|Appili Therapeutics Inc., of Halifax, Nova Scotia||Favipiravir||Broad-spectrum antiviral||Mild to moderate COVID-19||Submitted an IND to the FDA for a phase III study in 826 patients; study expected to launch in Fall of 2020|
|Immupharma plc, of London, and Avion Pharmaceuticals LLC, of Atlanta||Lupuzor (forigerimod)||Modulates activation of autoreactive T cells||Lupus||FDA has not responded to the submission of a special protocol assessment more than 45 days after submission due to current workload at the agency|
|Junshi Biosciences Co. Ltd., of Shanghai||Toripalimab||Monoclonal antibody targeting PD-1||Nasopharyngeal carcinoma||FDA granted breakthrough therapy designation|
|Seres Therapeutics Inc., of Cambridge, Mass.||SER-109||Firmicute bacteria in spore form||Recurrent C. difficile infection||FDA reaffirmed prior guidance of efficacy requirements to support a BLA and guidance that at least 300 patients will be required for the safety database|
|Sol-Gel Technologies Ltd., of Ness Ziona, Israel||Epsolay (benzoyl peroxide)||Microencapsulated benzoyl peroxide cream||Inflammatory lesions of rosacea||FDA accepted the NDA; PDUFA action date is April 26, 2021|
For more information about individual companies and/or products, see Cortellis.