- Marinus Pharmaceuticals Inc MRNS announced that the Biomedical Advanced Research and Development Authority (BARDA) exercised its first contract option, valued at approximately $12.3 million, to support U.S. onshoring of the manufacturing capabilities for ganaxolone active pharmaceutical ingredient (API).
- This contract option was exercised under Marinus' ongoing cost-share contract with BARDA awarded in 2020 to support the development of intravenous (IV) ganaxolone for refractory status epilepticus (RSE).
- Total potential BARDA funding under the contract if all options are exercised is approximately $51 million.
- Related: Marinus Pharma Delays Status Epilepticus, IV Ganaxolone Clinical Trials Into 2023.
- In addition to enabling a second, domestically sourced manufacturing capability for ganaxolone API, the onshoring initiative has the potential to drive a greater than 30% reduction in API supply cost.
- Marinus has an ongoing Phase 3 clinical trial in RSE (the RAISE trial) and a complementary planned Phase 3 RSE trial for European registration (RAISE II) expected to begin in the second half of 2023.
- Topline results for the RAISE trial are expected in the second half of 2023.
- Ganaxolone development in the RAISE trial is partly funded with federal funds under the BARDA contract.
- Price Action: MRNS shares are down 3.00% at $6.47 on the last check Thursday.
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