Today’s Research Reports on Stocks to Watch: Sage Therapeutics and Galmed Pharmaceuticals

It was an exciting day for biotech stocks Sage Therapeutics and Galmed Pharmaceuticals. Sage rose higher after announcing that the FDA has allowed expedited development on its major depressive drug. Shares of Galmed soared to a new high after announcing positive results from its Phase 2b ARREST study.

RDI Initiates Coverage on:

Sage Therapeutics, Inc.

Galmed Pharmaceuticals Ltd.

Sage Therapeutics, Inc. shares closed up 19.62% on Tuesday with nearly 2.4 million shares traded. The stock climbed the most in 2 months after the company announced that the FDA has given the green light to allowing an expedited development program for one of Sage’s most promising drug candidates – SAGE-217. The drug is being evaluated to treat major depressive disorder and postpartum depression. Sage is permitted to conduct a single 450-patient study for major depressive disorder to support an application for marketing approval. The company has plans to commence a phase 3 trial in major depressive disorder in the second half of this year. The company’s ongoing trial in postpartum depression is now called a "pivotal trial" and positive data could support a regulatory filing. "Sage is excited to receive feedback from the FDA that provides a possible groundbreaking path forward for the development of SAGE-217 for the treatment of depression," remarked CEO Dr. Jeff Jonas.

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Galmed Pharmaceuticals Ltd. shares closed up almost a whopping 150% in Tuesday trading, on monster volume of 16.3 million shares compared to the stock’s average of just about 45,000 shares. It was positive results from a clinical study that sent shares of the stock flying higher yesterday. Results from the company’s Phase 2b ARREST study, which lasted 52 weeks, sought to see how effective using Aramchol to treat non-alcoholic steatohepatitis was. The study compared patients results from the start to the end. The study reached its primary endpoints which had Wall Street cheering. The study found a statistically significant reduction in liver fat which was demonstrated by Magnetic Resonance Spectroscopy (MRS) in patients completing treatment with Aramchol 400mg versus a placebo. Professor Vlad Taziu, M.D., the principal investigator on the study said, "Some studies have shown an effect on NASH and some on fibrosis, while this study has shown an effect on both. Concomitant ALT reduction strengthens the histological findings." Professor Scott Friedman M.D stated, "Results seen in the ARREST 52-week study are comparable to other one-year trials recently published or presented in the NASH space. Pre-clinical studies had demonstrated that Aramchol has a unique mechanism of action that addresses both the metabolic dysfunction and fibrosis directly, and these mechanisms have been validated by findings in the ARREST study." CEO of Galmed Pharmaceuticals, Allen Baharaff, remarked, "We are excited with the ARREST results that will enable Galmed to meet with the regulators as soon as possible and discuss the pivotal study design. It is extremely gratifying that Aramchol’s scientific rationale for disease modification of NASH is being translated into clinical coherent results." The stock hit a new high of $27.06 yesterday.

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Our Actionable Research on Sage Therapeutics, Inc. (NASDAQ: SAGE) and Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) can be downloaded free of charge at Research Driven Investing.

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