Highest-materiality recent filing
FDA Advisory Committee set for July 29 to review Capricor's Deramiocel BLA; PDUFA date Aug 22
FDA CTGTAC Advisory Committee meeting scheduled for July 29, 2026, to discuss Capricor's Deramiocel BLA for Duchenne muscular dystrophy.
Capricor shareholders fail to approve officer exculpation amendment at annual meeting
All eight director nominees elected; Linda Marbán, Ph.D. re-elected with 25.5M votes for.
Capricor Q1 net loss $33.9M ($0.59/share); Deramiocel BLA PDUFA Aug 22, 2026
Net loss of $33.9M ($0.59/share) for Q1 2026 vs net loss of $24.4M ($0.53/share) in Q1 2025.
Capricor sues Nippon Shinyaku over failed Deramiocel launch preparations; seeks agreement rescission
Filing of complaint in NJ Superior Court alleges fundamental pricing flaw in distribution agreement making Deramiocel commercially unviable under Medicare.
Capricor FY2025 net loss $105M; Deramiocel PDUFA date Aug 22, 2026
Net loss of $30.2M in Q4 2025 ($0.62/sh) and $105.0M for FY2025 ($2.26/sh).
FDA lifts CRL for Deramiocel BLA; new PDUFA date August 22, 2026
FDA resumed review of Deramiocel BLA for Duchenne muscular dystrophy cardiomyopathy after lifting CRL.
Capricor Therapeutics prices $150M public offering of 6M shares at $25/sh
Offering 6,000,000 shares at $25.00 per share; expected gross proceeds ~$150M.
Primary endpoint PUL v2.0 met with 54% slowing of progression (p=0.029) in 105 evaluable patients.
Capricor provides HOPE-3 trial update via slide presentation, no new data disclosed
Filed Item 7.01 with slide presentation dated Dec 3, 2025 on HOPE-3 Phase 3 top-line results.
Capricor reports Q3 net loss $24.6M; HOPE-3 topline DMD data expected in Q4 2025
Net loss of $24.6M ($0.54/share) vs $12.6M ($0.38) in Q3 2024; operating expenses $26.3M, up 72%.
Capricor Q2 net loss $25.9M; FDA accepts all PLI observations; StealthX vaccine enters clinic
Net loss of $25.9M ($0.57 per share) for Q2 2025 vs $11.0M ($0.35) in Q2 2024; revenue $0 vs $4.0M.
FDA issued CRL stating BLA lacks substantial evidence of effectiveness; additional clinical data needed.
Capricor stockholders approve 2025 Equity Incentive Plan (3.5M shares plus 5% annual increase)
Stockholders approved 2025 Equity Incentive Plan (3.5M shares reserved) with ~54% of votes cast in favor (9.7M FOR, 8.2M AGAINST).
Capricor Q1 net loss $24.4M; deramiocel BLA PDUFA Aug 31, 2025
Net loss of $24.4M ($0.53/sh) vs $9.8M loss ($0.31/sh) in Q1 2024; revenue $0 vs $4.9M.
Director Earl Collier not standing for re-election at May 22, 2025 annual meeting
Earl Collier will not stand for re-election to the Board at the May 22, 2025 Annual Meeting.
Capricor Therapeutics reports Q4 net loss $7.1M, BLA for deramiocel accepted with PDUFA Aug 31, 2025
FDA accepted BLA for deramiocel to treat DMD cardiomyopathy; Priority Review, PDUFA date August 31, 2025.
FDA accepted BLA for deramiocel (cell therapy) to treat Duchenne muscular dystrophy cardiomyopathy.
Capricor submits BLA for deramiocel to FDA for DMD cardiomyopathy; receives $10M milestone
BLA for deramiocel (cell therapy) submitted to FDA for DMD cardiomyopathy on Jan 2, 2025.
Capricor reports Q3 net loss $12.6M; starts BLA for deramiocel, signs $715M European deal
Q3 net loss $12.6M ($0.38/sh) vs $6.4M ($0.25/sh); revenue $2.3M vs $6.2M.
Capricor Therapeutics prices ~$75M public offering of 4.4M shares at $17/sh
Gross proceeds ~$75M from 4,412,000 shares at $17.00/sh; underwriters have 30-day option for up to 661,800 additional shares.
Capricor files BLA for deramiocel in DMD cardiomyopathy; reports ~$85M cash as of Sept 30
BLA for deramiocel filed Oct 2024 seeking full approval for DMD cardiomyopathy; full submission by year-end 2024.
Capricor initiates rolling BLA submission to FDA for deramiocel in DMD cardiomyopathy
Rolling submission started Oct 9, 2024; plans to complete by end of 2024.
Plans to file BLA for deramiocel to treat DMD cardiomyopathy based on existing cardiac and natural history data; rolling submission begins Oct 2024 with full submission by year-end 2024.
Nippon Shinyaku to commercialize deramiocel in EU, UK and other European countries; Capricor receives double-digit revenue share.
Capricor Q2 2024: $11M loss, positive FDA pre-BLA meeting, DMD trial fully enrolled
Net loss $11.0M ($0.35/sh) in Q2 2024 vs $7.4M ($0.29) in Q2 2023; revenue $4.0M.
Amendment to increase authorized common shares from 50M to 100M approved (12.3M for, 8.7M against).
Capricor Therapeutics increases authorized common shares from 50M to 100M
Stockholders approved amendment at May 14, 2024 annual meeting.
Capricor Q1 net loss $9.8M; HOPE-3 Cohort A fully enrolled for Q4 data
Net loss $9.8M ($0.31/share) vs $7.8M loss prior year; revenue $4.9M from Nippon Shinyaku milestone.
Enrollment complete in HOPE-3 Phase 3 Cohort A (N=61); topline 12-month data expected Q4 2024.
Capricor reports Q4 net loss $0.8M; Phase 3 DMD trial on track for top-line data Q4 2024
Q4 2023 net loss $0.8M ($0.02/share) vs $7.7M ($0.31) in Q4 2022; revenue $12.1M from Nippon Shinyaku agreement.
Capricor receives $10M milestone from Nippon Shinyaku; HOPE-3 trial continues
Milestone payment of $10.0 million received from Nippon Shinyaku under 2022 commercialization agreement.
Positive interim futility analysis from DSMB; trial to continue as planned.
Capricor completes HOPE-3 enrollment; Q3 net loss $6.4M, cash $28.5M
Completed targeted enrollment for HOPE-3 Phase 3 trial of CAP-1002 in Duchenne muscular dystrophy; interim futility analysis expected Q4 2023.
Capricor announces positive FDA Type-B meeting confirming Phase 3 path to BLA for CAP-1002 in DMD
FDA aligned on HOPE-3 trial design; key endpoints unchanged; BLA submission targeted for 2025.
Capricor raises $23M in registered direct offering of stock and warrants
Gross proceeds ~$23M from 4,935,621 shares plus warrants at $4.66/unit.
Capricor Therapeutics appoints Michael Kelliher to Board of Directors
Michael Kelliher appointed to Board effective September 1, 2023; Board size increased from 8 to 9.
Capricor reports Q2 net loss $7.4M; HOPE-3 DMD trial on track for Q4 2023 interim analysis
Cash, equivalents & marketable securities $37.8M as of June 30, down from $41.4M Dec 31, 2022.
Capricor expands board to 8, appoints former Novartis BD executive Philip Gotwals
Board increased from 7 to 8 directors; Philip Gotwals, Ph.D. elected effective July 21, 2023.
Capricor board member Manzo resigns; appoints Paul Auwaerter, M.D. to board
Louis Manzo resigned from board effective July 11, 2023, with no disagreement over operations.
Capricor amends 8-K: officer exculpation proposal did not pass, correcting prior report
Proposal 4 (officer exculpation amendment) failed: 5,037,656 for, 1,816,404 against, 103,335 abstain, 9,390,464 broker non-votes.
Capricor files Certificate of Correction voiding amendment to exculpation provisions
Certificate of Correction filed June 15, 2023 voids the Certificate of Amendment filed June 13, 2023.
Seven director nominees elected: Litvack, Marbán, Musket, Dunbar, Manzo, Collier, Es Sabar (FOR votes 4.9M-5.9M; ~9.4M broker non-votes).
Capricor Therapeutics amends charter to extend officer exculpation under DGCL
Stockholders approved the amendment on June 12, 2023.
Capricor Q1 2023 net loss $7.8M; HOPE-3 DMD trial interim analysis on track for Q4 2023
Net loss $7.8M ($0.31 per share) flat YoY; revenue $3.0M from Nippon Shinyaku deal vs zero prior year.
Q4 2022 revenue $1.0M (Nippon Shinyaku upfront recognition) vs $0; net loss $7.7M vs $6.2M in Q4 2021.
Capricor partners with Nippon Shinyaku for CAP-1002 in Japan; $12M upfront, up to $89M milestones
Exclusive Japan commercialization and distribution agreement for CAP-1002 in Duchenne muscular dystrophy.
Capricor Q3 2022 net loss $6.4M, cash $46.6M; HOPE-3 enrollment on track
Revenue $1.6M from Nippon Shinyaku upfront recognition; net loss $0.26/shr vs $0.17/shr a year ago.
Capricor Q2 net loss $7.1M; CAP-1002 Phase 3 trial underway, cash $51.4M
Net loss $7.1M ($0.29/share) vs $4.7M ($0.21/share) in Q2 2021.
Capricor dosed first patient in Phase 3 HOPE-3 trial of CAP-1002 for Duchenne MD
First patient dosed in randomized, double-blind, placebo-controlled HOPE-3 trial enrolling ~70 patients in U.S.
Capricor provides top-line update from HOPE-2 open label extension trial
Capricor reported top-line results from HOPE-2 OLE (1-year data) via slide presentation on June 27, 2022.
On April 8, 2025, Mr. Earl Collier, a member of the Board of Directors (the “Board”) of Capricor Therapeutics, Inc., a Delaware corporation (the “Company”), informed the Board he will not stand for re-election to the Board following the Annual Meeting of Shareholders which is scheduled to occur on May 22, 2025.
On September 1, 2023, the Board of Directors (the “Board”) of Capricor Therapeutics, Inc. (the “Company”), pursuant to the authority given to it under the Certificate of Incorporation and Bylaws of the Company, approved an increase of the size of the Board from eight to nine directors, and thereafter elected Michael Kelliher as a member of the Board to fill the newly created vacancy, effective immediately.
approved an increase of the size of the Board from seven to eight directors, and elected Philip Gotwals, Ph.D. as a member of the Board to fill the newly created vacancy, effective immediately.
On July 11, 2023, Mr. Louis Manzo, a member of the Board of Directors (the “Board”) of Capricor Therapeutics, Inc., a Delaware corporation (the “Company”), resigned from the Board effective immediately.
On July 11, 2023, the Board elected Paul Auwaerter, M.D. as a member of the Board, effective immediately.
Max materiality 0.90 · Median 0.68 · Most common event earnings