Company Product Description Indication Status
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

Notes

For more information about individual companies and/or products, see Cortellis.

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