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Pipeline
December 21, 2020
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| COVID-19 Trials and Actions | |||
| AbbVie | ABBV-47D11 | adults hospitalized with COVID-19 | initiation of phase 1 trial |
| Codagenix and the Serum Institute of India | COVI-VAC | single-dose intranasal, live attenuated vaccine against SARS-CoV-2 | initiation of phase 1 trial |
| FSD Pharma | FSD201 (ultramicronized palmitoylethanolamide) | hospitalized patients with COVID-19 | first patient dosed in phase 2a trial |
| ARCA Bio | rNAPc2 (AB201) | patients hospitalized with COVID-19 | first patients dosed in phase 2b trial |
| Abpro | ABP 300 | treatment of COVID-19 | initiation of phase 2/3 trial |
| CureVac | CVnCoV | mRNA COVID-19 vaccine | first patient enrolled in phase 2b/3 trial |
| Pfizer BioNTech |
COVID-19 vaccine | COVID-19 | Emergency Use Authorization (EUA) granted by the FDA |
| Abbot | BinaxNOW COVID-19 Ag Card rapid test | detection of COVID-19 infection | EUA granted by the FDA |
| Applied BioCode | BioCode SARS CoV-2 molecular diagnostic assay with pooled patient samples | pooled COVID-19 testing | EUA granted by the FDA |
| Ellume | Ellume rapid, at-home COVID-19 antigen test | home use for the detection of active COVID-19 in individuals with or without symptoms, and in adults and children aged 2 years and above | EUA granted by the FDA |
| Other Trials and Actions | |||
| CNS Pharma | Berubicin | glioblastoma multiforme | IND approved by the FDA |
| Entera Bio | EB613 | osteoporosis | IND approved by the FDA |
| Graphite Bio | GPH101 | severe sickle cell disease | IND approved by the FDA |
| V2ACT Therapeutics | V2ACT | newly diagnosed surgically resectable pancreatic cancer | IND approved by the FDA |
| Arecor | AT278, ultra-concentrated rapid acting insulin | diabetes | first patient dosed in phase 1 trial |
| Kineta | KCP506 | chronic neuropathic pain | first patient dosed in phase 1 trial |
| Liminal BioSciences | fezagepras | idiopathic pulmonary fibrosis | first patient dosed in phase 1 trial |
| Plus Therapeutics | Rhenium NanoLiposome | recurrent glioblastoma | completion of the sixth dosing cohort in phase 1 trial |
| Protagonist Therapeutics | PN-235 (JNJ-77242113) | inflammation | first patient dosed in phase 1 trial |
| Synlogic | SYNB1891 | intratumoral treatment of solid tumors and lymphoma | initiation of combination therapy stage of ongoing phase 1 trial |
| Cerecor | CERC-007 | relapsed or refractory multiple myeloma | first patient dosed in phase 1b trial |
| STALICLA | STP1 | autism spectrum disorder | first patient enrolled in phase 1b trial |
| TFF Pharmaceuticals | Voriconazole Inhalation Powder | aspergillosis infections in patients with asthma | first patient dosed in phase 1b trial |
| Bellicum Pharmaceuticals | BPX-603 | tumors that express human epidermal growth factor 2 | first patient enrolled in phase 1/2 trial |
| Nektar Therapeutics | NKTR-255 | relapsed or refractory head and neck squamous cell carcinoma or colorectal cancer | first patient dosed in phase 1/2 trial |
| Prevail Therapeutics | PR006 | frontotemporal dementia patients with GRN mutations | first patient dosed in phase 1/2 trial |
| Hepion Pharmaceuticals | CRV431 | nonalcoholic steatohepatitis | first patient dosed in second dosing cohort of phase 2a trial |
| PureTech Health | LYT-100 (deupirfenidone) | breast cancer-related, upper limb secondary lymphedema | initiation of phase 2a trial |
| Bellus Health | BLU-5937 | chronic pruritus associated with atopic dermatitis | first patient dosed in phase 2 trial |
| Daiichi Sankyo | datopotamab deruxtecan (DS-1062) | patients with advanced or metastatic nonsmall-cell lung cancer with actionable genomic alterations with progression on or after at least one tyrosine kinase inhibitor and at least one regimen of platinum-based chemotherapy | initiation of phase 2 trial |
| DiaMedica Therapeutics | DM199 | chronic kidney disease | last patient enrolled in phase 2 trial |
| Elysium Health | BASIS | prevention of acute kidney injury in patients that have undergone a cardiac surgery | initiation of phase 2 trial |
| Emalex Biosciences | ecopipam | stuttering | first adult patient dosed in phase 2 trial |
| Harmony Biosciences | pitolisant | excessive daytime sleepiness and other key symptoms in patients with Prader-Willi Syndrome | first patient enrolled in phase 2 trial |
| Innovent | BI310 in combination with TYVY | patients with second-line or above advanced cervical cancer | first patient dosed in phase 2 trial |
| REGENXBIO | suprachoroidal delivery of RGX-314 using the SCS Microinjector | diabetic retinopathy | first patient dosed in phase 2 trial |
| Sanofi | fitusiran | hemophilia A or B | patient dosing resumed in phase 2 trial |
| Verastem Oncology | VS-6766 | KRAS mutant nonsmall-cell lung cancer | initiation of phase 2 trial |
| Kiniska | vixarelimab | prurigo nodularis | patient dosing initiated in phase 2b trial |
| Daiichi Sankyo | datopotamab deruxtecan (DS-1062) | patients with advanced or metastatic nonsmall-cell lung cancer without actionable genomic alterations who have previously received platinum-based chemotherapy and immunotherapy | initiation of phase 3 trial |
| Erytech Pharma | eryaspase | second-line metastatic pancreatic cancer | patient enrollment complete in phase 3 trial |
| Amgen | sotorasib | patients locally advanced or metastatic nonsmall-cell lung cancer with KRAS G12C mutation | Breakthrough Therapy designation granted by the FDA |
| Avelas Biosciences | pegloprastide (AVB-620) | intraoperative detection and visualization of positive margins during breast cancer surgery | Breakthrough Therapy designation granted by the FDA |
| Cyprium Therapeutics | CUTX-101 | Menkes disease | Breakthrough Therapy designation granted by the FDA |
| IO Biotech | IO102 and IO103 with anti-PD-1 mAb | unresectable/ metastatic melanoma | Breakthrough Therapy designation granted by the FDA |
| Novartis | iptacopan (LNP023) | paroxysmal nocturnal hemoglobinuria | Breakthrough Therapy designation granted by the FDA |
| Novartis | iptacopan (LNP023) | C3 glomerulopathy | Rare Pediatric Disease designation granted by the FDA |
| GlaxoSmithKlien | Benlysta | lupus nephritis | approved by the FDA |
| MacroGenics | Margenza (margetuximab-cmkb) | adults with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease | approved by the FDA |
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