Company Product Description Indication Status
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia NP-120 (ifenprodil) NMDA receptor antagonist Acute lung injury, including COVID-19 Received feedback from FDA regarding plans to reformulate repurposed drug into intravenous product suited for hospital and ICU use; agency advised that single animal 30-day study would be acceptable for toxicology program
Athersys Inc., of Cleveland Multistem Cell therapy Severe traumatic injury FDA authorized IND for phase II study for early treatment of traumatic injuries and the subsequent complications that result following severe trauma
Forma Therapeutics Inc., of Watertown, Mass. FT-4202 Activator of pyruvate kinase-R Sickle cell disease FDA granted orphan designation
Gensight Biologics SA, of Paris Lumevoq (GS-010; lenadogene nolparvovec) Gene therapy Leber hereditary optic neuropathy Completed pre-submission meeting with EMA; confirmed intention to submit MAA in September 2020
Harbour Biomed Therapeutics Ltd., of Cambridge, Mass. NBM-9161 Antibody targeting neonatal Fc receptor Immune thrombocytopenia Received IND approval from China’s NMPA to begin phase II/III trial in adults; approval provides accelerated development pathway, allowing phase III to proceed directly following phase II
Humanigen Inc., of Burlingame, Calif. Lenzilumab Anti-human GM-CSF monoclonal antibody COVID-19 FDA cleared start of phase III trial testing drug for prevention of respiratory failure and/or death in hospitalized patients with pneumonia associated with SARS-CoV-2 infection
Pfenex Inc., of San Diego PF-708 Therapeutic equivalent candidate to Forteo (teriparatide injection) Osteoporosis FDA said additional comparative use human factors data, specifically from Forteo-experienced users, would be required before therapeutic equivalence could be determined
Remegen Ltd., of Yantai, China RC-18 Recombinant transmembrane activator, calcium modulator and cyclophil ligand interactor fusion protein Systemic lupus erythematosus FDA granted fast track designation
Sinovac Biotech Ltd., of Beijing Vaccine Inactivated SARS-CoV-2 vaccine COVID-19 Obtained approval to conduct human clinical trial in China
Tetra Bio-Pharma Inc., of Ottawa PPP-003 Activates type 2 cannabinoid receptor Prevention of proliferative vitreoretinopathy FDA granted orphan designation
Urogen Pharma Inc., of Princeton, N.J. Jelmyto (mitomycin gel) Alkylating drug Low-grade upper tract urothelial cancer  Approved by FDA under priority review

Notes

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

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