Home » Drug & Device Pipeline News - March 4, 2024
Drug & Device Pipeline News - March 4, 2024
March 4, 2024
This week’s Pipeline features a phase 1/2a trial approval for myotonic dystrophy type 1, a phase 3 trial start for intermediate-risk nonmuscle-invasive bladder cancer and an FDA drug approval for complicated urinary tract infections.
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Trials Authorized | |||
Immunofoco | IMC001 | EpCAM-positive advanced gastrointestinal tumors | IND for a phase 1 trial approved by the FDA |
Immunofoco | IMC001 | EpCAM-positive advanced gastrointestinal tumors | Approval for a phase 1 trial granted by China’s regulatory authority |
ARTHEx Biotech | ATX-01 | Myotonic dystrophy type 1 | IND for a phase 1/2a trial approved by the FDA |
Spero Therapeutics | SPR206 | Hospital-acquired and ventilator-associated bacterial pneumonia | IND for a phase 2 trial approved by the FDA |
Everest Medicines Kezar Life Sciences |
Zetomipzomib | Lupus nephritis | Approval for a phase 2b trial granted by China’s regulatory authority |
Trials Initiated | |||
Kura Oncology | Ziftomenib plus gilteritinib | Relapsed/refractory NPM1-mutant or KMT2A-rearranged acute myeloid leukemia | Initiation of a phase 1 trial |
PassPort Technologies | Zolmitriptan PassPort transdermal system | Acute migraine | Initiation of a phase 1 trial |
Dianthus Therapeutics | DNTH103 | Generalized myasthenia gravis | Initiation of a phase 2 trial |
BioLineRx | Motixafortide plus chemotherapy | First-line metastatic pancreatic cancer | Initiation of a phase 2 trial |
CG Oncology | Cretostimogene | Intermediate-risk nonmuscle-invasive bladder cancer | Initiation of a phase 3 trial |
Approvals | |||
Allecra Therapeutics | Exblifep (cefepime/enmetazobactam) | Complicated urinary tract infections including kidney infections | Approved by the FDA |
Gilead Sciences | Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) | HIV patients with suppressed viral loads and known or suspected M184V/I resistance | Approved by the FDA for expanded indication |