— Selling, general and administrative expenses jumped by 65% year-over-year while research and development expenses fell by 25%.
— Looking ahead into fiscal 2020, the company still expects Firdapse net revenues to be in the range of $135-155 million.
— The company expects to report top-line results from the phase 3 trial for myasthenia gravis (MG) patients with autoantibodies to muscle-specific tyrosine kinase (MuSK) in the second quarter of 2020.
— Catalyst expects to report top-line results from the SMA Type 3 proof of concept trial in the second quarter of 2020. It predicts potential approval of New Drug Submission (NDS) for Firdapse to treat LEMS in Canada in the second half of 2020.
— Assuming the MuSK-MG trial is successful, the company hopes to submit a supplemental NDA for Firdapse for MuSK-MG around the end of 2020.
— In the face of the coronavirus Covid-19 outbreak, the company has been asked to provide a continuous uninterrupted supply of Firdapse. As of today, Catalyst has more than an adequate supply of Firdapse ready for shipment in the warehouse to meet patients’ needs through the end of this year.
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