Company Product Description Indication Status
Alligator Bioscience AB, of Lund, Sweden Mitazalimab Monoclonal antibody targeting CD40 Metastatic pancreatic cancer Submitted a CTA to the relevant European regulatory authorities for the 66-patient Optimize phase II study testing mitazalimab in combination with the chemotherapy mFolfirinox; study expected to start in the first half of 2021
Altimmune Inc., of Gaithersburg, Md. AdCOVID Intranasal SARS-VoV-2 adenovirus vector vaccine COVID-19 infection FDA placed clinical hold on phase I IND, requesting protocol modifications and submission of additional CMC data, to which company agreed in written response; no significant impact on development timetable expected
Arctic Vision Biotechnology Co. Ltd., of Shanghai ARVN-001 (triamcinolone acetonide) Corticosteroid Uveitic macular edema China National Medical Products Administration cleared the IND for a phase III study
Audentes Therapeutics Inc., of San Francisco, a unit of Astellas Pharma Inc. AT-132 AAV8-delivered gene therapy X-linked myotubular myopathy FDA lifted the clinical hold on the phase I/II Aspiro study
Astrazeneca plc, Cambridge, U.K., and Merck & Co. Inc., of Kenilworth, N.J. Lynparza (olaparib) PARP inhibitor Ovarian, prostate and pancreatic cancer Japanese Ministry of Health, Labor and Welfare approved the 3 indications
Bristol Myers Squibb, of New York Zeposia (ozanimod) Sphingosine-1-phosphate receptor modulator Severely active ulcerative colitis EMA validated the MAA
Cara Therapeutics Inc., of Stamford, Conn. Korsuva (difelikefalin) KOR agonist Moderate-to-severe pruritus in hemodialysis patients Submitted NDA to the FDA with a request for a priority review
Innocare Pharma Ltd., of Beijing Orelabrutinib BTK inhibitor Relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma and relapsed/refractory mantle cell lymphoma China National Medical Products Administration approved the 2 indications
Innovent Biologics Inc., of Suzhou, China Byvsda Biosimilar to the anti-VEGF monoclonal antibody bevacizumab Recurrent glioblastoma China National Medical Products Administration approved the expanded indication
Inotrem SA, of Paris Nangibotide Formulation of TREM-1 inhibitor LR-12 COVID-19 infection French government steering committee for therapeutic clinical trials and other research designated ongoing phase IIa study in severe forms of infection as national priority research, allowing accelerated enrollment and activation of fast-track reviews and approval processes by French regulators
Janssen Biotech Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson Amivantamab Epidermal growth factor receptor and mesenchymal epithelial transition factor bispecific antibody Metastatic non-small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations after failure of platinum-based chemotherapy Submitted an MMA to the EMA
Orphazyme A/S, of Copenhagen Arimoclomol Chaperonin stimulator; Hsp70 stimulator Niemann-Pick Disease Type C FDA extended review period; updated PDUFA target action date is 6/17/21
Verrica Pharmaceuticals Inc., of West Chester, Pa. VP-102 (cantharidin) Protein phosphatase 2A inhibitor Molluscum contagiosum Resubmitted the NDA that was issued a complete response letter in June 2020

Notes

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