New York, June 2, 2026, 07:06 EDT
- Capricor finished at $28.53 on Monday, falling 4.8% before the start of Tuesday’s regular U.S. trading session.
- The next big event for the stock is the FDA’s Aug. 22 target decision on deramiocel, Capricor’s experimental Duchenne muscular dystrophy therapy.
- Biotech underperformed Monday. The Nasdaq Biotechnology Index dropped 1.9%. The Nasdaq Composite added 0.4%.
Capricor Therapeutics shares moved lower in early trading Tuesday, following a 4.8% decline in the regular session. The rare-disease biotech is trading near $28.53 before the bell, as the stock stays focused on its looming U.S. regulatory date, not the broader market rally. Capricor’s current market value stands at around $1.64 billion.
Capricor isn’t trading like a typical small-cap biotech anymore. Its valuation is tied to deramiocel, its experimental cell therapy for Duchenne muscular dystrophy, and the decision from the U.S. Food and Drug Administration, due by Aug. 22.
Nasdaq trading hadn’t started yet in New York. Nasdaq’s official 2026 calendar still keeps June 2 as a normal trading day. U.S. equities are set to trade as usual when the primary cash session begins later in the morning.
Capricor shares bucked the market trend Monday, sinking while the main U.S. indexes gained. The S&P 500 finished up 0.3%, the Dow inched 0.1% higher, and the Nasdaq Composite rose 0.4% to 27,086.81. The Russell 2000 small-cap index slipped 0.5%.
Biotech stocks lost ground Monday. The Nasdaq Biotechnology Index fell 1.9% to 5,878.62. The index tracks Nasdaq-listed biotech and pharma firms and is weighted by market cap.
Capricor’s Biologics License Application is under review at the FDA, with a PDUFA target date set for Aug. 22. The PDUFA deadline is when the agency aims to make a decision on the filing. CEO Linda Marbán called it a “pivotal moment” for the company and said Capricor’s “highest priority is execution.” Capricor Therapeutics, Inc.
Capricor is looking to prove it can get a product to launch after approval. The company last week named Michael Maurer as chief commercial officer. He worked on the U.S. rollout of Sarepta Therapeutics’ Elevidys, which is an approved Duchenne gene therapy. Marbán called Maurer’s experience “supporting the Duchenne community” key as Capricor moves closer to possible commercialization. Capricor Therapeutics, Inc.
Peer competition is close. Sarepta’s Elevidys is listed by the FDA as an adeno-associated virus vector-based gene therapy for ambulatory Duchenne patients 4 and up. Regenxbio is still enrolling for its RGX-202 trial, an investigational single-dose gene therapy for Duchenne. Capricor’s deramiocel takes another approach as a cardiac-derived cell therapy aiming to preserve skeletal and heart muscle.
Duchenne muscular dystrophy is a rare genetic disorder that leads to muscle wasting and early death, with Capricor estimating around 15,000 cases among boys and young men in the U.S. Heart-muscle disease is the main cause of death in Duchenne, so the FDA’s move is more important than a usual pipeline update.
Capricor said it had $278.6 million in cash, equivalents and marketable securities on March 31. The company posted no revenue for the first quarter and reported a net loss of $33.9 million, or 59 cents per share. Capricor expects its cash will last into the fourth quarter of 2027, if there are no product sales or sales of a priority review voucher. The balance sheet gives the company time, but not certainty.
But there’s still a clear downside. Deramiocel hasn’t gotten commercial approval yet. The FDA could ask Capricor for more data, limit the scope, or push back its decision. The company is also locked in a dispute with Nippon Shinyaku and NS Pharma about U.S. distribution. At an earlier stage, after a regulatory delay, Piper Sandler’s Edward Tenthoff told Reuters that Vinay Prasad had been “vocal in his opposition to single-arm trials and accelerated approval.” That shows how agency risk can swing the stock. Reuters
Capricor is still moving on a near-term FDA decision, cash in hand, and not much room for disappointment. The setup means the stock stays volatile while other names trade more quietly.
