Stifel Reiterates Buy on Momenta Pharma (MNTA) Following Positive Phase 3 Data
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Pre-Open Stock Movers 11/29: (CYTR) (VBLT) (THO) Higher; (NVLS) (FOLD) (SCVL) Lower (more...)
November 29, 2016 9:18 AM ESTToday's Pre-Open Stock Movers
Nivalis Therapeutics (NASDAQ: NVLS) 53.6% LOWER; announced topline results from the Company's Phase 2 trial evaluating the efficacy and safety of two doses of cavosonstat, 200 mg and 400 mg, in adult patients with CF who had two copies of the F508del-CFTR mutation and were being treated with Orkambi. There were no dose limiting toxicities and cavosonstat was well tolerated at all doses in the trial. The trial failed, however, to demonstrate benefit in absolute change in percent predicted FEV1, the trials primary endpoint, or in sweat chloride reduction... More
Momenta Phama (MNTA) Announces M923 Phase 3 Met Primary Endpoint in Chronic Plaque Psoriasis
November 29, 2016 8:01 AM ESTMomenta Pharmaceuticals, Inc. (Nasdaq: MNTA) announced that the confirmatory Phase 3 clinical study of M923, a biosimilar HUMIRA® (adalimumab) candidate developed in collaboration with Baxalta, now part of Shire plc, in patients with moderate-to-severe chronic plaque psoriasis, met its primary endpoint. The proportion of subjects in the study who achieved the primary endpoint, at least 75% reduction in the Psoriasis Area and Severity Index (PASI-75) following 16 weeks of treatment, was equivalent between M923 and HUMIRA. The estimated difference in responders was well within the pre-specified confidence interval, confirming equivalence.
Equivalence was... More
