CAPR · Capricor Therapeutics
Conviction · Low · more likely to lag the S&P 500 over the next three months
Wrong if: a daily close above $20.10
Updated ·
Price against the kill line
52.6% clear of its kill line on the 13 November 2026 close.
How to read this
This note expects the shares to lag the market, so its kill line sits above the price: a close above the red mark would prove the view wrong. Prices run from low on the left to high on the right. The dot is where the stock closed on 13 November 2026, left of the mark while it is below the line; a dot right of the mark has closed through it.
The scale is stretched near the line, so close calls are easy to see. More than 8% from the line, the stock reads well clear, with a hollow dot to show the figure is off the drawn scale.
The kill line is the research note's own test. The portfolio sells on business facts, not on a price. How the portfolio decides
Three months against the kill line
$20.10 ↑ kill line, off the scale above
Daily closes, to . The kill line, a daily close above $20.10, is too far above the closes to draw: well clear. The shares are up 27.9% since the close; the S&P 500 is down 2.1% over the same sessions. Figures in the note can cover a different window.
Kill line
A daily close above $20.10, over the 200-day moving average, which would show the market pricing deramiocel's approval as likely. FDA approval of the deramiocel biologics license application by the 22 November 2026 action date would also prove the call wrong.
Research onlyNot in the portfolio.
Catalyst
Key figures from the filings · Health Care
Quarter to 30 September 2026, filed 10 November 2026; valuation at the 13 November 2026 close
- Free cash flow, four quarters ($M)
- −133
- Free-cash-flow yield (%)
- −23.9
All filed numbers
What Capricor Therapeutics reports to the SEC in its quarterly and annual filings. Each group states its period and filing date once; a figure dated otherwise says so. Built from the filings known on .
| Pre-tax income ($M) | −42.7 |
| Net income ($M) four quarters: −148 | −42.7 |
| Diluted shares, change on a year (%) against the quarter to 30 September 2025 | +27.2 |
| Operating cash flow ($M) | −120 |
| Capital spending ($M) | 12.7 |
| Free cash flow ($M) | −133 |
| Cash and short-term investments ($M) | 198 |
| Debt ($M) | Not available |
| Net cash, cash less debt ($M) | Not available |
| Deferred revenue ($M) 0.0% on a year | 12.0 |
| Backlog, orders not yet delivered ($M) | Not reported |
| Receivables ($M) | Not reported |
| Inventory ($M) | Not reported |
| Shareholders' equity ($M) | 210 |
| Market value ($M) | 554 |
| Enterprise value, market value plus net debt ($M) | Not available |
| Enterprise value to sales (×) | Not available |
| Enterprise value to operating income (×) | Not available |
| Price to earnings (×) | Not meaningful |
| Price to book value (×) | 2.6 |
| Free-cash-flow yield (%) | −23.9 |
Short interest (FINRA, settled 15 October 2026, published 13 November 2026): 34.2% of shares outstanding sold short, 6.6 days of average trading to cover, +5.5% since the previous report.
| Window | Bought | Sold |
|---|---|---|
| 90 daysfrom | $0 | $0 |
| 12 monthsfrom | $0 | $8.4M |
The thesis
Capricor Therapeutics' shares are more likely to lag the S&P 500 over the next three months than to lead it. The company has no revenue. Its value rests on one FDA decision on deramiocel, a cell therapy for Duchenne muscular dystrophy (DMD). On 29 July 2026, an FDA advisory committee voted 9-3 that the main trial behind deramiocel did not show it works. The FDA's action date of 22 November 2026 settles the case.
Since the vote, Capricor has narrowed its request. In August 2026 it amended the biologics license application (BLA). The amendment added two-year open-label data and asked for a narrower label: upper-limb impairment in patients older than 9, according to the company's 10 November 2026 results release. The FDA classed the amendment as major, which moved the action date from 22 August to 22 November 2026 (company 8-K, 24 August 2026).
FDA staff did not object to missing data. They objected to post hoc changes in the trial's statistical analysis plan, including how the endpoints were defined (GEN, 2 August 2026). Open-label data has no placebo group, so in this analyst's view it answers that objection only in part.
The shares closed at $11.22 on 11 November 2026. That close is 166.5% above three months earlier and 72.2% below the 52-week intraday high of $40.37 set on 3 December 2025. At that price, the market is assigning a partial chance of approval. The rating is Low because the outcome is binary and both the FDA's reviewers and its outside panel have already called the evidence insufficient. An approval would prove the call wrong.
Bullish and bearish views on Capricor Therapeutics, Inc.
The bull case on Capricor Therapeutics, Inc. (CAPR), in brief: peer-reviewed data shows a significant effect. The bear case: the FDA panel and staff rejected the evidence.
Bull case
- Peer-reviewed data shows a significant effect. In July 2026, The Lancet published the HOPE-3 trial. It showed slower decline in upper-limb function on the Performance of the Upper Limb scale (PUL 2.0), with p=0.029 (company release, 10 November 2026).
- Two-year open-label data shows a lasting effect. Patients who switched from placebo to deramiocel declined 1.56 points less on PUL 2.0 than in their placebo year, a 76% slowing. Capricor presented the data at the World Muscle Society congress in October 2026 (company release, 10 November 2026).
- Cash lasts past the decision. Cash, equivalents, restricted cash and marketable securities totalled $198.5 million at 30 September 2026. The company sold no shares under its at-the-market program from 1 January 2026 through 10 November 2026 (company release, 10 November 2026).
- An analyst upgrade came after the report. Jones Trading upgraded the shares to Buy with a $25 target on 11 November 2026. The stock closed at $11.22 that day, against $8.87 on 10 November 2026.
- An approval could bring a voucher worth cash. Deramiocel's Rare Pediatric Disease designation may qualify Capricor for a priority review voucher if it is approved. The company's financial outlook excludes any sale of one (company release, 10 November 2026).
Bear case
- The FDA panel and staff rejected the evidence. The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee voted 9-3 on 29 July 2026 that HOPE-3 did not provide substantial evidence of effectiveness. Staff pointed to post hoc changes to endpoint definitions, analysis methods and the handling of missing data (GEN, 2 August 2026).
- Safety and blinding questions remain open. Hypersensitivity reactions occurred in 42% of deramiocel patients against 15% on placebo. FDA staff said the different side-effect profiles could have let investigators work out who was on the drug (GEN, 2 August 2026).
- A trial inspection left one open observation. The FDA's bioresearch monitoring inspection of the trial in July 2026 ended with a Form 483 listing one observation. Capricor has responded and is waiting for FDA feedback (company release, 10 November 2026).
- Costs are rising with no revenue. Third-quarter 2026 operating expenses were $44.7 million, against $26.3 million a year earlier. The net loss was $42.7 million, or $0.73 a share. Cash fell from $318.1 million at 31 December 2025, and the company cut about 10% of its staff in the quarter (company release, 10 November 2026).
- The US sales partner is in a dispute. Capricor withdrew its motion for a preliminary injunction against its distribution partner NS Pharma and is pursuing arbitration. A hearing is expected to begin in mid-2027 (company release, 10 November 2026). Total liabilities rose to $120.6 million at 30 September 2026 from $50.2 million at 31 December 2025.
Price setup
The shares closed at $11.22 on 11 November 2026, after $8.87 on 10 November 2026 and $9.85 on 9 November 2026. Closes between 4 November 2026 and 11 November 2026 ranged from $8.60 to $11.22.
As of the 11 November 2026 close, the 50-day moving average was $8.09 and the 200-day moving average was $20.08. The shares sit above the 50-day average and well below the 200-day, which still includes prices from before the panel.
The 52-week closing low is $3.85, set on 31 July 2026, the last session of the week the FDA briefing documents came out and the panel voted. The close three months earlier was $4.21 on 13 August 2026.
In this analyst's view, the action date decides which level comes next. A complete response letter (a rejection) would bring the July and August closes back into view. An approval would bring the 200-day average and Jones Trading's $25 target into view.
Catalysts ahead
- 22 November 2026: FDA action date for the deramiocel biologics license application (narrowed to upper-limb impairment in DMD patients over 9). An approval would prove the lag call wrong. A complete response letter would leave Capricor with no approved product, $198.5 million of cash at 30 September 2026, and rising costs.
What would change the view
A daily close above $20.10, over the 200-day moving average, which would show the market pricing deramiocel's approval as likely. FDA approval of the deramiocel biologics license application by the 22 November 2026 action date would also prove the call wrong.
What it trades with
The shares move on FDA and company news, with little link to the broad market. The largest moves on record came in the week of 27 July 2026, when the FDA briefing documents were released and the panel voted. The latest came on 11 November 2026, the session after the third-quarter report and the day of the Jones Trading upgrade.
Until the FDA acts, index and biotech-sector moves matter less than news on the review. Once the FDA acts, its decision sets the shares' direction for the rest of the three-month window. A securities class action filed in August 2026 over the company's statements about deramiocel's data adds legal risk that does not depend on the market.
Notes
- The FDA action date for deramiocel, 22 November 2026, falls on a Sunday; the agency can act on or before that date.
- Capricor reports no product revenue; its value depends on the FDA decision on its single lead product, deramiocel.
- A securities class action filed in August 2026 alleges false statements about deramiocel's clinical data; the allegations are unproven.
- US distribution rights for deramiocel are in dispute with partner NS Pharma, with an arbitration hearing expected to begin in mid-2027.
The evidence, claim by claim (8)
- An FDA advisory committee voted 9-3 that HOPE-3 did not provide substantial evidence of deramiocel's effectiveness; FDA staff cited post hoc changes to the statistical analysis plan. GEN StockWatch, 2 August 2026 · as of
- Hypersensitivity reactions occurred in 42% of deramiocel patients versus 15% on placebo in HOPE-3. GEN StockWatch, 2 August 2026 · as of
- The FDA classed Capricor's BLA amendment as major, moving the action date from 22 August to 22 November 2026. Capricor 8-K, 24 August 2026 · as of
- Q3 2026 net loss of $42.7M ($0.73/share) and operating expenses of $44.7M versus $26.3M a year earlier; no revenue. Capricor Q3 2026 results release and 10-Q, 10 November 2026 · as of
- Cash, equivalents, restricted cash and marketable securities of $198.5M at 30 September 2026, down from $318.1M at 31 December 2025. Capricor Q3 2026 results release, 10 November 2026 · as of
- The FDA's July 2026 bioresearch monitoring inspection of the trial ended with a Form 483 listing one observation; FDA feedback on Capricor's response is pending. Capricor Q3 2026 results release, 10 November 2026 · as of
- HOPE-3, published in The Lancet in July 2026, showed slower upper-limb decline on PUL 2.0 with p=0.029. Capricor Q3 2026 results release, 10 November 2026 · as of
- Jones Trading upgraded Capricor to Buy with a $25 price target. Jones Trading rating action, 11 November 2026 · as of
Sources
- Capricor Therapeutics Reports Third Quarter 2026 Financial Results and Provides Corporate Update · capricor.com ·
- StockWatch: Capricor Plunges as FDA Panel, Staff Question Effectiveness of Lead Candidate Deramiocel · genengnews.com ·
- CAPRICOR THERAPEUTICS, INC. - Form 8-K - FY2026 · sec.gov ·
- Capricor's PDUFA date for FDA to review Deramiocel has been extended to November 22, 2026 · cureduchenne.org
- CAPR Investor Announcement: Capricor Therapeutics Sued on behalf of Investors to Recover Losses after Clinical Data Leads to 64% Stock Drop · morningstar.com ·
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