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O MARINUS PHARMACEUTICALS NEWS RELEASE Marinus Pharmaceuticals Provides Business Update and Reports Third Quarter 2021 Financial Results 11/9/2021 ● European Medicines Agency has accepted the Marketing Authorization Application for ganaxolone in CDKL5 deficiency disorder for review under accelerated assessment • European Commission granted orphan drug designation to ganaxolone in tuberous sclerosis complex ; Phase 3 TrustTSC program on track to initiate patient enrollment Q1 2022 • Continued improvements in site activation for Phase 3 RAISE trial in refractory status epilepticus • Nine abstracts accepted for poster session presentations and virtual analyst and investor event planned for December 6 at American Epilepsy Society 2021 Annual Meeting • Received additional $ 30 million of funding under the existing Oaktree Capital Management , L.P. credit agreement RADNOR , Pa .-- ( BUSINESS WIRE ) -- Marinus Pharmaceuticals , Inc. ( Nasdaq : MRNS ) , a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders , today provided an update on its clinical and regulatory development activities and reported its financial results for the third quarter ended September 30 , 2021 . " The third quarter provided steady progress across the wide breadth of our clinical programs and commercialization planning efforts . Our goal is to have ganaxolone available commercially , both in the U.S. and Europe , by the middle of next year following regulatory approvals , " said Scott Braunstein , M.D. , Chief Executive Officer of Marinus Pharmaceuticals . “ We also made significant advancements on the regulatory and patent exclusivity front , continued to build our commercial leadership team and expanded our patient - centric advocacy framework . In addition , we have prioritized second generation ganaxolone with a goal of beginning Phase 1 clinical trials early next year . " 1