Drug & Device Pipeline News
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| Glenmark Specialty | GRC 54276 | Advanced solid tumors and lymphomas | IND for a phase 1/2 trial approved by the FDA |
| Sapience Therapeutics | ST316 | Solid tumors | IND for a phase 1/2 trial approved by the FDA |
| Cognition Therapeutics | CT1812 | Geographic atrophy secondary to dry age-related macular degeneration | IND for a phase 2 trial approved by the FDA |
| Vivasure Medical | Vivasure PerQseal closure system | Percutaneous vessel closure following percutaneous cardiovascular procedures | IDE approved by the FDA |
| Trials Initiated | |||
| Bio-Thera Solutions | BAT8007 | Advanced solid tumors | Initiation of a phase 1 trial |
| ITM Isotope Technologies | ITM-31 | Malignant glioblastoma | Initiation of a phase 1 trial |
| Anaveon | ANV419 | Relapsed/refractory multiple myeloma | Initiation of a phase 1/2 trial |
| Alterity Therapeutics | ATH434 | Multiple system atrophy | Initiation of a phase 2 trial |
| First Wave BioPharma | Enhanced adrulipase formulation | Exocrine pancreatic insufficiency in patients with cystic fibrosis | Initiation of a phase 2 trial |
| Microbion | Topical pravibismane | Moderate chronic diabetic foot ulcer infections | Initiation of a phase 2 trial |
| Tonix Pharmaceuticals | TNX-601 ER | Major depressive disorder | Initiation of a phase 2 trial |
| Immutep | Eftilagimod alpha plus paclitaxel | Metastatic HER2-/low breast cancer | Initiation of a phase 2/3 trial |
| Sermonix Pharmaceuticals | Lasofoxifene plus abemaciclib | Locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation | Initiation of a phase 3 trial |
| Approvals | |||
| Acadia Pharmaceuticals | Daybue (trofinetide) | Rett syndrome in adults and pediatric patients two and older | Approved by the FDA |
| Pfizer | Zavzpret (zavegepant) | Acute treatment of migraines with or without aura | Approved by the FDA |
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