Boehringer Ingelheim's in-development injection for psoriasis outpaced Johnson & Johnson's blockbuster Stelara in a Phase II trial, setting the table for late-stage development.
Evgen Pharma has rebooted its IPO plans months after abandoning an attempt to raise £20 million ($30 million) on the London Stock Exchange. The aim now is to tap investors for £5 million, a sum that will support Phase II trials of Evgen's vegetable-inspired drug in breast cancer and stroke.
Neurocrine Biosciences says its experimental drug for tardive dyskinesia hit the primary endpoint in a Phase III study, setting up a near-term application with the FDA and spurring a 28% spike in the biotech's share price in premarket trading.
French drugmaker Servier has outlicensed some early-stage cancer treatments to Horizon Discovery, holding on to the rights to buy them back if they come through in preclinical development.
Axovant Sciences, rolling the dice on a once-failed Alzheimer's disease treatment, kicked off its big Phase III trial, a make-or-break effort that could spawn a blockbuster drug or liquidate the company's value.
Genentech has added another piece of the trial puzzle for its MEK inhibitor cobimetinib. The big Roche subsidiary's partner Exelixis announced early Tuesday that the drug combined with Zelboraf hit the mark in a Phase III study, offering a statistically significant overall survival benefit among advanced melanoma patients carrying a BRAF V600 mutation.
Otonomy, developing treatments for ear disorders, got FDA clearance to start a clinical trial of its therapy for tinnitus.
Turing Pharmaceuticals has revealed its first post-Daraprim R&D project: an early-stage therapy for rare and severe brain disorders. Called TUR-004, Turing's candidate is designed to serve as an add-on treatment for easing seizures tied to epileptic encephalopathies, a group of syndromes that crop up in early childhood and are often fatal.
Partners Baxalta and Momenta Pharmaceuticals are setting sights on the world's top-selling drug with a biosimilar of their own, moving into Phase III with a copy of AbbVie's cornerstone medicine.
After repeatedly batting back doubts about its lead gene therapy, Spark Therapeutics says its pivotal study for SPK-RPE65, an FDA-designated "breakthrough" for sight-blighting inherited retinal dystrophies, came through with positive data. The biotech says that the treatment hit the primary and two of three secondary endpoints in the late-stage study, setting up a biologics license application at the FDA next year.