Capricor Secures $35M Deal for European Rights to DMD Therapy Ahead of FDA Application

Deal Details:
Capricor Therapeutics has sold the European rights to its Duchenne muscular dystrophy (DMD) therapy for $35 million as it prepares to submit an application to the FDA.

Therapy Overview:
The therapy, known as CAP-1002, is a cell-based treatment that aims to regenerate skeletal and cardiac muscle cells in boys and young men with DMD.

Clinical Progress:
Capricor is initiating a phase 3 trial, the HOPE-3 study, which will evaluate the therapy's effectiveness in improving upper limb strength and cardiac function in approximately 70 patients.

Partnership:
Capricor has partnered with Nippon Shinyaku for the distribution and commercialization of the drug in the U.S., with potential milestones worth up to $705 million.

Market Context:
The DMD market is competitive, with other companies like Pfizer and Sarepta working on gene therapies, but Capricor's CEO believes CAP-1002 could complement these treatments by modulating inflammatory responses.