Investigation into Atkore and Others by Johnson Fistel
- Shareholder Investigation: Johnson Fistel, PLLP is investigating whether executives at Atkore Inc. and others breached their fiduciary duties, allowing shareholders who held shares continuously since specific dates to seek corporate governance reforms.
- Antitrust Allegations: Atkore is accused in a lawsuit of colluding with other PVC pipe manufacturers to engage in price-fixing, which artificially inflated prices and led to a significant decline in pricing once exposed, severely impacting the company's operations.
- Lack of Transparency at Axsome: Axsome Therapeutics faces allegations of failing to disclose critical chemistry and manufacturing issues during the preparation of its New Drug Application, potentially jeopardizing its market prospects and investor confidence.
- CTO's Financial Misrepresentation: CTO Realty Growth is accused of misleading investors about the sustainability of its dividends and using deceptive practices to inflate its financial performance, undermining investor trust in the company's future prospects.
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- FDA Decision Approaches: Capricor is awaiting an FDA decision on its DMD treatment Deramiocel, expected by August 22, which will directly impact the company's market performance and investor confidence.
- Clinical Data Support: The resubmission included results from the Hope-3 trial, showing a 54% slower deterioration in upper-limb function and a 91% slowing of cardiac disease progression, providing strong statistical support for the drug's approval.
- Executive Transition Impact: Former VP Houman Hemmati is being considered for the FDA's Center for Biologics Evaluation and Research, which could improve approval prospects for Capricor and other biotech firms, as reflected by a 1% rise in stock price during premarket trading.
- Market Sentiment Shift: With Hemmati's potential appointment, retail sentiment for Capricor shifted from 'bearish' to 'bullish', with expectations that the stock could exceed $75 upon approval, indicating a positive outlook for the company's future.
- FDA Review Resumed: The U.S. FDA has lifted the previously issued Complete Response Letter and resumed the review of the Biologics License Application for Deramiocel, with a decision expected by August 22, 2026, bringing renewed hope for Capricor's treatment prospects.
- Analyst Price Target Increases: B. Riley raised Capricor's price target from $50 to $63 while maintaining a ‘Buy’ rating, reflecting increased confidence in a smooth approval path for Deramiocel ahead of the decision date, with shares expected to rise.
- Positive Market Reaction: Despite Capricor reporting a wider-than-expected loss in its latest earnings call, leading to a 9% drop in shares, Roth Capital analysts view this pullback as a transient market correction and recommend buying, with a target price of $41.
- Strong Cash Position: Piper Sandler increased Capricor's price target from $45 to $58, noting the company ended 2025 with $318 million in cash to fund operations through 2027, indicating a solid financial foundation for future growth.
- Price Increase Announcement: Capricor Therapeutics has raised its target price from $50 to $63.
- Analyst Involvement: The price adjustment was made by analyst B. Riley, indicating a positive outlook for the company's stock.

CEO's Stance on Regulatory Approval: Linda Marban, CEO of Capricor Therapeutics, dismissed concerns regarding the conditional FDA approval for their therapy, Deramciclus, emphasizing that the trial met both primary and key secondary endpoints.
Financial Performance: Capricor reported a wider-than-expected Q4 loss of $0.62 per share with no revenue, but ended 2025 with approximately $318.1 million in cash, which will support operations into late 2027.
Launch Preparations: The company is preparing for a potential commercial launch of Deramciclus, having completed FDA pre-license inspections and planning to stockpile doses once labeling discussions are finalized.
Positive Clinical Data: Recent Phase 3 trial results showed significant improvements in upper limb function and cardiac health for patients with Duchenne muscular dystrophy, leading to increased physician interest and inquiries about the therapy.
- FDA Review Progress: Capricor's biologics license application for Deramiocel has been accepted by the FDA, with a target decision date set for August 22, 2026, marking a significant milestone in the treatment of Duchenne muscular dystrophy, and if approved, it will be the first therapy addressing both skeletal and cardiac manifestations.
- Clinical Trial Results: The HOPE-3 pivotal Phase III trial demonstrated a 91% slowing of disease progression in all evaluable patients, not only validating the efficacy of Deramiocel but also laying a solid foundation for future market launch, enhancing the company's position in the competitive biopharmaceutical landscape.
- Strong Financial Position: As of December 31, 2025, Capricor reported cash and cash equivalents totaling approximately $318.1 million, which is expected to support operations into the fourth quarter of 2027, showcasing robust financial resilience and growth potential.
- Commercial Readiness and Expansion: The company is actively advancing commercial preparations for Deramiocel, including market access and patient support plans, while also planning to expand manufacturing capacity by late 2027 to meet anticipated market demand, further strengthening its competitive edge.









