BARDA Exercises First Contract Option With Marinus Pharma For Its Epilepsy Candidate

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.