https://seekingalpha.com/article/440389 ... transcript
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The application comes after the drug showed statistically significant and clinically meaningful improvements in sleep duration and patient-perceived sleep quantity and quality in the phase 3 registration program.
Subject to the US Food and Drug Administration's approval, the biotech company expects to launch the drug in the US in the first half of 2022.
The company's shares rose about 1% at the end of trading on Tuesday.
They did it!!!! Ponvory goedgekeurd door FDA!!! 8% royalties!!!!
Idorsia Ltd (SIX: IDIA) was informed by the Janssen Pharmaceutical Companies of Johnson & Johnson that the European Commission (EC) has approved Ponvory™▼(ponesimod) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.
Idorsia and Actelion Pharmaceuticals Ltd, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, have entered into a revenue-sharing agreement in respect to ponesimod. Under the terms of the revenue-sharing agreement, Idorsia is entitled to receive quarterly payments of 8% of the net sales of ponesimod products from Actelion.