{"success":true,"data":{"pressRelease":{"id":"160618","rtpr_id":"nGNX6Tsfpq-20261005","ticker":"CAPR","exchange":"NASDAQ","all_tickers":["CAPR"],"title":"Capricor Therapeutics Presents Positive HOPE-3 Open-Label Extension Data on Upper Limb Function in Duchenne Muscular Dystrophy at 2026 World Muscle Society Congress","author":"Globe Newswire","published_at":"2026-10-05T13:00:01.281Z","article_body":"-24-Month Crossover Analysis: Patients Starting Deramiocel After a Year on\nPlacebo Slowed Upper Limb Decline by 76% Compared with Their Own Prior Year-\n\n-At 24 Months, Both Groups Showed Slower Decline in Upper Limb Function Than\nNatural History Predicts-\n\n-Data Included in Deramiocel BLA Major Amendment; PDUFA Target Action Date\nNovember 22, 2026-\n\n-Webinar Scheduled for October 7, 2026, at 1:00 p.m. ET in Collaboration with\nPPMD to Discuss the Data-\n\nSAN DIEGO, Oct. 05, 2026 (GLOBE NEWSWIRE) -- Capricor Therapeutics\n(https://www.globenewswire.com/Tracker?data=sLPF7F4qbaVmBfH4A6srdHRaNH5RbtGh9XEc5fdBSkAmRIWZm4JVH5FFhhqsPCPLYje9va6qqphScUpq-RVZssb6-WKn_gyerw3XqH_32ew=)\n(NASDAQ: CAPR), a biotechnology company developing transformative cell and\nexosome-based therapeutics for the treatment of rare diseases, today announced\npositive new data from its ongoing HOPE-3 open-label extension (OLE) study for\nits lead asset, Deramiocel, for the treatment of upper limb impairment in\nDuchenne muscular dystrophy (DMD). The data were highlighted in a\nlate-breaking poster presentation at the 31(st) Annual Congress of the World\nMuscle Society (WMS) in Hiroshima, Japan, supporting HOPE-3’s previously\nreported 12-month results, which were also presented in a separate oral\nsession on Deramiocel's musculoskeletal and cardiac efficacy.\n\nKey results from the late-breaking abstract are summarized below.\n\nHOPE-3 Open-Label Extension: Upper Limb Function (PUL 2.0)\n\n PUL 2.0 Total Score                     Year 1                      Year 2 (OLE)                Difference, Year 2 vs   Reduction in            \n                                         LS mean change (a)          LS mean change (a)          Year 1                  rate of                 \n                                                                                                 (95% CI)                decline (c)             \n Year-by-year change                                                                                                                             \n Placebo arm (delayed start) (b)         −2.05 on placebo n=52       −0.49 on Deramiocel n=49    1.56 (0.47 to 2.64)     76 %                    \n Deramiocel arm (early start) (b)        −0.95 on Deramiocel n=54    −0.89 on Deramiocel n=49    0.05 (−1.03 to 1.14)    —                       \n Month 24 change vs natural history (d)                                                                                                          \n                                         Observed at Month 24 (e)                                Predicted by natural history                    \n Placebo arm 12 months on Deramiocel     −3.76                                                   −5.35                                           \n Deramiocel arm 24 months on Deramiocel  −3.42                                                   −5.88                                           \n\nITT population: 106 randomized; 98 entered the OLE (49 per arm). Negative\nvalues indicate decline. 95% CIs are two-sided. No alpha was allocated to\nthese open-label analyses, and the extension was not powered for Month 24\ncomparisons.\n(a)Least-squares mean change from a mixed model for repeated measures, with\neach year measured from its own starting point (Day 0 or Month 12) and\nadjusted for starting score, cohort, site and slow-progressor status.\n(b)Groups are named by original randomized assignment. \n(c)Difference as a percentage of the Year 1 decline on placebo.\n(d)Observed mean change (unadjusted) vs a natural history model (Michaëls\n2025; Niks 2026) that predicts each patient’s decline from baseline score,\nage and ambulatory status. In its untreated year, the Placebo arm tracked the\nmodel (−2.7 observed vs −2.9 predicted at Month 12) and a published\nnon-ambulant cohort (about −2.7 points per year; Coratti 2025). Descriptive\nonly; no matching or statistical testing.\n(e)Patients assessed at Month 24: n=42 (Placebo arm), n=40 (Deramiocel arm).\n\n“Upper limb function is critical to quality of life for young men with DMD\nbecause it is directly tied to their independence,” said Craig McDonald, MD,\nPrincipal Investigator of the HOPE-3 trial at UC Davis Health. “When the\nyoung men who had been declining on placebo started Deramiocel, their rate of\nupper limb loss dropped by roughly 75% in their first year of treatment. Just\nas important, patients who were on Deramiocel both years declined at a similar\nrate in year 1 and year 2, which suggests that the slower decline was\ntriggered by starting treatment, not the passage of time. Being able to follow\nthe same young man before and after he starts treatment is a powerful way to\nsee a treatment effect, and what we saw was consistent with the randomized,\nplacebo-controlled period. As a clinician seeing these patients, I have had\nvery little to offer them that could meaningfully slow the progression of\nupper limb functional loss once they were non-ambulant. These data suggest\nthere could be a way to treat this aspect of the disease. Their arms are how\nthey feed themselves, control their wheelchairs and use their phones, and how\nthey stay independent. Time is muscle, and slowing that loss means more time\ndoing the things that matter most to them.”\n\n“These results add to a growing body of evidence for Deramiocel,” said\nLinda Marbán, Ph.D., CEO of Capricor. “What we saw in the HOPE-3 open-label\nextension aligns with our previous clinical studies, which together show the\nsame pattern across multiple years of treatment. The FDA has received these\ndata as part of the recent major amendment to the Deramiocel Biologics License\nApplication, along with extensive sensitivity and robustness analyses we\nproduced to support the results of the HOPE-3 randomized clinical trial. We\nwill continue to work with the FDA through the remainder of the review, ahead\nof the November 22, 2026, PDUFA target action date.”\n\nCopies of all Capricor WMS presentations will be made available in the\npublications\n(https://www.globenewswire.com/Tracker?data=q9UDD7h-6OPy0klyaqAckl45xOcFc806Yb8B3nQzSFt3pC6HJsaxNjv8moMDAN4gKJaVQozS0jXoFigQehVUm1x9E5vo0JT13iXjXY7X8vrX7t_9KXSycdTpyc-cNA7zCuyU5g7C6gCyawk4GGjOdEWBsaZ0-drwktPW9NxbCu9Av6DeQbghOvcP5ZNZAMu9Qj_C53SRoQNMcLriPlBe-b_72DW77EP89C4Vkh9edthpxKPUv32HeYvxT_NOuTpviBFg0XXv3mSXAv8fya0oKO4HCA7rBxcoMb0ZY79tIjCILdw0LKbWwdf0FnNhWQegsCVl1C-2E-8fLQwbIsZRb_j6X0Zb5ojoy2lpGyb3o6OXA0Cw3ErHWjIQIelIbFeaph1MiG_UPRaZawV6l4S8i1MJ-W5p_G_sW_lJsBzvqkuhnfpuTKpyQyDhhUyOkXABvzH2ua_kdRZ-O2grfJJroWnvwupQypjJ5HZgo1LuUI67LnyCtDHQLCuSxXL0VS6CS78z-Xk3y5tEOfamxjtyq_yx8cCSxmgDnE05bzRoXvA=) section\nof the Capricor website. The full WMS program is available at\nwms2026.com/page/programme\n(https://www.globenewswire.com/Tracker?data=Wx2igMv2-B0JfcGIguRcgeBB9W1o4x07AuMNFQ_M56S47evOArA1xAFmEmYNt5X7tDyuCqChFfBy7p2gPln3AdbfDt4zFcgPvNAgHn3oGB66-ftJrrvYiIFmS4IEE1kZ).\n\nWebinar Information\n\nA webinar is scheduled for Wednesday, October 7, 2026, at 1:00 p.m. ET in\ncollaboration with Parent Project Muscular Dystrophy (PPMD) to discuss these\nresults in more detail. To register for the webinar, please click here\n(https://www.globenewswire.com/Tracker?data=RUKD2mDUhmjpgRgioG-ueqaf10j29xTzi4KS_vrkucLwa_KYepN0X4PLhZfve0CjSgrOdMQPT1tqs3Q7CaZOaUGq_vunS49VmYLab6sMkD8qtX2wATqIdL4QV0o8LZI8KzjYV43OT8csvFTGhlnkstN_rRGcrPX7KROPdyapJwc=).\nFor additional details, please visit Parent Project Muscular Dystrophy's\nwebsite\n(https://www.globenewswire.com/Tracker?data=JcOgIywToRS_u_JfC8qkztdBvXyjxrHM3jtiPhX-Y5om0XH6OD-95so_NYJd4s_F-r8fh3D_lqec_7x7ge04G74dEb902THnHvv-6ucQzUHCyvcEEXBiF8BsHgD4g0YK7nsFEtfpA0ywGgmfykEUMP5G3QMqr7NeRedrOMnbsaXSOnoDrRv6sGggTeo0kiT9-u-GIddHSwHlAztDVekshA==).\n\nAbout the HOPE-3 Study\n\nHOPE-3 is a Phase 3, randomized, double-blind, placebo-controlled trial\nevaluating Deramiocel in patients with Duchenne muscular dystrophy. The study\nenrolled 106 patients, randomized to receive Deramiocel or placebo\nadministered intravenously every three months over a 12-month treatment\nperiod. One-year results were published in The Lancet\n(https://www.globenewswire.com/Tracker?data=5KsXEtTLFZyUidMi_0Fp1WhelZkK-StbGN83Mu2PF2FmO0J2jgjxlzlpXyA5H-cExTe-GPCrfwYSDLZRXyULkUJvqEwp8Awrh95CSJDo26yqRWxsSN6EAcEolMlmsevx_LwZb0Vb4diCS5xhwv2JwA3e6Jjl4WobYdSzZhHyTktTCOmniXtZzH8_hxyuXGtrKRf96ua_E0MeJwAwLGXmaMKbV7ZBXdAoaUd2vPaxti0_vXR8vnTRCmemYufrQNkwmKU__ETVJCu7FSKCnJHFDfxBtcix73Lkz7gS_6w-Do-7uCCyejPVV411agNLmzL4a83o1tvlJv1WxobWnrEbLQ==)\nin July 2026. Patients who completed the randomized portion of the study were\neligible to continue receiving Deramiocel in an open-label extension (OLE).\n\nAbout Duchenne Muscular Dystrophy\n\nDuchenne muscular dystrophy (DMD) is a severe, X-linked genetic disorder\ncharacterized by progressive muscle degeneration affecting the skeletal,\nrespiratory, and cardiac muscles. It is caused by the absence of functional\ndystrophin, a key structural protein in muscle cells. DMD affects\napproximately 15,000 individuals in the United States and primarily impacts\nboys. Over time, deterioration of the heart muscle leads to cardiomyopathy and\nheart failure, the leading cause of death in DMD. There is no cure, and\ntreatment options remain limited.\n\nAbout Deramiocel\n\nDeramiocel (CAP-1002) consists of allogeneic cardiosphere-derived cells\n(CDCs), a rare population of cardiac cells that have been shown in preclinical\nand clinical studies to exert immunomodulatory and anti-fibrotic actions in\nthe preservation of skeletal and cardiac muscle function in muscular\ndystrophies such as DMD. CDCs act by secreting extracellular vesicles known as\nexosomes, which target macrophages and alter their expression profile to adopt\na healing rather than pro-inflammatory phenotype. For the treatment of DMD,\nDeramiocel holds Orphan Drug, RMAT and Rare Pediatric Disease designations in\nthe U.S., and Orphan Drug and ATMP designations in Europe. The Rare Pediatric\nDisease designation may qualify Capricor for a Priority Review Voucher upon\napproval.\n\nAbout Capricor Therapeutics\n\nCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to\nadvancing cell and exosome-based therapeutics for the treatment of rare\ndiseases. Our lead product candidate, Deramiocel, is an allogeneic\ncardiac-derived cell therapy in late-stage development for the treatment of\nDuchenne muscular dystrophy (DMD), evaluated in clinical studies for its\npotential to preserve skeletal and cardiac muscle function. Capricor is also\nadvancing its proprietary StealthX™ exosome platform for the targeted\ndelivery of oligonucleotides, proteins, and small-molecule therapeutics across\na range of diseases. At Capricor, we are committed to delivering new therapies\nfor patients with rare diseases. For more information, visit capricor.com\n(https://www.globenewswire.com/Tracker?data=4UEjd4j_ImZmwbZ_Lr0UT4LTW6gGgMqk4ShmqpGkMZTWTW2RN2fyDscGwmhCNmfpXySM2LuGNbXkEA1FPhpxv8GIKSWRys4JEmNk4aVDuLBB0mmgslrHL0NeSdN5O0WUXnWOvB0VCLrMk3puBsM5BcVF_jC6rsgJW-MXovVQhlqau_YkQm4OUA5nBkjOOzhBPW_-HDbSgQsH2u57un-gsu3J4rGywbM9mnD6vXgIR8fIZpyc0Wa_2hRQ-f1mU6K_EDklCzyx49z_ua-RIjT7j904s5tBetcKcn4w3RZpgkDUrq1p4lfVUP8RYUYrEFBScJvoKtO4GZSxfzcIh6YhynhtTKpHu5ph63Ln1J1yGpEmjWorlFYvC_XLoFjVHIvPME1bAkOD1zxY-JWF4-yEeqxFW1xJs_sLxzNIZomwgV-ID1ER9AD7bh7AIJTnpo1329K1lM7QZ0eY1iPHWICrvgp0_jeQ8T1QRFnI70xfgsxTG6zGNDNKaaMdqh2fTwfcULzFPKnWilO9gChKAZHE9GQhioHhvM7XpR5SkjlAI-lAuA-bKaSBdcFcS3PtMIB8_86bQtvUj5glr1XkKwgNa6UfRmtdlqa2jyA-cIiRjP8A9uM-3savecsU-dJWaCwbUZNhhOelBC7ywrpW-Bl5_-z7a4Iy2hqFAawM1_0JTDx0gtMd8Gnw9fvkcgaT-Bzw2hrZ8YM4_wXKHrmDtreX1GUbp0Gmsi-wFAR7deJm6Z8C2QLsL7WYN5i8UbWyy0QqiVEEM20qANDPqbloWxyD4_yXNxlMr1Ug42L3Pru_BzNLLfREzACOliN34AIQJC6RGNP7aXlpJLWcmBW772nx6KwDV-g_rFWoPju9voKrKgALUAMWKlS0EJzagSa67Kn8)\nand follow Capricor 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SW1HBQaQZ8h71QG2vXjsGal3dx2tOuu0SuxHi8IM7tNlMwDJplDuexUA_4cjzwQLKP09utOo-tNqpzMEjHjgPcjWxz2j56oV8331cDjKhmcHmshT737pMqoGEuBgoDFb4c9BiUBEmVr4ZmEguqN9iyz_EPYSAbPrE5b-kyKUVEr6sprnNj-OkqA4xd3SHmYIPZkA-i2y1fTAD6TjUFflApTNb9JYymgSkg==).\n\nCautionary Note Regarding Forward-Looking Statements\n\nStatements in this press release regarding the efficacy, safety, and intended\nutilization of Capricor’s product candidates; the initiation, conduct, size,\ntiming and results of clinical trials; the pace of enrollment of clinical\ntrials; plans regarding regulatory filings, future research and clinical\ntrials; regulatory developments involving products, including future\ninteractions with regulatory authorities and the ability to obtain regulatory\napprovals or otherwise bring products to market; manufacturing capabilities;\ndates for regulatory meetings; the potential that required regulatory\ninspections may be delayed or not be successful which would delay or prevent\nproduct approval, revenue and reimbursement estimates, projected terms of\ndefinitive agreements, our financial position, our possible uses of existing\ncash and investment resources; results of securities litigation; and\nstatements regarding our litigation with Nippon Shinyaku Co., Ltd. and NS\nPharma, Inc., including the nature of the dispute, our expectations regarding\nany legal proceedings, and our ability to commercialize Deramiocel independent\nof our existing distribution agreement and any other statements about\nCapricor’s management team’s future expectations, beliefs, goals, plans or\nprospects constitute forward-looking statements within the meaning of the\nPrivate Securities Litigation Reform Act of 1995. Any statements that are not\nstatements of historical fact (including statements containing the words\n“believes,” “plans,” “could,” “anticipates,” “expects,”\n“estimates,” “should,” “target,” “will,” “would” and\nsimilar expressions) should also be considered to be forward-looking\nstatements. There are a number of important factors that could cause actual\nresults or events to differ materially from those indicated by such\nforward-looking statements. More information about these and other risks that\nmay impact Capricor’s business is set forth in Capricor’s Annual Report on\nForm 10-K for the year ended December 31, 2025, as filed with the Securities\nand Exchange Commission on March 17, 2026 and in our Quarterly Report on Form\n10-Q for the quarter ended June 30, 2026, as filed with the Securities and\nExchange Commission on August 14, 2026. All forward-looking statements in this\npress release are based on information available to Capricor as of the date\nhereof, and Capricor assumes no obligation to update these forward-looking\nstatements.\n\nDeramiocel and Capricor’s StealthX™ exosome therapeutics are\ninvestigational and have not been approved for commercial use in any\nindication.\n\nFor more information, please contact:\n\nCapricor Media Contact:\nCaitlin Kasunich / Raquel Cona\nKCSA Strategic Communications\nckasunich@kcsa.com / rcona@kcsa.com\n212.896.1241 / 516.779.2630\n\nCapricor Company Contact:\nAJ Bergmann, Chief Financial Officer\nabergmann@capricor.com\n858.727.1755\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/16ce4387-5b8f-447c-96b8-7c453633f9bf)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX6Tsfpq-20261005","title":"Capricor Therapeutics Presents Positive HOPE-3 Open-Label Extension Data on Upper Limb Function in Duchenne Muscular Dystrophy at 2026 World Muscle Society Congress","author":"Globe Newswire","ticker":"CAPR","created":"2026-10-05T13:00:01.281Z","tickers":["CAPR"],"exchange":"NASDAQ","article_body":"-24-Month Crossover Analysis: Patients Starting Deramiocel After a Year on\nPlacebo Slowed Upper Limb Decline by 76% Compared with Their Own Prior Year-\n\n-At 24 Months, Both Groups Showed Slower Decline in Upper Limb Function Than\nNatural History Predicts-\n\n-Data Included in Deramiocel BLA Major Amendment; PDUFA Target Action Date\nNovember 22, 2026-\n\n-Webinar Scheduled for October 7, 2026, at 1:00 p.m. ET in Collaboration with\nPPMD to Discuss the Data-\n\nSAN DIEGO, Oct. 05, 2026 (GLOBE NEWSWIRE) -- Capricor Therapeutics\n(https://www.globenewswire.com/Tracker?data=sLPF7F4qbaVmBfH4A6srdHRaNH5RbtGh9XEc5fdBSkAmRIWZm4JVH5FFhhqsPCPLYje9va6qqphScUpq-RVZssb6-WKn_gyerw3XqH_32ew=)\n(NASDAQ: CAPR), a biotechnology company developing transformative cell and\nexosome-based therapeutics for the treatment of rare diseases, today announced\npositive new data from its ongoing HOPE-3 open-label extension (OLE) study for\nits lead asset, Deramiocel, for the treatment of upper limb impairment in\nDuchenne muscular dystrophy (DMD). The data were highlighted in a\nlate-breaking poster presentation at the 31(st) Annual Congress of the World\nMuscle Society (WMS) in Hiroshima, Japan, supporting HOPE-3’s previously\nreported 12-month results, which were also presented in a separate oral\nsession on Deramiocel's musculoskeletal and cardiac efficacy.\n\nKey results from the late-breaking abstract are summarized below.\n\nHOPE-3 Open-Label Extension: Upper Limb Function (PUL 2.0)\n\n PUL 2.0 Total Score                     Year 1                      Year 2 (OLE)                Difference, Year 2 vs   Reduction in            \n                                         LS mean change (a)          LS mean change (a)          Year 1                  rate of                 \n                                                                                                 (95% CI)                decline (c)             \n Year-by-year change                                                                                                                             \n Placebo arm (delayed start) (b)         −2.05 on placebo n=52       −0.49 on Deramiocel n=49    1.56 (0.47 to 2.64)     76 %                    \n Deramiocel arm (early start) (b)        −0.95 on Deramiocel n=54    −0.89 on Deramiocel n=49    0.05 (−1.03 to 1.14)    —                       \n Month 24 change vs natural history (d)                                                                                                          \n                                         Observed at Month 24 (e)                                Predicted by natural history                    \n Placebo arm 12 months on Deramiocel     −3.76                                                   −5.35                                           \n Deramiocel arm 24 months on Deramiocel  −3.42                                                   −5.88                                           \n\nITT population: 106 randomized; 98 entered the OLE (49 per arm). Negative\nvalues indicate decline. 95% CIs are two-sided. No alpha was allocated to\nthese open-label analyses, and the extension was not powered for Month 24\ncomparisons.\n(a)Least-squares mean change from a mixed model for repeated measures, with\neach year measured from its own starting point (Day 0 or Month 12) and\nadjusted for starting score, cohort, site and slow-progressor status.\n(b)Groups are named by original randomized assignment. \n(c)Difference as a percentage of the Year 1 decline on placebo.\n(d)Observed mean change (unadjusted) vs a natural history model (Michaëls\n2025; Niks 2026) that predicts each patient’s decline from baseline score,\nage and ambulatory status. In its untreated year, the Placebo arm tracked the\nmodel (−2.7 observed vs −2.9 predicted at Month 12) and a published\nnon-ambulant cohort (about −2.7 points per year; Coratti 2025). Descriptive\nonly; no matching or statistical testing.\n(e)Patients assessed at Month 24: n=42 (Placebo arm), n=40 (Deramiocel arm).\n\n“Upper limb function is critical to quality of life for young men with DMD\nbecause it is directly tied to their independence,” said Craig McDonald, MD,\nPrincipal Investigator of the HOPE-3 trial at UC Davis Health. “When the\nyoung men who had been declining on placebo started Deramiocel, their rate of\nupper limb loss dropped by roughly 75% in their first year of treatment. Just\nas important, patients who were on Deramiocel both years declined at a similar\nrate in year 1 and year 2, which suggests that the slower decline was\ntriggered by starting treatment, not the passage of time. Being able to follow\nthe same young man before and after he starts treatment is a powerful way to\nsee a treatment effect, and what we saw was consistent with the randomized,\nplacebo-controlled period. As a clinician seeing these patients, I have had\nvery little to offer them that could meaningfully slow the progression of\nupper limb functional loss once they were non-ambulant. These data suggest\nthere could be a way to treat this aspect of the disease. Their arms are how\nthey feed themselves, control their wheelchairs and use their phones, and how\nthey stay independent. Time is muscle, and slowing that loss means more time\ndoing the things that matter most to them.”\n\n“These results add to a growing body of evidence for Deramiocel,” said\nLinda Marbán, Ph.D., CEO of Capricor. “What we saw in the HOPE-3 open-label\nextension aligns with our previous clinical studies, which together show the\nsame pattern across multiple years of treatment. The FDA has received these\ndata as part of the recent major amendment to the Deramiocel Biologics License\nApplication, along with extensive sensitivity and robustness analyses we\nproduced to support the results of the HOPE-3 randomized clinical trial. We\nwill continue to work with the FDA through the remainder of the review, ahead\nof the November 22, 2026, PDUFA target action date.”\n\nCopies of all Capricor WMS presentations will be made available in the\npublications\n(https://www.globenewswire.com/Tracker?data=q9UDD7h-6OPy0klyaqAckl45xOcFc806Yb8B3nQzSFt3pC6HJsaxNjv8moMDAN4gKJaVQozS0jXoFigQehVUm1x9E5vo0JT13iXjXY7X8vrX7t_9KXSycdTpyc-cNA7zCuyU5g7C6gCyawk4GGjOdEWBsaZ0-drwktPW9NxbCu9Av6DeQbghOvcP5ZNZAMu9Qj_C53SRoQNMcLriPlBe-b_72DW77EP89C4Vkh9edthpxKPUv32HeYvxT_NOuTpviBFg0XXv3mSXAv8fya0oKO4HCA7rBxcoMb0ZY79tIjCILdw0LKbWwdf0FnNhWQegsCVl1C-2E-8fLQwbIsZRb_j6X0Zb5ojoy2lpGyb3o6OXA0Cw3ErHWjIQIelIbFeaph1MiG_UPRaZawV6l4S8i1MJ-W5p_G_sW_lJsBzvqkuhnfpuTKpyQyDhhUyOkXABvzH2ua_kdRZ-O2grfJJroWnvwupQypjJ5HZgo1LuUI67LnyCtDHQLCuSxXL0VS6CS78z-Xk3y5tEOfamxjtyq_yx8cCSxmgDnE05bzRoXvA=) section\nof the Capricor website. The full WMS program is available at\nwms2026.com/page/programme\n(https://www.globenewswire.com/Tracker?data=Wx2igMv2-B0JfcGIguRcgeBB9W1o4x07AuMNFQ_M56S47evOArA1xAFmEmYNt5X7tDyuCqChFfBy7p2gPln3AdbfDt4zFcgPvNAgHn3oGB66-ftJrrvYiIFmS4IEE1kZ).\n\nWebinar Information\n\nA webinar is scheduled for Wednesday, October 7, 2026, at 1:00 p.m. ET in\ncollaboration with Parent Project Muscular Dystrophy (PPMD) to discuss these\nresults in more detail. To register for the webinar, please click here\n(https://www.globenewswire.com/Tracker?data=RUKD2mDUhmjpgRgioG-ueqaf10j29xTzi4KS_vrkucLwa_KYepN0X4PLhZfve0CjSgrOdMQPT1tqs3Q7CaZOaUGq_vunS49VmYLab6sMkD8qtX2wATqIdL4QV0o8LZI8KzjYV43OT8csvFTGhlnkstN_rRGcrPX7KROPdyapJwc=).\nFor additional details, please visit Parent Project Muscular Dystrophy's\nwebsite\n(https://www.globenewswire.com/Tracker?data=JcOgIywToRS_u_JfC8qkztdBvXyjxrHM3jtiPhX-Y5om0XH6OD-95so_NYJd4s_F-r8fh3D_lqec_7x7ge04G74dEb902THnHvv-6ucQzUHCyvcEEXBiF8BsHgD4g0YK7nsFEtfpA0ywGgmfykEUMP5G3QMqr7NeRedrOMnbsaXSOnoDrRv6sGggTeo0kiT9-u-GIddHSwHlAztDVekshA==).\n\nAbout the HOPE-3 Study\n\nHOPE-3 is a Phase 3, randomized, double-blind, placebo-controlled trial\nevaluating Deramiocel in patients with Duchenne muscular dystrophy. The study\nenrolled 106 patients, randomized to receive Deramiocel or placebo\nadministered intravenously every three months over a 12-month treatment\nperiod. One-year results were published in The Lancet\n(https://www.globenewswire.com/Tracker?data=5KsXEtTLFZyUidMi_0Fp1WhelZkK-StbGN83Mu2PF2FmO0J2jgjxlzlpXyA5H-cExTe-GPCrfwYSDLZRXyULkUJvqEwp8Awrh95CSJDo26yqRWxsSN6EAcEolMlmsevx_LwZb0Vb4diCS5xhwv2JwA3e6Jjl4WobYdSzZhHyTktTCOmniXtZzH8_hxyuXGtrKRf96ua_E0MeJwAwLGXmaMKbV7ZBXdAoaUd2vPaxti0_vXR8vnTRCmemYufrQNkwmKU__ETVJCu7FSKCnJHFDfxBtcix73Lkz7gS_6w-Do-7uCCyejPVV411agNLmzL4a83o1tvlJv1WxobWnrEbLQ==)\nin July 2026. Patients who completed the randomized portion of the study were\neligible to continue receiving Deramiocel in an open-label extension (OLE).\n\nAbout Duchenne Muscular Dystrophy\n\nDuchenne muscular dystrophy (DMD) is a severe, X-linked genetic disorder\ncharacterized by progressive muscle degeneration affecting the skeletal,\nrespiratory, and cardiac muscles. It is caused by the absence of functional\ndystrophin, a key structural protein in muscle cells. DMD affects\napproximately 15,000 individuals in the United States and primarily impacts\nboys. Over time, deterioration of the heart muscle leads to cardiomyopathy and\nheart failure, the leading cause of death in DMD. There is no cure, and\ntreatment options remain limited.\n\nAbout Deramiocel\n\nDeramiocel (CAP-1002) consists of allogeneic cardiosphere-derived cells\n(CDCs), a rare population of cardiac cells that have been shown in preclinical\nand clinical studies to exert immunomodulatory and anti-fibrotic actions in\nthe preservation of skeletal and cardiac muscle function in muscular\ndystrophies such as DMD. CDCs act by secreting extracellular vesicles known as\nexosomes, which target macrophages and alter their expression profile to adopt\na healing rather than pro-inflammatory phenotype. For the treatment of DMD,\nDeramiocel holds Orphan Drug, RMAT and Rare Pediatric Disease designations in\nthe U.S., and Orphan Drug and ATMP designations in Europe. The Rare Pediatric\nDisease designation may qualify Capricor for a Priority Review Voucher upon\napproval.\n\nAbout Capricor Therapeutics\n\nCapricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to\nadvancing cell and exosome-based therapeutics for the treatment of rare\ndiseases. Our lead product candidate, Deramiocel, is an allogeneic\ncardiac-derived cell therapy in late-stage development for the treatment of\nDuchenne muscular dystrophy (DMD), evaluated in clinical studies for its\npotential to preserve skeletal and cardiac muscle function. Capricor is also\nadvancing its proprietary StealthX™ exosome platform for the targeted\ndelivery of oligonucleotides, proteins, and small-molecule therapeutics across\na range of diseases. At Capricor, we are committed to delivering new therapies\nfor patients with rare diseases. For more information, visit capricor.com\n(https://www.globenewswire.com/Tracker?data=4UEjd4j_ImZmwbZ_Lr0UT4LTW6gGgMqk4ShmqpGkMZTWTW2RN2fyDscGwmhCNmfpXySM2LuGNbXkEA1FPhpxv8GIKSWRys4JEmNk4aVDuLBB0mmgslrHL0NeSdN5O0WUXnWOvB0VCLrMk3puBsM5BcVF_jC6rsgJW-MXovVQhlqau_YkQm4OUA5nBkjOOzhBPW_-HDbSgQsH2u57un-gsu3J4rGywbM9mnD6vXgIR8fIZpyc0Wa_2hRQ-f1mU6K_EDklCzyx49z_ua-RIjT7j904s5tBetcKcn4w3RZpgkDUrq1p4lfVUP8RYUYrEFBScJvoKtO4GZSxfzcIh6YhynhtTKpHu5ph63Ln1J1yGpEmjWorlFYvC_XLoFjVHIvPME1bAkOD1zxY-JWF4-yEeqxFW1xJs_sLxzNIZomwgV-ID1ER9AD7bh7AIJTnpo1329K1lM7QZ0eY1iPHWICrvgp0_jeQ8T1QRFnI70xfgsxTG6zGNDNKaaMdqh2fTwfcULzFPKnWilO9gChKAZHE9GQhioHhvM7XpR5SkjlAI-lAuA-bKaSBdcFcS3PtMIB8_86bQtvUj5glr1XkKwgNa6UfRmtdlqa2jyA-cIiRjP8A9uM-3savecsU-dJWaCwbUZNhhOelBC7ywrpW-Bl5_-z7a4Iy2hqFAawM1_0JTDx0gtMd8Gnw9fvkcgaT-Bzw2hrZ8YM4_wXKHrmDtreX1GUbp0Gmsi-wFAR7deJm6Z8C2QLsL7WYN5i8UbWyy0QqiVEEM20qANDPqbloWxyD4_yXNxlMr1Ug42L3Pru_BzNLLfREzACOliN34AIQJC6RGNP7aXlpJLWcmBW772nx6KwDV-g_rFWoPju9voKrKgALUAMWKlS0EJzagSa67Kn8)\nand follow Capricor 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SW1HBQaQZ8h71QG2vXjsGal3dx2tOuu0SuxHi8IM7tNlMwDJplDuexUA_4cjzwQLKP09utOo-tNqpzMEjHjgPcjWxz2j56oV8331cDjKhmcHmshT737pMqoGEuBgoDFb4c9BiUBEmVr4ZmEguqN9iyz_EPYSAbPrE5b-kyKUVEr6sprnNj-OkqA4xd3SHmYIPZkA-i2y1fTAD6TjUFflApTNb9JYymgSkg==).\n\nCautionary Note Regarding Forward-Looking Statements\n\nStatements in this press release regarding the efficacy, safety, and intended\nutilization of Capricor’s product candidates; the initiation, conduct, size,\ntiming and results of clinical trials; the pace of enrollment of clinical\ntrials; plans regarding regulatory filings, future research and clinical\ntrials; regulatory developments involving products, including future\ninteractions with regulatory authorities and the ability to obtain regulatory\napprovals or otherwise bring products to market; manufacturing capabilities;\ndates for regulatory meetings; the potential that required regulatory\ninspections may be delayed or not be successful which would delay or prevent\nproduct approval, revenue and reimbursement estimates, projected terms of\ndefinitive agreements, our financial position, our possible uses of existing\ncash and investment resources; results of securities litigation; and\nstatements regarding our litigation with Nippon Shinyaku Co., Ltd. and NS\nPharma, Inc., including the nature of the dispute, our expectations regarding\nany legal proceedings, and our ability to commercialize Deramiocel independent\nof our existing distribution agreement and any other statements about\nCapricor’s management team’s future expectations, beliefs, goals, plans or\nprospects constitute forward-looking statements within the meaning of the\nPrivate Securities Litigation Reform Act of 1995. Any statements that are not\nstatements of historical fact (including statements containing the words\n“believes,” “plans,” “could,” “anticipates,” “expects,”\n“estimates,” “should,” “target,” “will,” “would” and\nsimilar expressions) should also be considered to be forward-looking\nstatements. There are a number of important factors that could cause actual\nresults or events to differ materially from those indicated by such\nforward-looking statements. More information about these and other risks that\nmay impact Capricor’s business is set forth in Capricor’s Annual Report on\nForm 10-K for the year ended December 31, 2025, as filed with the Securities\nand Exchange Commission on March 17, 2026 and in our Quarterly Report on Form\n10-Q for the quarter ended June 30, 2026, as filed with the Securities and\nExchange Commission on August 14, 2026. All forward-looking statements in this\npress release are based on information available to Capricor as of the date\nhereof, and Capricor assumes no obligation to update these forward-looking\nstatements.\n\nDeramiocel and Capricor’s StealthX™ exosome therapeutics are\ninvestigational and have not been approved for commercial use in any\nindication.\n\nFor more information, please contact:\n\nCapricor Media Contact:\nCaitlin Kasunich / Raquel Cona\nKCSA Strategic Communications\nckasunich@kcsa.com / rcona@kcsa.com\n212.896.1241 / 516.779.2630\n\nCapricor Company Contact:\nAJ Bergmann, Chief Financial Officer\nabergmann@capricor.com\n858.727.1755\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/16ce4387-5b8f-447c-96b8-7c453633f9bf)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-10-05T13:00:02.521527076Z","server_sent_at_ms":1791205202521},"received_at":"2026-10-05T13:00:02.629Z","source_url":null},"analysis":{"id":"149174","press_release_id":"160618","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["Open-label, unadjusted analyses with no alpha allocated and not powered for Month 24 comparisons","Ongoing litigation with Nippon Shinyaku/NS Pharma referenced in forward-looking statements"],"eventType":"clinical_trial","narrative":"Capricor presented positive 24-month HOPE-3 open-label extension data showing patients who crossed over from placebo to Deramiocel slowed upper limb decline by 76% versus their own prior year on placebo.\n\nBoth treatment groups declined more slowly at 24 months than natural history models predict, and the early-start group showed stable decline rates across both years, suggesting a treatment effect rather than time alone.\n\nThese data were included in the major amendment to the Deramiocel BLA, with an FDA PDUFA target action date of November 22, 2026, making the dataset directly relevant to the pending approval decision.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Strong OLE crossover data de-risk the Deramiocel BLA ahead of the Nov 22, 2026 PDUFA date."},"keyFigures":{"drugName":"Deramiocel (CAP-1002)","phaseOfTrial":"Phase 3","customDimensions":{"pdufa_date":"November 22, 2026","trial_name":"HOPE-3 open-label extension","ole_patients":98,"patients_enrolled":106,"reduction_in_decline_rate":"76%"}},"quotedText":"When the young men who had been declining on placebo started Deramiocel, their rate of upper limb loss dropped by roughly 75% in their first year of treatment.","namedEntities":{"people":[{"name":"Linda Marbán, Ph.D.","role":"CEO of Capricor"},{"name":"Craig McDonald, MD","role":"Principal Investigator of the HOPE-3 trial at UC Davis Health"},{"name":"AJ Bergmann","role":"Chief Financial Officer"}],"products":["Deramiocel","CAP-1002","StealthX™"],"companies":[{"name":"Capricor Therapeutics","ticker":"CAPR","relationship":"filer"},{"name":"Parent Project Muscular Dystrophy (PPMD)","relationship":"webinar collaborator / patient advocacy group"},{"name":"UC Davis Health","relationship":"trial site"},{"name":"Nippon Shinyaku Co., Ltd. and NS Pharma, Inc.","relationship":"litigation counterparty (mentioned in boilerplate)"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"Positive 24-month open-label extension data showing a 76% reduction in rate of upper limb decline, included in the BLA major amendment ahead of the November 22, 2026 PDUFA date. Not itself an approval, but supportive of a lead-asset binary event."},"tickerRelevance":{"others":[],"primary":"CAPR"},"globalImportance":42,"audienceRelevance":38,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"mid/small-cap biotech","eventGravity":"positive Phase 3 OLE data supporting pending BLA decision","eventProximity":"PDUFA within ~7 weeks","issuerAuthored":true}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":3,"narrative":"Capricor presented positive 24-month HOPE-3 open-label extension data showing patients who crossed over from placebo to Deramiocel slowed upper limb decline by 76% versus their own prior year on placebo.\n\nBoth treatment groups declined more slowly at 24 months than natural history models predict, and the early-start group showed stable decline rates across both years, suggesting a treatment effect rather than time alone.\n\nThese data were included in the major amendment to the Deramiocel BLA, with an FDA PDUFA target action date of November 22, 2026, making the dataset directly relevant to the pending approval decision.","key_figures":{"drugName":"Deramiocel (CAP-1002)","phaseOfTrial":"Phase 3","customDimensions":{"pdufa_date":"November 22, 2026","trial_name":"HOPE-3 open-label extension","ole_patients":98,"patients_enrolled":106,"reduction_in_decline_rate":"76%"}},"named_entities":{"people":[{"name":"Linda Marbán, Ph.D.","role":"CEO of Capricor"},{"name":"Craig McDonald, MD","role":"Principal Investigator of the HOPE-3 trial at UC Davis Health"},{"name":"AJ Bergmann","role":"Chief Financial Officer"}],"products":["Deramiocel","CAP-1002","StealthX™"],"companies":[{"name":"Capricor Therapeutics","ticker":"CAPR","relationship":"filer"},{"name":"Parent Project Muscular Dystrophy (PPMD)","relationship":"webinar collaborator / patient advocacy group"},{"name":"UC Davis Health","relationship":"trial site"},{"name":"Nippon Shinyaku Co., Ltd. and NS Pharma, Inc.","relationship":"litigation counterparty (mentioned in boilerplate)"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-05T13:00:14.059Z","global_importance":42,"audience_relevance":38,"importance_components":{"tickerTier":"mid/small-cap biotech","eventGravity":"positive Phase 3 OLE data supporting pending BLA decision","eventProximity":"PDUFA within ~7 weeks","issuerAuthored":true}},"durationMs":6476,"modelName":"glm-5.3-flashx"}}