Company Product Description Indication Status
Albireo Pharma Inc., of Boston Odevixibat Bile acid modulator Biliary atresia FDA cleared the IND for a global pivotal study
Aprea Therapeutics Inc., of Boston APR-246 Small molecule targeting p53 Myelodysplastic syndromes FDA granted breakthrough therapy for use in combination with azacitidine in patients whose disease is susceptible to the TP53 mutation
Astellas Pharma Inc., of Tokyo, and Fibrogen Inc., of San Francisco Evrenzo (roxadustat) Oral inhibitor of hypoxia-inducible factor prolyl hydroxylase Anemia associated with chronic kidney disease  Submitted supplemental NDA to Japan’s Ministry of Health, Labour and Welfare for use in nondialysis-dependent patients 
F-star Therapeutics Ltd., of Cambridge, U.K. FS-120 Tetravalent bispecific antibody targeting CD137 and OX40 Advanced malignancies FDA accepted IND for phase I study
Follicum AB, of Lund, Sweden FOL-005 Modified, short version of endogenous protein osteopontin Alopecia German Medicines Agency and German Ethics Committee cleared start of phase IIa trial of topical formulation of drug
Merakris Therapeutics LLC, of Research Triangle Park, N.C. Dermacyte liquid  Amniotic wound care liquid for subcutaneous infection Nonhealing venous stasis ulcers Filed a pre-IND meeting request with FDA
Proqr Therapeutics NV, of Leiden, the Netherlands QR-421a RNA-based oligonucleotide Retinitis pigmentosa FDA granted rare pediatric disease designation for RP caused by mutations in exon 13 of the USH2A gene
Pulmatrix Inc., of Lexington, Mass. PUR-1900 Inhaled itraconazole antifungal candidate Allergic bronchopulmonary aspergillosis in asthma patients FDA granted fast track designation
Vistagen Therapeutics Inc., of South San Francisco AV-101 Oral NMDAR glycine site antagonist Dyskinesia in Parkinson’s disease FDA cleared the IND for a phase II study


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

No Comments