Drug & Device Pipeline News

May 16, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Cue Biopharma	CUE-102	Wilms’ tumor 1 (WT1)-expressing cancers	IND approved by the FDA
Elpiscience Biopharmaceuticals	ES014	Advanced solid tumors	IND approved by the FDA
Regulus Therapeutics	RGLS8429	Autosomal dominant polycystic kidney disease	IND approved by the FDA
Neogene Therapeutics	NT-125	Advanced solid tumors	Clinical trial authorized by the Dutch regulatory authory
ReAlta Life Sciences	RLS-0071	Severe asthma	Approval for a phase 1b trial granted by Germany’s regulatory authority
Spine BioPharma	SB-01 for injection	Chronic low back pain caused by degenerative disc disease	Study may proceed letter issued by the FDA
Zylorion Health	Almond Therapy	Treatment-resistant depression	Approval for a phase 2 trial granted by Canada’s regulatory authority
Trials Initiated
Arcellx	ACLX-001	Relapsed or refractory multiple myeloma	Initiation of phase 1 trial
Bio-Thera Solutions	BAT7104	Advanced solid tumors	Initiation of phase 1 trial in Australia
Zhimeng Biopharma	CB03	Refractory epilepsy	Initiation of phase 1 trial
Immatics	IMA401	Advanced solid tumors	Initiation of phase 1 trial
Imago Biosciences	Bomedemstat in combination with atezolizumab	Extensive-stage small-cell lung cancer	Initiation of phase 1/2 trial
Myeloid Therapeutics	MT-101	Peripheral T-cell lymphoma	Initiation of phase 1/2 trial
Eledon Pharmaceuticals	Tegoprubart	IgA nephropathy	Initiation of phase 2a trial
Intercept Pharmaceuticals	Obeticholic acid and bezafibrate	Primary biliary cholangitis	Initiation of phase 2 trial
Sen-Jam Pharmaceutical	SJP-002C	COVID-19	Initiation of phase 2 trial
Zenith Epigenetics	ZEN-3694 plus talazoparib	Triple negative breast cancer	Initiation of phase 2b trial
Anthos Therapeutics	Abelacimab	Cancer-associated thrombosis	Initiation of phase 3 trial
Faraday Pharmaceuticals	FDY-5301	Anterior ST-segment elevation myocardial infarction	Initiation of phase 3 trial
Approvals
Eli Lilly	Olumiant (baricitinib)	COVID-19 in certain hospitalized adults requiring various degrees of oxygen support	Approved by the FDA