Drug & Device Pipeline News

August 15, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Cure Rare Disease	CRD-TMH-001 CRISPR therapy	Duchenne muscular dystrophy	IND approved by the FDA
Immunis	IMM01-STEM	Muscle atrophy related to knee osteoarthritis	IND approved by the FDA
ProfoundBio	PRO1184	Ovarian, endometrial, breast, non-small cell lung cancer and mesothelioma	IND approved by the FDA
CereVasc	eShunt System	Communicating hydrocephalus following subarachnoid hemorrhage	IDE approved by the FDA
Neurocrine Biosciences	NBI-1117568	Schizophrenia	IND approved by the FDA for a phase 2 trial
Trials Initiated
Arbele Biopharmaceutical	ARB202	Advanced gastrointestinal cancer	Initiation of phase 1 trial in Australia
Ascletis Pharma	ASC61	Advanced solid tumors	Initiation of phase 1 trial
Inmagene Biopharmaceuticals HutchMed	IMG-004	Inflammatory and autoimmune diseases	Initiation of phase 1 trial
Innovent Biologics	IBI324	Diabetic macular edema	Initiation of phase 1 trial
Upstream Bio	UPB-101	Asthma	Initiation of phase 1b trial
Gamida Cell	GDA-201	Follicular and diffuse large B-cell lymphomas	Initiation of phase 1/2 trial
Graphite Bio	GPH101 (nulabeglogene autogedtemcel)	Sickle cell disease	Initiation of phase 1/2 trial
Tarsus Pharmaceuticals	TP-03 (lotilaner ophthalmic solution)	Meibomian gland disease in patients with Demodex mites	Initiation of phase 2a trial
Artios	ART4215	BRCA-deficient breast cancer	Initiation of phase 2 trial
Disc Medicine	Bitopertin	Erythropoietic protoporphyria or X-linked protoporphyria	Initiation of phase 2 trial
Olema Oncology	OP-1250	ER+/HER2- metastatic breast cancer	Initiation of phase 2 trial
Saol Therapeutics	SL-1002	Knee pain associated with osteoarthritis	Initiation of phase 2 trial
Noema Pharma	Gemlapodect (NOE-105)	Childhood onset fluency disorder	Initiation of phase 2b trial
Union Therapeutics	Orismilast MR tablet	Moderate-to-severe atopic dermatitis	Initiation of phase 2b trial
Daiichi Sankyo	Patritumab deruxtecan (HER3-DXd)	EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer	Initiation of phase 3 trial
Pfizer Valneva	VLA15 Lyme disease vaccine	Lyme disease	Initiation of phase 3 trial
Approvals
Myovant Sciences Pfizer	Myfembree (relugolix, estradiol and norethindrone acetate)	Moderate-to-severe endometrial pain in premenopausal women	Approved by the FDA for new indication
Daiichi Sankyo AstraZeneca	Enhertu (fam-trastuzumab deruxtecan-nxki)	HER2-low metastatic breast cancer	Approved by the FDA for expanded indication
Orion Bayer	Nubeqa (darolutamide)	Metastatic hormone-sensitive prostate cancer	Approved by the FDA for expanded indication
AstraZeneca Merck	Lynparza (olaparib)	gBRCA-mutated, HER2-negative high-risk early breast cancer	Approved by the European Commission