Company Completes FDA Submission on Time
Capricor Therapeutics, a biotechnology firm focused on developing innovative treatments, has successfully completed its rolling biologics license application filing with the Food and Drug Administration (FDA) for its treatment of Duchenne muscular dystrophy cardiomyopathy using deramiocel. This achievement triggers a $10M milestone payment from partner Nippon Shinyaku.
Milestone Payment and FDA Feedback
The company’s firm stance on the treatment, as outlined in their research note, indicates no changes to their Buy rating or price target of $77. The analyst is optimistic about the potential Prescription Drug User Fee Act date in the second half of 2025, pending a priority review. It’s anticipated that the FDA will provide feedback by Q1 2025, with an expected Prescription Drug User Fee Act date if the firm receives priority review.
Expectations and Outlook
The company’s confidence in its treatment’s potential for success is reflected in their commitment to advancing deramiocel as a solution for Duchenne muscular dystrophy cardiomyopathy. With a strong focus on innovation and patient care, Capricor Therapeutics continues to make strides in the biotechnology sector.
References
- Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news.
Leave A Comment