Drug & Device Pipeline News
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| Biomea Fusion | BMF-500 | Relapsed or refractory acute leukemia with FLT3 mutations | IND for a phase 1 trial approved by the FDA |
| Kiromic BioPharma | Deltacel (KB-GDT-01) | Non-small cell lung cancer | IND for a phase 1 trial approved by the FDA |
| RNAimmune | RV-1730 (SARS-CoV-2 vaccine booster) | COVID-19 | IND for a phase 1 trial approved by the FDA |
| Zevra Therapeutics | KP1077 | Narcolepsy | IND for a phase 1 trial approved by the FDA |
| Atsena Therapeutics | ATSN-201 | X-linked retinoschisis | IND for a phase 1/2 trial approved by the FDA |
| Sequana Medical | DSR 2.0 | Congestive heart failure | IND for a phase 1/2 trial approved by the FDA |
| Protara Therapeutics | TARA-002 | Pediatric patients with lymphatic malformations | IND for a phase 2 trial approved by the FDA |
| Senhwa Biosciences | Silmitasertib (CX-4945) | Treatment of hospitalized patients with moderate-to-severe COVID-19 | IND for a phase 2 trial approved by Taiwan’s regulatory authority |
| Aquavit | DTX-023 (aqubotulinumtoxinA) | Primary axillary hyperhidrosis | IND for a phase 2/3 trial approved by the FDA |
| Aquavit | DTX-024 (aqubotulinumtoxinA with intradermal microinjector) | Palmar hyperhidrosis | IND for a phase 2/3 trial approved by the FDA |
| NLS Pharmaceutics | Quilience (mazindol extended-release) | Narcolepsy | IND for two phase 3 trials approved by the FDA |
| Trials Initiated | |||
| Verismo Therapeutics | SynKIR-110 | Pleural mesothelioma, cholangiocarcinoma and ovarian cancer | Initiation of a phase 1 trial |
| Scorpion Therapeutics | STX-478 | HR+/HER2- breast cancer and other solid tumors | Initiation of a phase 1/2 trial |
| Horizon Therapeutics | Daxdilimab | Lupus nephritis | Initiation of a phase 2 trial |
| OKYO Pharma | OK-101 | Dry eye disease | Initiation of a phase 2 trial |
| Horizon Therapeutics | Tepezza (teprotumumab-trbw) | Chronic/low clinical activity score thyroid eye disease | Initiation of a phase 3 trial in Japan |
| PharmaEssentia | Besremi (ropeginterferon alfa-2b-njft) | Polycythemia vera | Initiation of a phase 3b trial |
| Approvals | |||
| Avadel Pharmaceuticals | Lumryz (sodium oxybate) | Cataplexy or excessive daytime sleepiness in adults with narcolepsy | Approved by the FDA |
| GSK | Arexvy (respiratory syncytial virus vaccine, adjuvanted) | Respiratory syncytial virus in adults age 60 and older | Approved by the FDA |
| Pfizer | Prevnar 20 (20-valent pneumococcal conjugate vaccine) | Invasive pneumococcal disease and otitis media in patients age six weeks through 17 years | Approved by the FDA |
| Otsuka US Lundbeck |
Abilify Asimtufii (aripiprazole) | Treatment of schizophrenia or maintenance monotherapy treatment of bipolar I disorder in adults | Approved by the FDA in a new formulation |
| Teva Pharmaceuticals MedinCell |
Uzedy (risperidone) extended-release injectable suspension | Schizophrenia | Approved by the FDA in a new formulation |
| Vertex Pharmaceuticals | Kalydeco (ivacaftor) | Cystic fibrosis in eligible infants age one month to less than four months | Approved by the FDA for expanded age indication |
| Tempus | xT CDx | Diagnostic for solid tumor profiling | Approved by the FDA |
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