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Pipeline
February 8, 2021
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| COVID-19 Trials and Actions | |||
| Selva Therapeutics | SLV213 | nonhospitalized COVID-19 patients | completion of phase 1 trial |
| Valneva | VLA2001 | COVID-19 vaccine | patient enrollment complete in phase 1/2 trial |
| Arch Biopartners | LSALT peptide (Metablok) | acute lung injury and acute kidney injury caused by inflammation in patients with severe cases of COVID-19 | approval from ethics committee in Turkey to dose 20 additional patients in phase 2 trial |
| Atea Pharmaceuticals | AT-527 | mild or moderate COVID-19 patients | first patient dosed in phase 2 trial |
| Biophytis | Sarconeos (BIO101) | acute respiratory failure associated with COVID-19 | initiation of patient recruitment in the U.S. and Brazil in part 2 of phase 2/3 trial |
| NeuroRx | inhaled Zyesami (aviptadil) | severe COVID-19 | initiation of phase 2/3 trial |
| Corvus Pharma | CPI-006 | hospitalized patients with COVID-19 | initiation of phase 3 trial |
| Humanigen | lenzilumab | hospitalized and hypoxic patients with COVID-19 pneumonia | patient enrollment complete in phase 3 trial |
| Other Trials and Actions | |||
| KemPharm | KP879 | stimulant use disorder | IND approved by the FDA |
| Tetra Bio-Pharma | QIXLEEF | cancer patients with breakthrough pain | IND approved by the FDA |
| Vertex Pharmaceuticals | VX-880 | type 1 diabetes | IND approved by the FDA |
| Crinetics Pharmaceuticals | CRN04894 | Cushing’s disease and congenital adrenal hyperplasia | initiation of phase 1 trial |
| Daiichi Sankyo | DS-6000 | patients with advanced renal cell carcinoma or ovarian cancer with disease progression following standard treatment | first patient dosed in phase 1 trial |
| Dynavax Serum Institute of India |
tetanus, diphtheria and acellular pertussis (Tdap) booster vaccine adjuvanted with CpG 1018 | prevention of tetanus, diphtheria and acellular pertussis | first patient dosed in phase 1 trial |
| Kira Pharmaceuticals | P014 | complement-mediated diseases | first patient dosed in phase 1 trial |
| LB Pharmaceuticals | LB-102 | acute schizophrenia | first patient dosed in phase 1b trial |
| BridgeBio Pharma Venthera |
BBP-68/ VT30 topical gel | patients with venous, lymphatic and venolymphatic malformations | first patient dosed in phase 1/2 trial |
| Exonate Johnson & Johnson |
EXN 407 | center-involved diabetic macular edema | first patient dosed in phase 1b/2 trial |
| ImCyse | IMCY-0098 | recent onset type 1 diabetes | first patients dosed in phase 1b/2a trial |
| Sio Gene Therapies | AXO-AAV-GM2 | GM2 gangliosidosis | first patient dosed in phase 1/2 trial |
| Spark Therapeutics | SPK-3006 | late-onset Pompe disease | first patient dosed in phase 1/2 trial |
| Chemomab | CM-101 | primary sclerosing cholangitis | first patient enrolled in phase 2a trial |
| Gemini Therapeutics | GEM103 | patients with wet AMD who have, or may be at risk for, macular atrophy but require ongoing anti-VEGF treatment | initiation of phase 2a trial |
| ADC Therapeutics | camidanlumab tesirine (ADCT-301) | relapsed or refractory Hodgkin lymphoma | completion of patient enrollment in phase 2 trial |
| Curis | CA-4948 | anemia in patients with very low-, low- or intermediate-risk myelodysplastic syndromes | initiation of phase 2 trial |
| Daiichi Sankyo | patritumab deruxtecan | patients with EGFR-mutated metastatic or locally advanced nonsmall-cell lung cancer previously treated with a TKI and platinum-based chemotherapy | initiation of phase 2 trial |
| I-Mab | TJ107 (efineptakin alpha) | glioblastoma multiforme | first patients dosed in phase 2 trial in China |
| Surface Ophthalmics | SURF-200 (betamethasone in Klarity vehicle) | acute dry eye | first patients dosed in phase 2 trial |
| Viacyte | VC01-103, encapsulated cell therapy | type 1 diabetes | first patients dosed in phase 2 trial |
| Arena Pharmaceuticals | etrasimod | moderately to severely active ulcerative colitis | patient enrollment complete in phase 3 trial |
| Novan | SB206 | molluscum contagiosum | patient enrollment complete in phase 3 trial |
| VectivBio | apraglutide | short bowel syndrome | first patient dosed in phase 3 trial |
| Chinook Therapeutics | CHK-336 | primary hyperoxaluria | Rare Pediatric Disease designation granted by the FDA |
| Cerecor | CERC-803 | leukocyte adhesion deficiency type II | Fast-Track designation granted by the FDA |
| Gan & Lee Pharmaceuticals | GLR2007 | glioblastoma | Fast-Track designation granted by the FDA |
| Theratechnologies | TH1902 | sortilin-positive recurrent advanced solid tumors that are refractory to standard therapy | Fast-Track designation granted by the FDA |
| Adamas Pharmaceuticals | Gocovri (amantadine) extended-release capsules | adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF episodes | approved by the FDA for expanded indication |
| Biocryst Pharma | Rapivab (peramivir injection) | acute uncomplicated influenza in patients six months and older who have been symptomatic for no more than two days | approved by the FDA for expanded indication |
| Biogen | Plegridy (peginterferon beta-1a) | relapsing forms of multiple sclerosis | approved by the FDA for new intramuscular injection route of administration |
| DURECT | Posimir (bupivacaine solution) | postsurgical pain for up to 72 hours following arthroscopic subacromial decompression | approved by the FDA |
| Galderma | Restylane Defyne | chin augmentation | approved by the FDA |
| Johnson & Johnson | TECNIS Eyhance and TECNIS Eyhance Toric II intraocular lens | cataract patients with or without astigmatism | approved by the FDA |
| Medtronic | DiamondTemp Ablation (DTA) system | patients with recurrent, symptomatic paroxysmal atrial fibrillation and who have been unresponsive to drug therapy | approved by the FDA |
| Merck KGaA | Tepmetko (tepotinib) | adults with metastatic nonsmall-cell lung cancer who have a MET exon 14 skipping alteration | approved by the FDA |
| Soliton | Rapid Acoustic Pulse technology | short-term improvement in the appearance of cellulite | approved by the FDA |
| Astellas | Xospata (gilteritinib) | relapsed or refractory acute myeloid leukemia with a FLT3 mutation | approved in China |
| Innovent Eli Lilly |
Tyvyt (sintilimab injection) in combination with pemetrexed and platinum chemotherapy | first-line therapy for nonsquamous nonsmall-cell lung cancer | approved in China for new indication |
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