Company Product Description Indication Status
Abivax SA, of Paris ABX-464 Up-regulates miR-124 Elderly or high-risk patients with COVID-19 German regulators Bundesinstitut für Arnzeimittel und Medizinprodukte approved the start of the phase IIb/III study in 1,034 patients
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia Ifenprodil N-methyl-D-aspartate receptor antagonist COVID-19 hospitalized patients Submitted IND to FDA for a phase IIb/III study measuring mortality, blood oxygen levels, time spent in intensive care and time to mechanical ventilation
Alnylam Pharmaceuticals Inc., of Cambridge, Mass. Lumasiran RNAi targeting hydroxyacid oxidase 1 Primary hyperoxaluria type 1 FDA accepted the NDA and granted a priority review with a PDUFA action date of Dec. 3, 2020
Aurinia Pharmaceutical Inc., of Victoria, British Columbia Voclosporin Calcineurin inhibitor Lupus nephritis Completed rolling submission of the NDA to the FDA with a request for a priority review
Cytrx Corp., of Los Angeles, and Orphazyme A/S, of Copenhagen Arimoclomol Amplifies the production of heat-shock proteins Amyotrophic lateral sclerosis FDA granted fast track designation
Expression Therapeutics LLC, of Atlanta ET-3 Gene therapy expressing factor VIII Hemophilia A FDA cleared IND for a phase I study
Hansa Biopharma AB, of Lund, Sweden Imlifidase  Cleaves IgG-antibodies Sensitized kidney transplant patients Company submitted responses to outstanding questions from the EMA; CHMP decision expected at the June 22-25, 2020, meeting
Kala Pharmaceuticals Inc., of Watertown, Mass. Eysuvis (loteprednol etabonate) Corticosteroid Dry eye disease FDA accepted the NDA resubmission and set a PDUFA action date of Oct. 30, 2020
Neurobo Pharmaceuticals Inc., of Boston Gemcabene Peroxisome proliferation-activated receptor agonist Dyslipidemia After reviewing an amendment to the FDA's partial hold letter, the FDA declined to lift the hold on the phase II study
Novaremed AG, of Basel, Switzerland NRD135S.E1 Allosteric modulator of Lyn kinase Painful diabetic peripheral neuropathy Submitted IND to FDA for a phase II study
Qurient Co. Ltd., of Seongnam-Si, Korea Q-702 Targets Axl, Mer and CSF1 receptor tyrosine kinases Advanced solid tumors FDA cleared IND for a phase I study scheduled to start in the third quarter of 2020
Rockwell Medical Inc., of Wixom, Mich. Triferic Avnu (ferric pyrophosphate citrate) Iron replacement Hemodialysis-dependent chronic kidney disease Filed a new drug submission with Health Canada
Sino Biopharmaceutical Ltd., of Hong Kong, and Akeso Inc., of Zhongshan, China Penpulimab Monoclonal antibody targeting PD-1 Relapsed or refractory classical Hodgkin lymphoma National Medical Products Administration of China accepted the NDA
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan Alunbrig (brigatinib) ALK inhibitor First-line ALK+ metastatic non-small-cell lung cancer FDA approved the expanded indication
Zealand Pharma A/S, of Copenhagen Hypopal (dasiglucagon) Glucagon analogue Hypoglycemia  FDA accepted the NDA and assigned a PDUFA action date of March 27, 2021

Notes

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

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