Drug & Device Pipeline News

January 23, 2023

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Exegenesis Bio	EXG102-031	Neovascular age-related macular degeneration	IND for a phase 1 trial approved by the FDA
Cyrano Therapeutics	CYR-064	Post-viral smell loss	IND for a phase 2 trial approved by the FDA
Orthogen	Orthogen device	Knee osteoarthritis stages II through IV	IDE for a phase 3 trial approved by the FDA
Trials Initiated
Ceruvia Lifesciences	NYPRG-101 (BOL-148)	Neurological and psychiatric disorders, including cluster headaches	Initiation of a phase 1 trial
Trefoil Therapeutics	TTHX1114	Corneal epithelial defects	Initiation of a phase 1 trial
Asher Biotherapeutics	AB248 and AB248 plus Keytruda	Locally advanced/metastatic solid tumors, including melanoma, renal cell carcinoma, non-small cell lung cancer and squamous cell carcinoma of the head and neck	Initiation of a phase 1a/1b trial
Biomea Fusion	BMF-219	KRAS-mutated unresectable, locally advanced or metastatic non-small cell lung cancer, colorectal cancer and pancreatic ductal adenocarcinoma	Initiation of a phase 1/1b trial
Cardiol Therapeutics	CardiolRx	Recurrent pericarditis	Initiation of a phase 2 trial
ORYZON Therapeutics	Iadademstat	Relapsed/refractory high-grade neuroendocrine carcinomas	Initiation of a phase 2 trial
Apex Labs	APEX-52 (synthetic psilocybin)	Post-traumatic stress disorder	Initiation of a phase 2b trial
Palatin Technologies	Bremelanotide	Type 2 diabetic kidney disease	Initiation of a phase 2b trial
Plus Therapeutics	Rhenium (186Re) obisbemeda	Recurrent glioblastoma	Initiation of a phase 2b trial
Theriva Biologics	VCN-01 plus chemotherapy	Newly diagnosed metastatic pancreatic ductal adenocarcinoma	Initiation of a phase 2b trial
Versanis Bio	Bimagrumab and bimagrumab plus Rybelsus (semaglutide)	Obesity	Initiation of a phase 2b trial
Stemedica Cell Technologies	Allogeneic mesenchymal stem cells	Ischemic stroke	Initiation of a phase 2b/3 trial
Life Molecular Imaging	PI-2620 imaging agent	Alzheimer’s disease	Initiation of a phase 3 trial
Approvals
Luye Pharma	Rykindo (risperidone) for extended-release injectable suspension	Schizophrenia and bipolar 1 disorder in adults	Approved by the FDA for new formulation
Novo Nordisk	Rybelsus (semaglutide)	First-line treatment for type 2 diabetes in adults	Approved by the FDA for expanded indication
Abbott	Navitor transcatheter aortic valve implantation system	Severe aortic stenosis in patients at high or extreme risk for open heart surgery	Approved by the FDA
Shanghai Henlius Biotech	Hansizhuang (serplulimab) injection in combination with carboplatin and etoposide	Extensive-stage small cell lung cancer	Approved in China