Biotech Stocks Soar in After-Hours Trading: CAPR and TMDX Top the List Following Trial News and Earnings Boost
Biotech Stocks Surge: Several biotech and medical technology stocks experienced significant gains in after-hours trading, driven by earnings optimism, clinical trial progress, and speculative positioning, with notable movers including Seres Therapeutics and TransMedics.
Key Developments: TransMedics received FDA approval for its heart trial, while Capricor announced a milestone in its vaccine trial. Other companies like Karyopharm and Coya Therapeutics saw stock rebounds despite lacking specific news catalysts, indicating investor anticipation for future developments.
Market Volatility: Stocks such as Meihua International and Jin Medical showed notable price movements without specific news, reflecting technical rebounds and investor positioning in a volatile market environment.
Earnings Reports and Guidance: TransMedics raised its revenue guidance for 2025, projecting significant growth, while other companies are preparing for upcoming earnings reports and trial milestones, contributing to the overall market momentum in the biotech sector.
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Capricor (CAPR) Plans February FDA Data Submission After 2% Stock Drop
- FDA Data Request: Capricor Therapeutics announced that the FDA has requested the full HOPE-3 clinical study report without asking for additional clinical studies or new patient data, providing the company an opportunity to advance its application.
- Clinical Trial Progress: Although the FDA rejected the Deramiocel application in July due to insufficient evidence of effectiveness, the results from the December HOPE-3 study indicated significant improvements in muscle and heart function, which may help meet the FDA's requirements.
- Future Plans: Capricor plans to submit the requested data to the FDA in February, expecting that this will support the continued review of its application and address the concerns raised by the FDA in July, aiming to provide faster treatment options for late-stage DMD patients.
- Market Reaction: Despite a 2% drop in Capricor's stock on Tuesday morning, the stock has gained 69% over the past 12 months, reflecting some market optimism regarding the approval of Deramiocel, although overall retail sentiment remains bearish.

Capricor Therapeutics Achieves Phase 3 Trial Success for DMD Therapy, Stock Soars 439.4%
- Phase 3 Trial Success: Capricor Therapeutics' Deramiocel met its primary and secondary endpoints in the Phase 3 HOPE-3 trial, significantly slowing upper limb functional decline by 54% and left ventricular ejection fraction decline by 91%, offering hope for DMD patients.
- Future Outlook: With FDA approval anticipated in 2026, Deramiocel could generate up to $1.5 billion in milestone payments, indicating the substantial market value of this therapy.
- Successful Financing: Following the announcement, the company raised $150 million in a public offering, providing crucial funding for further research and market launch, thereby boosting investor confidence.
- Market Potential: With approximately 200,000 global DMD patients, Capricor's commercialization agreement with Nippon Shinyaku highlights its strategic positioning in the U.S., Japan, and European markets.






