Before the FDA Could Approve This Therapy, the Distributor Tried to Take It Back
Capricor Therapeutics spent nearly two decades and tens of millions of dollars building a therapy for a fatal muscle-wasting disease. Its US distribution partner then asked for the whole thing back.
On May 7, 2026, Capricor filed suit against Nippon Shinyaku and its US subsidiary, NS Pharma, in Superior Court of New Jersey. The company alleges that NS Pharma proposed a contract amendment in April that would require what Capricor's complaint calls "complete surrender" of Deramiocel to the distributor. Capricor rejected the proposal on May 6 and filed suit the following day.
Deramiocel is a cell therapy for Duchenne muscular dystrophy, a fatal genetic disorder affecting roughly 15,000 people in the United States, primarily boys and young men. The disease progressively destroys muscle function, and most patients are unable to walk by their teens. The cardiac complications — the heart muscle wasting that leads to early death — are among the most feared aspects of the disease. In Capricor's HOPE-3 Phase 3 trial, Deramiocel slowed skeletal muscle deterioration by approximately 54% and cardiac decline by approximately 91% compared to placebo, both statistically significant results. No therapy previously approved for DMD has demonstrated an effect on cardiac decline.
The FDA's target decision date is August 22, 2026. If approved, Deramiocel would be the first therapy with a demonstrated effect on cardiac decline in DMD. Capricor has invested approximately $35-40 million in expanded manufacturing capacity in San Diego specifically to support a commercial launch.
The distribution agreement signed in January 2022 gave NS Pharma exclusive US rights to sell Deramiocel. The agreement established a pricing formula tied to the therapy's average selling price, or ASP — the standard benchmark that Medicare uses to calculate reimbursement for physician-administered drugs. Under that framework, Medicare pays physicians and hospitals a set rate based on the drug's ASP plus a standard markup. Capricor alleges in its complaint that the interaction between the pricing formula in the distribution agreement and the way Medicare calculates that ASP creates a structural problem that gets worse over time as more patients are treated and the average selling price drops. At some point in the not-distant future, Capricor claims, the reimbursement rate would fall below the cost of manufacturing and distributing the drug, making it economically impossible to sell Deramiocel to Medicare patients. Capricor says NS Pharma was aware of this dynamic when the agreement was signed in 2022, and that the pricing formula was never adjusted to account for it.
Then, on April 10, 2026, NS Pharma followed up with a written amendment that Capricor's CEO described in the complaint as demanding complete surrender of Deramiocel to the Distributor — not a renegotiation of the pricing formula, but a transfer of ownership or control over the therapy itself. Capricor's CEO, Dr. Linda Marban, has spent nearly two decades building Capricor with the stated goal of making Deramiocel available to treat those boys.
The lawsuit seeks equitable relief — a court order blocking the amendment and enforcing the original distribution terms. But with the FDA target date less than three months away, the real question is what happens to patients if the drug is approved and the commercial relationship remains broken. Capricor built the manufacturing capacity. Capricor ran the trials. Capricor spent the money. The distribution agreement was supposed to get Deramiocel to patients. Instead, Capricor is in court trying to unstick a deal it says was never supposed to work the way it ended up working.
What NS Pharma intended by the amendment remains unanswered. The company has not explained its position publicly. Capricor's characterization of the amendment as a demand for "complete surrender" is one account of what happened; NS Pharma has not filed a response in court as of May 8. A company with a strong legal defense typically responds quickly and publicly to allegations this specific. The silence is not evidence, but it is notable.
The second-order question is larger than this lawsuit. Cell therapies and other advanced biologics with distribution agreements structured around ASP-based reimbursement are not uncommon in rare disease. If the pricing formula in a bilateral distribution agreement can interact with Medicare's reimbursement framework in a way that makes a commercially approved therapy economically unviable at launch, that is a systemic problem — not just a Capricor-NS Pharma dispute. The August 22 PDUFA date is fixed. The patients do not have time to wait for a press release.
Capricor's stock dropped approximately 14% to $29.20 after the filing on May 7. NS Pharma and Nippon Shinyaku have not responded publicly to the allegations. No counter-statement from either company had appeared in available coverage as of May 8.