Company Product Description Indication Status
Alzecure Pharma AB, of Stockholm ACD-856 NGF receptor modulator; TrkA receptor modulator; TrkB receptor modulator; brain-derived neurotrophic factor ligand modulator Alzheimer’s disease Received approval from regulatory authorities in Sweden to start phase I trial
Apollomics Inc., of Foster City, Calif. APL-102 Oral multikinase inhibitor  Advanced solid tumors China’s NMPA cleared IND for phase I study
Bavarian Nordic A/S, of Copenhagen, Denmark Imvamune Non-replicating smallpox vaccine Smallpox Health Canada expanded approval to include additional indications, specifically monkeypox and related orthopoxvirus infections and disease in adults 18 and older determined to be at high risk for exposure
Halozyme Therapeutics Inc., of San Diego, and Janssen Pharmaceutical Cos., part of New Brunswick, N.J.-based Johnson & Johnson Darzalex Faspro (daratumumab and hyaluronidase-fihj)  ADP ribosyl cyclase-1 inhibitor Relapsed/refractory multiple myeloma Janssen submitted regulatory applications to the FDA and EMA seeking approval for use in combination with pomalidomide and dexamethasone to treat patients who have received at least 1 prior line of therapy
Mycovia Pharmaceuticals Inc., of Durham, N.C. Oteseconazole (VT-1161) Lanosterol-14 demethylase inhibitor; oral antifungal Recurrent vulvovaginal candidiasis Completed pre-NDA meeting with FDA
Neonmind Biosciences Inc., a subsidiary of Better Plant Sciences Inc., of Vancouver, British Columbia Psilocybin  5-HT receptor agonist Weight loss Received Health Canada approval to advance its preclinical trial on psilocybin-based research
Valeo Pharma Inc., of Montreal Amikacin Antibiotic Infection Received notice of compliance from Health Canada granting marketing authorization 
Vasomune Therapeutics Inc., of Toronto AV-001 Tie2 tyrosine kinase receptor agonist COVID-19 FDA allowed the IND for clinical testing in hospitalized patients diagnosed with moderate to severe COVID-19

Notes

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