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Celyad's C-Cure IND Authorized in U.S. for Phase III Study

Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.

Earlier this week, Celyad SACYAD announced that its Investigational New Drug (IND) application to proceed its lead cardiology candidate, C-Cure, to a phase III study has been authorized in the U.S. The authorization will allow the company to evaluate C-Cure delivered via the catheter C-Cathez in the phase III CHART-2 study for the treatment of patients with ischemic heart failure.

The prospective, multi-centre, randomized, sham-controlled, patient- and evaluator-blinded study will evaluate C-Cure in comparison to a sham treatment. The study will assess the efficacy of the candidate in the treatment for heart failure of ischemic origin on patients with chronic advanced symptomatic heart failure.

We note that C-Cure is currently being evaluated in the phase III CHART-1 study on patients with chronic advanced symptomatic heart failure in Europe and Israel. Last week, the company announced that a methods paper on the study design has been published in the European Journal of Heart Failure. Celyad expects to release full data from the study in mid-2016.

Meanwhile, Celyad continues to progress with other candidates in its pipeline. Earlier this month, the company initiated the second cohort of its phase I study on NKG2D CAR T-Cell for the treatment of patients with acute myeloid leukemia and multiple myeloma. Data from the study is expected in mid-2016.

Celyad currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Achillion Pharmaceuticals, Inc. ACHN , Anika Therapeutics Inc. ANIK and Corcept Therapeutics Incorporated CORT , each sporting a Zacks Rank #1 (Strong Buy).

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CORCEPT THERAPT (CORT): Free Stock Analysis Report

ACHILLION PHARM (ACHN): Free Stock Analysis Report

ANIKA THERAPEUT (ANIK): Free Stock Analysis Report

CELYAD-ADR (CYAD): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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