This page aggregates CAPR's FDA catalysts from pdufa.bio's own calendar and decision archive. Each item links to its source page. Facts and dates only; verify against primary FDA / SEC / company filings.
Computed from this stock's own daily closing prices, on the same T-120 basis as the run-up study: the baseline is the close 120 trading sessions before the eve of the decision. These are measurements of what already happened, not predictions.
| Decision | Outcome | T-120 to eve | T-120 to peak |
|---|---|---|---|
| 2025-07-11 | CRL | -15.4% | +18.4% |
| 2024-09-24 | APPROVAL | -13.4% | +0.0% |
Deramiocel is an experimental cell therapy made from heart cells recovered from donated human hearts. It is given as a drip into a vein once every three months in an outpatient clinic, so there is no surgery and no hospital stay. The cells are not meant to replace damaged muscle: the idea is that they release tiny packages called exosomes that calm inflammation and scarring, with the aim of slowing the loss of heart and arm function in boys and young men with Duchenne muscular dystrophy.
In clinical terms. Human allogeneic cardiosphere-derived cells (CDCs) derived from cadaver donor hearts. 1.5 x 10^8 (150 million) cells per intravenous infusion, every three months; four doses over twelve months in the Phase 3 trial. Capricor describes the mechanism as exosome-mediated macrophage reprogramming with immunomodulatory and anti-fibrotic effects; the FDA describes the same mechanism as hypothesised. Source
This is the trial the decision turns on, and whether it succeeded depends entirely on which version of the analysis plan you read. Under the plan written in 2022, before anyone had seen the data, arm function declined by 1.73 points on the drug and 2.39 points on placebo. That gap of 0.66 points was well within the range of chance. Heart function was essentially identical between the two groups. After the blinded phase ended, the analysis plan was rewritten twice. The final version measured arm function as a percentage change rather than an absolute one, ranked the heart results instead of averaging them, and changed how missing data from a small number of patients were handled. Under that final plan both results became statistically significant. The FDA re-ran the new model using the original missing-data rules and the significance disappeared again.
The numbers. Primary endpoint, PUL 2.0 at 12 months. Pre-specified SAP 1.1: difference 0.66 (95% CI -0.45 to 1.77), p=0.24. SAP 3.0 as modified in the clinical study report: 4.55% (0.47 to 8.63), p=0.029. FDA re-analysis of SAP 3.0 without the applicant's imputation: 2.53% (-1.48 to 6.53), p=0.21. Key secondary endpoint, LVEF by cardiac MRI. Pre-specified: -0.041 percentage points (-2.58 to 2.49), p=0.97. SAP 3.0 as modified: ranked change 11.65 (0.47 to 22.82), p=0.041. FDA re-analysis without imputation: 6.88 (-4.29 to 18.05), p=0.22. Randomised, double-blind, placebo-controlled, 20 US sites. Mean age about 15, predominantly non-ambulatory. Mean baseline LVEF 57%, with only 5 of 106 patients below 45%. Source
This earlier trial was designed for 84 patients but stopped after 20, which left it too small to reliably detect a benefit. It was published as positive, but that result came from a re-analysis performed after the treatment codes were opened. On the analysis agreed in advance, it did not show a significant effect on its main measure or on any secondary measure.
The numbers. Primary endpoint mid-level elbow PUL 1.2 at 12 months. Published result: percentile difference 36.2 (95% CI 12.7 to 59.7), p=0.014, using a percentile-rank transformation applied after unblinding. FDA: on the model pre-specified before unblinding, no statistically significant effect on the primary or any secondary endpoint. Source
Hypersensitivity reactions, meaning allergic-type responses to the infusion, occurred in about 42% of patients on the drug against 15% on placebo. Serious adverse events were uncommon and were actually more frequent in the placebo group, including one life-threatening allergic reaction that the FDA attributes to ingredients shared by both the drug and the placebo.
The numbers. Hypersensitivity reactions 22/53 (41.5%) deramiocel against 8/52 (15.4%) placebo. Six serious adverse events in total, five in placebo patients and one in a deramiocel patient. One Grade 4 anaphylactic reaction, in a placebo recipient. The FDA noted that the differing reaction profile raises the possibility that patients and investigators could infer treatment assignment despite formal blinding. Source
On the same morning in July 2026, The Lancet published HOPE-3 as a trial that met its primary endpoint, and an FDA advisory committee voted 9 to 3 that the evidence did not establish effectiveness. Both were looking at the same patients. The difference is which analysis plan counts. Peer reviewers assessed the plan the company finalised in November 2025; the FDA assessed the plan agreed in 2022 and objected that the later version was never submitted to it, that the submitted analyses departed even from that later version, and that the result rests on how missing data from two placebo patients were handled. The committee was asked only whether the evidence showed effectiveness. It was not asked to weigh benefit against risk, a point Capricor has emphasised. The FDA acknowledged in its own briefing document that there is an urgent unmet need, since no approved therapy exists for heart disease in Duchenne. [1] [2] [3]
Closing price on the announcement date against the previous close, measured from daily data when this page was built. Announcements made before the open move that day; announcements after the close move the next session. This records what happened, and does not claim the announcement caused it.
| Date | Event | Move | Close |
|---|---|---|---|
| 2026-07-30 | Advisory committee vote disclosed (3 for, 9 against) | -36.2% | $6.57 to $4.19 |
| 2026-07-27 | FDA briefing document published | -64.5% | $19.70 to $7.00 |
| 2026-03-10 | Complete Response Letter lifted, new PDUFA date set | +9.0% | $30.63 to $33.40 |
| 2025-12-03 | HOPE-3 topline announced | +371.1% | $6.36 to $29.96 |
| 2025-07-11 | Complete Response Letter disclosed | -33.0% | $11.40 to $7.64 |
Compiled from primary sources and last reviewed 2026-08-03. Every figure above links to the filing, regulator document or journal it came from. This is information, not investment advice, and nothing here forecasts an FDA decision.
November 22, 2026. The next catalyst for Capricor Therapeutics Inc. is Deramiocel (CAP-1002) - (HOPE-3) (PDUFA). That date is a confirmed date. Dates are taken from FDA notices, company filings or ClinicalTrials.gov, and we do not publish a specific day when the source only gives a month or a quarter.
Yes, 1 in our archive: 0 approval(s) and 1 Complete Response Letter(s). The most recent was on July 11, 2025 and was a Complete Response Letter. Each one has its own page with the source document and the share-price reaction we measured.
Measured from this company's own daily closing prices: Since its T-120 baseline on 2026-06-02 ($27.34), CAPR is -64.9% to $9.59 at the close on 2026-08-28. The highest close since that baseline is +11.2% above it. These are historical measurements of what already happened, not forecasts, and we publish no price targets or probability of approval.
FDA publications, company filings with the SEC, company press releases and ClinicalTrials.gov, with share prices measured from daily closing data. Every date and outcome links the document it came from. Where an outcome was inferred from the price reaction rather than read from a filing, the page says so on its face.