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Pipeline
May 18, 2020
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| COVID-19 Trials and Actions | |||
| Enlivex Therapeutics | Allocetra | COVID-19 | initiation of phase 2 trial |
| Bellerophon Therapeutics | INOpulse inhaled nitric oxide | COVID-19 | IND approved by the FDA |
| Moderna Therapeutics | mRNA-1273 | COVID-19 vaccine | IND approved by the FDA; Fast Track designation granted by the FDA |
| Pluristem | PLX cells | severe COVID-19 cases complicated by Acute Respiratory Distress Syndrome (ARDS) | IND approved by the FDA |
| Redhill Biosciences | opaganib (Yeliva, ABC294640) | moderate-to-severe SARS-CoV-2 infection | IND approved by the FDA |
| Abbott | SARS-CoV-2 IgG lab-based serology blood test | COVID-19 antibody detection test | Emergency Use Authorization (EUA) granted by the FDA |
| Applied DNA Sciences | Linea COVID-19 RT-PCR test | SARS-CoV-2 detection | EUA granted by the FDA |
| Quidel | the Sofia 2 SARS Antigen FIA | rapid detection of SARS-Cov-2 antigens | EUA granted by the FDA |
| Rutgers Clinical Genomics Laboratory | Spectrum Solutions LLC SDNA-1000 Saliva Collection Device | COVID-19 antibody detection test | EUA granted by the FDA |
| Sherlock Biosciences | Sherlock CRISPR SARS-CoV-2 kit | rapid detection of SARS-Cov-2 antigens | EUA granted by the FDA |
| Zymo Research | Quick SARS-CoV-2 rRT-PCR Kit | rapid detection of SARS-Cov-2 antigens | EUA granted by the FDA |
| Other Trials and Actions | |||
| Ocular Therapeutix | OTX-CSI (cyclosporine intracanalicular insert) | dry eye disease | dosing of first patient in phase 1 trial |
| I-Mab Biopharma | TJ004309 | advanced solid tumors | dosing of first patients in phase 1/2 trial |
| Rubius Therapeutics | RTX-240 | relapsed/refractory or locally advanced solid tumors | dosing of first patients in phase 1/2 trial |
| Strongbridge Biopharma | Recorlev (levoketoconazole) | endogenous Cushing’s syndrome | completion of patient enrollment in phase 3 trial |
| AgenTus Therapeutics | agenT-797 | cancer | IND approved by the FDA |
| Histogen | HST 001 | androgenic alopecia in men | IND approved by the FDA |
| SciMount Pharmatech | SMP-100 | Irritable Bowel Syndrome with diarrhea | IND approved by the FDA |
| Amgen Cytokinetics |
omecamtiv mecarbil | chronic heart failure with reduced ejection fraction | Fast Track designation granted by the FDA |
| AstraZeneca Daichi Sankyo |
Enhertu (fam-trastuzumab deruxtecan-nxki) | patients with HER2 positive unresectable or metastatic gastric cancer who have received two or more prior regimens including trastuzumab | Breakthrough Therapy designation granted by the FDA |
| CRISPR Therapeutics Vertex Pharmaceuticals |
CTX001 | severe sickle cell disease and transfusion-dependent beta thalassemia | Regenerative Medicine Advanced Therapy designation granted by the FDA |
| Eli Lilly | Retevmo (selpercatinib) | adults with metastatic RET fusion-positive non-small cell lung cancer and adult and pediatric patients <12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer or advanced or metastatic RET fusion-positive thyroid cancer | approved by the FDA |
| AstraZeneca Merck |
Lynparza (olaparib) in combination with bevacizumab | first-line maintenance treatment for HRD-positive advanced ovarian cancer | approved by the FDA |
