Capricor sues Nippon Shinyaku over failed Deramiocel launch preparations; seeks agreement rescission

CAPRICOR THERAPEUTICS, INC.

Filing of complaint in NJ Superior Court alleges fundamental pricing flaw in distribution agreement making Deramiocel commercially unviable under Medicare.
Distributor accused of failing to complete gross-to-net model, mock launch, or obtain required sub-distributor consents for Capricor's cell therapy.
Pricing structure renders Deramiocel economically impracticable for Medicare, Medicaid, and private insurance patients, per complaint.
Capricor seeks rescission of distribution agreement, declaratory judgment, and preliminary injunction ahead of PDUFA date of August 22, 2026.
FDA Priority Review for Deramiocel remains on track; Capricor states it is building commercial readiness independently.

item 7.01 item 8.01 item 9.01

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form_type: 8-K
ticker: CAPR
cik: 0001133869
company_name: CAPRICOR THERAPEUTICS, INC.
filed_at: 2026-05-07T23:59:59+00:00
discovered_at: 2026-05-14T18:02:31.995707+00:00
generated_at: 2026-05-14T21:24:33.384416+00:00
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