Company	Drug/Device	Medical Condition	Status
Trials Authorized
Atom Bioscience	ABP-745	Acute gout	IND for a phase 1 trial approved by the FDA
Pasithea Therapeutics	PAS-004	Advanced solid tumors	IND for a phase 1 trial approved by the FDA
OBI Pharma	OBI-992	Advanced solid tumors including non-small cell lung cancer, small cell lung cancer and gastric cancer	IND for a phase 1/2 trial approved by the FDA
NKGen Biotech	SNK01	Moderate Alzheimer’s disease	Approval for a phase 1/2a trial granted by Canada’s regulatory authority
ENYO Pharma	Vonafexor	Alport syndrome	IND for a phase 2 trial approved by the FDA
Arch Biopartners	LSALT peptide	Cardiac surgery-associated acute kidney injury	Approval for a phase 2 trial granted by Turkey’s regulatory authority
Trials Initiated
ReCode Therapeutics	RCT1100	Primary ciliary dyskinesia caused by DNAI1 gene mutations	Initiation of a phase 1 trial
Sitryx Therapeutics       Eli Lilly	SIT-011	Chronic autoimmune and inflammatory diseases	Initiation of a phase 1 trial
Ventus Therapeutics	VENT-03	Inflammatory disorders	Initiation of a phase 1 trial
Genascence	GNSC-001 gene therapy	Knee osteoarthritis	Initiation of a phase 1b trial
INmune Bio	INKmune	Metastatic castration-resistant prostate cancer	Initiation of a phase 1/2 trial
Tango Therapeutics	TNG348 alone and with olaparib	BRCA1/2-mutant or other HRD+ cancers	Initiation of a phase 1/2 trial
Upstream Bio	Verekitug	Chronic rhinosinusitis with nasal polyps	Initiation of a phase 2 trial
Spero Therapeutics	Tebipenem HBr	Complicated urinary tract infections including acute pyelonephritis	Initiation of a phase 3 trial
Stuart Therapeutics	ST-100	Dry eye disease	Initiation of a phase 3 trial
Innovent Biologics	IBI362	Obesity	Initiation of a phase 3 trial in China
Approvals
Pfizer	Beqvez (fidanacogene elaparvovec) gene therapy	Moderately severe-to-severe hemophilia B	Approved in Canada