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Pipeline
December 14, 2020
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| COVID-19 Trials and Actions | |||
| Sorrento Therapeutics | intravenous (IV) STI-2020 (COVI-AMG) | healthy volunteers and outpatient COVID-19 patients with mild symptoms | IND approved by the FDA |
| Cyxone | rabeximod | patients with moderate Covid-19 | regulatory authority granted in Poland to initiate phase 2 trial |
| Puretech | LYT-100 (deupirfenidone) | long COVID respiratory complications and related sequelae | initiation of phase 2 trial |
| Senhwa Biosciences | silmitasertib | patients with moderate Covid-19 | first patient enrolled in phase 2 trial |
| Inovio Advaccine Biopharmaceuticals Suzhou |
INO-4800 | COVID-19 vaccine | first patient dosed in phase 2 trial in China |
| Inovio | INO-4800 | COVID-19 vaccine | first patient dosed in phase 2/3 trial |
| Moderna | mRNA-1273 | COVID-19 vaccine | first adolescent patients dosed in phase 2/3 study |
| NeuroRx Relief Therapeutics |
RLF-100 (aviptadil) | respiratory failure in patients with critical COVID-19 | patient enrollment complete in phase 2b/3 trial |
| Rheonix | Rheonix COVID-19 MDx Assay | detection of SARS-CoV-2 | expanded Emergency Use Authorization (EUA) to include use of saliva as a sample |
| LabCorp | PIXEL | home test kit for COVID-19 | EUA granted by the FDA |
| Other Trials and Actions | |||
| Alligator Biosciences | mitazalimab | pancreatic cancer | IND approved by the FDA |
| Antengene | ATG-010 (selinexor) combined with R-GDP (SR-GDP) | relapsed/refractory diffuse large B-cell lymphoma | IND approved by China’s National Medical Products Administration |
| Cerecor | CERC-007 | relapsed or refractory multiple myeloma | IND approved by the FDA |
| Eyenovia | MicroLine (pilocarpine) | presbyopia | IND approved by the FDA for a phase 3 trial |
| Altimmune | ALT-801 | nonalcoholic steatohepatitis | first patients dosed in phase 1 trial |
| Cabaletta Bio | DSG3-CAART | mucosal-dominant pemphigus vulgaris | first patients dosed in phase 1 trial |
| Fusion Pharmaceuticals | [225Ac]-FPI-1434 (FPI-1434) | advanced solid tumors | first patient dosed in multi-dose portion of phase 1 study |
| Larimar Therapeutics | CTI-1601 | Friedreich’s ataxia | patient dosing complete in phase 1 trial |
| Panbela Therapeutics | SBP-101 | first-line treatment of patients with metastatic pancreatic ductal adenocarcinoma | patient enrollment complete in phase 1 trial |
| Arcturus Therapeutics | ARCT-810 | ornithine transcarbamylase deficiency | first patients dosed in phase 1b trial |
| Celldex | CDX-0159 | chronic inducible urticaria | first patients dosed in phase 1b trial |
| Arch Oncology | AO-176 | relapsed/refractory multiple myeloma | first patient dosed in phase 1/2 trial |
| OSE Immunotherapeutics | FR104 | patients undergoing renal transplant | approval from French National Agency for Medicines and Health Products Safety and the French Central Ethics Committee for a phase 1/2 trial |
| Spero Therapeutics | SPR720 | nontuberculous mycobacterial pulmonary disease | first patient dosed in phase 2a trial |
| CG Oncology | CG0070 in combination with Keytruda (pembrolizumab) | patients with nonmuscle-invasive bladder cancer unresponsive to Bacillus Calmette-Guerin | first patient dosed in phase 2 trial |
| CytoKinetics | CK-3773274 (CK-274) | hypertrophic cardiomyopathy | first patient dosed in second cohort of phase 2 trial |
| Magenta Therapeutics | MGTA-145 stem cell mobilization therapy | multiple myeloma | initiation of phase 2 trial |
| Sojournix | SJX-653 | moderate to severe vasomotor symptoms due to menopause | phase 2 trial resumed after pause due to COVID-19 |
| Bellus Health | BLU-5937 | refractory chronic cough | first patient dosed in phase 2b trial |
| Monopar Therapeutics | Validive | prevention of chemoradiotherapy-induced severe oral mucositis in patients with oropharyngeal cancer | initiation of phase 2b/3 trial |
| Aldeyra Therapeutics | 0.25% reproxalap ophthalmic solution | dry eye disease | first patient enrolled in phase 3 trial |
| Alnylam | lumasiran | advanced primary hyperoxaluria type 1 | patient enrollment complete in phase 3 trial |
| Arcutis Biotherapeutics | roflumilast 0.3% cream | chronic plaque psoriasis | last patient visit complete in both phase 3 trials |
| Arena Pharmaceuticals | once-daily etrasimod | patients with moderately to severely active ulcerative colitis | patient enrollment complete in phase 3 trial |
| Brickell Biotech | sofpironium bromide gel, 15% | primary axillary hyperhidrosis | first patient dosed in phase 3 trial |
| Novaliq | CyclASol (0.1% cyclosporine A in EyeSol) | chronic dry eye disease | first patient enrolled in phase 3 trial |
| Novocure | Optune concurrent with radiation therapy | newly diagnosed glioblastoma | first patient enrolled in phase 3 trial |
| Relmada Therapeutics | REL-1017 | adjunctive treatment for major depressive disorder | first patient enrolled in phase 3 trial |
| Ultragenyx | UX701 | Wilson disease | Orphan Drug designation granted by the FDA |
| United Therapeutics | treprostinil | idiopathic pulmonary fibrosis | Orphan Drug designation granted by the FDA |
| ReGelTec | Hydrafil | low back pain due to degenerative disc disease | Breakthrough Device designation granted by the FDA |
| Turning Point Therapeutics | repotrectinib | patients with ROS1-positive metastatic nonsmall-cell lung cancer who have not been treated with a ROS1 tyrosine kinase inhibitor | Breakthrough Therapy designation granted by the FDA |
| Advanced Bionics Phonak |
Marvel Cochlear Implant Platform and sound processor | adult and pediatric cochlear implant wearers | approved by the FDA |
| Biocryst | Orladeyo (berotralstat) | prophylaxis to prevent attacks of hereditary angioedema | approved by the FDA |
| Novo Nordisk | Saxenda (liraglutide) injection 3 mg | obesity in adolescents (12–17 years) | approved by the FDA for expanded indication |
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