Company Product Description Indication Status
Agilent Technologies Inc., of Santa Clara, Calif. IHC 22C3 PD-L1 companion diagnostic Non-small-cell lung cancer FDA approved expanded use to identify prospective patients to treat with Libtayo (cemiplimab-rwlc, Sanofi SA/Regeneron Pharmaceuticals Inc.)
Elicio Therapeutics Inc., of Cambridge, Mass. ELI-002 KRAS GTPase stimulator Solid tumors FDA cleared IND for phase I/II trial in people with metastatic KRAS-mutated pancreatic ductal adenocarcinoma and other solid tumors
Hoth Therapeutics Inc., of New York HT-001 (aprepitant, topical formulation) NK1 receptor antagonist Cancer patients suffering from dermatological ailments during EGFR inhibitor treatment Completed a pre-IND meeting with FDA regarding the proposed development plan
Iaso Biotherapeutics Co. Ltd., of Nanjing, China, and Innovent Biologics Inc., of Suzhou, China IBI-326/CT-103A Anti-BCMA CAR T Relapsed/refractory multiple myeloma China's NMPA granted breakthrough therapy designation 
Neoimmunetech Inc., of Rockville, Md. NT-I7 (efineptakin alfa) Long-acting human interleukin-7 Progressive multifocal leukoencephalopathy FDA cleared its IND application for a pilot study 
Noven Pharmaceuticals Inc., of Miami, a wholly owned subsidiary of Hisamitsu Pharmaceutical Co. Inc. Dextroamphetamine transdermal system Amphetamine-based transdermal treatment  Attention deficit hyperactivity disorder Submitted an NDA with the FDA for patients 6 and older
Ocugen Inc., of Malvern, Pa. OCU-400 Gene therapy consisting of functional copy of nuclear hormone receptor gene NR2E3 Retinitis pigmentosa and Leber congenital amaurosis European Commission granted orphan medicinal product designation
Russian Direct Investment Fund (RDIF), of Moscow  Sputnik V COVID-19 spike glycoprotein modulator COVID-19 prophylaxis Approved in Guyana and Kyrgyzstan
Sanofi SA, of Paris, and Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. Libtayo (cemiplimab) Monoclonal antibody targeting PD-1 Advanced non-small-cell lung cancer  FDA approved it in patients whose tumors have high PD-L1 expression
Scpharmaceuticals Inc., of Burlington, Mass. Furoscix  Furosemide solution formulated to a neutral pH Worsening heart failure due to congestion Received the official type A meeting minutes from the FDA regarding the requirements for resubmission of the NDA following the complete response letter received on Dec. 3, 2020; FDA is not requiring modifications to the device nor additional clinical studies, but the company will run additional modified bench tests 

Notes

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