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idorsia Media Release April 22 , 2021 Idorsia announces financial results for the first quarter 2021 – substantial progress made across the pipeline – launch - preparations well underway Allschwil , Switzerland - April 22 , 2021 Idorsia Ltd ( SIX : IDIA ) today announced its financial results for the first quarter of 2021 . Business highlights Daridorexant new drug application ( NDA ) submitted to the US FDA in January 2021 and has been accepted for review Daridorexant marketing authorisation application ( MAA ) submitted to the European Medicines Agency ( EMA ) in March 2021 Daridorexant MAA submitted to Switzerland's health authority , Swissmedic , in April 2021 Daridorexant Phase 3 program has concluded - supporting the chronic use of daridorexant in insomnia Ponesimod to treat relapsing forms of multiple sclerosis was approved by the US FDA and a positive CHMP opinion was received in March 2021 , Idorsia has a revenue - sharing agreement in respect to ponesimod Clazosentan NDA submitted to the Japanese Pharmaceuticals and Medical Devices Agency ( PMDA ) in March 2021 MODIFY Phase 3 study with lucerastat for Fabry disease fully recruited , results expected in Q4 2021 PRECISION Phase 3 study with aprocitentan for resistant hypertension fully recruited , results expected mid - 2022 Recruitment of patients into the CARE Phase 2b study with cenerimod for systemic lupus erythematosus completed , results expected in Q4 2021 Recruitment commenced into Phase 2 study with ACT - 539313 for binge eating disorder in March 2021 Financial highlights US GAAP operating expenses in Q1 2021 at CHF 129 million Non - GAAP operating expenses in Q1 2021 at CHF 121 million Guidance for 2021 : US GAAP operating expenses below CHF 685 million and non - GAAP operating expenses below CHF 640 million ( both measures include inventory build of around CHF 35 million and exclude unforeseen events ) . Jean - Paul Clozel , MD and Chief Executive Officer , commented : " This first quarter of 2021 is loaded with important progress and milestones ; we submitted the marketing registration dossiers for daridorexant to both the FDA , and the EMA and for clazosentan in Japan , and now in April the MAA submission for daridorexant to Switzerland's Swissmedic has also occurred . J & J received the marketing approval for ponesimod in the US and a positive CHMP opinion in the EU which represents patients being able to benefit from a drug discovered by our scientists and the first revenues for Idorsia . We also completed the recruitment of patients into the pivotal trials for lucerastat and aprocitentan , as well as the large Phase 2b study with cenerimod . We are all getting