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