Capricor Therapeutics reported zero revenue for the third quarter of 2026, missing expectations as the company remains in a pre-commercial phase. Net loss widened to $42.7 million, or $0.73 per share, compared to a loss of $24.6 million in the prior year period, reflecting a significant ramp in manufacturing scale-up and pre-launch activities.
Key Highlights
- FDA PDUFA target action date for deramiocel in DMD is set for November 22, 2026, following a major BLA amendment that extended the review.
- Two-year HOPE-3 OLE data showed a 76% slower decline in upper limb function for patients switching from placebo to deramiocel.
- Cash and marketable securities decreased to $198.5 million from $318.1 million at the end of 2025, prompting a 10% workforce reduction in the third quarter.
- Ongoing contractual dispute with Nippon Shinyaku/NS Pharma remains active with an arbitration hearing scheduled for mid-2027.