
FDA Disputes Deramiocel Efficacy; HIV Funding Hits 20-Year Low
247 Health News Editorial
·29 July 2026
·3 min read
·healthtechThe FDA has disputed Capricor Therapeutics' Phase 3 efficacy claims for deramiocel in Duchenne muscular dystrophy ahead of an advisory committee hearing, raising serious questions about the drug's approval pathway. Simultaneously, a 2026 UNAIDS report reveals global government HIV funding fell 18% to a 20-year low of $7.3 billion in 2025, threatening prevention infrastructure across sub-Saharan Africa.
Originally reported by STAT News
References
- 1.Silverman, E. (2026, July 28). Pharmalittle: We're reading about FDA views on a Duchenne drug, GSK cost savings, and more. STAT News. https://www.statnews.com/pharmalot/2026/07/28/fda-duchenne-drug-gsk-cost-savings-plan/
- 2.UNAIDS. (2026). Global HIV & AIDS statistics — Financing report 2026. Joint United Nations Programme on HIV/AIDS. https://www.unaids.org/en/resources/documents/2026
- 3.Duan, D., Goemans, N., Takeda, S., Mercuri, E., & Aartsma-Rus, A. (2021). Duchenne muscular dystrophy. Nature Reviews Disease Primers, 7(1), 13. https://doi.org/10.1038/s41572-021-00248-3
- 4.Capricor Therapeutics. (2025). Capricor Therapeutics announces positive Phase 3 results for deramiocel in Duchenne muscular dystrophy [Press release]. Capricor Therapeutics Investor Relations. https://www.capricor.com
- 5.Bekker, L. G., Alleyne, G., Baral, S., Cepeda, J., Daskalakis, D., Dowdy, D., Dybul, M., Eholie, S., Esom, K., Garnett, G., Grimsrud, A., Hakim, J., Havlir, D., Isbell, M. T., Johnson, L., Kamarulzaman, A., Kasaie, P., Kazatchkine, M., & Kilonzo, N. (2018). Advancing global health and strengthening the HIV response in the era of the Sustainable Development Goals. The Lancet, 392(10144), 312–358. https://doi.org/10.1016/S0140-6736(18)31070-5
- 6.Australian Government Department of Health and Aged Care. (2023). Eighth National HIV Strategy 2023–2030. Australian Government. https://www.health.gov.au/resources/publications/eighth-national-hiv-strategy-2023-2030
- 7.Kesselheim, A. S., & Avorn, J. (2022). Accelerated approval of cancer drugs — weighing the trade-offs. New England Journal of Medicine, 386(18), 1677–1680. https://doi.org/10.1056/NEJMp2201045
- 8.Kates, J., Wexler, A., & Lief, E. (2025). Financing the response to HIV in low- and middle-income countries: International assistance from donor governments. Kaiser Family Foundation / UNAIDS. https://www.kff.org/global-health-policy/report/financing-the-response-to-hiv-in-low-and-middle-income-countries-international-assistance-from-donor-governments/
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