Drug & Device Pipeline News

October 3, 2022

Company	Drug/Device	Medical Condition	Status
Trials Authorized
Napo Pharmaceuticals	NP-300	Moderate-to-severe diarrhea from bacterial, viral and parasitic infections, including Vibrio cholerae	IND approved by the FDA
CatalYm	Visugromab	Advanced solid tumors that are relapsed/refractory to prior anti-PD1/PD-L1 treatment	IND approved by the FDA for phase 2 trial
Azura Ophthalmics	AZR-MD-001	Meibomian gland dysfunction	IND approved by the FDA for phase 2 trial
MoonLake Immunotherapeutics	Sonelokimab	Active psoriatic arthritis	IND approved by the FDA for phase 2 trial
C4 Therapeutics	CFT1946	BRAF-V600 mutant solid tumors	Study May Proceed letter issued by the FDA for phase 1/2 trial
Angel Pharmaceuticals	Mupadolimab	Non-small cell lung cancer and head and neck cancer	IND approved by China’s regulatory authority
Qu Biologics	QBECO SSI	Reduction of postoperative immune suppression, disease progression in patients with late-stage colorectal cancer	Approval for a phase 2 trial granted by Canada’s regulatory authority
Everest Medicines	EVER001	Glomerular diseases	IND approved by China’s regulatory authority
atai Life Sciences EmpathBio	EMP-01, MDMA derivative	Post-traumatic stress disorder	Approval for a phase 1 trial granted by New Zealand’s regulatory authority
Trials Initiated
Aura Biosciences	Belzupacap sarotalocan	Nonmuscle-invasive bladder cancer	Initiation of phase 1 trial
CinRx Pharma	CIN-109	Obesity	Initiation of phase 1 trial
Harbour BioMed	HBM9378	Moderate-to-severe asthma	Initiation of phase 1 trial
Lassen Therapeutics	LASN01	Fibrosis	Initiation of phase 1 trial
VBI Vaccines	VBI-2901 multivalent coronavirus vaccine	COVID-19 vaccine	Initiation of phase 1 trial
Kling Biotherapeutics	KBA1412	Advanced solid tumors	Initiation of phase 1b trial
Avidity Biosciences	AOC 1020	Adults with facioscapulohumeral muscular dystrophy	Initiation of phase 1/2 trial
Ichnos Sciences	ISB 1442	Relapsed/refractory multiple myeloma	Initiation of phase 1/2 trial
Evommune	EVO101	Atopic dermatitis	Initiation of phase 2a trial
Alumis	ESK-001	Moderate-to-severe plaque psoriasis	Initiation of phase 2 trial
EyePoint Pharmaceuticals	EYP-1901	Nonproliferative diabetic retinopathy	Initiation of phase 2 trial
Sparrow Pharmaceuticals	SPI-62	Cushing’s syndrome	Initiation of phase 2 trial
SpringWorks Therapeutics	Nirogacestat	Recurrent ovarian granulosa cell tumors	Initiation of phase 2 trial
Telix Pharmaceuticals	TLX591 (177Lu-DOTA-rosopatamab)	First recurrence of prostate-specific antigen after initial therapy for prostate cancer	Initiation of phase 2 trial in Australia
Acticor Biotech	Glenzocimab	Acute ischemic stroke	Initiation of phase 2/3 trial
aTyr Pharma	Efzofitimod	Pulmonary sarcoidosis	Initiation of phase 3 trial
Neurophth Therapeutics	NR082	Leber hereditary optic neuropathy	Initiation of phase 3 trial
Oncternal Therapeutics	Zilovertamab	Relapsed/refractory mantle cell lymphoma	Initiation of phase 3 trial
REVA Medical	MOTIV sirolimus-eluting bioresorbable vascular scaffold	Chronic limb-threatening ischemia	Initiation of phase 3 trial
Approvals
Harrow Sintetica	Iheezo (chloroprocaine hydrochloride ophthalmic gel) 3%	Ocular surface anesthesia	Approved by the FDA
Santen UBE	Omlonti (omidenepag isopropyl ophthalmic solution) 0.002% eye drops	Primary open-angle glaucoma or ocular hypertension	Approved by the FDA
Daiichi Sankyo	Ezharmia (valemetostat tosilate)	Relapsed/refractory adult T-cell leukemia/lymphoma	Approved in Japan
Legend Biotech	Carvykti (ciltacabtagene autoleucel)	Relapsed/refractory multiple myeloma	Approved in Japan
Merck	Keytruda (pembrolizumab)	HER2-negative breast cancer at high risk of recurrence, renal cell carcinoma, cervical cancer and stage IIB or IIC melanoma	Approved in Japan
Regeneron Sanofi	Dupixent (dupilumab) injection	Adults with prurigo nodularis	Approved by the FDA