Company Product Description Indication Status
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia NP-120 (repurposed ifenprodil) NDMA receptor glutamate receptor antagonist COVID-19-related pneumonia Regulatory submission filed with South Korea's Ministry of Food and Drug Safety for investigator-led phase II study in 40 individuals with severe disease; primary endpoint is lung function improvement measured by blood oxygen levels; secondary endpoints include mortality, rate of mechanical ventilation and patient-reported effects on cough and dyspnea
Athenex Inc., of Buffalo, N.Y. Oral paclitaxel + encequidar  P-glycoprotein 1 inhibitor Metastatic breast cancer Following meeting with FDA to discuss clinical section of NDA, filing on track per agency guidance
Biohaven Pharmaceutical Holding Co. Ltd., of New Haven, Conn. Vazegepant CGRP receptor antagonist COVID-19-related lung inflammation FDA approved IND for placebo-controlled phase II study, expected to begin within weeks, of intranasal drug to treat individuals hospitalized with disease and requiring supplemental oxygen; primary outcome measure includes resolution of pulmonary symptoms vs. progression to ventilator support or death
Calcimedica Inc., of La Jolla, Calif. CM-4620-IE Ca2+ release activated Ca2+ channel 1 inhibitor COVID-19-related pneumonia FDA issued letter to proceed with open-label phase II study in combination with standard of care (n=40) vs. standard of care alone (n=20) in individuals with severe disease at risk to progress to acute respiratory distress syndrome; initial participants enrolled at first study site
EMD Serono, unit of Merck KGaA, of Darmstadt, Germany, and Pfizer Inc., of New York Bavencio (avelumab) PD-L1 inhibitor Urothelial carcinoma sBLA submission to FDA completed for first-line maintenance treatment of locally advanced or metastatic disease; FDA granted breakthrough therapy designation in indication and is reviewing submission under real-time oncology review pilot program
Kiadis Pharma NV, of Amsterdam KNK-002 Haploidentical natural killer cell therapy Hematologic cancer IND filed with FDA for phase I/II NK-Realm study to evaluate KNK-002 as adjunctive therapy, along with standard-of-care post-transplant cyclophosphamide protocol, in 63 participants undergoing haploidentical hematopoietic stem cell transplant; study designed to confirm proof-of-concept data suggesting potential to improve outcomes
Lannett Co. Inc., of Philadelphia Insulin glargine biosimilar Insulin ligand; insulin receptor agonist Diabetes mellitus; non-insulin dependent diabetes FDA approved request for biosimilar biological product development type II meeting, set for June 9, 2020, to discuss design and endpoint of any additional human studies required for BLA filing
Pfizer Inc., of New York Braftovi (encorafenib) Raf B protein kinase inhibitor Colorectal cancer FDA approved drug in combination with cetuximab (Erbitux, Merck & Co. Inc.) to treat adults with metastatic disease with BRAFV600E mutation, following prior therapy
Viracta Therapeutics Inc., of San Diego Nanatinostat Histone deacetylase inhibitor Lymphoma FDA provided feedback during type C meeting on March 31, 2020, on combination program with DNA polymerase inhibitor valganciclovir to treat relapsed/refractory Epstein-Barr virus-associated disease; meeting covered patient selection and clinical data needed to ensure readiness for registrational trial


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