Due to a recent licensing decision, Capricor Therapeutics, Inc.’s (NASDAQ: CAPR) stock value has been dramatically on the US stock charts today. As of the latest pre-market check, CAPR shares were up 8.75% at $18.64. The main cause of this rise in stock price is Capricor’s announcement of a significant development in its regulatory process with the US Food and Drug Administration (FDA).
Capricor Commenced Licensing Process
Capricor (CAPR) has formally started the FDA’s rolling submission procedure for a biologics license application (BLA), in an effort to get its flagship medication, deramiocel, approved. Deramiocel is intended to treat cardiomyopathy in individuals with Duchenne muscular dystrophy (DMD), a debilitating illness for whom there are presently no recognized therapies.
This action represents a significant turning point in Capricor’s pursuit of complete FDA clearance, which would allow the business to provide patients in need with this cutting-edge medication.
Possibility of Priority Evaluation and Quick Approval
Capricor aims to complete its BLA submission by the end of 2024. Given the potential impact of deramiocel on the safety and effectiveness of DMD cardiomyopathy treatment, the application may qualify for priority review. Should the FDA grant this status, it could significantly expedite the approval process, enabling faster access to this first-in-class therapy for DMD patients.
CAPR Presenting Long-term Data at WMS 2024
In parallel with its regulatory advancements, Capricor has been showcasing the long-term safety and efficacy data from its HOPE-2 open-label extension (OLE) study at the 29th Annual Congress of the World Muscle Society (WMS 2024) in Prague. This data underscores the multi-faceted benefits of deramiocel and has reinforced the company’s recent decision to move forward with the BLA submission.
The presentation at WMS highlights the foundational results supporting deramiocel’s long-term impact, strengthening Capricor’s (CAPR) position as a leader in innovative therapies for rare diseases like DMD.
