CAPRICOR THERAPEUTICS, INC.
CAPR evidence brief
What we can confirm
What it means
What to watch
Prepared research question
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Traceable citations · Unknowns marked
BioSniper AI · CAPR
Capricor Therapeutics is a clinical-stage biotechnology company developing deramiocel, a cell therapy for Duchenne muscular dystrophy, and an early-stage exosome platform (StealthX™) for vaccines and therapeutics.
Key risk: Regulatory approval risk
BioSniper Score
Based on 6 of 6 signals
Financial data as of Jun 30, 2026.
Tracking 1 pipeline candidate · 2 clinical trials · 2 catalysts for CAPRICOR THERAPEUTICS, INC..
Capricor Therapeutics is a clinical-stage biotechnology company developing deramiocel, a cell therapy for Duchenne muscular dystrophy, and an early-stage exosome platform (StealthX™) for vaccines and therapeutics.
- Lead candidate deramiocel is under FDA review for Duchenne muscular dystrophy with a PDUFA date of November 22, 2026 [sec_mda · as of 2026-08-14].
- Cash, cash equivalents, and marketable securities totaled $20.9 million as of June 30, 2026 [latest reported financials].
- Net loss was $40.7 million for the six months ended June 30, 2026 [latest reported financials].
- The company has raised approximately $600 million since inception through equity financings, collaborations, and grants [sec_mda · as of 2026-05-13].
- Exosome platform (StealthX™) is in early-stage development, with a Phase 1 study for a COVID-19 vaccine planned under Project NextGen [sec_mda · as of 2025-03-26].
What works
- Deramiocel is the most advanced program, with a BLA submitted and a PDUFA date set, representing a potential near-term commercial catalyst [sec_mda · as of 2026-08-14].
- The company has secured non-dilutive funding and partnerships, including a $10 million milestone payment from Nippon Shinyaku in January 2025 [sec_mda · as of 2025-05-14].
- The StealthX™ exosome platform has government backing through Project NextGen for a COVID-19 vaccine, indicating external validation [sec_mda · as of 2025-03-26].
What to weigh
- Capricor has no approved products and has not generated any revenue from product sales to date [sec_mda · as of 2025-08-11].
- The company has a history of significant operating losses, with a net loss of $40.7 million in the first half of 2026 [latest reported financials].
- Cash burn is substantial; cash and equivalents of $20.9 million as of June 30, 2026 may require additional financing before deramiocel can generate revenue [latest reported financials].
- The exosome platform is at a very early stage, with no clinical data yet, and its development timeline and costs are uncertain [sec_mda · as of 2026-08-14].
From the filings
Quoted directly from source documents.
Company has raised ~$600 million since inception
“Since our inception, we have received approximately $600 million through a combination of equity financings, strategic collaborations, grants and other non-dilutive funding sources.”
SEC MD&A · May 13, 2026
Catalyst timeline
- 2026-11-22 · PDUFA · deramiocel — FDA decision on the Biologics License Application for deramiocel for Duchenne muscular dystrophy.
- 2026-12-01 · Phase3_Topline — Topline results from a Phase 3 randomized, double-blind, placebo-controlled trial of deramiocel.
Risks & what to watch (4)›
Key risks
- Regulatory approval risk — Deramiocel may not receive FDA approval; PDUFA date is Nov 22, 2026 [sec_mda · as of 2026-08-14].
- Cash runway uncertainty — Cash of $20.9M as of June 30, 2026 may be insufficient to fund operations until revenue [latest reported financials].
- No product revenue history — Company has never generated revenue from product sales and may not for several years [sec_mda · as of 2025-08-11].
- Early-stage exosome platform — Exosome program is preclinical/early-stage; no clinical data yet, and costs are uncertain [sec_mda · as of 2026-08-14].
What to watch
- FDA decision on deramiocel BLA by November 22, 2026 [sec_mda · as of 2026-08-14].
- Phase 3 topline data for deramiocel expected December 1, 2026 [upcoming catalysts].
- Progress of StealthX™ exosome vaccine Phase 1 study under Project NextGen [sec_mda · as of 2025-03-26].
- Future capital raises or partnership deals to extend cash runway [sec_mda · as of 2026-05-13].
Sources: SEC MD&A · Generated August 29, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 6 of 6 signals · derived from public data
21.8 months
D/E 0.50 · 0% dilution
Lead: Phase 2
1 candidate
2 upcoming, next in ~84d
0 buys · 13 sells (180d)
Runway
Catalysts
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
179
Total value held
$1.20B
| Holder | Shares | Value |
|---|---|---|
| vanguard capital management llc | 4,055,464 | $123.3M |
| suvretta capital management, llc | 3,818,600 | $116.1M |
| blackrock, inc. | 3,421,815 | $104.0M |
| tang capital management llc | 3,399,900 | $103.4M |
| state street corp | 2,181,901 | $66.3M |
| ra capital management, l.p. | 1,507,844 | $45.8M |
| citadel advisors llc | 1,439,832 | $43.8M |
| susquehanna international group, llp | 1,365,075 | $41.5M |
| geode capital management, llc | 1,118,326 | $34.0M |
| diadema partners lp | 1,031,551 | $31.4M |
Showing top 10 of 179 institutional holders of CAPRICOR THERAPEUTICS, INC.. Open the full 13F history after sign-in.
Short Interest
as of May 20, 2026- % of float
- 20.1%
- Days to cover
- 10.7
- Shares short
- 10,515,168
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
CAPR short interestGovernance
Frequently asked questions
What is the AI investment thesis for CAPRICOR THERAPEUTICS, INC.?
Capricor Therapeutics is a clinical-stage biotechnology company developing deramiocel, a cell therapy for Duchenne muscular dystrophy, and an early-stage exosome platform (StealthX™) for vaccines and therapeutics.
What is CAPRICOR THERAPEUTICS, INC.'s lead drug candidate?
CAPRICOR THERAPEUTICS, INC.'s most advanced tracked candidate is Deramiocel (Phase 2) for Muscular Dystrophies; Duchenne Muscular Dystrophy.
What is CAPRICOR THERAPEUTICS, INC.'s next catalyst?
CAPRICOR THERAPEUTICS, INC.'s next tracked catalyst is a PDUFA event — "PDUFA Date: deramiocel" — expected November 22, 2026.
Who is the CEO of CAPRICOR THERAPEUTICS, INC.?
Dr. Linda Marbán Ph.D. is the chief executive officer of CAPRICOR THERAPEUTICS, INC. (CAPR).
Where is CAPRICOR THERAPEUTICS, INC. headquartered?
CAPRICOR THERAPEUTICS, INC. (CAPR) is headquartered in San Diego, CA, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.