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Pipeline
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| MyoKardia, Inc. | MYK-224 | hypertrophic cardiomyopathy (HCM) | Phase 1 trial initiated enrolling healthy adults |
| Bio-Thera Solutions, Ltd. | single subcutaneous dose of either BAT2506 or EU-sourced Simponi (golimumab) | ulcerative colitis | Phase 1 trial initiated enrolling 182 subjects |
| Kite Pharma, a Gilead company | KITE-439 | HPV-associated cancers with HPV type 16, a strain which causes about 70% of all cervical cancers worldwide, as well as oropharyngeal, anal, penile and vaginal cancers | Phase 1 trial initiated enrolling subjects who must be HLA-A*02:01 positive, relapsed or refractory after at least one line of therapy at City of Hope in Duarte, CA |
| NKMax America | SNK | plaque psoriasis | Phase 1 trial initiated enrolling nine subjects with mild to severe plaque psoriasis in Tijuana, Mexico |
| Forendo Pharma | HSD17B1 inhibitor FOR-6219 | endometriosis | Phase 1b trial initiated enrolling healthy premenopausal women |
| BioInvent International AB | BI-1206 in combination with pembrolizumab (Keytruda) | solid tumors | Phase 1/2a trial initiated enrolling subjects with advanced solid tumors, who have been previously treated with anti-PD1 or anti-PD-L1 antibodies |
| Rocket Pharmaceuticals, Inc. | RP-L102 | Fanconi anemia | Phase 2 trial initiated enrolling up to five pediatric patients who have not developed severe bone marrow failure in Europe |
| Landos Biopharma | BT-11 | mild to moderate ulcerative colitis (UC) | Phase 2 trial initiated enrolling 195 UC subjects with mild to moderate disease in 11 countries with 60 sites throughout the U.S., Europe and Eastern Europe. |
| Inovio Pharmaceuticals, Inc. | VGX-3100 immunotherapy | human papillomavirus (HPV) | Phase 2 trial initiated enrolling 24 subjects with precancerous lesions of the anus, i.e. anal high-grade squamous intraepithelial lesions (anal HSIL, aka anal intraepithelial neoplasia) |
| Knopp Biosciences LLC | oral dexpramipexole | eosinophilic asthma | Phase 2 trial initiated enrolling 100 subjects with moderate-to-severe eosinophilic asthma |
| Emalex Biosciences, Inc. | ecopipam HCl tablets | Tourette Syndrome (TS) | Phase 2b trial initiated enrolling 150 children and adolescent subjects (aged >6 to <18 years) at multiple centers in the United States, Canada, and the European Union |
| Satsuma Pharmaceuticals, Inc. | STS101 (dihydroergotamine (DHE) nasal powder) | acute treatment of migraine | Phase 3 trial initiated enrolling 1,140 subjects at sites across U.S. |
| ActoBio Theraputics, Inc. | AG017 | celiac disease | IND approval granted by the FDA |
| Vyaire Medical, Inc. | Vyntus ONE | Pulmonary Function Testing (PFT) | 510(k) clearance granted by the FDA |
| Vyaire Medical, Inc. | Vyntus BODY with SentrySuite Software | Pulmonary Function Testing (PFT) | 510(k) clearance granted by the FDA |
| Moderna, Inc. | mRNA-1893 | Zika virus infection | Fast Track designation granted by the FDA |
| Genentech | Rozlytrek (entrectinib) | ROS1-positive, metastatic non-small cell lung cancer (NSCLC) | Accelerated approval granted by the FDA |
| CVRx, Inc. | BAROSTIM NEO device for heart failure | Chronic heart failure | Premarket approval granted by the FDA |
| Nabriva Therapeutics | Xenleta (lefamulin) | community-acquired bacterial pneumonia | Approval granted by the FDA |
| AbbVie | Rinvoq (upadacitinib) | moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX-IR) | Approval granted by the FDA |
| Boston Scientific Corporation | ImageReady MRI labeling for the Vercise Gevia Deep Brain Stimulation (DBS) System | Parkinson's Disease | Approval granted by the FDA |
| Zimmer Biomet | The Tether anterior vertebral body tethering (AVBT) solution | scoliosis, providing a fusion-less alternative for young patients requiring surgery | Approval granted by the FDA |
| Celgene | Inrebic (fedratinib) capsules | Myelofibrosis | Approval granted by the FDA |
| TB Alliance | Pretomanid tablets in combination with bedaquiline and linezolid | Extensively Drug-Resistant Tuberculosis (XDR-TB) and treatment intolerant/non-responsive Multidrug-Resistant (MDR) TB | Approval granted by the FDA |
| Harmony Biosciences LLC | WAKIX (pitolisant) | excessive daytime sleepiness (EDS) in adult patients with narcolepsy | Approval granted by the FDA |
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