Company Product Description Indication Status
Aeon Biopharma Inc., of Newport Beach, Calif. ABP-450 (prabotulinumtoxinA) Botulinum toxin complex Cervical dystonia FDA accepted IND to begin phase II testing
Cytodyn Inc., of Vancouver, Washington Leronlimab (PRO-140) CCR5 antagonist COVID-19 U.K. MHRA requested meeting Sept. 9, 2020, to discuss company’s request for fast track approval to treat patients with mild to moderate symptoms; on the suggestion of the MHRA, Cytodyn will submit its current phase III CD12 study for severe to critical COVID-19 patients in the U.K. to the Urgent Public Health Research scheme to receive possible financial support from the trial sites and government
Cytodyn Inc., of Vancouver, Washington Leronlimab (PRO-140) CCR5 antagonist HIV FDA advised the company it has scheduled a type A meeting Sept. 8, 2020, following receipt of written responses concerning the BLA seeking approval for leronlimab as a combination therapy for highly treatment-experienced HIV patients; agency clarified items it need primarily related to dosage levels
Innovent Biologics Inc., of San Francisco Sulinno (adalimumab) Biosimilar of Humira Rheumatoid arthritis, ankylosing spondylitis and psoriasis National Medical Products Administration of China approved the drug
Nippon Shinyaku Co. Ltd., of Kyoto, Japan  Viltepso (viltolarsen) Morpholino antisense oligonucleotide Duchenne muscular dystrophy FDA issued a priority review voucher for the approval of a rare pediatric disease product application

Notes

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