Regado Biosciences Inc (NASDAQ:RGDO) shares plummeted nearly 40% after the company announced late Wednesday that the Data Safety Monitoring Board initiated an unplanned review of data from a trial of its treatment for blood clots.
Following DSMB’s digging deeper in data from a Phase3 study of a drug system designed by the company, Regado’s shares plummeted in after-market trading.
DSMB’s unplanned review
The biopharmaceutical company focused on the discovery and development of Revolixys Kit (previously known as REG1) announced Wednesday that DSMB has initiated an unplanned review of data from REGULATE-PCI trial. Patient enrollment has been paused until the DSMB has completed its analysis and communicated its recommendations, which are anticipated within the next eight weeks. The DSMB will conduct a full analysis of safety and treatment benefit-risk ratio of all patients enrolled to date (3234) with a focus on serious adverse events related to allergic reactions.
Moreover, Regado Biosciences Inc (NASDAQ:RGDO) and the trial’s academic leadership have been and will remain blinded to study results during this period.
Regado’s big gamble
Regado Biosciences Inc (NASDAQ:RGDO) took a big gamble as it chose to run a 13,200-patients study in 500 sites around the world, a job that Big Pharma, and all its financial wherewithal and manpower, is best suited for. Such a high-risk plan was one of the main reasons Regado had trouble getting out of the IPO gate.
The biopharmaceutical company has said it anticipates to infuse some $150 million into the trial, and investors were hesitant to buy in during the offering. Though the company set a $14 to $16 per share range for its offering, but eventually it had to price at just $4 per share, garnering $47 million. The low pricing occurred at a time when the IPO window for biotechs was at its peak last August. Regado subsequently was forced to raise additional cash.
Regado Biosciences Inc (NASDAQ:RGDO)’s shares climbed subsequently in March over 38% to $11.30 per share after the company announced that the United States Food and Drug Administration (FDA) designated a fast track development for its REG1 anticoagulant drug.