Drug & Device Pipeline News
| 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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