CAPRICOR THERAPEUTICS, INC.
No SEC Form 4 filings for $CAPR in the last 30 days.
See all $CAPR insider activity →Capricor Therapeutics (CAPR) reported Q2 2026 results and said the FDA is reviewing its Deramiocel BLA for Duchenne muscular dystrophy. On July 29, 2026 an FDA advisory panel voted 3-9 against evidence of effectiveness for DMD cardiomyopathy. FDA also conducted a BIMO inspection. Cash was $238M; net loss $40.7M. CAPR traded up in pre-market.
US stock index futures edged higher after the S&P 500 and Nasdaq 100 hit record levels. Tech and AI-related shares led, with Sandisk up in premarket after JPMorgan’s overweight rating. Reuters said the BOJ is considering a September rate hike. Several single-stock moves followed earnings, guidance, tariffs, and analyst actions, including AVAV, AEHR, SPRY, CAPR, NU, RDDT, and GLOB.
Capricor Therapeutics (CAPR) shares rose 115% in pre-open after the company said the FDA is willing to accept an amendment to its deramiocel biologics license application, using 24-month HOPE-3 open-label extension data. The FDA would extend the PDUFA action date after filing. Cantor Fitzgerald upgraded CAPR to Overweight, lifting its target to $28 from $3.50; Q2 loss was $0.70/share vs $0.58 est., with no revenue.
Over the past 7 days, alphai's AI scored 7 news stories mentioning CAPR (CAPRICOR THERAPEUTICS, INC.). Coverage has skewed bullish: 4 bullish, 1 neutral, and 2 bearish.
Recent CAPR coverage spans market movers, regulation and financial news.
Regulatory review uncertainty is the dominant driver, with pre-market pricing implying a high probability of approval or a favorable FDA path despite the panel vote.
FDA willingness to review an amendment is a high-impact regulatory pathway catalyst, supporting a sharp repricing.
Regulatory path appears to have improved materially, driving a sharp pre-open reversal despite a Q2 revenue miss.
FDA openness to a revised deramiocel application is a near-term binary catalyst, likely supporting momentum and raising probability of a refined indication.
Upgrade and target hike are a fresh, catalyst-driven setup for CAPR, likely sustaining momentum into the open.
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) reported Q2 2026 results and said the FDA is reviewing its Deramiocel BLA for Duchenne muscular dystrophy. On July 29, 2026 an FDA advisory panel voted 3-9 against evidence of effectiveness for DMD cardiomyopathy. FDA also conducted a BIMO inspection. Cash was $238M; net loss $40.7M. CAPR traded up in pre-market.
5 min readUS stock index futures edged higher after the S&P 500 and Nasdaq 100 hit record levels. Tech and AI-related shares led, with Sandisk up in premarket after JPMorgan’s overweight rating. Reuters said the BOJ is considering a September rate hike. Several single-stock moves followed earnings, guidance, tariffs, and analyst actions, including AVAV, AEHR, SPRY, CAPR, NU, RDDT, and GLOB.
7 min readCapricor Therapeutics (CAPR) shares rose 115% in pre-open after the company said the FDA is willing to accept an amendment to its deramiocel biologics license application, using 24-month HOPE-3 open-label extension data. The FDA would extend the PDUFA action date after filing. Cantor Fitzgerald upgraded CAPR to Overweight, lifting its target to $28 from $3.50; Q2 loss was $0.70/share vs $0.58 est., with no revenue.
4 min readCapricor Therapeutics shares rose over 60% after CEO Linda Marbán said the FDA is willing to review an amended deramiocel submission for Duchenne muscular dystrophy, with an Aug. 22 decision deadline. Cytokinetics sued Bristol Myers Squibb over patents tied to Myqorzo. Valneva gained after EMA accepted a Pfizer vaccine application. Other updates covered funding, licensing, and drug availability.
4 min readU.S. stock futures paused after the S&P 500 hit a record close, with softer July PPI easing near-term Fed rate-hike fears. Retail sales are set for Friday. Capricor (CAPR) surged after Cantor Fitzgerald upgraded it to Overweight and raised its target to $28. Other movers include AMAT, SNDK, WDAY, CRM, and SPCX.
7 min readCAPRICOR THERAPEUTICS, INC. (CAPR) filed an SEC Form 8-K — Results of Operations and Financial Condition. EX-99.1 2 capr-20260813xex99d1.htm EX-99.1 Exhibit 99.1 Capricor Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update ● Deramiocel Biologics License Application (BLA) under active FDA review ● HOPE-3 Phase 3 results published in The Lancet; pri
6 min readBleichmar Fonti & Auld LLP said a class action lawsuit was filed against Capricor Therapeutics (NASDAQ:CAPR) and executives for alleged securities fraud tied to Deramiocel and its BLA data. The complaint cites a July 27, 2026 64.5% stock drop and alleges undisclosed statistical analysis plan changes before FDA resubmission. Lead plaintiff deadline is Sept. 28, 2026.
4 min readJohnson & Johnson and Sail Biomedicines agreed to develop in vivo CAR T therapies. J&J will pay $785 million upfront, including a $465 million equity investment, with $140 million more for milestones, and has an option to acquire Sail for $2.58 billion. Separately, an FDA advisory committee voted 3-9 against deramiocel for Duchenne cardiomyopathy.
6 min readCapricor 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.
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