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Home » Drug & Device Pipeline News

Drug & Device Pipeline News

September 20, 2021
Company Drug/Device Medical Condition Status
Trials Authorized
Hummingbird Bioscience HMBD-002 Cancers with VISTA-mediated immune suppression IND approved by the FDA
Instil Bio ITIL-168 Advanced melanoma IND approved by the FDA
Viewpoint Molecular Targeting VMT-α-NET Imaging of neuroendocrine tumors IND approved by the FDA
Telix Pharmaceuticals TLX250 (177Lu-DOTA-girentuximab) Kidney cancer IND approved by the FDA
Sigilon Therapeutics SIG-005 Mucopolysaccharidosis Type I Phase 1/2 trial authorized by the UK regulatory authority
Excision BioTherapeutics EBT-101 CRISPR-based therapy for chronic HIV IND approved by the FDA
Neurogene NGN-101 Batten disease IND approved by the FDA
Magenta Therapeutics MGTA-117 relapsed/refractory acute myeloid leukemia and myelodysplastic syndromes IND approved by the FDA
Neovasc COSIRA-II Refractory angina Investigational Device Exemption approved by the FDA
Trials Initiated
Alzamend Neuro AL001 Dementia related to Alzheimer’s disease Initiation of phase 1 trial
Celldex Subcutaneous formulation of CDX-0159 Chronic urticarias Initiation of phase 1 trial
Legend Biotech LB1901 Relapsed or refractory peripheral T-cell lymphoma or cutaneous T-cell lymphoma Initiation of phase 1 trial
Pacylex Pharmaceuticals PCLX-001 NonHodgkins lymphomas and solid tumors Initiation of phase 1 trial
GammaDelta Therapeutics GDX012 Acute myeloid leukemia Initiation of phase 1 trial
Icosavax IVX-121 Respiratory syncytial virus/human metapneumovirus vaccine Initiation of phase 1/1b trial
ALX Oncology ALX148 (evorpacept) with rituximab and lenalidomide Indolent and aggressive nonHodgkins lymphoma Initiation of phase 1/2 trial
NLS Pharmaceuticals Quilience Excessive daytime sleepiness and cataplexy Initiation of phase 2 trial
Perception Neuroscience PCN-101 (R-ketamine) Treatment-resistant depression Initiation of phase 2a trial
DiaMedica Therapeutics DM199 Acute ischemic stroke Initiation of phase 2/3 trial
VistaGen Therapeutics PH94B Adults with social anxiety disorder Initiation of phase 3 trial
Zynerba Pharmaceuticals Zygel (cannabidiol formulated in a transdermal gel) Children and adolescents with Fragile X syndrome Initiation of phase 3 trial
Axsome Therapeutics AXS-12 Narcolepsy Initiation of phase 3 trial
Biogen nusinersen Later-onset spinal muscular atrophy Initiation of phase 3 trial
Approvals
Visby Medical Reverse transcription-polymerase chain reaction COVID-19 test Pooled testing of up to five patient samples Emergency Use Authorization (EUA) granted by the FDA
Cepheid Xpert Xpress CoV-2/Flu/RSV+ diagnostic test COVID-19, influenza and respiratory syncytial virus EUA granted by the FDA
Quanterix Simoa SARS-CoV-2 N protein antigen test COVID-19 EUA granted by the FDA
BeiGene Brukinsa (zanubrutinib) Relapsed or refractory marginal-zone lymphoma Approved by the FDA
Takeda Pharmaceutical Exkivity (mobocertinib) EGFR Exon20 insertion+ nonsmall-cell lung cancer Approved by the FDA

 

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