Company Product Description Indication Status
Allovir Inc., of Cambridge, Mass. ALVR-109 Allogeneic virus-specific T-cell therapy COVID-19 infection FDA cleared IND application for proof-of-concept trial, expected to begin in fourth quarter of 2020
Celltrion Group, of Incheon, South Korea CT-P59 COVID-19 Spike glycoprotein inhibitor COVID-19 infection Korea's MFDS cleared IND application for pivotal phase II/III trial in people with mild to moderate symptoms of infection; top-line data from phase II portion expected by year-end 2020
Chemocentryx Inc., of Mountain View, Calif. Avacopan Complement 5a receptor inhibitor Vasculitis FDA accepted NDA covering treatment of ANCA-associated disease, setting July 7, 2021, PDUFA date; agency did not issue determination on advisory committee meeting
Hutchison China Meditech Ltd. (Chi-Med), of Hong Kong Surufatinib Angio-immuno kinase inhibitor  Pancreatic neuroendocrine tumors China's NMPA accepted NDA covering treatment of advanced disease
Roche Holding AG, of Basel, Switzerland Risdiplam SMN2 gene modulator Spinal muscular atrophy U.K.’s MHRA issued positive opinion on early access to medicines scientific opinion for patients, 2 months and older with type 1 or type 2 SMA not suitable for authorized treatments
Sorrento Therapeutics Inc., of San Diego STI-1499 (COVI-GUARD) COVID-19 Spike glycoprotein inhibitor COVID-19 infection FDA cleared IND for phase I trial in people hospitalized with infection
Zynerba Pharmaceuticals Inc., of Devon, Pa. Zygel  Cannabidiol gel 22q11.2 deletion syndrome FDA granted orphan designation


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

No Comments