Drug & Device Pipeline News

December 12, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Beam Therapeutics	BEAM-201	Relapsed/refractory T-cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma	IND approved by the FDA for a phase 1 trial
AltruBio	ALTB-268	Ulcerative colitis	IND approved by the FDA for a phase 1 trial
Pyxis Oncology	PYX-201	Solid tumors	IND approved by the FDA for a phase 1 trial
Pyxis Oncology	PYX-106	Solid tumors	IND approved by the FDA for a phase 1 trial
BioCardia	Allogeneic NK1R+ human mesenchymal stem cells	Ischemic heart failure	IND approved by the FDA for a phase 1/2 trial
Opus Genetics	OPGx-001	Leber congenital amaurosis resulting from biallelic mutations in the LCA5 gene	IND approved by the FDA for a phase 1/2 trial
IN8bio	INB-400	Newly diagnosed glioblastoma	IND approved by the FDA for a phase 2 trial
Hexaell Biotechnology	HepaCure Biocolumn bioartificial liver	Acute-on-chronic liver failure syndromes	IND approved by China’s regulatory authorities for a phase 1/2 trial
Trials Initiated
Cytokinetics	CK-3828136	Heart failure with reduced ejection fraction and other types of heart failure	Initiation of phase 1 trial
Federation Bio	FB-001	Enteric hyperoxaluria	Initiation of phase 1 trial
Horizon Therapeutics	HZN-457	Gout	Initiation of phase 1 trial
Sionna Therapeutics	SION-638	Cystic fibrosis	Initiation of phase 1 trial
Innovent Biologics Union Therapeutics	Orismilast	Inflammatory disorders including psoriasis and atopic dermatitis	Initiation of phase 1 trial in China
Arcutus Biotherapeutics	ARQ-255	Alopecia areata	Initiation of phase 1b trial
Bio-Path Holdings	BP1001-A	Solid tumors, including ovarian, endometrial, pancreatic and breast cancer	Initiation of phase 1/1b trial
iOnctura SA	IOA-289	Metastatic pancreatic cancer	Initiation of phase 1b trial
Dragonfly Therapeutics	DF9001	Locally advanced or metastatic solid tumors	Initiation of phase 1/2 trial
Qurient	Q901	Advanced solid tumors	Initiation of phase 1/2 trial
Baudax Bio	BX1000	Neuromuscular blockade in patients undergoing elective surgery	Initiation of phase 2 trial
Dragonfly Therapeutics	DF1001	Advanced solid tumors	Initiation of phase 2 trial
Lynk Pharmaceuticals	LNK01003	Active ulcerative colitis	Initiation of phase 2 trial
Ventyx Biosciences	VTX958	Moderate-to-severe plaque psoriasis	Initiation of phase 2 trial
Otsuka Pharmaceuticals Sunovion Pharmaceuticals	Ulotaront	Major depressive disorder	Initiation of phase 2/3 trial
Celcuity	Gedatolisib	HR+/HER2- advanced breast cancer	Initiation of phase 3 trial
Approvals
Rigel Pharmaceuticals	Rezlidhia (olutasidenib)	Relapsed/refractory acute myeloid leukemia with susceptible IDH1 mutation	Approved by the FDA
SCYNEXIS	Brexafemme (ibrexafungerp tablets)	Reduction in the incidence of recurrent vulvovaginal candidiasis	Approved by the FDA for additional indication
Endomag	Magtrace lymphatic tracer	Breast cancer surgery	Approved by the FDA
Acutus Medical	AcQMap 3D Imaging and Mapping Catheter	Ultrasound imaging	Approved in the European Union
PTC Therapeutics	Waylivra (volanesorsen)	Familial partial lipodystrophy	Approved in Brazil