Drug & Device Pipeline News

September 19, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Transcenta	TST003	Solid tumors	IND approved by the FDA
Akouos	AK-OTOF gene therapy	Otoferlin gene-mediated hearing loss in pediatric patients	IND approved by the FDA for phase 1/2 trial
AVROBIO	Autologous hematopoietic stem cell gene therapy	Infants diagnosed with neuronopathic mucopolysaccharidosis type II (Hunter syndrome)	CTA approved by the UK regulatory authority for phase 1/2 trial
Inversago Pharma	INV-202	Diabetic kidney disease	IND approved by the FDA for phase 2 trial
I-Mab Biopharma	Lemzoparlimab with azacitidine	First-line treatment of patients with newly diagnosed higher-risk myelodysplastic syndrome	Approval for a phase 3 trial granted by China’s regulatory authority
Trials Initiated
Vaxxinity	UB-313	Migraine	Initiation of phase 1 trial
Excision BioTherapeutics	EBT-101	HIV-1	Initiation of phase 1/2 trial
Shasqi	SQ3370	Locally advanced and/or metastatic solid tumors	Initiation of phase 2 portion of phase 1/2a trial
Cidara Therapeutics	CD388	Influenza	Initiation of phase 2a trial
Adverum Biotechnologies	Ixoberogene soroparvovec	Wet age-related macular degeneration	Initiation of phase 2 trial
Agenus	Botensilimab alone and with balstilimab	Microsatellite stable colorectal cancer	Initiation of phase 2 trial
Agenus	Botensilimab	Advanced melanoma	Initiation of phase 2 trial
BioMed Valley Discoveries	Ulixertinib (BVD-523) in combination with hydroxychloroquine	Advanced gastrointestinal malignancies with MAPK mutations	Initiation of phase 2 trial
Hepion Pharmaceuticals	Rencofilstat	Non-alcoholic steatohepatitis	Initiation of phase 2 trial
Pardes Biosciences	PBI-0451	Treatment of nonhospitalized symptomatic adults with COVID-19 who aren’t at risk of progressing to severe illness	Initiation of phase 2 trial
Sparrow Pharmaceuticals	SPI-47 (prednisolone and SPI-62)	Polymyalgia rheumatica	Initiation of phase 2 trial
MC2 Therapeutics	MC2-25 cream	Stage 3-5 chronic kidney disease-associated pruritus	Initiation of phase 2 trial in Europe
Locus Biosciences	LBP-EC01	Urinary tract infections	Initiation of phase 2/3 trial
Axsome Therapeutics	AXS-05	Alzheimer’s disease agitation	Initiation of phase 3 trial
Lyra Therapeutics	LYR-210	Chronic rhinosinusitis in adults	Initiation of phase 3 trial
Pfizer	Quadrivalent modified RNA influenza vaccine	Influenza	Initiation of phase 3 trial
Approvals
Bristol Myers Squibb	Sotyktu (deucravacitinib)	Moderate-to-severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy	Approved by the FDA
Mallinckrodt	Terlivaz (terlipressin) injection	Hepatorenal syndrome	Approved by the FDA
Revance Therapeutics	Daxxify (daxibotulinumtoxinA-lanm) for injection	Temporary improvement of moderate-to-severe frown lines in adults	Approved by the FDA
Spectrum Pharmaceuticals	Rolvedon (eflapegrastim-xnst) injection	Febrile neutropenia in adults with nonmyeloid malignancies receiving myelosuppressive anticancer drugs	Approved by the FDA
Pfizer BioNTech	Comirnaty COVID-19 vaccine	COVID-19 in children six months to less than five years of age	Approved in Canada