CAPR Stock Slides After FDA Requests More Data For Genetic Disorder Therapy — What Does Retail Think?

• The U.S. Food and Drug Administration did not request any additional clinical studies or new patient data, as per the company.
• Capricor now plans to submit the data requested by the FDA in February.
• CEO Linda Marbán said that the company is “pleased” that the FDA requested the clinical study report, adding that the request was expected.

Shares of Capricor Therapeutics (CAPR) fell 2% on Tuesday morning after the company said that the U.S. Food and Drug Administration (FDA) has requested more data from its trials of Deramiocel.

In July, the FDA refused to approve Capricor’s application for Deramiocel for the treatment of Duchenne muscular dystrophy, stating that it does not meet the requirement for substantial evidence of effectiveness, while also expressing the need for additional clinical data. The company said at the time that it intends to meet the FDA’s additional clinical data requirement with a late-stage study and resubmit its application.

In December, the company provided the FDA with results from its late-stage HOPE-3 study in which Deramiocel delivered strong signals of benefit for muscle and heart function. However, after reviewing the data, the FDA has formally requested the full HOPE-3 clinical study report (CSR) and supporting data, Capricor said on Tuesday. The agency, however, did not request any additional clinical studies or new patient data, it added.

Fresh Timelines

Capricor now plans to submit the new data requested by the FDA in February and expects that the submission will support continued review of its application and address the concerns raised by the FDA in July.  

CEO of Capricor, Linda Marbán, said that the company is “pleased” that the FDA requested the clinical study report, adding that the request was expected.

“Our near-term priority is to address the FDA’s request and continue working collaboratively so that patients with late-stage DMD, who currently have very limited treatment options, may gain access to Deramiocel as soon as possible,” Marbán added.

DMD is a genetic disorder characterized by progressive weakness and chronic inflammation of the skeletal, heart, and respiratory muscles. The disease affects approximately 15,000 individuals in the United States and primarily impacts boys.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around CAPR stock stayed within the ‘bearish’ territory while message volume stayed at ‘low’ levels.

A Stocktwits user voiced optimism for the drug getting approved in the following three to five months.

Another user voiced hopes for the stock touching as much as $100 by end of year following Deramiocel approval.

CAPR stock has gained 69% over the past 12 months.  

Read More: Moderna Shares Rise On Five-Year Follow-Up Takeaways For Skin Cancer Vaccine: Retail Applauds ‘Solid’ Update

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