Galmed Pharmaceuticals Ltd GLMD shares are on a tear after the Israeli pharma company reported positive trial results for its non-alcoholic stateohepatitis, or NASH, drug candidate.
The stock was ripping higher by 177.43 percent to $19.42 at the time of publication Tuesday.
What Happened
Topline Phase 2b data released for Aramchol, evaluated in the global ARREST study in the treatment of NASH, showed a statistically significant reduction in liver fat.
Aramchol is an oral, once-daily and liver-targeted SCD1 modulator.
The Israeli company said significantly more patients treated with Aramchol 600 mg vs. a placebo showed NASH resolution without worsening fibrosis in the 52-week biopsy. This is a regulatory approvable endpoint, Galmed said Tuesday.
The pipeline candidate showed a favorable safety and tolerability profile, according to Galmed.
Why It's Important
The results come as several companies — including Gilead Sciences, Inc. GILD, Allergan plc AGN, Bristol-Myers Squibb Co BMY and Shire PLC (ADR) SHPG — race to bring a NASH treatment to market.
What's Next
The results of the two biopsy endpoints in the 600mg dose may become a primary endpoint for a Phase 3 trial to support Galmed's FDA marketing application, the company said.
"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," President and CEO Allen Baharaff said in a statement.
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