Regado Biosciences, Inc.
) shares nosedived a massive 53.43% last week after it announced
that the Data Safety Monitoring Board (DSMB) has started a sudden
review of data from the phase III REGULATE-PCI study on its lead
candidate, Revolixys Kit.
Patient enrolment for the study has also been halted until DSMB
completes the review process and conveys its recommendations to the
company. The DSMB is expected to complete its analysis in the next
The DSMB will evaluate the safety and treatment benefit-risk ratio
of the enrolled patients. The review board's primary focus will be
on serious adverse events related to allergic reactions.
The candidate is being developed for the treatment of patients
suffering from coronary artery disease during percutaneous coronary
interventions (PCI). Earlier in the year, the FDA granted fast
track designation to Revolixys for the PCI indication. Regado is
also expected to file regulatory applications for the candidate in
early 2016 depending on the success of the REGULATE-PCI study.
We are highly disappointed with the halting of the study. Regado
currently has no approved products in its portfolio. A pause in the
study on its lead candidate means a further delay in gaining
approval. Further, the stock will be adversely affected if the DSMB
review reveals unfavourable safety issues. We expect investor focus
to remain on Revolixys going forward. Regado also has REG2 in its
Regado currently carries a Zacks Rank #4 (Sell). Some better-ranked
stocks worth considering include
Regeneron Pharmaceuticals, Inc.
Synergy Pharmaceuticals, Inc.
). All these stocks carry a Zacks Rank #1 (Strong Buy).
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