Intercept Announces NASH Primary Endpoint Met: FLINT Trial Stopped Early for Efficacy Based on Highly Statistically Significant Improvement in Liver Histology

Intercept Pharmaceuticals, Inc. (ICPT) (Intercept) today announced that the FLINT trial of obeticholic acid (OCA) for the treatment of nonalcoholic steatohepatitis (NASH) has been stopped early for efficacy based on a planned interim analysis showing that the primary endpoint of the trial has been met. FLINT is a multi-center, double-blind, placebo-controlled clinical trial assessing the safety and efficacy of a 25 mg oral dose of OCA administered daily to biopsy-proven adult NASH patients over a 72-week treatment period. The trial has been sponsored and conducted by the National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK), a part of the National Institutes of Health, at eight leading US academic hepatology centers comprising the NIDDK's NASH clinical research network (CRN).

ARCA biopharma Announces US FDA Acceptance of Gencaro Companion Diagnostic Test IDE

Phase 2B/3 GENETIC-AF Trial on Track to Begin Patient Enrollment in Q1 2014
Gencaro Potentially the First Genetically-Targeted Cardiovascular Treatment

ARCA biopharma, Inc. (ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced that Laboratory Corporation of America (LabCorp®) (LH) has informed ARCA that the U.S. Food and Drug Administration (FDA) has accepted LabCorp’s Investigational Device Exemption (IDE) application for the planned companion diagnostic test for Gencaro^TM (bucindolol hydrochloride), a pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation (AF). The IDE allows the companion diagnostic test to be used in the planned GENETIC-AF clinical trial. ARCA’s Gencaro Investigational New Drug (IND) application for AF has been accepted by the U.S. Food and Drug Administration (FDA) and is active.

XTL Biopharmaceuticals In-licenses hCDR1, a Phase 2 Clinical Stage Asset for the Treatment of Lupus

XTL Biopharmaceuticals Ltd. (XTLB) (XTL.TA) ("XTL" or the "Company"), a clinical-stage biopharmaceutical company focused on the acquisition, development and commercialization of pharmaceutical products for the treatment of unmet clinical needs, today announced it has signed a licensing agreement with Yeda Research and Development Company Ltd. ("Yeda") to develop hCDR1, a Phase II-ready asset for the treatment of Systemic Lupus Erythematosus (SLE).

"Lupus is a debilitating disease affecting approximately five million people worldwide and represents a tremendous unmet medical need. In fact, only one new treatment, Benlysta, has been approved in the last 50 years," stated Josh Levine, Chief Executive Officer of XTL.

Epizyme and Celgene Advance EPZ-5676 DOT1L Inhibitor Clinical Program to Benefit Cancer Patients with Acute Leukemias, Achieving $25 Million Clinical Proof of Concept Milestone

– Epizyme Also Achieves $4 Million Development Candidate Milestone with GSK
– 2013 End-of-Year Cash Guidance Increased –
– Five Clinical Proof of Concept Programs Planned in 2014 –

Epizyme, Inc. (EPZM), a clinical stage biopharmaceutical company creating innovative personalized therapeutics for patients with genetically defined cancers, today announced the achievement of the proof of concept (POC) milestone in the EPZ-5676 DOT1L inhibitor clinical program, earning a $25 million payment under the company's collaboration with Celgene Corporation.