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Pipeline
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| COVID-19 Trials and Actions | |||
| Arcturus Therapeutics | ARCT-021, COVID-19 vaccine | COVID-19 | IND approved by the FDA for a phase 2 trial |
| Windtree Therapeutics | lucinactant | acute lung injury in adults with COVID-19-associated lung injury and acute respiratory distress syndrome | first patient dosed in phase 2 trial |
| Nirmidas Biotech | MidaSpot COVID-19 Antibody Combo Detection Kit | COVID-19 rapid antibody IgG/IgM test | Emergency Use Authorization granted by the FDA |
| Moderna | COVID-19 Vaccine | COVID-19 | approved by the European Commission |
| Other Trials and Actions | |||
| BlueRock Therapeutics | pluripotent stem cell-derived dopaminergic neurons | Parkinson's disease | IND approved by the FDA |
| CURE Pharma | CUREfilm Blue, an oral soluble film of sildenafil citrate | erectile dysfunction | IND approved by the FDA |
| Forge Biologics | FBX-101 | Krabbe disease | IND approved by the FDA |
| Inozyme | INZ-701 | adults with ENPP1 deficiency | IND approved by the FDA |
| Precigen | PRGN-2012 | recurrent respiratory papillomatosis | IND approved by the FDA |
| Union Therapeutics | oral orismilast | plaque psoriasis in adults | IND approved by the FDA |
| VISEN Pharmaceuticals | TransCon C-Type Natriuretic Peptide | achondroplasia | IND approved by the National Medical Products Administration (NMPA) of the People's Republic of China for a phase 2 trial |
| Everest Medicines | sacituzumab govitecan-hziy | metastatic urothelial cancer | Phase 3 trial authorized by the NMPA of the People's Republic of China |
| F-star Therapeutics | FS222 | advanced malignancies | first patient dosed in phase 1 trial |
| IDEAYA Biosciences | IDE196 and crizotinib | metastatic uveal melanoma | first patient dosed in phase 1 trial |
| Replimune Group | RP3 alone and in combination with anti-PD-1 therapy | advanced solid tumors | first patient dosed in phase 1 trial |
| Vir Biotechnology | VIR-1111; HIV T-cell vaccine | HIV | initiation of phase 1 trial |
| AsclepiX Therapeutics | AXT107 | diabetic macular edema | first patient dosed in phase 1/2a trial |
| Harpoon Therapeutics | HPN328 | Small-cell lung cancer and other tumors associated with DLL3 expression | first patient dosed in phase 1/2 trial |
| Metacrine | MET409 (50 mg) in combination with empagliflozin (Jardiance) | patients with both type 2 diabetes mellitus and nonalcoholic steatohepatitis | first patient dosed in phase 2a trial |
| Aptinyx | NYX-2925 | painful diabetic peripheral neuropathy | patient enrollment recommenced in phase 2 trial |
| Immutep | eftilagimod alpha in combination with Keytruda (pembrolizumab) | head and neck cancer | patient enrollment complete in phase 2 trial |
| Lexicon Pharma | LX9211 | post-herpetic neuralgia | first patients dosed in phase 2 trial |
| Graybug Vision | GB-102 | wet age-related macular degeneration | completion of patient dosing in phase 2b trial |
| Axsome Therapeutics | AXS-05 | Alzheimer’s disease agitation | initiation of phase 3 trial |
| Biohaven Pharma | troriluzole | obsessive-compulsive disorder | initiation of phase 3 trial |
| InflaRx | vilobelimab (IFX-1) | antineutrophil cytoplasmic antibody-associated vasculitis | patient enrollment complete in phase 3 trial |
| Kedrion Pharma | 10% intravenous immunoglobulin | primary immunodeficiency disease | patient enrollment complete in phase 3 trial |
| Ocuphire Pharma | Nyxol | night-vision disturbances | initiation of phase 3 trial |
| Ocuphire Pharma | Nyxol | reversal of pharmacologically induced mydriasis | patient enrollment complete in phase 3 trial |
| PharmaEssentia | ropeginterferon alfa-2b (P1101) | essential thrombocythemia | initiation of phase 3 trial |
| TLC | TLC599 | osteoarthritis knee pain | patient enrollment complete in phase 3 trial |
| Inversago Pharma | INV-101 | Prader-Willi syndrome | Rare Pediatric Disease designation granted by the FDA |
| Genentech | tiragolumab in combination with Tecentriq (atezolizumab) | first-line treatment of patients with metastatic nonsmall-cell lung cancer with high PD-L1 expression with no EGFR or ALK genomic tumor aberrations | Breakthrough Therapy designation granted by the FDA |
| Ascentage Pharma | APG-2575 | acute myeloid leukemia | Orphan Drug designation granted by the FDA |
| Bioserenity | Neuronaute EEG System and IceCap EEG wearable device | remote monitoring of electrical brain activity in patients with epilepsy | approved by the FDA |
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