FDA rejects muscle disease drug application, Capricor Therapeutics plummets in pre-market trading
Due to the rejection of the company's application for a treatment drug for a fatal muscle disease by U.S. regulators, Capricor Therapeutics' stock price plummeted by more than 60% at one point. The San Diego-based biotech company has been developing cell therapies for heart problems associated with Duchenne muscular dystrophy. Duchenne muscular dystrophy is a hereditary disease that primarily affects boys, characterized by muscle atrophy and weakness. The company stated that the U.S. Food and Drug Administration (FDA) indicated that its drug application failed to meet the requirement for "substantial evidence of effectiveness." Capricor also mentioned that the FDA's rejection letter referred to "unresolved issues" related to the drug's chemistry, manufacturing, and quality control, but the company believes it has resolved most of these issues. The company stated that it plans to submit data from a late-stage trial to address the FDA's concerns. Trial results are expected to be announced in the third quarter of this year. Capricor's stock fell as much as 62% in pre-market trading, and as of the time of publication, the stock was down 38.6%
According to the Zhitong Finance APP, Capricor Therapeutics (CAPR.US) saw its stock price plummet over 60% after U.S. regulators rejected the company's application for a treatment for a fatal muscle disease.
The San Diego-based biotech company has been developing cell therapies for cardiac issues related to Duchenne muscular dystrophy. Duchenne muscular dystrophy is a hereditary disease that primarily affects boys, characterized by muscle wasting and weakness.
In a statement, the company noted that the U.S. Food and Drug Administration (FDA) indicated that its drug application failed to meet the requirements for "substantial evidence of effectiveness."
Capricor also mentioned that the FDA's rejection letter referred to "unresolved issues" related to the drug's chemistry, manufacturing, and quality control, but the company believes it has addressed most of these issues.
The company stated that it plans to submit data from a late-stage trial to respond to the FDA's concerns. Trial results are expected to be announced in the third quarter of this year.
Capricor's stock fell as much as 62% in pre-market trading, and as of the time of publication, the stock was down 38.6%
