Regado Biosciences, Inc.’s 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 eight weeks.
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 pipeline.
Regado currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks worth considering include Regeneron Pharmaceuticals, Inc. (REGN - Free Report) , Synergy Pharmaceuticals, Inc. (SGYP - Free Report) and Actelion Ltd. . All these stocks carry a Zacks Rank #1 (Strong Buy).