Company Product Description Indication Status
Agios Pharmaceuticals Inc., of Cambridge, Mass. AG-946  Pyruvate kinase-R activator Hemolytic anemias FDA cleared the IND; company plans to start a phase I trial in healthy volunteers in mid-2020
Anheart Therapeutics Co. Ltd., of Hangzhou, China Taletrectinib  ROS1 and NTRK inhibitor Non-small-cell lung cancer  Chinese Center for Drug Evaluation cleared IND and issued clinical trial authorizations for 2 phase II trials in China in patients with ROS1 mutations and locally advanced or metastatic solid tumors with NTRK mutations
Arch Therapeutics Inc., of Framingham, Mass. AC5 topical gel Hemostatic agent Pressure sores, leg ulcers, diabetic ulcers, surgical wounds FDA cleared the marketing of the gel using an additional supplier and additional manufacturing processes
Biohaven Pharmaceutical Holding Co. Ltd., of New Haven, Conn. Vazegepant Calcitonin gene-related peptide receptor antagonist Acute migraine Following a successful end-of-phase-II interaction with the FDA, company plans to start a phase III study with the 10-mg dose
Bone Therapeutics SA, of Gosselies, Belgium Allob Allogeneic cell therapy Difficult tibial fractures Belgian regulatory authorities approved the clinical trial application
Bone Therapeutics SA, of Gosselies, Belgium JTA-004  Mix of plasma proteins, hyaluronic acid, a natural component of knee synovial fluid and a fast-acting analgesic Osteoarthritic knee pain Denmark regulatory authorities approved the clinical trial application
Can-Fite Biopharma Ltd., of Petach Tikva, Israel Piclidenoson   A3 adenosine receptor agonist  COVID-19 Submitted drug to the institutional review board at Rabin Medical Center for a compassionate use program
Eiger Biopharmaceuticals Inc., of Palo Alto, Calif. Lonafarnib  Farnesyltransferase inhibitor Progeria and progeroid laminopathies Submitted NDA to FDA
Eli Lilly and Co., of Indianapolis, and Boehringer Ingelheim GmbH, of Ingelheim, Germany Jardiance (empagliflozin) SGLT2 inhibitor Type 1 diabetes FDA issued a complete response letter
Genentech, of South San Francisco, a member of the Roche Group Actemra (tocilizumab) Interleukin-6 receptor antagonist COVID-19 pneumonia FDA approved a phase III trial testing the drug in combination with standard of care
Helsinn Healthcare SA, of Lugano, Switzerland Akynzeo (fosnetupitant/palonosetron) Netupitant prodrug Chemotherapy-induced nausea and vomiting European Commission approved the intravenous formulation of Akynzeo
Stoke Therapeutics Inc., of Bedford, Mass. STK-001 Antisense oligonucleotide to up-regulate NaV1.1 protein expression Dravet syndrome FDA confirmed company can start part A of its phase I/IIa Monarch study; the agency placed part B testing a higher dose of the drug on a partial clinical hold, pending additional preclinical toxicology data

Notes

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

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