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Home » Drug & Device Pipeline News

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

 

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