Drug & Device Pipeline News

February 14, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Ascletis Pharma	ASC61	Advanced solid tumors	IND approved by the FDA
Pardes Bio	PBI-0451	SARS-CoV-2 infections and associated diseases	IND approved by the FDA
CereVasc	eShunt System	Hydrocephalus	Investigational device exemption granted by the FDA
Antengene	ATG-037	Metastatic solid tumors	Approval for a phase 1 trial granted by Australia’s regulatory authority
Akeso	AK115	Pain	Approval for a phase 1 trial granted by China’s regulatory authority
Revolo Biotherapeutics	‘1805	Rheumatoid arthritis	Approval for a phase 2 trial granted by the UK’s regulatory authority
Revolo Biotherapeutics	‘1805	Noninfectious, active, intermediate, or posterior uveitis or panuveitis	Approval for a phase 2 trial granted by the UK’s regulatory authority
EuBiologics	EuCorVac-19 COVID-19 vaccine	COVID-19	Approval for a phase 3 trial granted by South Korea’s regulatory authority
Trials Initiated
CureVac	CVSQIV seasonal influenza vaccine	Seasonal influenza	Initiation of phase 1 trial
MapLight Therapeutics	ML-007	Schizophrenia and dyskinesia	Initiation of phase 1 trial
Sirnaomics	STP707	Solid tumors	Initiation of phase 1 trial
Active Biotech	Tasquinimod	Relapsed or refractory multiple myeloma	Initiation of phase 1b/2 trial
HutchMed	HMPL-453	Advanced solid tumors	Initiation of phase 1b/2 trial
uniQure	AMT-130	Huntington’s disease	Initiation of phase 1b/2 trial in Europe
Neoimmunetech	NT-I7 (efineptakin alfa)	High-risk skin cancers	Initiation of phase 2a trial
Actuate Therapeutics	Elraglusib (9-ING-41) plus Folfirinox	Advanced pancreatic cancer	Initiation of phase 2 trial
BioRestorative Therapies	BRTX-100	Chronic lumbar disc disease	Initiation of phase 2 trial
Dompé	Cenegermin	Sjögren's-related dry eye disease	Initiation of phase 3 trial
Sunovion Otsuka	Nonracemic amisulpride (SEP-4199)	Major depressive episodes associated with bipolar 1 disorder	Initiation of phase 3 trial
TearClear	TC-002	Glaucoma	Initiation of phase 3 trial
Approvals
Allergan	Juvederm Volbella XC	Infraorbital hollows	Approved by the FDA
Azurity Pharmaceuticals	Fleqsuvy (baclofen oral suspension)	Spasticity from multiple sclerosis or spinal cord injuries	Approved by the FDA for a new dosing regimen
Sanofi	Enjaymo (sutimlimab-jome)	Cold agglutinin disease	Approved by the FDA
Novavax	Nuvaxovid COVID-19 vaccine	COVID-19	Conditional approval granted in the UK