Drug & Device Pipeline News
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| 4D Molecular Therapeutics | 4D-150 | Wet age-related macular degeneration | IND approved by the FDA |
| 4D Molecular Therapeutics | 4D-710 | Cystic fibrosis | IND approved by the FDA |
| Tenax Therapeutics | Delayed-release imatinib | Pulmonary arterial hypertension | IND approved by the FDA |
| Cocrystal Pharma | CC-42344 | Pandemic and seasonal influenza A | Approval for a phase 1 trial granted by Australia’s regulatory authority |
| Revelation Biosciences | REVTx-99 | Allergic rhinitis and chronic nasal congestion | Approval for a phase 1b trial granted by Australia’s regulatory authority |
| Intellia Therapeutics | NTLA-2002 | Adults with hereditary angioedema | Approval for a phase 1/2 trial granted by New Zealand’s regulatory authority |
| Pharmaxis | PXS-5505 | Bone marrow cancer myelofibrosis | Approval for the phase 2 portion of a phase 1c/2a trial approved by the FDA |
| Trials Initiated | |||
| AlzeCure Pharma | ACD856 | Alzheimer’s disease | Initiation of phase 1 trial |
| Antares Pharma | ATRS-1902 | Adrenal crisis rescue | Initiation of phase 1 trial |
| Appello Pharmaceuticals | AP-472 | Parkinson’s disease | Initiation of phase 1 trial |
| Dialectic Therapeutics | DT2216 | Relapsed or refractory solid tumor and hematologic malignancies | Initiation of phase 1 trial |
| Inhalon Biopharma | IN-006 | Treatment of COVID-19 | Initiation of phase 1 trial |
| Rafael Pharmaceuticals | CPI-613 (devimistat) in combination with hydroxychloroquine | Clear-cell sarcoma | Initiation of phase 1 trial |
| Altimmune | pemvidutide | Nonalcoholic fatty liver disease | Initiation of phase 1b trial |
| Elicio Therapeutics | ELI-002 | mKRAS+ solid tumors | Initiation of phase 1/2 trial |
| Lutris Pharma | LUT014 | Radiation-induced dermatitis in breast cancer patients | Initiation of part two of phase 1/2 trial |
| Precirix NV | CAM-H2 | HER2-positive metastatic cancer | Initiation of phase 1/2 trial |
| Viracta Therapeutics | nanatinostat plus valganciclovir | EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors | Initiation of phase 1b/2 trial |
| Boston Pharmaceuticals | BOS-580 | Nonalcoholic fatty liver disease and/or nonalcoholic steatohepatitis | Initiation of phase 2a trial |
| BioNTech | BNT122 (autogene cevumeran) personalized vaccine | Stage II/III colorectal cancer | Initiation of phase 2 trial |
| Covicept Therapeutics | PSJ-539 | Mild-to-moderate COVID-19 | Initiation of phase 2 trial |
| PharmaTher Holdings | ketamine | Levodopa-induced dyskinesia in patients with Parkinson’s disease | Initiation of phase 2 trial |
| Vaxart | COVID-19 oral tablet vaccine | Prevention of COVID-19 | Initiation of phase 2 trial |
| Cassava Sciences | simufilam | Alzheimer’s disease | Initiation of phase 3 trial |
| VYNE Therapeutics | Amzeeq (minocycline) topical foam, 4% | Moderate-to-severe acne | Initiation of phase 3 trial in China |
| Approvals | |||
| PerkinElmer | PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 assay | RT-PCR test to detect and differentiate SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus | Emergency Use Authorization granted by the FDA |
| Kite Pharmaceuticals | Tecartus (brexucabtagene autoleucel) | Adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia | Approved by the FDA |
| ChoiceSpine | Triton sacroiliac joint fixation system | Degenerative sacroiliitis and sacroiliac joint disruption | Approved by the FDA |
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