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Home » Drug & Device Pipeline News

Drug & Device Pipeline News

January 16, 2023
Company Drug/Device Medical Condition Status
Trials Authorized
American CryoStem ATCell Long COVID/PASC IND for a phase 1 trial approved by the FDA
Immorna JCXH-105 shingles vaccine Shingles IND for a phase 1 trial approved by the FDA
Minerva Biotechnologies huMNC2-CAR22 (MUC1*-CAR-1XX) Metastatic breast cancer IND for a phase 1 trial approved by the FDA
Transgene TG6050 Advanced non-small cell lung cancer Phase 1 trial authorized by France’s regulatory authority
Orchard Therapeutics OTL-203 Hurler subtype of mucopolysaccharidosis type I IND for a phase 3 trial approved by the FDA
Trials Initiated
Cellf Bio BioSphincter implant Severe passive fecal incontinence Initiation of a phase 1 trial
Frontera Therapeutics FT-001 Leber congenital amaurosis 2 Initiation of a phase 1 trial
Theriva Biologics VCN-01 High-grade brain tumors scheduled for surgical resection Initiation of a phase 1 trial
Trevena TRV045 Epilepsy and other CNS disorders Initiation of a phase 1 trial
VYNE Therapeutics VYN201 Vitiligo Initiation of a phase 1a/b trial
Aprea Therapeutics ATRN-119 Advanced solid tumors with DDR mutations Initiation of a phase 1/2a trial
Avenge Bio AVB-001 Relapsed refractory ovarian cancer Initiation of a phase 1/2 trial
Hemab Therapeutics HMB-001 Glanzmann thrombasthenia Initiation of a phase 1/2 trial
Surface Oncology SRF114 Advanced solid tumors Initiation of a phase 1/2 trial
Bexion Pharmaceuticals BXQ-350 plus mFOLFOX7 and bevacizumab Newly diagnosed metastatic colorectal carcinoma Initiation of a phase 1b/2 trial
Alterity Therapeutics ATH434 Multiple system atrophy Initiation of a phase 2 trial
Compass Therapeutics CTX-009 Metastatic colorectal cancer Initiation of a phase 2 trial
Glycomine GLM101 Phosphomannomutase 2-congenital disorder of glycosylation Initiation of a phase 2 trial
Panbela Therapeutics CPP-1X-T (eflornithine tablets) Recent-onset type 1 diabetes Initiation of a phase 2 trial
Shanton Pharma SAP-001 Refractory and tophaceous gout Initiation of a phase 2b trial
Cyclo Therapeutics Trappsol Cyclo Early Alzheimer’s disease Initiation of a phase 2b trial
Biofrontera Bioscience Ameluz and BF-RhodoLED XL Actinic keratosis on the extremities, neck and trunk Initiation of a phase 3 trial
Maggie’s Pearl Epalrestat PMM2-CDG (phosphomannomutase-2-congenital disorder of glycosylation) Initiation of a phase 3 trial
Ocuphire Pharma Nyxol and Nyxol plus adjunctive low-dose pilocarpine therapy Presbyopia Initiation of a phase 3 trial
Zenas BioPharma Obexelimab Prevention of IgG4-related disease flare Initiation of a phase 3 trial
Innovent Biologics Mazdutide Type 2 diabetes Initiation of a phase 3 trial in China
Approvals
Biogen

Eisai
Leqembi (lecanemab-irmb) Alzheimer’s disease Accelerated approval granted by the FDA

 

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