Company Product Description Indication Status
Bacainn Therapeutics Inc., of Concord, Mass. BT-051 Controls neutrophil migration into the lumen of the gastrointestinal tract Healthy volunteers (eventually ulcerative colitis) FDA cleared the IND for a phase I study testing the safety, tolerability and pharmacokinetics of the drug; data expected by the end of 2020
Curis Inc., of Lexington, Mass. CI-8993 Monoclonal antibody targeting VISTA Cancer FDA cleared the IND; phase Ia/Ib study to start in second half of 2020
F2G Ltd., of Manchester, U.K. Olorofim (formerly F-901318) Dihydroorotate dehydrogenase inhibitor Coccidioidomycosis and invasive aspergillosis, scedosporiosis, lomentosporiosis, fusariosis and disease due to scopulariopsis species FDA granted qualified infectious disease product designation
Fulcrum Therapeutics Inc., of Cambridge, Mass. Losmapimod  p38alpha/beta mitogen activated protein kinase inhibitor COVID-19  Submitted an IND to the FDA for a phase III study
Pharnext SA, of Paris PXT-3003 Fixed-dose combination of baclofen, naltrexone and sorbitol Charcot-Marie-Tooth type 1A FDA agreed with company that a single pivotal phase III study plus previous studies would be sufficient to support an NDA; primary endpoint will be Overall Neuropathy Limitations Scale
Redhill Biopharma Ltd., of Tel Aviv, Israel Yeliva (opaganib) Sphingosine kinase-2 inhibitor Hospitalized severe COVID-19 with pneumonia Submitted a CTA to the Ministry of Health of the Russian Federation for a phase II/III study
Rezolute Inc., of Redwood City, Calif. RZ-358 Monoclonal antibody targeting the insulin receptor Congenital hyperinsulinism FDA granted rare pediatric disease designation
Vertex Pharmaceuticals Inc., of Boston Kalydeco (ivacaftor) Cystic fibrosis transmembrane conductance regulator potentiator Cystic fibrosis European Commission granted approval of the label extension to include children 6 months and older with a R117H mutiation in CFTR

Notes

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

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