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Drug & Device Pipeline News
This week’s Pipeline features a phase 1a trial approval for advanced gastrointestinal cancers, a phase 3 trial start for ulcerative pyoderma gangrenosum and an FDA approval for a hypertension device.
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| Grace Science | GS-100 AAV9 gene replacement therapy | NGLY1 deficiency | IND for a phase 1/2/3 trial approved by the FDA |
| Chimeric Therapeutics | CHM 2102 | Advanced colorectal cancer, gastric cancer and neuroendocrine tumors | IND for a phase 1a trial approved by the FDA |
| Cabaletta Bio | CABA-201 | Generalized myasthenia gravis | IND for a phase 1/2 trial approved by the FDA |
| Trials Initiated | |||
| Qualigen Therapeutics | QN-302 | Advanced/metastatic solid tumors | Initiation of a phase 1a trial |
| Kiromic BioPharma | KB-GDT-01 | Metastatic non-small cell lung cancer | Initiation of a phase 1 trial |
| Vaxart | Bivalent GI.1/GII.4 norovirus vaccine | Norovirus | Initiation of a phase 1 trial |
| Molecular Templates | MT-8421 | Advanced solid tumors | Initiation of a phase 1 trial |
| Terns Pharmaceuticals | TERN-601 | Obesity | Initiation of a phase 1 trial |
| BioRay Pharmaceutical | BRY812 | Advanced malignant tumors | Initiation of a phase 1 trial in China |
| Vaxcyte | VAX-31 pneumococcal conjugate vaccine | Invasive pneumococcal disease | Initiation of a phase 1/2 trial |
| Trishula Therapeutics | TTX-030 plus chemotherapy | Metastatic pancreatic ductal adenocarcinoma | Initiation of a phase 2 trial |
| Amydis | AMDX-2011P | Amyloid beta detection in glaucoma patients | Initiation of a phase 2 trial |
| Sunstone Therapies | Psilocybin plus concurrent therapy | Cancer and major depressive disorder in adults | Initiation of a phase 2 trial |
| Trevi Therapeutics | Oral nalbuphine extended release | Refractory chronic cough | Initiation of a phase 2a trial |
| MaaT Pharma | MaaT033 | Blood cancer in patients receiving allo-HSCT | Initiation of a phase 2b trial |
| InflaRx | Vilobelimab | Ulcerative pyoderma gangrenosum | Initiation of a phase 3 trial |
| Approvals | |||
| Takeda | Fruzaqla (fruquintinib) | Previously treated metastatic colorectal cancer | Approved by the FDA |
| Eli Lilly | Zepbound (tirzepatide) | Chronic weight management in adults with obesity or excessive weight with at least one weight-related condition | Approved by the FDA |
| Recor Medical | Paradise Ultrasound Renal Denervation system | Hypertension | Approved by the FDA |
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