Shares of Cambridge, MA-based CoLucid Pharmaceuticals $CLCD soared 90% Tuesday morning after the company declared a success for its Phase III study of the oral migraine drug lasmiditan. Investigators say that the drug scored on the primary as well as key secondary endpoints in their late-stage study. The primary endpoint tracked patients’ experience in the two hours after taking the drug, with the 100 mg and 200 mg dosing arms being pain free at roughly twice the 15% placebo response rate. About a third of all the patients, though, were washed out after failing to qualify for the modified ITT group.
Sage Therapeutics $SAGE has picked up the FDA’s breakthrough drug designation for Sage-547 as an experimental therapy for postpartum depression. The Cambridge, MA-based biotech recently touted data from a very small study indicating that its drug had a major impact on PPD. The BTD designation should provide ready access to regulators who can help hurry along its development.
Shares of Berkeley, CA-based Dynavax were roasted ahead of the Labor Day weekend, after the biotech put out word that the FDA had cancelled its November panel review for Heplisav-B, a new hepatitis B vaccine. Its stock plunged 30%. The company’s statement included this: “The FDA also confirmed to Dynavax that it will review the overall immunogenicity data from HBV-23, the company’s most recent pivotal Phase 3 trial, to support the proposed indication for adults 18 years of age and over. However, the Agency has decided it will not review immunogenicity data related to sub-populations including results in individuals with diabetes because these data were not a direct response to the FDA’s February 22, 2013 Complete Response Letter and therefore fell outside of the review time allocated to a Class 2 resubmission. Thus, it was suggested the data should be submitted as a supplemental BLA following approval.”
Horizon Discovery in Cambridge, UK will put its CRISPR tech to work in a discovery program with Fulcrum Therapeutics. They’ll be hunting for new ways to treat genetic diseases.
It’s Novo’s turn to take a back seat at the FDA. After delaying a GLP-1/insulin combo from the Sanofi-Zealand team last month, the agency is now delaying its final decision on Novo’s rival product Xultophy (IdegLira) by three months. A decision is now expected in December. These products are widely expected to earn billions once they make it to the market, but the FDA has a well-known track record on taking its time on new diabetes therapies intended for mass markets.
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