Regado Biosciences, Inc. (RGDO) 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 September.
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.
Our Take
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 Actelion Ltd. (ALIOF), Synergy Pharmaceuticals, Inc. (SGYP) and Biogen Idec Inc. (BIIB). All these stocks carry a Zacks Rank #1 (Strong Buy).
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