Regado Biosciences, Inc.
) announced that the FDA has placed a clinical hold on patient
enrollment and dosing in the ongoing phase III REGULATE-PCI study.
This announcement comes on the heels of Regado's decision to
voluntarily stop enrolling patients in the study.
Regado is evaluating Revolixys Kit in patients with acute coronary
syndrome undergoing percutaneous coronary intervention (PCI). The
company's shares were down 3.57% at the end of trading yesterday.
We remind investors that last week, a Data Safety Monitoring Board
(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. The DSMB is expected
to complete its analysis by the end of August or beginning of
Regado said that it will remain blinded to the data until the DSMB
discusses the results of its analysis related to the safety,
efficacy and benefit/risk ratio of Revolixys Kit with the company.
The conclusions drawn by the DSMB would affect the decision
regarding the re-initiation of patient enrolment in the
REGULATE-PCI study. Any such decision will be taken in agreement
with the FDA.
We are concerned about the clinical hold placed on the phase III
study. Revolixys Kit is the lead candidate in the company's
pipeline. Now that the FDA has placed a clinical hold, we have low
visibility as to when the hold will be lifted and the study can be
continued. Further, the stock will be adversely affected if the
DSMB review reveals unfavourable safety issues. We expect investor
focus to remain on Revolixys-related upgrades going forward.
Regado currently carries a Zacks Rank #4 (Sell). Some better-ranked
stocks worth considering include
Synergy Pharmaceuticals, Inc.
Biogen Idec Inc.
). All these stocks carry a Zacks Rank #1 (Strong Buy).
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