Drug & Device Pipeline News

October 4, 2021

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Bexion Pharmaceuticals	BXQ-350	Newly diagnosed stage 4 metastatic colorectal cancer	IND approved by the FDA
Pharmazz	centhaquine	Hypovolemic shock	IND approved by the FDA
Everest Medicines	SPR206 (EVER206)	Multi-drug resistant gram-negative bacterial infections	IND approved by China’s regulatory authority
I-Mab	enoblituzumab in combination with pembrolizumab (Keytruda)	Selected solid tumors	IND approved by China’s regulatory authority for a phase 2 trial
Transcenta Holding	TST002	Postmenopausal osteoporosis	IND approved by China’s regulatory authority
AB Science	masitinib	Treatment of patients with symptomatic mild-to-moderate COVID-19	Approval for a phase 2 trial granted by Russia and South Africa’s regulatory authorities
Krystal Biotech	KB407	Cystic fibrosis	Approval for a phase 1 trial granted by Australia’s regulatory authority
MRM Health	MH002	Ulcerative colitis	Approval for a Phase 1b/2a trial granted by Belgium’s regulatory authority
Revelation Biosciences	REVTx-99	Prevention of influenza	Approval for a Phase 2b trial granted by Belgium’s regulatory authority
Kintor Pharma	Proxalutamide	Hospitalized COVID-19 patients	Approval for a phase 3 trial granted by Brazil’s regulatory authority
Lipidor	AKP02	Psoriasis	Approval for a phase 3 trial granted by India’s regulatory authority
Trials Initiated
ADC Therapeutics	ADCT-901	Selected advanced solid tumors	Initiation of phase 1 trial
CyanVac Blue Lake Biotechnology	CVXGA1 intranasal COVID-19 vaccine	COVID-19 vaccine	Initiation of phase 1 trial
Dicerna	DCR-AUD	Alcohol use disorder	Initiation of phase 1 trial
Glyscend	Polymer duodenal exclusion therapy	Obesity	Initiation of phase 1 trial
VBI Vaccines	VBI-2905	SARS-CoV-2 vaccine	Initiation of phase 1b trial
Artios Pharma	ART4215	Advanced or metastatic solid tumors	Initiation of phase 1/2 trial
GenFleet Therapeutics Innovent	GFH925	KRAS G12C mutated late-stage nonsmall-cell lung cancer and gastrointestinal cancer	Initiation of phase 1/2 trial
Addex Therapeutics	dipraglurant	Blepharospasm	Initiation of phase 2a trial
Allena Pharmaceuticals	ALLN-346	Gout in patients with chronic kidney disease	Initiation of phase 2a trial
Immunic	IMU-838	Progressive multiple sclerosis	Initiation of phase 2 trial
InMed Pharmaceuticals	INM-755 (cannabinol) cream	Epidermolysis Bullosa	Initiation of phase 2 trial
Arrowhead Pharmaceuticals	ARO-APOC3	Mixed dyslipidemia.	Initiation of phase 2b trial
Pfizer	PF-07321332, co-administered low dose ritonavir	Prevention of COVID-19 infection	Initiation of phase 2/3 trial
SAB Biotherapeutics	SAB-185	Nonhospitalized patients with mild-to-moderate COVID-19	Initiation of phase 3 portion of phase 2/3 trial
Janssen	Respiratory syncytial virus (RSV) vaccine	Lower respiratory tract disease caused by RSV	Initiation of phase 3 trial
Syros Pharmaceuticals	SY-2101	Newly diagnosed acute promyelocytic leukemia patients	Initiation of phase 3 trial
Approvals
AbbVie	Qulipta (atogepant)	Preventive treatment of episodic migraine in adults	Approved by the FDA
Amgen	Repatha (evolocumab)	Adjunct for the treatment of patients older than 10 years old with heterozygous familial hypercholesterolemia (HeFH) to reduce LDL-C	Approved by the FDA for expanded indication
Eli Lilly	Erbitux (cetuximab injection) in combination with Braftovi (encorafenib)	Adults with previously treated metastatic colorectal cancer with a BRAF V600E mutation	Approved by the FDA for new indication
Mirum Pharmaceuticals	Livmarli (maralixibat) oral solution	Cholestatic pruritus in patients with Alagille syndrome older than one year of age	Approved by the FDA
Biotronik	Orsiro Mission bioabsorbable polymer drug-eluting stent system	Percutaneous coronary intervention device	Approved by the FDA
ANP Technologies	NIDS COVID-19 Antigen Rapid Test Kit	Detection of SARS-CoV-2	Emergency Use Authorization granted by the FDA
Astellas SeaGen	Padcev (enfortumab vedotin)	Radically unresectable urothelial carcinoma that has progressed after anti-cancer chemotherapy	Approved in Japan
ChemoCentryx Kissei Pharmaceuticals	Tavneos (avacopan)	Microscopic polyangiitis and granulomatosis with polyangiitis	Approved in Japan
Pfizer	Cibnqo (abrocitinib)	moderate-to-severe atopic dermatitis in patients older than 12 years of age	Approved in Japan