Contradictions Unveiled: Insights from the Latest Deramiocel Earnings Call on Launch Timelines, AdCom Expectations, and Manufacturing Readiness
Earnings DecryptTuesday, May 20, 2025 12:28 pm ET
2min read
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BLA Progress and FDA Interactions:
- has filed a Biologics License Application (BLA) seeking full approval for deramiocel in treating Duchenne muscular dystrophy cardiomyopathy.
- The company is preparing for an FDA advisory committee meeting, considered positive as it provides an opportunity to highlight the strength of their data and supports the potential approval of deramiocel.
Financial Performance:
- reported $0 in revenues for Q1 2025 due to the full recognition of the U.S. distribution agreement with Nippon Shinyaku, which totaled $40 million in 2024.
- Research and development expenses for Q1 2025 were $16.2 million, excluding stock compensation, compared to $10.1 million in Q1 2024.
Manufacturing Expansion:
- Capricor's San Diego GMP manufacturing facility is fully operational and currently producing doses of deramiocel.
- Expansion plans are underway to build additional clean rooms, with the expansion expected to be operational by mid-to-late 2026 to bolster supply.
Executive Appointments and Partnerships:
- Capricor Therapeutics appointed Michael Binks as Chief Medical Officer, with over 25 years of experience in leading global clinical development.
- The company is working with Nippon Shinyaku for potential European distribution and has extended negotiations through the end of Q2 2025.
BLA Progress and FDA Interactions:
- has filed a Biologics License Application (BLA) seeking full approval for deramiocel in treating Duchenne muscular dystrophy cardiomyopathy.
- The company is preparing for an FDA advisory committee meeting, considered positive as it provides an opportunity to highlight the strength of their data and supports the potential approval of deramiocel.
Financial Performance:
- reported $0 in revenues for Q1 2025 due to the full recognition of the U.S. distribution agreement with Nippon Shinyaku, which totaled $40 million in 2024.
- Research and development expenses for Q1 2025 were $16.2 million, excluding stock compensation, compared to $10.1 million in Q1 2024.
Manufacturing Expansion:
- Capricor's San Diego GMP manufacturing facility is fully operational and currently producing doses of deramiocel.
- Expansion plans are underway to build additional clean rooms, with the expansion expected to be operational by mid-to-late 2026 to bolster supply.
Executive Appointments and Partnerships:
- Capricor Therapeutics appointed Michael Binks as Chief Medical Officer, with over 25 years of experience in leading global clinical development.
- The company is working with Nippon Shinyaku for potential European distribution and has extended negotiations through the end of Q2 2025.
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