Drug & Device Pipeline News

March 7, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Aquestive Therapeutics	AQST-109	Severe allergic reactions	IND approved by the FDA
RedCloud Bio	H002	EGFR-positive nonsmall-cell lung cancer	IND approved by the FDA
Sorrento Therapeutics	STI-9199 (Covishield)	COVID-19	IND approved by the FDA
Harbour BioMed	HBM7008	Solid tumors	Approval for a phase 1 trial granted by Australia’s regulatory authority
InnoCare Pharma	Orelabrutinib	Neuromyelitis optica spectrum disorder	Approval for a phase 2 trial granted by China’s regulatory authority
Trials Initiated
ProJenX	PRO-101	Amyotrophic lateral sclerosis	Initiation of phase 1 trial
Oncocross	OC514	Sarcopenia	Initiation of phase 1 trial in Australia
Elpiscience	ES104	Colorectal cancer	Initiation of phase 1/2 trial in China
Genprex	Reqorsa plus Tagrisso	Nonsmall-cell lung cancer	Initiation of phase 1/2 trial
Intellia Therapeutics	NTLA-5001	Acute myeloid leukemia	Initiation of phase 1/2 trial
Bold Therapeutics	BOLD-100	Advanced gastrointestinal cancers	Initiation of phase 2 portion of phase 1b/2 trial
Transcenta	TST001	Biliary tract cancer	Initiation of phase 2a trial in China
Xalud Therapeutics	XT-150	Facet joint osteoarthritis pain	Initiation of phase 2a trial
Actuate Therapeutics	Elraglusib plus retifanlimab	Advanced pancreatic cancer	Initiation of phase 2 trial
Aramis Biosciences	A197	Dry eye disease	Initiation of phase 2 trial
CatalYm	CTL-002 (visugromab)	Solid tumors	Initiation of phase 2 trial
Kazia Therapeutics	Paxalisib	Glioblastoma	Initiation of phase 2 trial
Kintor Pharmaceutical	KX-826 (pyrilutamide)	Male androgenetic alopecia	Initiation of phase 2 trial
Lynk Pharmaceuticals	LNK01001	Atopic dermatitis	Initiation of phase 2 trial
ALX Oncology Eli Lilly	Evorpacept plus ramucirumab	HER2-positive gastric cancer or gastroesophageal junction cancer	Initiation of phase 2/3 trial
Seelos Therapeutics	SLS-005	Amyotrophic lateral sclerosis	Initiation of phase 2/3 trial
Lyra Therapeutics	LYR-210	Chronic rhinosinusitis	Initiation of phase 3 trial
NewAmsterdam Pharma	Obicetrapib	Atherosclerotic cardiovascular disease	Initiation of phase 3 trial
Approvals
Boehringer Ingelheim	Jardiance (empagliflozin)	All types of heart failure	Approved by the FDA for expanded indication
CTI BioPharma	Vonjo (pacritinib)	Myelofibrosis and thrombocytopenia	Accelerated approval granted by the FDA
Legend Biotech	Carvykti (ciltacabtagene autoleucel)	Relapsed or refractory multiple myeloma	Approved by the FDA
Kaléo	Naloxone auto-injector	Exposure to ultrapotent weaponized opioids	Approved by the FDA
Medicago GlaxoSmithKline	Covifenz COVID-19 vaccine	COVID-19	Approved in Canada