Company Product Description Indication Status
Adial Pharmaceuticals Inc., of Charlottesville, Va. AD-04 (repurposed ondansetron)
5-HT 3 receptor antagonist
Alcohol use disorder EMA accepted pediatric investigation plan and will not require additional trials for individuals ages 12 to 17
Cymabay Therapeutics Inc., of Newark, Calif. Seladelpar PPAR-delta agonist Nonalcoholic steatohepatitis; primary biliary cholangitis; primary sclerosing cholangitis  FDA lifted clinical hold on INDs; development to resume initially in PBC
Elsalys Biotech SAS, of Lyon, France, unit of Mediolanum Farmaceutici Spa, of Milan Leukotac (inolimomab) IL-2 receptor alpha subunit inhibitor Graft-vs.-host disease BLA submitted to FDA under Real-Time Oncology Review pilot program
Inotrem SA, of Paris Nangibotide TREM receptor 1 antagonist COVID-19 infection French, Belgian and U.S. regulators authorized phase IIa trial in about 60 critically ill people showing features of systemic inflammation; outcome measures include impact on severity of respiratory failure, duration of mechanical ventilation, ICU length of stay and mortality
Milestone Pharmaceuticals Inc., of Montreal Etripamil Calcium channel inhibitor Paroxysmal supraventricular tachycardia FDA agreed with plan to modify ongoing Node-301B (Rapid) study, including primary endpoint of time to conversion within 30 minutes, to complete pivotal program efficacy requirements for NDA filing; enrollment expected to reopen by year-end, with results expected by early 2022
Neumentum Inc., of Palo Alto, Calif. NTM-006 Non-opioid, non-NSAID analgesic Neuropathic and moderate to severe chronic pain Type C meeting with FDA scheduled for October 2020 to discuss development pathway
Neumentum Inc., of Palo Alto, Calif. NTM-001 (pre-mixed bag ketorolac) Cyclooxygenase/oxidoreductase inhibitor Postsurgical pain Guidance letter from FDA authorized rapid phase III development, with pivotal post-bunionectomy efficacy study expected to begin after company's next equity financing
Vita Therapeutics Inc., of Baltimore VTA-110 Allogenic iPSC-based therapy Duchenne muscular dystrophy FDA granted orphan drug designation

Notes

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