Phase III
Shares of Progenics Pharmaceuticals are up more than 20% in premarket trading after the company announced positive top-line results from its Phase III prostate cancer imaging tool PyL.
Heading into the holidays, there was still plenty of clinical trial news last week. Here’s a look.
Boston-based Stealth BioTherapeutics reported that its Phase III MMPOWER-3 clinical trial of elamipetride failed to meet its primary endpoint.
MC2 Therapeutics announced that its EU Phase 3 trial on the company’s investigational drug, Wynzora™ Cream, met its primary endpoint and that a Marketing Authorization Application is now in preparation for H1 2020.
Xenikos B.V. announced that the first patient has been treated in their U.S.-based Phase 3 registration trial designed to evaluate the use of T-Guard for treating steroid-refractory acute graft-versus-host disease in patients following allogeneic stem cell transplantation.
Arcus Biosciences and Genentech, a Roche company, are partnering on two clinical trials for colorectal and pancreatic cancer. They will evaluate Arcus’s AB928 in various combinations.
Adamas Pharmaceuticals reported that its Phase III INROADS trial of Gocovri (ADS-5102) for multiple sclerosis (MS) with walking impairment met its primary endpoint. That would seem to be good news, but the trial failed to meet secondary measures which worried investors, causing shares to drop by 45%.
Almost one month after BeiGene’s Bruton’s kinase inhibitor Brukinsa won accelerated approval for mantle cell lymphoma, the company reported the drug failed to hit the mark in a late-stage trial assessing the drug as a treatment for Waldenström’s macroglobulinemia.
The trial met its primary efficacy endpoint and all tested secondary endpoints.
GlaxoSmithKline announced results from its pivotal DREAMM-2 Phase III trial of belantamab mafodotin in multiple myeloma.
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