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Capricor Therapeutics, Inc.

CAPR
OvervaluedPharma · Clinical
FDA catalysts, PDUFA dates & pipeline intelligence
$8.4
▼ -0.55 · -6.15%

Financials

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52W LOW $2.9652W HIGH $40.37
Volume
1.05 M
Value Traded
11.97 M
Short % Float
37.38%
-2.81%Week
-6.57%1 Month
-62.26%3 Month
-73.28%6 Month
+644.07%5 Year
-96.39%All Time

Cash Data

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  • SEC Filing

Key Stats

Market Cap
487.20 M
EPS (TTM)
-2.23
P/E Ratio
-
Ent. Value
242.87 M
Total Shares
58.16 M
Float Shares
52.65 M
Insiders
9.44%
Institutions
75.00%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
Phase 3 data presentation
Deramiocel (CAP-1002)
Upper limb impairment in Duchenne muscular dystrophy (DMD)
RMATOrphanRare Pediatric
Phase 3Cell TherapiesMusculoskeletal System
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PoA blends historical approval base rates, trial design score and FDA review track record.

CAPR Catalyst Timeline

Dated clinical, regulatory and corporate events for Capricor Therapeutics, Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for Capricor Therapeutics, Inc.

814Total events
14Upcoming
212Tier-1 (high impact)
2009 to 2027Coverage

Upcoming catalysts 2

T1IP Litigation Ruling
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T1PDUFA Date
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DeramiocelFiled

Event history 50

◆Long Term DataDeramiocelFiledClinical Data
HOPE-3 and OLE 24-month skeletal muscle and cardiac outcomes to be presented
Duchenne muscular dystrophysource ↗
◆Timing GuidanceDeramiocelFiledPresentation
HOPE-3 and OLE 24-month skeletal muscle and cardiac outcomes to be presented at WMS 2026
Duchenne muscular dystrophysource ↗
●Major Amendment SubmittedDeramiocelFiledRegulatory Filing
BLA amendment submitted with 24-month open-label extension data and robustness analyses
Duchenne muscular dystrophysource ↗
●Long Term DataDeramiocelFiledClinical Data
24-month open-label extension data from HOPE-3 included in BLA amendment
Duchenne muscular dystrophysource ↗
●Quarterly UpdateCorporate
Capricor reported Q2 2026 financial results
◆Timing GuidanceDeramiocelFiledPresentation
Company plans to provide regulatory update on conference call today
●IP Litigation RulingDeramiocelFiledIP / Competition
Preliminary injunction motion withdrawn; arbitration to begin this fall
●Major Amendment SubmittedDeramiocelFiledRegulatory Filing
Capricor submits major amendment to deramiocel BLA with 24-month HOPE-3 open-label extension data and request to refine indication to upper limb function
Duchenne muscular dystrophy (DMD)source ↗
●Long Term DataDeramiocelFiledClinical Data
24-month open-label extension data from Phase 3 HOPE-3 study included in BLA amendment
Duchenne muscular dystrophy (DMD)source ↗
▼AdCom OutcomeDeramiocelFiledAdvisory Committee
FDA Advisory Committee voted 9-3 that evidence did not support effectiveness of Deramiocel for cardiomyopathy in DMD
cardiomyopathy in Duchenne muscular dystrophysource ↗
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Past FDA Catalysts and PDUFA Decisions

How CAPR actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2026-10-02StealthX muscle-targeting extracellular vesicles (acid α-glucosidase) Pre-clinical data presentation Pre-clinical
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

C49 / 100
Pipeline Score
$190M
Pipeline Value
Overvalued
Valuation Signal
3
Drugs Scored
0.4x
rNPV / MCap
Top 18%
Micro Cap
(rank 119 of 658)
Percentile Rank
Capricor Therapeutics, Inc. carries a moderate pipeline score (49/100), with $730M risk-adjusted pipeline value, led by CAP-1002 in Covid19 (Phase 2).
Showing 1 of 3 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
CAP-1002 Monoclonal antibodyCompletedNCT03406780Muscular DystrophiesPhase 2 COMPLETED 20Mar 1, 2020
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Clinical Trial Results

Readouts, endpoints and source filings for every CAPR program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
Deramiocel
PriorityRMATOrphan+1
Duchenne muscular dystrophyPhase 32026-09-1754 percent versus placebo as measured by Performance of the Upper Limb (PUL) version 2.0 (p=0.03)Read MoreCapricor Therapeutics to Present HOPE-3 and HOPE-3 Open-Label Extension Data at 2026 World Muscle Society CongressRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
Krasney KarenOfficer (EVP, GENERAL COUNSEL)Option 24,100 54,647 held$3.18 06/25/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
TANG CAPITAL MANAGEMENT LLC 4.5 % (-13.5 %) 98.72 M 4.10 M 20.59% ( 700.00 K)
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Shares held by hedge funds each quarter, and who bought or sold.

CAPR Institutional Ownership Trends

Options Data

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Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2026-10-23
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Real-Time Option Chain

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Competitive positioning

How CAPR ranks across every disease it competes in

Competitive Position is a premium feature
See how CAPR ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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CAPR News

CAPR
Oct 5, 2026
CAPRPhases
▼ -6.1%today

Capricor Therapeutics Presents Positive HOPE-3 Open-Label Extension Data on Upper Limb Function in Duchenne Muscular Dystrophy at 2026 World Muscle Society Congress

Capricor Therapeutics presented encouraging data from the HOPE-3 open-label extension study at the World Muscle Society Congress. The study showed that patients who began treatment with Deramiocel after a year on placebo experienced a 76% slower decline in upper limb function. This data supports the efficacy of Deramiocel in treating Duchenne muscular dystrophy, with the FDA reviewing the findings as part of a major amendment to its Biologics License Application.

Read more →
CAPR
Sep 17, 2026
CAPRConferences/Events
▲ +10%on this newsshared move

Capricor Therapeutics to Present HOPE-3 and HOPE-3 Open-Label Extension Data at 2026 World Muscle Society Congress

Capricor Therapeutics announced the presentation of data from the HOPE-3 study and its open-label extension at the World Muscle Society Congress in 2026. The study evaluates Deramiocel for Duchenne muscular dystrophy, with results indicating significant efficacy in slowing upper limb decline. The company is also showcasing additional preclinical data from its StealthX exosome platform.

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CAPR
Aug 24, 2026
CAPRFDA Updates
▲ +8.1%on this news· ran to +60% by day 3

Capricor Therapeutics Announces Extension of PDUFA Target Action Date as FDA Continues Review of Deramiocel BLA

Capricor Therapeutics announced that the FDA has extended the PDUFA target action date for its Biologics License Application for Deramiocel to November 22, 2026. This extension follows the submission of additional Phase 3 data aimed at refining the proposed indication for the treatment of Duchenne muscular dystrophy. The FDA's acceptance of the amendment highlights the significant unmet medical need in this area.

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CAPR
Aug 21, 2026
CAPRGeneral
▼ -8%on this news· ran to +37% by day 3shared move

Kaos Capital Calls on Capricor (NASDAQ: CAPR) Shareholders

Kaos Capital, a significant shareholder of Capricor Therapeutics, has called for an immediate meeting with the Board of Directors to discuss the company's strategic direction and financial management. The firm aims to nominate two independent directors and establish a committee to explore mergers and acquisitions. Kaos Capital emphasizes the need for a cash preservation plan and a disciplined approach to governance amidst ongoing legal challenges.

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CAPR
Aug 13, 2026
CAPRFDA Updates
▲ +58%on this news· ran to +90% by day 3

Capricor Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update

Capricor Therapeutics reported its Q2 2026 financial results, highlighting the ongoing FDA review of Deramiocel. The company achieved a significant primary endpoint in the HOPE-3 Phase 3 trial, but faced challenges with the FDA Advisory Committee's recent vote against its cardiomyopathy indication. Despite a net loss, Capricor maintains a strong cash position and is preparing for potential commercialization.

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CAPR
Aug 10, 2026
CAPRGeneral
▼ -5.9%on this newsshared move

Capricor Therapeutics to Report Second Quarter 2026 Financial Results and Provide Recent Corporate Update on August 13

Capricor Therapeutics will announce its second quarter 2026 financial results on August 13, 2026. The company will also provide a corporate update during a conference call scheduled for the same day. Capricor is focused on developing cell and exosome-based therapies for rare diseases, with its lead candidate, Deramiocel, in late-stage development for Duchenne muscular dystrophy.

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CAPR
Jul 30, 2026
CAPRFDA Updates
▲ +35.2%on this news

Capricor Therapeutics Provides Update on FDA Advisory Committee Meeting for Deramiocel

Capricor Therapeutics announced that the FDA's Advisory Committee voted against the effectiveness of Deramiocel for treating cardiomyopathy in Duchenne muscular dystrophy (DMD). Despite this, the Committee provided supportive feedback on the clinical evidence from the Phase 3 HOPE-3 trial. Capricor remains committed to pursuing FDA approval ahead of the upcoming PDUFA target action date.

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CAPR
Jul 29, 2026
CAPRFDA Updates
▼ -36.2%on this newsshared move

The Lancet Publishes HOPE-3 Data for Capricor Therapeutics’ Deramiocel in Duchenne Muscular Dystrophy

Capricor Therapeutics announced that The Lancet published results from its Phase 3 HOPE-3 trial of Deramiocel for Duchenne muscular dystrophy. The trial met its primary endpoint, showing a 54% reduction in upper limb function decline compared to placebo. The findings also indicated significant cardiac benefits, reinforcing the potential of Deramiocel as a transformative therapy. The FDA is currently reviewing the Biologics License Application for Deramiocel, with a target action date set for August 22, 2026.

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CAPR
Jul 27, 2026
CAPRFDA Updates
▲ +9%on this news· ran to -40% by day 3shared move

Capricor Comments on Briefing Materials Ahead of July 29 FDA Advisory Committee Meeting for Deramiocel

Capricor Therapeutics has provided an update ahead of the FDA Advisory Committee meeting regarding its Biologics License Application for Deramiocel, a cell therapy for Duchenne muscular dystrophy. The company emphasizes its transparency with the FDA and highlights positive results from the Phase 3 HOPE-3 trial. However, there are concerns about the reliance on outdated analysis materials.

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CAPR
Jun 26, 2026
CAPRFDA Updates

Capricor Therapeutics Announces FDA Advisory Committee Meeting to Review BLA for Deramiocel for the Treatment of Duchenne Muscular Dystrophy

Capricor Therapeutics announced an upcoming FDA Advisory Committee meeting on July 29, 2026, to review its Biologics License Application for Deramiocel, a cell therapy for Duchenne muscular dystrophy. The application is supported by positive results from Phase 2 and Phase 3 trials. The company aims to engage with the FDA and the DMD community during this critical review process.

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CAPR
Jun 26, 2026
CAPRConferences/Events
▼ -13%on this news· ran to -24% by day 3shared move

Capricor to Present Positive Five-Year HOPE-2 OLE Data and HOPE-3 Phase 3 Results for Deramiocel in Duchenne Muscular Dystrophy at PPMD 2026 Annual Conference

Capricor Therapeutics announced positive five-year data from its HOPE-2 Open-Label Extension study of Deramiocel for Duchenne Muscular Dystrophy. The study demonstrated a significant attenuation of disease progression and stable cardiac function. These findings will be presented at the PPMD 2026 Annual Conference, alongside results from the successful HOPE-3 Phase 3 trial. The company is preparing for a potential FDA approval by August 2026.

Read more →
CAPR
Jun 8, 2026
CAPRConferences/Events

Capricor Therapeutics to Present at Upcoming Investor Conferences

Capricor Therapeutics announced its participation in several upcoming investor conferences, including the Goldman Sachs 47th Annual Global Healthcare Conference and the Oppenheimer CNS and Neuro-Muscular Summit. The company's lead product, Deramiocel, is in late-stage development for Duchenne muscular dystrophy and aims to preserve cardiac and skeletal muscle function. The events will provide opportunities for management to engage with investors and discuss the company's advancements.

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CAPR
May 29, 2026
CAPRGeneral

Capricor Therapeutics Expands Commercial Leadership Team

Capricor Therapeutics has appointed Michael Maurer as Chief Commercial Officer to enhance its commercial leadership team. With extensive experience in rare disease commercialization, Maurer will support the launch readiness of Deramiocel, an investigational therapy for Duchenne muscular dystrophy. His role will focus on market access, patient support, and distribution strategy as the company approaches its PDUFA date.

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CAPR
May 12, 2026
CAPRFDA Updates

Capricor Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update

Capricor Therapeutics reported its first quarter 2026 financial results, highlighting the ongoing FDA review of its BLA for Deramiocel, with a target action date of August 22, 2026. The HOPE-3 Phase 3 trial successfully met its primary endpoint, and the company is preparing for a potential commercial launch. However, Capricor has filed a lawsuit against NS Pharma regarding a distribution agreement, which may affect its operations.

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CAPR
May 7, 2026
CAPRGeneral

Capricor Therapeutics Takes Legal Action to Protect Patient Access to Deramiocel for Duchenne Muscular Dystrophy -Complaint outlines its distribution partner's failure to prepare for launch of DMD therapy; Capricor seeks

Capricor Therapeutics has initiated legal action against Nippon Shinyaku Co., Ltd. and its U.S. subsidiary to address failures in their distribution agreement for Deramiocel, an investigational therapy for Duchenne muscular dystrophy (DMD). The lawsuit highlights issues related to pricing flaws that could restrict patient access to this critical treatment. Capricor aims to ensure that Deramiocel reaches patients, particularly as the FDA has granted it Priority Review status. The company is working towards commercial readiness for a responsible launch pending FDA approval.

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CAPR
May 4, 2026
CAPRConferences/Events
▲ +8.4%on this newsshared move

Capricor Therapeutics to Report First Quarter 2026 Financial Results and Provide Recent Corporate Update on May 12

Capricor Therapeutics is set to release its financial results for the first quarter of 2026 on May 12, alongside a corporate update. Management will host a conference call for investors to discuss these developments. The company continues to advance its lead product candidate, Deramiocel, and is focusing on exosome technology for treating rare diseases. The results are anticipated with interest from stakeholders, reflecting the company's ongoing efforts in the biotech sector.

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CAPR
Apr 22, 2026
CAPRPhases

Capricor Therapeutics Announces Late-Breaking Presentation of HOPE-3 Phase 3 Results at the American Academy of Neurology 2026 Annual Meeting

Capricor Therapeutics presented promising results from its Phase 3 HOPE-3 trial of Deramiocel for Duchenne muscular dystrophy at the AAN 2026 Annual Meeting. The data indicated a statistically significant improvement in upper limb function and a meaningful impact on disease progression. With a BLA under FDA review, Capricor aims to expedite access to this potential therapy for patients.

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CAPR
Mar 13, 2026
CAPRGeneral
▼ -8.7%on this news

Capricor Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update

Capricor Therapeutics reported its financial results for Q4 and full year 2025, highlighting a strong cash position of approximately $318.1 million. The company is focused on the potential FDA approval of Deramiocel for Duchenne muscular dystrophy, with a PDUFA target date set for August 22, 2026. Despite reporting zero revenues for the quarter, recent clinical data supports the therapeutic's promise.

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CAPR
Mar 13, 2026
CAPRPhases
▼ -8.7%on this news

Capricor Therapeutics Announces Late-Breaking HOPE-3 Data at the 2026 MDA Conference Demonstrating Significant Functional Benefits of Deramiocel for Duchenne Muscular Dystrophy

Capricor Therapeutics presented new data from the Phase 3 HOPE-3 trial of Deramiocel for Duchenne muscular dystrophy at the 2026 MDA Conference. The findings highlight significant functional benefits for patients, particularly in daily activities. The company is currently awaiting FDA approval, with a target action date of August 22, 2026.

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About Capricor Therapeutics, Inc.

San Diego, CA 231 employees capricor.com
Headquarters10865 ROAD TO THE CURE, SAN DIEGO, CA, 92121
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