Maintains Equal Weight
Monday, August 5, 2019
Lilly’s Emgality successful in late-stage study in treatment-resistant migraine
A Phase 3 clinical trial, CONQUER, evaluating Eli Lilly’s (NYSE:LLY) Emgality (galcanezumab-gnlm) in patients with episodic migraine who failed two-to-four different standard-of-care migraine prevention medication categories met the primary and all key secondary endpoints.
The study showed that Emagity was superior to placebo as measured by the mean change from baseline in the number of monthly migraine days across months 1-3. Specifically, patients in the Emgality group experienced 4.1 fewer migraine days compared to 1.0 fewer in the control group (p<0.0001).
No new safety signals were observed.
The FDA first approved Emgality in September 2018.
Arvinas EPS misses by $0.14, beats on revenue
Arvinas (NASDAQ:ARVN): Q2 GAAP EPS of -$0.55 misses by $0.14.
Revenue of $4.01M (+17.9% Y/Y) beats by $0.32M.
Cardio benefit claim for AstraZeneca Forxiga OKd in Europe
The European Commission has approved a label update for AstraZeneca’s (NYSE:AZN) type 2 diabetes med Forxiga (dapagliflozin) to include cardiovascular (CV) benefit data generated in the Phase 3 DECLARE-TIMI 58study.
The good news is the study showed that treatment with Forxiga resulted in a statistically significant reduction in the composite of hospitalization for heart failure or CV death compared to placebo. The bad news is the separation from control on the other primary endpoint, the number of major adverse CV events, failed to achieve statistical significance.
Results from the 17,000-subject trial were published in The New England Journal of Medicine in January.
Minerva Neurosciences EPS beats by $0.10
Minerva Neurosciences (NASDAQ:NERV): Q2 GAAP EPS of -$0.32 beats by $0.10.
Cash and equivalents of $69.3M
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