Drug & Device Pipeline News

April 11, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Shanghai Junshi Biosciences	TAB009/JS009	Advanced solid tumors	IND approved by the FDA
Starton Therapeutics	STAR-OLZ	Chemotherapy-induced nausea and vomiting	IND approved by the FDA
Tonix Pharmaceuticals	TNX-102 SL	Long COVID	IND approved by the FDA
ValenzaBio	VB421	Thyroid eye disease	IND approved by the FDA
Sorrento Therapeutics	Abivertinib	Severe pneumonia in hospitalized patients due to COVID-19	Approval for a phase 2/3 trial granted by the FDA
Fractyl Health	Revita DMR system	Type 2 diabetes patients who are not yet on insulin	IDE approved by the FDA
Accutar Biotechnology	AC0682	ER+ breast cancer	IND approved by China’s regulatory authority
Ascletis Pharma	ASC60	Advanced solid tumors	IND approved by China’s regulatory authority
Claritas Pharmaceuticals	R-107	Pulmonary arterial hypertension	Approval for a phase 1 trial granted by Australia’s regulatory authority
Trials Initiated
Athira Pharma	ATH-1020	Neuropsychiatric conditions	Initiation of phase 1 trial
Bond Biosciences	BBI-001	Hemochromatosis	Initiation of phase 1 trial
NGM Bio	NGM831	Advanced solid tumors	Initiation of phase 1 trial
Nurix Therapeutics	DeTIL-0255	Advanced gynecological malignancies	Initiation of phase 1 trial
Sirnaomics	STP707	Liver fibrosis in primary sclerosing cholangitis	Initiation of phase 1 trial
Zhimeng Biopharma	CB06	Chronic hepatitis B virus infection	Initiation of phase 1 trial
PepGen	PGN-EDO51	Duchenne muscular dystrophy	Initiation of phase 1 trial in Canada
4D Molecular Therapeutics	4D-710	Cystic fibrosis	Initiation of phase 1/2 trial
Genprex	Reqorsa plus Keytruda	Nonsmall-cell lung cancer	Initiation of phase 1/2 trial
Ocugen	OCU400	Retinitis pigmentosa	Initiation of phase 1/2 trial
Processa Pharmaceuticals	PCS12852	Gastroparesis	Initiation of phase 2a trial
Altimmune	Pemvidutide	Obesity	Initiation of phase 2 trial
Lakewood-Amedex	Bisphosphocin Nu-3	Chronic diabetic foot ulcers	Initiation of phase 2 trial
Meiji Seika Pharma	ME3183	Plaque psoriasis	Initiation of phase 2 trial
NewAmsterdam Pharma	Obicetrapib in combination with ezetimibe	High levels of low-density lipoprotein cholesterol	Initiation of phase 2 trial
Verrica Pharmaceuticals	LTX-315	Basal cell carcinoma	Initiation of phase 2 trial
Respira Therapeutics	RT234	Pulmonary arterial hypertension	Initiation of phase 2b trial
Tonix Pharmaceuticals	TNX-102 SL	Fibromyalgia	Initiation of phase 3 trial
Approvals
BioXcel Therapeutics	Igalmi (dexmedetomidine) sublingual film	Agitation associated with schizophrenia or bipolar disorder in adults	Approved by the FDA
Kite Therapeutics	Yescarta (axicabtagene ciloleucel)	Relapsed or refractory large B-cell lymphoma	Approved by the FDA for expanded indication
Nobelpharma America	Hyftor (sirolimus topical gel)	Facial angiofibroma associated with tuberous sclerosis complex	Approved by the FDA
Novartis	Vijoice (alpelisib)	PIK3CA-related overgrowth spectrum	Approved by the FDA
Bristol Myers Squibb	Breyanzi (lisocabtagene maraleucel)	Certain forms of relapsed or refractory large B-cell lymphoma	Approved by the European Commission
Bristol Myers Squibb	Opdivo (nivolumab)	Adjuvant treatment of muscle-invasive urothelial carcinoma patients at high risk of recurrence after undergoing radical resection	Approved by the European Commission for expanded indication
Bristol Myers Squibb	Opdivo (nivolumab) plus Yervoy (ipilimumab)	Esophageal squamous cell carcinoma	Approved by the European Commission for expanded indication
Immunocore	Kimmtrak (tebentafusp)	Unresectable or metastatic uveal melanoma	Approved by the European Commission
Sanofi	Dupixent (dupilumab)	Severe asthma with type 2 inflammation in children age 6 to 11 years	Approved by the European Commission for expanded indication