Krasney Karen sold $27K of CAPR

Capricor Therapeutics (CAPR) fell 36% to a 52-week low after an FDA advisory committee voted 9-3 against recommending Deramiocel approval, citing clinical evidence concerns. JonesResearch downgraded CAPR to Hold. LKQ dropped 14% to a six-year low after Q2 revenue and EPS missed estimates and guidance was cut. Paramount Skydance (PSKY) slid 2% on ongoing legal issues around its Warner Bros. Discovery deal.

Capricor Therapeutics (CAPR) shares fell about 54% after an FDA Cellular, Tissue and Gene Therapies Advisory Committee voted that available evidence did not support Deramiocel’s effectiveness for cardiomyopathy in Duchenne muscular dystrophy. The stock was around $3.03 on Thursday, down from $6.57 the prior close on Nasdaq.

Capricor Therapeutics (NASDAQ: CAPR) said the FDA Cellular, Tissue and Gene Therapies Advisory Committee voted 3-9 (0 abstain) that available evidence does not support Deramiocel’s effectiveness for cardiomyopathy in Duchenne muscular dystrophy. The vote is non-binding and focused on a narrower indication than Capricor proposed. Capricor targets an Aug. 22, 2026 PDUFA action date.

Capricor Therapeutics’ Deramiocel for Duchenne muscular dystrophy fell after an FDA advisory panel voted 9-3 that the company did not provide sufficient evidence of effectiveness. FDA staff cited lack of substantial evidence from Study HOPE-3 and no significant differences vs placebo in HOPE-2. Capricor noted The Lancet published HOPE-3 results. Shares were down 52.36% to $3.13.

An FDA advisory panel voted 9-3 against effectiveness data for Capricor Therapeutics’ Duchenne muscular dystrophy treatment, according to STAT. The panel focused on whether it could treat Duchenne-related cardiomyopathy. The FDA previously declined approval and requested more data, and during the meeting criticized changes to the study’s statistical analysis plan.

U.S. stock index futures rose as Microsoft rallied after a fiscal Q4 2026 earnings beat, with revenue of $90.01B (+18% YoY) and non-GAAP EPS of $4.74. Quanta Services and Huntington Ingalls also gained on better-than-expected results and contract updates. Meta fell after earnings; other movers included Check Point, Capricor, Align, Hyatt, Sirius XM, Trinity, and ImmunityBio.