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Pipeline
May 6, 2019
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Forbius | AVID200 | myelofibrosis (MF) | Phase I trial initiated |
| Tetra Discovery Partners | BPN14770 | early Alzheimer’s disease (AD) | Phase II trial initiated enrolling 255 subjects ages 55-85 in 60 sites across the U.S. |
| Axovant Gene Therapies, Ltd. | AXO-Lenti-PD | Parkinson’s disease | Phase II trial initiated enrolling 60 subjects |
| 3-V Biosciences, Inc. | TVB-2640 | non-alcoholic steatohepatitis (NASH) | Phase II trial initiated enrolling 90 subjects in the U.S. and 25-30 subjects in China |
| OMEICOS Therapeutics | OMT-28 | persistent atrial fibrillation (AF) | Phase II trial initiated enrolling 120 subjects at sites in four European countries |
| Exelixis | cabozantinib (CABOMETYX) in combination with nivolumab (Opdivo) and ipilimumab (Yervoy) versus nivolumab and ipilimumab | previously untreated advanced renal cell carcinoma (RCC) | Phase III trial initiated enrolling 676 subjects at 150 sites globally |
| I-Mab Biopharma and MorphoSys AG | TJ202/MOR202 | relapsed or refractory multiple myeloma | Phase III trial initiated enrolling 291 subjects at sites in China and Taiwan |
| ACADIA Pharmaceuticals, Inc. | pimavanserin | major depressive disorder (MDD) | Phase III trial initiated enrolling 280 subjects at sites in the U.S. |
| CoapTech, LLC | PUMA-G System | gastrostomy | 510(k) clearance granted by the FDA |
| Purdue Pharma, L.P. | nalmefene hydrochloride (HCl) injection | emergency treatment of known or suspected opioid overdose | Competitive Generic Therapy (CGT) designation granted by the FDA |
| Belite Bio | LBS-008 (BPN-14967) | atrophic age-related macular degeneration and Stargardt disease | IND approval granted by the FDA |
| AVROBIO, Inc. | AVR-RD-01 | Fabry disease | IND approval granted by the FDA |
| Finch Therapeutics Group, Inc. | Full-Spectrum Microbiota (FSM) | pediatric Autism Spectrum Disorder (ASD) | Fast Track designation granted by the FDA |
| Bayer | darolutamide | non-metastatic castration-resistant prostate cancer (nmCRPC) | Priority Review designation granted by the FDA |
| GlaxoSmithKline | Benlysta (belimumab) intravenous (IV) infusion | pediatric systemic lupus erythematosus (SLE) | Priority Review designation granted by the FDA |
| United Therapeutics Corporation and XVIVO Perfusion, Inc. | XPS and STEEN Solution | ex-vivo lung perfusion (EVLP) | PMA approval granted by the FDA |
| Samsung Bioepis Co., Ltd. | ETICOVO (etanercept-ykro) | rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis | Approval granted by the FDA |
| Regeneron Pharmaceuticals, Inc. and Sanofi | Praluent (alirocumab) | reduce the risk of heart attack, stroke and unstable angina requiring hospitalization in adults with established cardiovascular (CV) disease | Approval granted by the FDA |
| Bausch Health Companies, Inc. | DUOBRII (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% | plaque psoriasis in adults | Approval granted by the FDA |
