Capricor and the FDA: A daring, risky filing strategy

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Daring, risky, and entirely justified. That’s how I’d describe Capricor Therapeutics’ plan to seek early approval from the Food and Drug Administration for a cell therapy designed to improve heart function in patients with Duchenne muscular dystrophy.

Shares of Capricor are up five-fold in price since late September, when the company’s new regulatory strategy was announced. At yesterday’s close of $21.36, the company is now worth $955 million. The investor reaction makes sense through the lens of an FDA that has loosened regulatory standards for the approval of Duchenne treatments. 

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