Company Product Description Indication Status
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia NP-120 (repurposed ifenprodil) NMDA receptor antagonist COVID-19-related severe pneumonia South Korea's Ministry of Food and Drug Safety approved investigator-led phase II study in 40 participants assessing lung function improvement; primary endpoint is blood oxygen levels (Pa02/Fi02); secondary endpoints include mortality, rate of mechanical ventilation and patient-reported effects on dyspnea; enrollment expected to begin May 8, 2020
Amidebio LLC, of Boulder, Colo. ABG-023 (glucagon analog; AB-GLC-0035) Glucagon receptor agonist Congenital hyperinsulinism FDA granted orphan drug designation
Caladrius Biosciences Inc., of Basking Ridge, N.J. CLBS-119 CD34+ cell therapy  COVID-19-induced lung damage FDA authorized IND application for study assessing therapy's ability to restore lung function in individuals with severe SARS-CoV-2 infection who required ventilation due to respiratory failure
CNS Pharmaceuticals Ag Inc., of Houston,  Berubicin (previously RTA-744) Topoisomerase II inhibitor Glioblastoma Orphan drug application submitted to FDA
Cstone Pharmaceuticals Co. Ltd., of Suzhou, China Avapritinib Inhibitor of KIT and PDGFRA mutant kinases Gastrointestinal stromal tumors China's NMPA accepted NDA to treat adults with unresectable or metastatic disease harboring platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations, and adults with unresectable or metastatic fourth-line disease
Immunomedics Inc., of Morris Plains, N.J. Trodelvy (sacituzumab govitecan-hziy) Anti-Trop-2 antibody-drug conjugate Metastatic triple-negative breast cancer FDA approved drug to treat adults who received at least 2 prior therapies for metastatic disease
Merck & Co. Inc., of Kenilworth, N.J. Keytruda (pembrolizumab) PD-1 inhibitor Various cancers Following CRL issued in February 2020, sBLA resubmitted to FDA updating dosing frequency to include 400-mg dose infused over 30 minutes every 6 weeks in all mono and combo therapy indications in adults
Rafael Pharmaceuticals Inc., of Cranbury, N.J. CPI-613 (devimistat) 2 oxoglutarate dehydrogenase inhibitor; pyruvate dehydrogenase inhibitor/kinase stimulator Acute myeloid leukemia India's Central Drugs Standard Control Organization and Health Canada approved opening of sites for phase III combination trial with cytarabine and mitoxantrone (HAM) vs. HAM alone in individuals 50 and older with relapsed or refractory disease; enrollment will begin when deemed safe by local officials due to COVID-19 pandemic
Revive Therapeutics Ltd., of Toronto Bucillamine (repurposed) Xanthine oxidase inhibitor COVID-19 infection Responding to pre-IND meeting, FDA recommended proceeding to confirmatory phase III trial in patients with mild to moderate infection and provided guidance on study design and outcome measures; IND filing expected within 60 days
Samsung Biologics Co. Ltd., of Seoul, and Immuneoncia Therapeutics Inc., of Yongin, South Korea IMC-002 CD47 antagonist Advanced solid tumors; relapsed/refractory lymphoma FDA approved IND for phase I trial that Immuneoncia will conduct
Vitalis LLC, of New York Monomethyl fumarate + aspirin; diroximel fumarate + aspirin Fixed-dose combinations of fumarate salts + VTS-aspirin Relapsing/remitting multiple sclerosis  FDA granted orphan drug designation to reduce flush

Notes

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

No Comments