Company Product Description Indication Status
Ascentage Pharma Group International, of Suzhou, China APG-115 MDM2-p53 inhibitor Relapsed/refractory T-cell prolymphocytic leukemia China’s NMPA cleared a phase IIa study testing drug as single agent or in combination with Bcl-2 inhibitor APG-2575
Catalyst Biosciences Inc., of South San Francisco Marzeptacog alfa (MarzAA) Subcutaneously administered next-generation engineered coagulation factor VIIa Hemophilia A or B FDA granted fast track designation for use in episodic bleeding in subjects with inhibitors
Elusys Therapeutics Inc., of Parsippany, N.J. Obiltoxaximab Monoclonal antibody anthrax antitoxin Inhalation anthrax European Commission approved treatment for use in all age groups in combination with appropriate antibacterial drugs for inhalational anthrax due to Bacillus anthracis; and for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not available or not appropriate
Kempharm Inc., of Celebration, Fla. KP-415 Serdexmethylphenidate co-formulated with immediate-release d-methylphenidate Attention deficit hyperactivity disorder In late-cycle communication meeting with FDA Dec. 1, agency did not raise any substantive issues related to safety and efficacy at this point in review; re-affirmed PDUFA date of March 2, 2021
LG Chem Life Sciences, of Seoul, Korea, and division of LG Chem, and Transthera Biosciences Co. Ltd., of Nanjing, China TT-01025 SSAO/VAP-1 inhibitor Nonalcoholic steatohepatitis FDA cleared IND for phase I trial in healthy subjects, expected to start in first quarter of 2021
Mesoblast Ltd., of New York and Melbourne, Australia Remestemcel-L Culture-expanded mesenchymal stromal cells derived from bone marrow of unrelated donor COVID-19 FDA granted fast track designation for treatment of acute respiratory distress syndrome due to COVID-19 infection
Oyster Point Pharma Inc., of Princeton, N.J. OC-01 (varenicline) nasal spray Selective cholinergic agonist Neurotrophic keratitis Submitted protocol to FDA to start study in adults with NK; enrollment of first patient in phase II Olympia study planned for first half of 2021
Pfizer Inc., of New York, and Biontech SE, of Mainz, Germany BNT-162b2 mRNA vaccine COVID-19 U.K. MHRA granted temporary authorization for emergency use
Protagonist Therapeutics Inc., of Newark, Calif. PTG-300 Injectable synthetic peptide mimetic of natural hormone hepcidin Polycythemia vera FDA granted fast track designation
Regent Pacific Group Ltd., of Hong Kong, and Wanbang Pharmaceutical Marketing and Distribution Co. Ltd., a company of Fosun Pharmaceutical, of Shanghai Fortacin/Sendstend (lidocaine + prilocaine) Sodium channel inhibitor Premature ejaculation Wanbang received approval from China NMPA to submit IND for human trial
Telix Pharmaceuticals Ltd., of Melbourne, Australia TLX-592 Targets PSMA Advanced prostate cancer Received clearance from TGA to begin phase I study
Vanda Pharmaceuticals Inc., of Washington Hetlioz (tasimelteon) capsule and liquid formulations Melatonin MT1/MT2 receptor agonist Smith-Magenis syndrome FDA approved for use in adults and children with nighttime sleep disturbances associated with SMS


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