CAPRICOR THERAPEUTICS, INC.
No SEC Form 4 filings for $CAPR in the last 30 days.
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.
Regulatory Recon roundup covers multiple items: FDA expands Pluvicto indication, AstraZeneca and Bristol Myers discuss a merger, Michigan Supreme Court allows review of Lilly insulin pricing, Amgen reports a data breach, and Curium plans up to an $8 billion deal for Lantheus. It also notes other biopharma, medtech, and legal updates.
Business of San Diego cites Carta data saying San Diego ranks 7th nationally for venture capital financings this year. It lists AI startups emerging from stealth, and notes four local firms that went public in 2026, including Solv Energy, Aevex Aerospace, Atrium, and Suja Juice, raising over $1.5B. It also covers deals such as Crinetics Pharmaceuticals to be acquired by Vertex for $10B and Qualcomm buying Modular for $3.9B.
Over the past 7 days, alphai's AI scored 2 news stories mentioning CAPR (CAPRICOR THERAPEUTICS, INC.). Coverage has skewed bearish: 0 bullish, 0 neutral, and 2 bearish.
Recent CAPR coverage spans regulation, financial news and market movers.
Regulatory denial risk is the dominant near-term driver, with added overhang from the company’s legal dispute with NS Pharma.
A negative adcomm plus potential legal action can increase uncertainty and delay timelines, weighing on CAPR sentiment.
FDA complete response letter increases regulatory uncertainty and can delay commercialization and future financing needs.
Deramiocel’s FDA review enters a near-term decision window, supported by phase 2/3 program references and an advisory committee meeting.
Negative FDA advisory vote increases regulatory uncertainty and can pressure near-term valuation and financing expectations.
alphai scores every news story that mentions CAPR with an AI model for sentiment and relevance, and aggregates insider trades from CAPRICOR THERAPEUTICS, INC.'s SEC EDGAR Form 4 filings. Figures refresh continuously.
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.
4 min readRegulatory Recon roundup covers multiple items: FDA expands Pluvicto indication, AstraZeneca and Bristol Myers discuss a merger, Michigan Supreme Court allows review of Lilly insulin pricing, Amgen reports a data breach, and Curium plans up to an $8 billion deal for Lantheus. It also notes other biopharma, medtech, and legal updates.
3 min readBusiness of San Diego cites Carta data saying San Diego ranks 7th nationally for venture capital financings this year. It lists AI startups emerging from stealth, and notes four local firms that went public in 2026, including Solv Energy, Aevex Aerospace, Atrium, and Suja Juice, raising over $1.5B. It also covers deals such as Crinetics Pharmaceuticals to be acquired by Vertex for $10B and Qualcomm buying Modular for $3.9B.
4 min readThe FDA’s August 2026 Prescription Drug User Fee Act calendar includes target action dates for multiple investigational drugs and therapies. Moderna’s mRNA-1010 has an Aug 5, 2026 PDUFA date. Gilead’s bictegravir/lenacapavir has Aug 27. Lantheus’ MK-6240 has Aug 13. Other listed PDUFA dates cover programs from Capricor, BMS, Jazz, Savara, Ultragenyx, PharmaEssentia, Regeneron, Takeda, and Priovant.
4 min readCapricor 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.
1 min readCapricor 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.
4 min readCapricor 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.
4 min readAnalysts issued multiple rating changes. Humana (HUM) was upgraded by Leerink to Outperform with a $513 target and by Piper Sandler to Overweight with a $463 target. Bloom Energy (BE), Sprouts (SFM), uniQure (QURE), and Core Scientific (CORZ) also saw upgrades. Las Vegas Sands (LVS) was downgraded to Hold by Argus. Other actions included P&G (PG), SiteOne (SITE), Capricor (CAPR), and Fannie Mae (FNMA).
3 min readAn 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.
2 min readU.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.
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