
Home » Drug & Device Pipeline News
Drug & Device Pipeline News
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Trials Authorized | |||
American CryoStem | ATCell | Long COVID/PASC | IND for a phase 1 trial approved by the FDA |
Immorna | JCXH-105 shingles vaccine | Shingles | IND for a phase 1 trial approved by the FDA |
Minerva Biotechnologies | huMNC2-CAR22 (MUC1*-CAR-1XX) | Metastatic breast cancer | IND for a phase 1 trial approved by the FDA |
Transgene | TG6050 | Advanced non-small cell lung cancer | Phase 1 trial authorized by France’s regulatory authority |
Orchard Therapeutics | OTL-203 | Hurler subtype of mucopolysaccharidosis type I | IND for a phase 3 trial approved by the FDA |
Trials Initiated | |||
Cellf Bio | BioSphincter implant | Severe passive fecal incontinence | Initiation of a phase 1 trial |
Frontera Therapeutics | FT-001 | Leber congenital amaurosis 2 | Initiation of a phase 1 trial |
Theriva Biologics | VCN-01 | High-grade brain tumors scheduled for surgical resection | Initiation of a phase 1 trial |
Trevena | TRV045 | Epilepsy and other CNS disorders | Initiation of a phase 1 trial |
VYNE Therapeutics | VYN201 | Vitiligo | Initiation of a phase 1a/b trial |
Aprea Therapeutics | ATRN-119 | Advanced solid tumors with DDR mutations | Initiation of a phase 1/2a trial |
Avenge Bio | AVB-001 | Relapsed refractory ovarian cancer | Initiation of a phase 1/2 trial |
Hemab Therapeutics | HMB-001 | Glanzmann thrombasthenia | Initiation of a phase 1/2 trial |
Surface Oncology | SRF114 | Advanced solid tumors | Initiation of a phase 1/2 trial |
Bexion Pharmaceuticals | BXQ-350 plus mFOLFOX7 and bevacizumab | Newly diagnosed metastatic colorectal carcinoma | Initiation of a phase 1b/2 trial |
Alterity Therapeutics | ATH434 | Multiple system atrophy | Initiation of a phase 2 trial |
Compass Therapeutics | CTX-009 | Metastatic colorectal cancer | Initiation of a phase 2 trial |
Glycomine | GLM101 | Phosphomannomutase 2-congenital disorder of glycosylation | Initiation of a phase 2 trial |
Panbela Therapeutics | CPP-1X-T (eflornithine tablets) | Recent-onset type 1 diabetes | Initiation of a phase 2 trial |
Shanton Pharma | SAP-001 | Refractory and tophaceous gout | Initiation of a phase 2b trial |
Cyclo Therapeutics | Trappsol Cyclo | Early Alzheimer’s disease | Initiation of a phase 2b trial |
Biofrontera Bioscience | Ameluz and BF-RhodoLED XL | Actinic keratosis on the extremities, neck and trunk | Initiation of a phase 3 trial |
Maggie’s Pearl | Epalrestat | PMM2-CDG (phosphomannomutase-2-congenital disorder of glycosylation) | Initiation of a phase 3 trial |
Ocuphire Pharma | Nyxol and Nyxol plus adjunctive low-dose pilocarpine therapy | Presbyopia | Initiation of a phase 3 trial |
Zenas BioPharma | Obexelimab | Prevention of IgG4-related disease flare | Initiation of a phase 3 trial |
Innovent Biologics | Mazdutide | Type 2 diabetes | Initiation of a phase 3 trial in China |
Approvals | |||
Biogen Eisai |
Leqembi (lecanemab-irmb) | Alzheimer’s disease | Accelerated approval granted by the FDA |

Upcoming Events
-
14Apr