Capricor parts ways with 10% of staff as FDA decision on DMD cell therapy nears. November 11, 2026 | Awaiting a decision on Nov. 22 for its embattled Duchenne muscular dystrophy cell therapy deramiocel, Capricor has reduced its workforce by 10% and slowed programs not directly related to deramiocel, the biotech revealed in its third quarter earnings report. As Capricor Therapeutics awaits a pivotal decision for its embattled Duchenne muscular dystrophy cell therapy deramiocel, the biotech revealed it cut around 10% of its workforce. Capricor had 231 fulltime employees as of Dec. 31, 2025, according to an SEC filing, meaning the layoffs may have affected around 23 individuals. The move was made "to align our organization with our near-term priorities," the biotech said in its third quarter earnings report on Tuesday. Capricor is nearing a possible end to a 16-month regulatory saga. Deramiocel was rejected by the FDA in July 2025 after a planned advisory committee meeting was canceled. Then, in December last year, the company claimed that the Phase 3 HOPE-3 trial hit both its primary endpoint, showing statistically significant benefits in upper-limb function, and the secondary endpoint of slowed decline in cardiac function, as measured by left ventricular ejection fraction. Six months after receiving a surprise rejection due to what the FDA called "lack of substantial evidence of effectiveness," Capricor's cell therapy deramiocel showed significant benefits in upper-limb function and slowed decline in cardiac function in a Phase III trial. December 3, 2025 However, the FDA questioned the therapy's success on these endpoints, and an adcomm in July did not go well. After much discussion on the FDA's decision to base its review on an outdated statistical analysis plan, the agency's Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) voted 9-3 against approval of deramiocel for Duchenne muscular dystrophy (DMD) cardiomyopathy. Discussion on the primary upper limb function endpoint was more positive, and Capricor went back to the FDA in August with additional data and a refined indication focused on upper limb function. This pushed the FDA's target action date from Aug. 22 - a deadline that had already passed when Capricor announced the delay - to Nov. 22. Capricor has also slowed programs not directly related to deramiocel, including the biotech's exosome-based platform, in order to prioritize the DMD cell therapy "pending further regulatory clarity," according to its third quarter earnings report on Tuesday. This decision is unlikely to please Kaos Capital. The firm, which in an August letter to other company stakeholders described itself as a "significant and growing shareholder" of Capricor, urged a greater focus on the company's efforts outside of deramiocel. Other Kaos demands included "an immediate meeting, board change, and capital-preservation plan." Less than two weeks away from a highly anticipated FDA ruling on its cell therapy for Duchenne muscular dystrophy, Capricor Therapeutics has reported increased investment in its San Diego plant to support commercial production. November 11, 2026 Capricor also revealed on Tuesday that it has initiated regulatory engagement in Europe and Japan for deramiocel. The company is also considering expanding the therapy into younger patients with DMD and Becker muscular dystrophy, a similar but less severe form of the disease, "with next steps to be informed by the U.S. regulatory outcome for Deramiocel," according to the earnings report. Capricor last month presented open label extension data from HOPE-3 showing that patients who transferred to the cell therapy after a year on placebo saw upper limb decline slow by 76% compared to their prior year data. These data were included in the August amendment. And on Monday, Capricor revealed that an abstract outlining the therapy's cardiac results from HOPE-3 and presented at the American Heart Association (AHA) conference this month received AHA's Outstanding Research Award in Pediatric Cardiology. Compared to placebo, treatment with deramiocel slowed the progression of heart muscle scarring as measured by cardiac MRI, Capricor CEO Linda Marbán said on Tuesday's earnings call. While the difference in ejection fraction across all patients did not reach statistical significance, in patients with existing cardiomyopathy this metric improved by approximately 2.8 percentage points relative to placebo, Marbán noted. There are currently no therapies available specifically targeting cardiomyopathy, which is the leading cause of death for patients with DMD, Marbán told BioSpace in August last year. "Put simply, the data tell a consistent story," Marbán said on the call. "One year, two years, two randomized trials and a decade of clinical experience all points in the same direction. We do not believe that this is a case that rests solely on unmet medical need, secondary endpoints or regulatory flexibility." Capricor Therapeutics met with the FDA last week for a type A meeting, during which CEO Linda Marbán aimed to explain to the regulator that it got it wrong. Capricor plans to resubmit the application based on deramiocel's existing dataset. August 20, 2025

Capricor ramps up manufacturing spend ahead of FDA decision for DMD therapy. November 11, 2026 | Less than two weeks away from a highly anticipated FDA ruling on its cell therapy for Duchenne muscular dystrophy, Capricor Therapeutics has reported increased investment in its San Diego plant to support commercial production. Capricor Therapeutics' operating expenses jumped 70% in the third quarter as the company scaled up manufacturing and otherwise prepared to market its Duchenne muscular dystrophy cell therapy, which the FDA is set to decide on by Nov. 22. Preparing for launch, Capricor spent $44.7 million in the third quarter, compared with $26.3 million one year ago. The biotech cited precommercial activities and manufacturing scale-up as the primary drivers of increased spending. Capricor's facility in San Diego is "up and running and ready to supply an initial launch if deramiocel is approved," CEO Linda Marbán said on the biotech's third-quarter earnings call Tuesday. The company will support the initial launch from a first-floor cleanroom, which has undergone a pre-license inspection and can make enough doses for 250 patients per year, the CEO said. The biotech is adding manufacturing capacity on the second floor of the facility to increase output. Once Capricor completes the expansion, the facility will have the capacity to support about 2,000 to 2,500 patients a year, Marbán said. Capricor's second-floor production plant "is pretty much built out" and scheduled to undergo validation during the first half of next year, the CEO added. Capricor will finish cleanrooms on the second floor "in sequential order as demand implies," she said. The cleanrooms are part of a long-term plan to meet demand for deramiocel. "We don't anticipate that supply will be a problem, either in early stages of launch or as we continue commercial development," Marbán said. "If we are lucky enough to get approval in the U.S., we're poised to continue the expansion of our manufacturing footprint into a new facility in San Diego, which we've already tentatively agreed to occupy and build out should the need prevail." Manufacturing issues contributed to the rejection of Capricor's first filing for approval in 2025, as the FDA's complete response letter cited certain deficiencies regarding deramiocel's chemistry, manufacturing, and controls (CMC). With an advisory committee recently voting 9-3 against approval of the cell therapy, the biotech faces doubts about whether it will bring deramiocel to market on its second attempt. Capricor is "focusing primarily on approval" but has spoken internally about what additional work it could do if the FDA rejects its filing, Marbán said. In response to a question regarding investment in another possible clinical trial, Marbán said she would be "reluctant to say goodbye to deramiocel if it required some simple clinical work that could further support it." If the FDA rejects deramiocel, the CEO said Capricor will assess the feedback and act "prudently based on if we think that there's a way to establish greater efficacy and/or safety doing another clinical trial."