Nine advisory committee members looked at the same trial data Capricor called a win and voted against it. The 9-3 result on July 29 didn’t kill Capricor’s Duchenne muscular dystrophy program, but it added a real question mark to a therapy the company insists already cleared its bar. INmune Bio spent the same stretch doing something far less dramatic: turning routine government paperwork into cash it didn’t have to raise from investors.
FDA Panel Votes 9-3 Against Capricor’s Duchenne Cell Therapy Deramiocel
The vote came down 9 to 3 on July 29. Members of the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee concluded Capricor Therapeutics (Nasdaq: CAPR) had not shown substantial evidence that deramiocel works for Duchenne muscular dystrophy-related cardiomyopathy, the same statistical analysis plan dispute previewed in the agency’s briefing document a week earlier. It is Capricor’s second rejection recommendation for the therapy in just over a year, following a Complete Response Letter the FDA issued in July 2025.
The timing made the vote harder to read than most. The same day the committee met, The Lancet published the full HOPE-3 trial results, showing deramiocel slowed skeletal-muscle weakening by 54% along with supportive cardiac findings. Peer review validated the underlying data. The advisory panel simply wasn’t convinced by the argument Capricor built on top of it.
CEO Linda Marban told the committee parts of the FDA’s own briefing document were hard to reconcile with what actually happened during the trial, arguing staff analysis leaned on an outdated draft statistical plan rather than the final version that governed the real results. The panel wasn’t persuaded. Piper Sandler analysts said afterward they now expect the FDA to issue a second Complete Response Letter rather than approve the therapy outright.
The FDA’s own decision, which does not have to follow the panel’s recommendation, is due August 22. Capricor says it holds roughly $279 million in cash, enough to fund operations into the fourth quarter of 2027 regardless of which way that decision goes.
INmune Bio Turns $4.6 Million in Government Rebates Into Extended Cash Runway
Not every biotech extends its runway by raising money from investors. INmune Bio (Nasdaq: INMB), a roughly $50 million clinical-stage company, disclosed on July 31 that it collected about $4.6 million in research and development rebates from Australia and the United Kingdom, cash that came without issuing a single new share.
The rebates, roughly $4.2 million from Australia and $0.4 million from the UK, exceeded what INmune Bio spent on operations in the second quarter. That is a rare thing for a clinical-stage company this size to say out loud.
The cash supports two platforms moving toward regulatory filings. CORDStrom, an umbilical cord-derived cell therapy for a rare skin disease called recessive dystrophic epidermolysis bullosa, is headed toward a UK marketing application later this year, with EU and US filings to follow. XPro1595, aimed at neuroinflammation in early Alzheimer’s disease, holds FDA Fast Track designation and is positioned for a Phase 2b/3 program the company says the FDA has already aligned on.
None of that changes the fundamentals of a company still years from its first approval. Rebates buy time. They do not replace a positive trial result.
CAPR, INMB: Forward-Looking FAQ
Very little procedurally. The FDA’s review is already underway and does not reopen for new data. Capricor’s real decision point comes after August 22, when a second Complete Response Letter would force a choice between funding a third submission or shelving deramiocel’s cardiomyopathy indication.
Not by much. The $4.6 million covers roughly one quarter of operations, while the Phase 2b/3 program for XPro1595 is a multi-year, likely nine-figure undertaking that will need additional financing or a partner regardless of this rebate.
Sources
- BioSpace: FDA advisers vote against approval of Capricor’s DMD therapy in chaotic adcomm meeting, July 29, 2026
- Capricor Therapeutics: Provides Update on FDA Advisory Committee Meeting for Deramiocel, July 30, 2026
- AJMC: FDA Advisory Panel Votes Against Approval of Deramiocel for DMD, July 30, 2026
- TechTimes: FDA Panel Rejects Deramiocel Evidence as Lancet Validates Same Trial Data, July 30, 2026
- StockTitan / GlobeNewswire: INmune Bio Receives R&D Rebates of Approximately $4.6 Million, July 31, 2026
Editorial Disclosure
This roundup is based entirely on publicly available information including named wire service releases, company press releases, and financial news reporting. Securities and entities discussed include Capricor Therapeutics, Inc. (Nasdaq: CAPR) and INmune Bio Inc. (Nasdaq: INMB). aktiego.com has not received any compensation from any company, IR firm, or third party mentioned. No staff member or principal of aktiego.com holds a position in any security mentioned at the time of publication. This section previously covered Capricor on July 21-28, 2026 in connection with the FDA’s briefing document; this article is a follow-up covering the July 29, 2026 advisory committee vote itself, sourced to Capricor’s own July 30, 2026 press release and named medical and financial press. The committee’s 9-3 vote is non-binding, and the FDA’s final decision on the Biologics License Application, due August 22, 2026, has not been made as of publication. The Piper Sandler prediction of a second Complete Response Letter is that firm’s own stated opinion, sourced to AJMC’s reporting, and has not been independently verified by aktiego.com. Capricor’s characterization of the FDA’s briefing document as relying on an outdated draft statistical plan is the company’s own stated position, not confirmed by the FDA. INmune Bio’s rebate figures and cash runway commentary are sourced to its July 31, 2026 press release. Both companies discussed are clinical-stage with no FDA-approved products for the indications named in this article; their ability to reach further milestones depends on continued access to capital or a favorable regulatory outcome. Small cap and micro-cap stocks listed on the CSE, TSX, TSXV, and Nasdaq are speculative investments carrying significant risk including potential total loss of capital. Coverage on aktiego.com is provided for informational and educational purposes only. aktiego.com is not a registered investment advisor. Nothing in this article constitutes financial, investment, or professional advice. Readers are encouraged to conduct their own due diligence and consult a qualified financial advisor before making any investment decisions. For more information please see our full DISCLAIMER.
