Capricor Therapeutics
Market cap $523M 58.1M shares (10-Q, Aug 13, 2026) × $9.00 close Nov 6, 2026
Most recent annual filing: 2026-03-17
- Deramiocel PDUFA dateNov 22, 2026Deramiocel PDUFA date, Nov 22, 2026, thesis-defining
Bar width shows how precise the guidance is — a pin is a stated date, a wide band a six-month window. Deeper blue means more of the thesis rides on the event; it is not a view on the stock.
Pipeline (2 active programs)
StealthX vaccine
Technology platforms
StealthX
Engineered exosome platform for vaccine and therapeutic development; supports targeted RNA, protein, and small molecule delivery; focus areas include infectious diseases, monogenic diseases, and other indications
StealthX · Life Technologies Corporation
CDC-derived exosomes platform technology for therapeutic development; disease focus includes Duchenne muscular dystrophy and other diseases with high unmet medical needs
Capital (as filed)
- Cash
- $20.9M cash and cash equivalents · Jun 30, 2026 (10-Q)
- Short-term investments
- $217M Jun 30, 2026
- Operating cash flow
- −$31.5M quarter Mar 31, 2026 → Jun 30, 2026, year-to-date difference (10-Q)
- As stated in coverage
- $238M cash per the update of Oct 5, 2026 — the company's own words as read there, not the filed figure
Cash, investments and operating cash flow are the company's own XBRL facts as filed with the SEC, each shown with its period end and tag. As-stated figures come from the company's own words as read in Biotech Distilled coverage, dated, and routinely count securities and planned financing that a balance sheet does not. Offering rows are the SEC cover pages as filed. Not investment advice. Figures as of Nov 7, 2026.
Biotech Distilled coverage (12)
- 2026-10-06 UPDATE: Capricor Therapeutics (CAPR) - The Before-and-After Picture 🔒 Paid
- 2026-08-24 UPDATE: Capricor Therapeutics (CAPR) — The New Date Is November 22 🔒 Paid
- 2026-08-22 UPDATE: Capricor Therapeutics (CAPR) — An Activist Kicks the Door In 🔒 Paid
- 2026-08-15 UPDATE: Capricor Therapeutics (CAPR) — The August 22 Binary Just Got Cancelled 🔒 Paid
- 2026-08-14 UPDATE: Capricor Therapeutics (CAPR) — The Cash Cushion Got Thinner Nine Days Before PDUFA 🔒 Paid
- 2026-08-04 UPDATE: Capricor Therapeutics (CAPR) — RA Capital Just Showed Up 🔒 Paid
- 2026-07-30 UPDATE: Capricor Therapeutics (CAPR) — The Key Secondary Just Lost Its Star 🔒 Paid
- 2026-07-30 UPDATE: Capricor Therapeutics (CAPR) — 9-3 Against, and the Stock Falls Below Cash 🔒 Paid
- 2026-07-28 UPDATE: Capricor Therapeutics (CAPR) — The FDA Showed Its Cards, and the Stock Lost Two-Thirds 🔒 Paid
- 2026-07-14 UPDATE: Capricor Therapeutics (CAPR) — Signing a 138-Month Lease Two Weeks Before AdCom 🔒 Paid
- 2026-06-26 UPDATE: Capricor Therapeutics (CAPR) — A Third Binary Lands on the Calendar 🔒 Paid
- 2026-06-19 Capricor Therapeutics (CAPR) — Scientific Deep Dive for Deramiocel and the StealthX Exosome Platform 🔒 Paid
Articles open on Substack. Some are subscriber-only; those marked ★ Distilled Pro are for Distilled Pro members.
Verdict history (12 calls)
Every verdict Biotech Distilled has published on Capricor Therapeutics, oldest first — the full history, never a selection. How calls are scored: the track record.
- 2026-06-19 Watch Capricor Therapeutics (CAPR) — Scientific Deep Dive for Deramiocel and the StealthX Exosome Platform Real Phase 3 data and best-in-class safety profile collide with a re-review that already failed once and a commercial structure the company is suing to escape, stacking too many live binaries to commit capital.
- 2026-06-26 Watch UPDATE: Capricor Therapeutics (CAPR) — A Third Binary Lands on the Calendar An FDA Advisory Committee on July 29 adds a third public failure mode without removing either original binary, keeping the watch-list stance intact until upgrade triggers are met.
- 2026-07-14 Watch UPDATE: Capricor Therapeutics (CAPR) — Signing a 138-Month Lease Two Weeks Before AdCom Management's 138-month lease signals internal approval confidence, but the trinary of injunction, AdCom, and PDUFA remains intact and unresolved, keeping the watch-list stance unchanged.
- 2026-07-28 Watch UPDATE: Capricor Therapeutics (CAPR) — The FDA Showed Its Cards, and the Stock Lost Two-Thirds FDA briefing documents contest the statistical analysis plan underlying HOPE-3's primary endpoint, repricing approval odds toward a CRL; the watch-list stance holds as the asymmetry now runs in both directions but no upgrade triggers have been met.
- 2026-07-30 Watch UPDATE: Capricor Therapeutics (CAPR) — The Key Secondary Just Lost Its Star LVEF revised to p=0.09 on AdCom morning and a BIMO Form 483 weaken the cardiac story further, but the primary endpoint survived peer review; one of three upgrade triggers now met, watch-list maintained pending the panel outcome.
- 2026-07-30 Watch UPDATE: Capricor Therapeutics (CAPR) — 9-3 Against, and the Stock Falls Below Cash A 9-3 panel vote against effectiveness in DMD cardiomyopathy makes a CRL the modal outcome, but the stock trading below cash with a surviving skeletal primary endpoint creates asymmetry that keeps the watch-list stance rather than triggering an avoid.
- 2026-08-04 Speculative buy speculative UPDATE: Capricor Therapeutics (CAPR) — RA Capital Just Showed Up RA Capital crossing 5.2% during the briefing-document collapse retires the 'no conviction money' bear-case pillar; combined with a market cap below cash and PRV optionality, the risk/reward has shifted enough to open a starter speculative position.
- 2026-08-14 Speculative buy speculative UPDATE: Capricor Therapeutics (CAPR) — The Cash Cushion Got Thinner Nine Days Before PDUFA Cash fell to $237.9M with a $42.9M quarterly burn and the NS injunction was withdrawn to arbitration, but the speculative buy is maintained as the upgrade rationale remains intact with slightly thinner margin.
- 2026-08-15 Speculative buy speculative UPDATE: Capricor Therapeutics (CAPR) — The August 22 Binary Just Got Cancelled FDA agreed to review a BLA amendment with 24-month HOPE-3 extension data for a refined upper-limb indication, converting a near-certain CRL binary into a multi-month process; Tang Capital at 7.1% further retires the holder-base bear case.
- 2026-08-22 Speculative buy speculative UPDATE: Capricor Therapeutics (CAPR) — An Activist Kicks the Door In Kaos Capital's activist campaign validates the burn-rate concern and creates pressure for cash discipline and strategic alternatives, but the science and regulatory path are unchanged; speculative buy maintained.
- 2026-08-24 Speculative buy speculative UPDATE: Capricor Therapeutics (CAPR) — The New Date Is November 22 FDA formally accepted the BLA amendment and set November 22 as the new PDUFA for a refined upper-limb indication, improving risk shape but not odds; speculative buy maintained with dilution risk elevated.
- 2026-10-06 Speculative buy speculative UPDATE: Capricor Therapeutics (CAPR) - The Before-and-After Picture 24-month OLE data shows a 76% reduction in arm-function decline for crossover patients and no fading in the early-start arm, supporting durability of the primary endpoint, but the evidence remains uncontrolled and the November 22 binary is unchanged.
- Long call · opened Aug 4, 2026 at $4.17 · +115.8% vs XBI +0.2% (Nov 6, 2026)
Every verdict Biotech Distilled has published on this company, in order, with the post it came from — the full history, never a selection. Position figures are the same ones shown on /track-record, computed by the same method. Editorial opinion, not investment advice.
Timing, in the company's words (2 quotes from 2 filings)
Sentences quoted verbatim from the company's SEC filings, newest filing first. Each sits under the filing it appeared in; the "matched to" tag names the calendar row it was read for.
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“In measuring the right-of-use asset and lease liability, the Company estimated the contractual commencement date of the ARE Lease to be August 22, 2026, the Prescription Drug User Fee Act (“PDUFA”) target action date for Deramiocel, representing management’s best estimate of the date on which the FDA approval contingency will be resolved, and the resulting rent commencement date to be August 22, 2027.”
matched to Deramiocel · regulatory decision · read as August 22, 2027
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“We remain focused on working with the FDA toward approval ahead of the August 22, 2026, PDUFA target action date.”
matched to Deramiocel · regulatory decision · read as August 22, 2026
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Timing sentences quoted from the company's own SEC filings, each under the filing it appeared in. The 'matched to' tag is the calendar row the sentence was read for; the filing is the source. Not investment advice.
Filings & releases (25)
SEC filings from EDGAR and press releases captured from the company's investor-relations site, newest first. Releases captured from Jul 27, 2026; filings from March 2026. Summaries come from the BD update that read the document; "BD extracted" counts point at the pipeline table above. All companies →
- Nov 3, 2026ReleaseCapricor Therapeutics to Report Third Quarter 2026 Financial Results and Provide Recent Corporate Update on November 10
- Oct 5, 2026ReleaseCapricor Therapeutics Presents Positive HOPE-3 Open-Label Extension Data on Upper Limb Function in Duchenne Muscular Dystrophy at 2026 World Muscle Society Congress→ BD updateThe 24-month HOPE-3 OLE data just landed publicly at WMS — patients who spent a year on placebo then switched to Deramiocel slowed their upper limb decline by 76%, and both arms outperformed natural-history predictions at month 24, giving the FDA's November 22 review its first durability signal.BD extracted 1 program update from this document → CAPR pipeline
- Sep 17, 2026ReleaseCapricor Therapeutics to Present HOPE-3 and HOPE-3 Open-Label Extension Data at 2026 World Muscle Society CongressBD extracted 1 program update from this document → CAPR pipeline
- Aug 24, 2026ReleaseCapricor Therapeutics Announces Extension of PDUFA Target Action Date as FDA Continues Review of Deramiocel BLA→ BD updateSummary on the 8-KBD extracted 1 program update from this document → CAPR pipeline
- Aug 24, 20268-KCurrent report: other events · EX-99.1→ BD updateThe FDA has formally accepted Capricor's BLA amendment as a major amendment and set November 22 as the new PDUFA date — the August 22 binary is officially closed, the skeletal-only refined indication strategy is now the company's official regulatory path, and the clock running at $40M/quarter just got three months longer.
- Aug 21, 2026ReleaseKaos Capital Calls on Capricor (NASDAQ: CAPR) Shareholdersvia aggregator→ BD update
- Aug 14, 202610-QQuarterly report
- Aug 13, 2026ReleaseCapricor Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate UpdateBD extracted 1 program update from this document → CAPR pipeline
- Aug 13, 20268-KCurrent report: results of operations · EX-99.1
- Aug 10, 2026ReleaseCapricor Therapeutics to Report Second Quarter 2026 Financial Results and Provide Recent Corporate Update on August 13
- Jul 30, 2026ReleaseCapricor Therapeutics Provides Update on FDA Advisory Committee Meeting for Deramiocel
- Jul 30, 20268-KCurrent report: other events · EX-99
- Jul 29, 2026ReleaseThe Lancet Publishes HOPE-3 Data for Capricor Therapeutics’ Deramiocel in Duchenne Muscular Dystrophy
- Jul 29, 20268-KCurrent report: other events · EX-99.1BD extracted 1 program update from this document → CAPR pipeline
- Jul 27, 2026ReleaseCapricor Comments on Briefing Materials Ahead of July 29 FDA Advisory Committee Meeting for DeramiocelBD extracted 1 program update from this document → CAPR pipeline
- Jul 14, 20268-KCurrent report: material agreement, debt / obligation
- Jun 26, 20268-KCurrent report: other events · EX-99.1
- Jun 8, 20268-KCurrent report: shareholder vote
- May 13, 202610-QQuarterly report
- May 12, 20268-KCurrent report: results of operations · EX-99.1
- May 7, 20268-KCurrent report: Reg FD disclosure, other events · EX-99.1
- Apr 10, 2026DEF 14AProxy statement
- Mar 17, 202610-KAnnual report
- Mar 12, 20268-KCurrent report: results of operations · EX-99.1
- Mar 10, 20268-KCurrent report: Reg FD disclosure, other events · EX-99.1
8 more filings (13G holder notices, S-8, proxy material, SEC correspondence …)
- Oct 14, 2026SCHEDULE 13G/A13G amendmentMillennium Management (Israel Englander's firm) disclosed 1,669,083 shares (2.9%) as of September 30 — a fourth specialist name on the register six weeks before the November 22 PDUFA, as CAPR sits 15% below the October 5 close.
- Sep 14, 2026SCHEDULE 13GPassive >5% holder (13G)Millennium Management (Izzy Englander's $70B+ multi-strat) just crossed 5.1% of CAPR with a September 8 event date — the third specialist institution to cross the 5% threshold, bringing disclosed specialist ownership to ~17% of the float with 10 weeks left to the November 22 PDUFA.
- Aug 19, 2026SCHEDULE 13GPassive >5% holder (13G)
- Aug 14, 2026SCHEDULE 13G/A13G amendment
- Aug 7, 2026SCHEDULE 13GPassive >5% holder (13G)
- Aug 3, 2026SCHEDULE 13GPassive >5% holder (13G)
- Apr 10, 2026ARSAnnual report to shareholders
- Mar 31, 2026PRE 14APRE 14A