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Home » Drug & Device Pipeline News

Drug & Device Pipeline News

November 7, 2022
Company Drug/Device Medical Condition Status
Trials Authorized
Antengene ATG-017 plus nivolumab Advanced solid tumors IND approved by the FDA
Aulos Bioscience AU-007 Advanced solid tumors IND approved by the FDA
Brexogen BRE-AD01 Atopic dermatitis IND approved by the FDA
Turnstone Biologics TIDAL-01 Advanced solid tumors IND approved by the FDA
Alzamend Neuro ALZN002 Mild-to-moderate Alzheimer’s dementia Study May Proceed letter from the FDA
Small Pharma SPL028 Depressive disorders Approval for a phase 1 trial granted by the UK’s regulatory authority
Dyadic DYAI-100 COVID-19 booster vaccine COVID-19 CTA approved by the South African regulatory authority
Trials Initiated
Equillium EQ102 Celiac disease Initiation of phase 1 trial
Orum Therapeutics ORM-5029 HER2-expressing advanced solid tumors Initiation of phase 1 trial
Verge Genomics VRG50635 Amyotrophic lateral sclerosis Initiation of phase 1 trial
Regulus Therapeutics RGLS8429 Autosomal dominant polycystic kidney disease Initiation of phase 1b trial
Innovent Biologics IBI343 Advanced solid tumors Initiation of phase 1 trial in Australia
Senhwa Biosciences Pidnarulex plus talazoparib Metastatic castration-resistant prostate cancer Initiation of phase 1 trial in Australia
Biomea Fusion BMF-219 Type 2 diabetes Initiation of phase 2 portion of phase 1/2 trial
Monte Rosa Therapeutics MRT-2359 MYC-driven solid tumors, including lung cancer Initiation of phase 1/2 trial
Omega Therapeutics OTX-2002 Relapsed or refractory hepatocellular carcinoma and solid tumors with MYC oncogene overexpression Initiation of phase 1/2 trial
Teon Therapeutics TT-816 Advanced solid tumors Initiation of phase 1/2 trial
Disc Medicine Bitopertin Erythropoietic protoporphyria in adults Initiation of phase 2 trial
Edgewise Therapeutics EDG-5506 Duchenne muscular dystrophy Initiation of phase 2 trial
Q32 Bio

Horizon Therapeutics
ADX-914 Atopic dermatitis Initiation of phase 2 trial
Renovion ARINA-1 Non-cystic fibrosis bronchiectasis Initiation of phase 2 trial
InnoCare Pharma ICP-723 Advanced or metastatic solid tumors with NTRK fusion genes Initiation of phase 2 trial in China
Vaccitech VTP-300 Chronic hepatitis B infection Initiation of phase 2b trial in the Asia-Pacific region
LianBio TP-03 Demodex blepharitis Initiation of phase 3 trial in China
Approvals
Gilead Vemlidy (tenofovir alafenamide) Chronic hepatitis B virus in patients age 12 years and older with compensated liver disease Approved by the FDA for expanded age indication

 

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