Capricor pumps up spending and factory prep while waiting for FDA verdict on muscle disease drug

Capricor Therapeutics has significantly accelerated its financial and operational preparations ahead of a crucial FDA decision regarding its cell therapy, deramiocel, scheduled for November 22. During the third quarter, the company's spending jumped to $44.7 million, marking a 70% increase compared to the same period last year, driven primarily by precommercial activities and the scale-up of manufacturing capabilities at its San Diego facility.

During a recent earnings call, CEO Linda Marbán confirmed that the first-floor cleanroom is fully operational, having passed a pre-license inspection and equipped to supply doses for up to 250 patients annually. Furthermore, Capricor is already expanding into the second floor to eventually support 2,000 to 2,500 patients per year, with validation scheduled for the first half of next year.

Despite these proactive measures, the path to commercialization remains bumpy. Capricor's previous filing faced rejection due to manufacturing deficiencies, and an advisory committee recently voted against the therapy, leaving its approval status uncertain. If the FDA rejects the current application, company leadership plans to carefully evaluate the feedback to determine if additional clinical trials are warranted.