Regado Biosciences, Inc (RGDO) announced that it is permanently terminating the enrollment process for its phase III REGULATE-PCI study on Revolixys Kit. Regado’s shares tumbled over 60% on the news.
Regado was dealt a severe blow with the Data and Safety Monitoring Board for a late-stage study recommending the permanent termination of patient enrolment. The phase III study was a part of the company’s lead program – Revolixys Kit. Shares were down more than 60% on the news
Regado was evaluating Revolixys Kit in patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI). The study was comparing the safety and efficacy of Revolixys Kit against The Medicines Company’s (MDCO) Angiomax (bivalirudin). The company’s decision to permanently stop enrollment for the phase III study comes after the Data Safety Monitoring Board (DSMB)’s analysis of data from the first 3250 patients enrolled in the study.
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Regado stated that the DSMB has found some serious allergic adverse events related to Revolixys. The board also recommended the termination of enrollment in this late-stage study.
In Jul 2014, Regado announced that the DSMB started an unplanned review of data from the phase III REGULATE-PCI study with a focus on serious unfavorable events related to allergic reactions in the patients. Soon after Regado voluntarily stopped patient enrollment for the study. Later in the month, the FDA placed a clinical hold on patient enrollment and dosing in the REGULATE-PCI study.
Regado now intends to review the database from the REGULATE-PCI study. The company expects the complete review process to take several months.
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The news of the permanent termination of enrollment for the late-stage study on Revolixys Kit, the company’s lead candidate, is a huge disappointment as the company lacks a decent pipeline. The news has dealt the company’s growth prospects a big blow.
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