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The Exosome Diagnostics & Therapeutics Market is projected to grow from USD 1.02 billion in 2024 to USD 3.28 billion by 2030, driven by chronic disease prevalence, personalized medicine advancements, and exosome isolation tech innovations. Strategic collaborations and investments are boosting research, while high costs, regulatory hurdles, and exosome biology understanding gaps pose challenges. Companies should focus on enhancing isolation techniques, scalable production, and novel therapeutic applications.

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Capricor Therapeutics announced EMA Orphan Drug and ATMP designations for deramiocel, its DMD treatment, potentially accelerating development and market exclusivity in Europe. The company has initiated a rolling BLA with the FDA, targeting full approval by year-end. Deramiocel, comprising allogeneic cardiosphere-derived cells, has shown immunomodulatory, antifibrotic, and regenerative properties in studies. Capricor continues to explore exosome technology and partnerships for deramiocel's commercialization.

Capricor Therapeutics announced EMA granted Orphan Drug and Advanced Therapy Medicinal Product designations to deramiocel for Duchenne muscular dystrophy. These designations offer benefits like market exclusivity and reduced fees, supporting deramiocel's development.

Capricor Therapeutics received a Buy rating from Jones Trading with a $40 target, spotlighting deramiocel for DMD-CM treatment. Positive feedback and EU approval potential bolster optimism. Capricor, partnering with Nippon Shinyaku, aims for FDA approval by 2025, despite a Q3 2024 net loss of $12.6M. The company is expanding treatment use and manufacturing, supported by a $165M cash balance.

Capricor Therapeutics plans to seek early FDA approval for a cell therapy to improve heart function in Duchenne muscular dystrophy patients, driving a five-fold increase in its stock price.

AI in Clinical Trials Market report by CoherentMI forecasts market growth from USD 1.52B in 2024 to USD 4.31B by 2031 at a CAGR of 16.2%, driven by efficiency, cost reduction, and improved recruitment in clinical trials.

Global exosome market to grow at ~20% CAGR by 2030, driven by chronic disease incidence, diagnostic improvements, and personalized medicine interest. North America leads, with key players like Danaher and Thermo Fisher Scientific. Notable developments include Aruna Bio's US patent for neural exosomes and EXO Biologics' EUR 16 million Series A funding.

Capricor Therapeutics closed a public offering of 5,073,800 shares, grossing $86.3 million, to fund product development, manufacturing, and general corporate purposes. Piper Sandler & Co. and Oppenheimer & Co. Inc. managed the offering, which was under a shelf registration statement filed with the SEC.