Updated December 3, 2025
Capricor Therapeutics, Inc. (NASDAQ: CAPR) has just turned into one of the wildest biotech stories of 2025.
After the company reported positive topline results from its pivotal Phase 3 HOPE‑3 trial of deramiocel in Duchenne muscular dystrophy (DMD) early Wednesday, CAPR stock exploded from roughly $6.36 at Tuesday’s close to around $30 in Wednesday’s trading — a move of about +380%, with intraday highs near $40 and gains at one point exceeding +500%. [1]
At the same time, Wall Street analysts, regulators and patient advocates are rapidly reassessing both the approval odds and the long‑term value of Capricor’s lead therapy.
Key takeaways for CAPR stock today
- HOPE‑3 Phase 3 trial met its primary and key secondary endpoints in DMD, with deramiocel significantly slowing loss of upper limb function and deterioration of heart function versus placebo. [2]
- CAPR shares surged about 4x–5x in a single session, on volume more than 20x average, amid very high prior short interest (~35% of float as of mid‑November). [3]
- The FDA previously rejected deramiocel in July 2025 but agreed that HOPE‑3 could serve as the “additional study” needed for a Class 2 resubmission with a roughly six‑month review clock, paving the way for a second approval attempt in 2026. [4]
- Analysts still show a “Strong Buy” consensus with an average 12‑month price target around $23–24 per share — figures largely set before today’s move and now sitting below the latest trading price. [5]
- Capricor ended Q3 2025 with about $98.6 million in cash and marketable securities, guiding that its current resources should fund operations into Q4 2026, even before any new milestones from its partner Nippon Shinyaku. [6]
Below is a detailed look at what happened on December 3, what’s inside the HOPE‑3 data, the regulatory path from here, Wall Street forecasts, and the core bull and bear cases for CAPR stock.
What happened today? CAPR stock explodes on HOPE‑3 success
Before the opening bell on December 3, Capricor released positive topline results from the Phase 3 HOPE‑3 trial of deramiocel, its cell therapy for DMD‑associated cardiomyopathy. [7]
The market reaction was immediate and violent:
- CAPR gapped up from a prior close of $6.36 to open around $30.
- Shares traded as high as about $40 intraday, according to coverage from BioPharma Dive and other outlets, before settling back into the high‑20s to low‑30s range by later trading. [8]
- Reuters reported the stock was up more than four‑fold, adding roughly $950 million in market value at one point. [9]
- Real‑time market data show volume over 40 million shares, compared with typical average daily volume near 2 million shares, and prior short interest of about 14.2 million shares, or 34.6% of float, suggesting a major short squeeze on top of fundamental buying. [10]
Investor’s Business Daily described the move as a skyrocket to an eight‑year high, with shares briefly up more than +500% on the day. [11]
In short: HOPE‑3 didn’t just beat the bar. It completely rewired expectations for both the drug and the stock.
Inside the HOPE‑3 trial: why the data matter so much
Capricor’s press release and independent coverage from Reuters, BioPharma Dive and others agree on the core HOPE‑3 message: deramiocel hit all the important marks. [12]
Key trial features:
- Design: randomized, double‑blind, placebo‑controlled Phase 3 trial in 106 boys and young men with DMD, across 20 U.S. centers. [13]
- Dosing: IV deramiocel (150 million cells/infusion) vs placebo, every three months for 12 months, on top of standard corticosteroids. [14]
- Population: average age around 15; ~90% on cardiac medications; >75% had cardiomyopathy at baseline — a relatively advanced, largely non‑ambulatory DMD cohort. [15]
Headline efficacy outcomes:
- Primary endpoint – PUL v2.0 (Performance of Upper Limb):
- Deramiocel slowed decline in upper limb function by ~54% vs placebo at 12 months, with statistical significance (p≈0.03). [16]
- Key secondary endpoint – LVEF (left ventricular ejection fraction by cardiac MRI):
- Deramiocel reduced worsening of heart function by ~91% vs placebo (p≈0.04). [17]
Capricor also reported that all type‑I‑error‑controlled secondary endpoints reached statistical significance and that safety and tolerability were in line with prior experience, with no new safety signals flagged. [18]
Clinicians quoted by the company stressed that a ~54% slowing of skeletal muscle decline in such severely affected patients is “extraordinary,” directly tied to preserving independence, while the cardiac benefit could meaningfully affect survival, given that cardiomyopathy is the leading cause of death in DMD. [19]
From an investor’s standpoint, HOPE‑3 matters because:
- It addresses the FDA’s request for more definitive evidence after the earlier rejection.
- It shows a coherent benefit in both muscle and heart — not just a marginal signal in one domain.
- It validates more than a decade of Capricor’s development work, including prior HOPE‑2 data and its long‑term extension. [20]
That combination explains why analysts and traders quickly shifted from skepticism to “this might actually be a first‑in‑class standard of care.”
The regulatory story: from rejection to a second shot at approval
To understand CAPR’s risk/reward from here, you need the 2025 regulatory timeline.
1. First approval attempt and FDA rejection
- Capricor originally filed a Biologics License Application (BLA) for deramiocel to treat cardiomyopathy associated with DMD.
- In May 2025, Reuters reported that the FDA planned to convene an advisory panel of outside experts before making a decision — a move that initially knocked the stock about 15%. [21]
- In July 2025, the FDA issued a Complete Response Letter (CRL), saying the existing data did not provide “substantial evidence of effectiveness,” and requested additional clinical data. [22]
Capricor responded publicly in September, posting both the CRL and its detailed written rebuttal to increase transparency and reaffirming that it expected HOPE‑3 topline data in Q4 2025. [23]
2. Type A meeting and regulatory reset
In a Type A meeting with FDA, summarized in a September 25 regulatory update, Capricor reported several critical points of alignment: [24]
- HOPE‑3 would serve as the “additional study” requested in the CRL.
- The trial’s primary endpoint (PUL v2.0) and key secondary endpoint (LVEF) were confirmed as appropriate measures, with LVEF expected to be eligible for labeling discussion.
- FDA agreed the company could submit HOPE‑3 data within the existing BLA, aiming for a label that reflects both skeletal and cardiac benefits.
- The agency told Capricor it would treat the resubmission as a Class 2 response, implying a target review period of up to six months.
Today’s Reuters story adds more color: CEO Linda Marbán reiterated that deramiocel’s resubmission would indeed be handled as a Class 2 filing and that the company will push for as rapid a review as possible. [25]
3. What HOPE‑3’s success means now
With HOPE‑3 now clearly positive:
- Capricor plans to submit its complete response to the CRL incorporating HOPE‑3 data, addressing both the efficacy and manufacturing questions raised by FDA. [26]
- The company notes that its commercial manufacturing facility in San Diego has already passed FDA pre‑license inspection, and previously identified CMC issues have been resolved. [27]
- Analysts quoted by Reuters and BioPharma Dive (e.g., B. Riley’s Madison El‑Saadi and Cantor Fitzgerald’s Kristen Kluska) now see the dataset as an “unambiguous” efficacy signal that could justify approval, especially given the lack of therapies specifically targeting DMD cardiomyopathy. [28]
The base‑case regulatory timeline implied by company commentary and FDA’s own classification:
- CRL response + HOPE‑3 data submission: likely in the near term (Capricor has been preparing for this since Q3). [29]
- Class 2 review: up to six months after FDA accepts the resubmission. [30]
- Potential U.S. approval and launch: management continues to guide for a possible 2026 approval and commercial introduction of deramiocel. [31]
Of course, “Class 2, six months” is not a guarantee — but it provides a clear anchor for investors modelling scenarios.
Financial position: runway into late 2026 and a partner waiting in the wings
The other pillar of the CAPR story is whether the company can survive and scale while the FDA process plays out.
From Capricor’s Q3 2025 financial results: [32]
- Cash, cash equivalents & marketable securities: about $98.6 million as of September 30, 2025.
- Revenues: $0 for Q3 and year‑to‑date 2025, versus $2.3 million and $11.1 million in the same periods of 2024. The drop reflects the full recognition of $50 million in upfront and milestone payments under the company’s U.S. distribution deal with Nippon Shinyaku (NS Pharma) by the end of 2024. [33]
- Operating expenses: about $26.3 million in Q3 2025 vs $15.3 million a year earlier, largely driven by clinical and manufacturing scale‑up.
- Net loss: approximately $24.6 million ($0.54 per share) in Q3 2025, and $74.9 million ($1.64 per share) for the first nine months of the year.
- Runway guidance: management believes its current cash should fund operations into Q4 2026, excluding any additional milestones under the Nippon Shinyaku commercialization and distribution agreements.
Crucially, Capricor already has an exclusive commercialization and distribution agreement with Nippon Shinyaku covering the U.S. and Japan, with the potential for additional milestone and royalty payments after approval. [34]
This means:
- The company is not yet revenue‑generating in 2025, but
- It doesn’t need to rush to raise capital immediately, and
- If deramiocel is approved, launch risk is partially shared with an established rare‑disease partner.
Analyst forecasts and price targets for CAPR
Wall Street coverage of Capricor has been relatively niche, but the available data paint a consistent picture: analysts have been bullish for months, even before HOPE‑3.
Consensus rating and targets
- StockAnalysis aggregates six analysts covering CAPR with an overall rating of “Strong Buy”. The average 12‑month price target is about $23.17, with a low target of $13 and a high of $30. [35]
- Public.com similarly lists CAPR with a “Strong Buy” consensus and a $23.17 target, based on third‑party analyst data. [36]
- QuiverQuant, tracking individual notes over the last six months, lists recent targets such as: [37]
- $13 from Roth Capital (Nov 12, 2025)
- $24 from H.C. Wainwright (Sept 25, 2025)
- $21 from B. Riley Securities (June 26, 2025)
- $29 from JonesTrading (June 25, 2025)
- $22 from Oppenheimer (June 23, 2025)
These targets were set before today’s explosive move and before the full HOPE‑3 topline data were public.
With CAPR now trading above the prior consensus high of $30, the market is clearly pricing in either:
- future target upgrades,
- higher sales / probability of approval than analysts had assumed,
- or a layer of speculative and short‑squeeze premium on top of fundamentals.
Revenue and earnings projections
According to StockAnalysis’ compiled forecasts: [38]
- 2025 revenue is expected around $1.35 million, down sharply from $22.27 million in 2024, reflecting the end of Nippon Shinyaku milestone recognition and the pre‑commercial stage.
- 2026 revenue is projected to jump to about $107.8 million, implying a dramatic ramp consistent with early deramiocel launch assumptions.
- EPS is forecast at roughly –$2.22 in 2025, improving to around –$1.84 in 2026 as revenue starts to ramp but investment remains heavy.
These estimates will almost certainly be revised after analysts fully digest HOPE‑3, recalibrate peak sales assumptions, and update their probability‑of‑approval models.
What today’s commentary says: from vindication to caution
The market headlines around CAPR on December 3 share a common theme — vindication for the drug, but lingering risk for the stock.
- BioPharma Dive highlighted that shares soared more than 300%, with investors now betting the Phase 3 data will be enough to overturn the July rejection and deliver the first treatment specifically for Duchenne cardiomyopathy. It noted that sentiment had been “mixed or low” going into the readout and that the dual success on both endpoints “far surpassed expectations.” [39]
- Reuters framed the story as Capricor “eyeing U.S. nod” after deramiocel met the main goal of a late‑stage study and reiterated that FDA will treat the coming filing as a Class 2 resubmission with about a six‑month review. [40]
- Investor’s Business Daily emphasized the technical side: Capricor shares blasted above key moving averages and prior resistance, logging one of the largest single‑day surges in biotech this year. [41]
- Seeking Alpha took a more cautious tone: in a piece titled “Capricor Therapeutics: Shares Soaring After DMD Study Win – Ball Now In FDA’s Court”, the author maintained a Hold rating. The logic: while deramiocel’s data are strong and could make the drug a blockbuster, the recent CRL, regulatory uncertainty, and extreme volatility justify some restraint until approval is secured. [42]
In other words: the drug looks much stronger today; the stock might have sprinted ahead of both analysts and the company’s own guidance — at least in the very short term.
Other moving pieces: short interest, options, and technicals
A few more datapoints add flavor to the CAPR story:
- Short interest: As of November 14, 2025, MarketBeat estimates about 14.15 million CAPR shares sold short, or 34.6% of the float, with a days‑to‑cover ratio of 7.9 based on average volume. [43]
- Today’s volume vs average: With over 40 million shares changing hands, trading was roughly 20x typical volume, a setup ripe for a short squeeze. [44]
- Options activity: CAPR options have been active in recent weeks, with Nasdaq reporting noteworthy put volume in late November when the stock still traded near $4–6 — a stark contrast to today’s price levels. [45]
- Pre‑move technical view: Just yesterday, some technical services were still projecting modest downside over the next three months based on a wide falling trend and resistance around the mid‑single digits — forecasts that were effectively obliterated by the HOPE‑3 data. [46]
Together, these data help explain why CAPR’s move was so extreme: a heavily shorted, thinly traded biotech with a binary catalyst that unexpectedly over‑delivered.
Bull case vs bear case for CAPR after the spike
Bull case: potential first‑in‑class standard of care
The optimistic view on CAPR looks something like this:
- Regulatory momentum flips positive.
- Commercial opportunity is meaningful despite rare‑disease scale.
- DMD affects tens of thousands of patients in the U.S., with cardiomyopathy being the leading cause of death. [49]
- If deramiocel becomes the first approved therapy targeted specifically at DMD cardiomyopathy, adoption among specialists could be rapid, particularly if the safety profile continues to look clean. [50]
- Financial leverage on approval.
- Consensus models already envision revenue scaling from almost nothing in 2025 to more than $100 million in 2026, with plenty of upside if pricing and uptake exceed early assumptions. [51]
- The Nippon Shinyaku partnership offers additional milestones and shared commercial muscle in the U.S. and Japan. [52]
- Platform upside.
- Beyond deramiocel, Capricor is advancing its StealthX exosome platform, including an NIAID‑sponsored Phase 1 vaccine trial with topline data expected in early 2026, potentially adding a second growth leg. [53]
In this scenario, bulls argue that even after a 300%–500% one‑day move, CAPR could still be undervalued if deramiocel achieves high penetration and the platform yields follow‑on indications or partnerships.
Bear case: valuation, binary risk, and volatility
The skeptical view stresses:
- Regulatory risk is not gone.
- The FDA already issued one CRL citing lack of “substantial evidence of effectiveness,” and the regulatory environment for cell and gene therapies has been unusually contentious. [54]
- HOPE‑3 is compelling, but the FDA could still focus on nuances of trial design, patient subgroups, or long‑term safety.
- The stock may have overshot.
- Execution and competition risks.
- Even if approved, Capricor still has to execute a complex commercial launch in a rare‑disease market that already includes gene therapy and other DMD‑modifying treatments, which could complicate positioning and payer negotiations. [57]
- Manufacturing, logistics (repeat IV infusions), and long‑term registries will be scrutinized.
- Balance sheet vs. burn.
- While runway into Q4 2026 is reassuring, the company is burning $20–25 million per quarter, and additional trials, launch prep, and post‑marketing commitments could push Capricor back to capital markets, especially if approval is delayed. [58]
In this framing, bears see today’s price as baking in a near‑perfect approval and launch outcome, leaving limited margin for error in a very high‑risk area of biotech.
Practical considerations for investors
If you’re evaluating CAPR after December 3, here are some pragmatic points to keep in mind:
- Expect extreme volatility. A stock that can move 300–500% in a single day can just as easily swing 30–50% in either direction on regulatory headlines, analyst revisions, or profit taking.
- Watch the next catalysts:
- Track updated analyst notes. Many existing price targets are now stale. New models will likely re‑anchor expectations around: peak deramiocel sales, probability of approval, and potential strategic interest (M&A, partnerships beyond Nippon Shinyaku). [61]
- Remember the short‑interest dynamic. With a third of the float previously sold short and today’s volume more than 20x normal, short‑covering has almost certainly amplified the move. Once the squeeze element fades, trading may become more two‑sided. [62]
Bottom line: CAPR after HOPE‑3
Capricor’s December 3 HOPE‑3 readout is a genuine inflection point:
- It rescues a drug that the FDA had effectively pushed back from the brink,
- It sets up a second, better‑armed shot at approval, and
- It transforms CAPR from a languishing small‑cap biotech into a high‑profile DMD player almost overnight.
Whether today’s share price ultimately proves too high, too low, or surprisingly reasonable will depend on:
- how quickly and cleanly the FDA process moves,
- how physicians and payers respond if deramiocel reaches the market, and
- whether Capricor can leverage this win into a broader platform story.
For now, CAPR is firmly in high‑risk, high‑reward territory. Anyone considering the stock should be comfortable with large drawdowns, binary regulatory outcomes, and the possibility that today’s euphoria could give way to sharp corrections.
This article is for informational and educational purposes only and does not constitute investment advice, a recommendation, or an offer to buy or sell any security. Always do your own research or consult a licensed financial professional before making investment decisions.
References
1. www.biopharmadive.com, 2. www.capricor.com, 3. www.marketbeat.com, 4. www.capricor.com, 5. stockanalysis.com, 6. www.capricor.com, 7. www.capricor.com, 8. www.biopharmadive.com, 9. www.reuters.com, 10. www.marketbeat.com, 11. www.investors.com, 12. www.capricor.com, 13. www.capricor.com, 14. www.capricor.com, 15. www.capricor.com, 16. www.capricor.com, 17. www.capricor.com, 18. www.capricor.com, 19. www.capricor.com, 20. www.capricor.com, 21. www.reuters.com, 22. www.capricor.com, 23. www.capricor.com, 24. www.capricor.com, 25. www.reuters.com, 26. www.capricor.com, 27. www.capricor.com, 28. www.reuters.com, 29. www.capricor.com, 30. www.capricor.com, 31. www.capricor.com, 32. www.capricor.com, 33. www.capricor.com, 34. www.capricor.com, 35. stockanalysis.com, 36. public.com, 37. www.quiverquant.com, 38. stockanalysis.com, 39. www.biopharmadive.com, 40. www.reuters.com, 41. www.investors.com, 42. seekingalpha.com, 43. www.marketbeat.com, 44. www.marketbeat.com, 45. www.nasdaq.com, 46. stockinvest.us, 47. www.capricor.com, 48. www.capricor.com, 49. www.reuters.com, 50. www.biopharmadive.com, 51. stockanalysis.com, 52. www.capricor.com, 53. www.capricor.com, 54. www.capricor.com, 55. stockanalysis.com, 56. www.marketbeat.com, 57. www.statnews.com, 58. www.capricor.com, 59. www.capricor.com, 60. www.capricor.com, 61. stockanalysis.com, 62. www.marketbeat.com
