of midstage trials for the jab that will keep it on track for expedited approval--and a showdown with Novartis' Bexsero.
Anxious to fight off Pfizer's $106 billion marriage proposal, AstraZeneca's research team has rushed its high-profile immuno-oncology drug into a late-stage test. And they're setting out by targeting non-small cell lung cancer in the first Phase III in the MEDI4736 program.
Shares of the penny stock biotech slid after the news was released.
Merck and partner Endocyte have stopped a late-stage study of the ovarian cancer-treating vintafolide on the advice of a data safety monitoring board, saying the much-hyped drug failed to move the needle on progression-free survival.
Teva announced that its abuse-resistant version of extended-release hydrocodone--the opioid CEP-33237--aced a pivotal Phase III. Unsurprisingly, the pain drug beat out a placebo in the chronic back pain study, which sets the stage for a new drug application for later in the year. Purdue Pharma, meanwhile, has already raced to the FDA with its own tamper-resistant version of hydrocodone.
Merrimack Pharmaceuticals got roughed up when it went public back in 2012, then took it on the chin--twice--when one of their cancer drugs partnered with Sanofi failed two mid-stage studies. But this morning its stock price sailed up about 90% on the news that its lead drug scored a win in Phase III in a population of patients with advanced pancreatic cancer.