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Pipeline
May 11, 2020
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| COVID-19 Trials and Actions | |||
| Organicell Regenerative Medicine | Organicell Flow | moderate to severe acute respiratory syndrome (SARS) due to COVID-19 infection | IND approved by the FDA |
| Global Institute of Stem Cell Therapy and Research (GIOSTAR) | mesenchymal stem cells | Covid-19 | expanded access for compassionate use granted by the FDA |
| Eiger Biopharmaceuticals | peginterferon lambda | patients with mild COVID-19 | first patient treated in phase 2 trial |
| Pulmotect | PUL-042 | prevention of infection with SARS-CoV-2 and the prevention of disease progression in patients with early COVID-19 disease | approval for two phase 2 trials granted by the FDA |
| Athersys | MultiStem cell therapy | COVID-19 Induced Acute Respiratory Distress Syndrome (ARDS) | enrollment of first patients in phase 2/3 trial |
| Mesoblast | remestemcel-L | COVID-19-infected patients with moderate to severe ARDS on ventilator support | first patients dosed in phase 2/3 trial |
| Aridis Pharmaceuticals | AR-301 | S. aureus induced pneumonia in COVID-19 patients on mechanical ventilators | enrollment of first patient in phase 3 trial |
| Gilead | remdesivir | COVID-19 | Emergency Use Authorization (EUA) granted by the FDA |
| EUROIMMUN (a PerkinElmer company) | Anti-SARS-CoV-2 ELISA (IgG) serology test | detection of COVID-19 antibodies | EUA granted by the FDA |
| Rheonix | Rheonix COVID-19 MDx Assay | detection of SARS-CoV-2 | EUA granted by the FDA |
| Roche | Elecsys Anti-SARS-CoV-2 antibody test | detection of COVID-19 antibodies | approved by the FDA |
| Other Trials and Actions | |||
| Bicycle Therapeutics | BT5528 in combination with nivolumab | advanced solid tumors in indications associated with EphA2 expression | first patient dosed in phase 1 trial |
| Scholar Rock | SRK-181 | locally advanced or metastatic solid tumors | first patients dosed in phase 1 trial |
| Viriom | VM1500A | HIV-infected patients | initiation of phase 2a trial |
| Kubota Vision | emixustat hydrochloride | macular atrophy secondary to Stargardt disease | completion of patient enrollment in phase 3 trial |
| Spero Therapeutics | tebipenem HBr | complicated urinary tract infection and acute pyelonephritis | completion of patient enrollment in phase 3 trial |
| Alume Biosciences | ALM-488 | peptide-dye conjugate for fluorescence highlighting of nerves during head and neck surgery | IND approved by the FDA |
| Green Valley Pharmaceutical | GV-971 | Alzheimer’s disease | IND approved by the FDA |
| Lipocine | LPCN 1148 | liver cirrhosis in adult male cirrhotic patients | IND approved by the FDA |
| Nanobiotix | NBTXR3 | patients with locally advanced or borderline resectable cases of pancreatic ductal adenocarcinoma | IND approved by the FDA |
| GeneTx Biotherapeutics Ultragenyx Pharmaceuticals |
GTX-102 | Angelman syndrome | Fast Track designation granted by the FDA |
| Ascentage Pharma | HQP1351 | chronic myeloid leukemia | Orphan Drug designation granted by the FDA |
| Seelos Therapeutics | SLS-005 | Sanfilippo syndrome | Orphan Drug designation granted by the FDA |
| AstraZeneca | Farxiga (dapagliflozin) | adults with New York Heart Association's functional class II-IV heart failure with reduced ejection fraction | approved by the FDA for new indication |
| Galderma Research | Restylane Kysse | lip augmentation and the correction of wrinkles around upper lips in adults over the age of 21 | approved by the FDA |
| Halozyme Therapeutics Janssen Biotech |
DARZALEX FASPRO (daratumumab hyaluronidase human- fihj) | multiple myeloma | approved by the FDA |
| Novartis | Tabrecta (capmatinib) | NSCLC tumors that have an abnormal mesenchymal-epithelial transition gene that leads to MET exon 14 skipping | approved by the FDA |
| Tolmar Pharmaceuticals | FENSOLVI (leuprolide acetate) | pediatric patients two years of age and older with central precocious puberty | approved by the FDA |
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