Company Product Description Indication Status
American Gene Technologies International Inc., of Rockville, Md. AGT103-T Lentiviral vector-based gene therapy HIV infection The FDA approved the start of a phase I clinical trial
Amidebio LLC, of Boulder, Colo. ABG-023 (glucagon analog; AB-GLC-0035) Glucagon receptor agonist Congenital hyperinsulinism The FDA granted rare pediatric disease designation
Axsome Therapeutics Inc., of New York AXS-07 (meloxicam + rizatriptan) Dual 5-HT 1b/1d receptor agonist; cyclooxygenase 2 inhibitor Migraine Completed a successful FDA pre-NDA meeting; based on feedback, the company's regulatory data package will be sufficient to support an NDA; on track to submit NDA in 4Q of 2020
Bristol Myers Squibb Co., of New York Opdivo (nivolumab) PD-1 inhibitor Unresectable advanced, recurrent or metastatic esophageal cancer after prior chemotherapy Positive scientific opinion issued in U.K. for early access to medicines scheme as monotherapy treatment of adult patients after prior fluoropyrimidine- and platinum-based chemotherapy.
Carsgen Therapeutics Co. Ltd., of Shanghai CT-041 Humanized CAR-claudin18.2 T-cell therapy  Claudin18.2-positive adenocarcinoma of the stomach, gastroesophageal junction or pancreas China's NMPA cleared its IND application
Kubota Vision Inc., of Seattle, a subsidiary of Kubota Pharmaceutical Holdings Co. Ltd. Emixustat hydrochloride Synthetic small-molecule non-retinoid drug Stargardt disease  Awarded FDA orphan products clinical trial grant to support  ongoing phase III study
Lidds AB, of Uppsala, Sweden Liproca Depot Androgen receptor antagonist Prostate cancer  Licensee, Jiangxi Puheng Pharma, is preparing documentation for an application targeting a newly issued regulatory guideline in China on conditional market approval, for unmet medical needs based on less comprehensive data than normally required
Polaryx Therapeutics Inc., of Paramus, N.J. PLX-200 Repurposed drug that binds to the retinoid X receptor-alpha Juvenile neuronal ceroid lipofuscinosis Received FDA fast track designation
Samsung Bioepis Co. Ltd., of Incheon, Korea Aybintio (bevacizumab biosimilar) Anti-VEGF antibody Multiple cancers The European Commission granted marketing authorization

Notes

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

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