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Pipeline
December 7, 2020
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| COVID-19 Trials and Actions | |||
| Rhizen Pharmaceutical | RP7214 | treatment of SARS-CoV-2 infection | IND approved by the FDA |
| City of Hope | COH04S1 | SARS-CoV-2 vaccine | initiation of phase 1 trial |
| NeoImmuneTech | NT-I7 (efineptakin alfa) | adult patients with mild COVID-19 | first patient dosed in phase 1 trial |
| Capricor Therapeutics | intravenous infusion of CAP-1002 | patients with SARS-CoV-2 who require supplemental oxygen | first patients dosed in phase 2 trial |
| Clear Creek Bio | brequinar | nonhospitalized patients with SARS-CoV-2 who are symptomatic | first patient dosed in phase 2 trial |
| Edesa Biotech | EB05 | hospitalized COVID-19 patients | first patient enrolled in phase 2/3 trial |
| Algernon Pharmaceuticals | NP-120 (Ifenprodil) | hospitalized patients with confirmed COVID-19 | final patient enrolled in phase 2b/3 trial |
| Apilli Therapeutics | Avigan tablets (favipiravir) | post-exposure prophylaxis for COVID-19 | initiation of phase 3 trial |
| Apilli Therapeutics | Avigan tablets (favipiravir) | patients with mild-to-moderate COVID-19 symptoms | initiation of phase 3 trial |
| ARCA Biopharma | AB201 | patients hospitalized with COVID-19 | Fast Track designation granted by the FDA |
| Mesoblast | remestemcel-L | acute respiratory distress syndrome (ARDS) due to COVID-19 infection | Fast Track designation granted by the FDA |
| Eli Lilly Incyte |
Olumiant (baricitinib) plus remdesivir | hospitalized patients diagnosed with COVID-19 who require supplemental oxygen or ventilation | Emergency Use Authorization (EUA) granted by the FDA |
| Pfizer BioNTech |
COVID-19 mRNA vaccine (BNT162b2) | COVID-19 vaccine | EUA granted in the UK |
| Regeneron | casirivimab and imdevimab | mild-to-moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 88 pounds, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization | EUA granted by the FDA |
| Other Trials and Actions | |||
| F-star Therapeutics | FS222 | cancer | clinical trial approved in Spain |
| Orchard Therapeutics | OTL-200 | metachromatic leukodystrophy | IND approved by the FDA |
| GEMoaB | UniCAR-T-PSMA | advanced solid tumors | initiation of phase 1a trial |
| NeuroTherapia | NTRX-07 | Alzheimer's Disease | completion of phase 1a trial |
| American Cryostem | ATCell Expanded Autologous, Adipose-Derived Mesenchymal Stem Cells | post-concussion syndrome in retired military and athletes | initiation of phase 1 trial |
| Bio-Path Holdings | BP1002 | refractory/relapsed lymphoma and chronic lymphocytic leukemia | first patient dosed in phase 1 trial |
| Codagenix | CodaVax-RSV vaccine | prevention of respiratory syncytial virus | patient dosing complete in phase 1 trial |
| F-star Therapeutics | FS120 | advanced cancer | first patient dosed in phase 1 trial |
| IGC Pharma | IGC-AD1 | mild-to-severe dementia due to Alzheimer’s disease | initiation of phase 1 trial |
| Junshi Biosciences | JS108 | advanced solid tumors | first patient dosed in phase 1 trial |
| MapLight Therapeutics | ML-004 | social deficit in autism spectrum disorder | patient dosing complete in phase 1 trial |
| Nordic Nanovector | Betalutin (177Lu lilotomab satetraxetan) | patients with relapsed/refractory diffuse large B-cell lymphoma not eligible for autologous stem cell transplantation | patient enrollment complete in phase 1 trial |
| North Sea Therapeutics | SEFA-1024 | hypertriglyceridemia | first patient dosed in phase 1 trial |
| QPex Biopharma | QPX7728 | drug resistant bacterial infections | initiation of phase 1 trial |
| Silicon Therapeutics | SNX281 | advanced solid tumors or lymphoma | first patients dosed in phase 1 trial |
| Phoenix Molecular Designs | PMD-026 | triple negative breast cancer | first patients dosed in phase 1b trial |
| Ascentage Pharma | APG-2575 | relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma | first patient dosed in phase 1/2 trial in Europe |
| Inovio | INO-3107 | recurrent respirator papillomatosis | first patient dosed in phase 1/2 trial |
| PMV Pharmaceuticals | PC14586 | advanced solid tumors with the specific p53 Y220C variant | first patient dosed in phase 1/2 trial |
| RegenxBio | RGX-111 | mucopolysaccharidosis Type I | first patient dosed in phase 1/2 trial |
| Sio Gene Therapies | AXO-AAV-GM1 | Type I (infantile) and Type II (late infantile and juvenile onset) GM1 gangliosidosis | first patient dosed in high-dose cohort of phase 1/2 trial |
| Turnstone Biologics Takeda |
RIVAL-01/TAK-605 | solid tumors | initiation of phase 1/2 trial |
| Apellis Swedish Orphan Biovitrum |
pegcetacoplan | sporadic amyotrophic lateral sclerosis | first patient dosed in phase 2 trial |
| Apnimed | AD109 | obstructive sleep apnea | first patient dosed in phase 2 trial |
| Athira Pharma | ATH-1017 | mild-to-moderate Alzheimer's disease | first patients dosed in phase 2 trial |
| Cara Therapeutics | oral Korsuva (difelikefalin tablets) | moderate-to-severe pruritus in atopic dermatitis patients | patient enrollment complete in phase 2 trial |
| Istari Oncology | PVSRIPO in combination with Keytruda | recurrent glioblastoma multiforme | first patient dosed in phase 2 trial |
| Oramed | oral insulin capsule ORMD-0801 | nonalcoholic steatohepatitis | initiation of phase 2 trial |
| Rafael Pharma | CPI-613 (devimistat) in combination with hydroxychloroquine | clear cell sarcoma of soft tissue | initiation of phase 2 trial |
| Verastem Oncology | VS-6766 | recurrent low-grade serous ovarian cancer | initiation of phase 2 trial |
| Abivax | ABX464 | ulcerative colitis | patient enrollment complete in phase 2b trial |
| Ionis Pharma AstraZeneca |
ION449 (AZD8233) | dyslipidemia | initiation of phase 2b trial |
| 3S Bio SOBI Selecta Biosciences |
SEL-212 | chronic refractory gout | initiation of phase 3 trial |
| Bausch Health and Bausch + Lomb | NOV03 (perfluorohexyloctane) | dry eye disease associated with Meibomian gland dysfunction | initiation of phase 3 trial |
| Bellerophon Therapeutics | INOpulse | fibrotic interstitial lung disease | first patient enrolled in phase 3 trial |
| Deciphera Pharmaceuticals | Quinlock | second-line gastrointestinal stromal tumor | patient enrollment complete in phase 3 trial |
| Insmed | brensocatib | bronchiectasis | first patient dosed in phase 3 trial |
| Ionis Pharmaceuticals | AKCEA-APOCIII-LRx | adult patients with familial chylomicronemia syndrome | initiation of phase 3 trial |
| Mycovia Pharmaceuticals | teseconazole (VT-1161) | recurrent vulvovaginal candidiasis | last patient visit complete in phase 3 trial |
| Oramed | oral insulin capsule ORMD-0801 | type 2 diabetes | initiation of phase 3 trial |
| PTC Therapeutics | vatiquinone (PTC743) | Friedreich ataxia | initiation of phase 3 trial |
| Phathom Pharmaceuticals | vonoprazan | healing and maintenance of healing of erosive esophagitis; relief of heartburn | patient enrollment complete in phase 3 trial |
| Pfizer | marstacimab (PF-06741086) | severe hemophilia A or B, with or without inhibitors | first patient dosed in phase 3 trial |
| Principa Biopharma | rilzabrutinib | patients with moderate-to-severe pemphigus who are either newly diagnosed or relapsing with chronic disease | patient enrollment complete in phase 3 trial |
| RedHill Biopharma | RHB-204 | pulmonary nontuberculous mycobacteria disease caused by Mycobacterium avium Complex (MAC) | initiation of phase 3 trial |
| Zymeworks | zanidatamab | previously treated HER2 gene-amplified biliary tract cancer | Breakthrough Therapy designation granted by the FDA |
| Moleculin Biotech | WP1066 | diffuse intrinsic pontine glioma, medulloblastoma and atypical teratoid rhabdoid tumor | Rare Pediatric Disease designation granted by the FDA |
| Asklepios BioPharmaceutical Selecta Biosciences |
MMA-101 | isolated methylmalonic acidemia due to methylmalonyl-CoA mutase gene mutations | Orphan Drug designation granted by the FDA |
| Catalyst Biosciences | Marzeptacog alfa | episodic bleeding in subjects with hemophilia A or B with inhibitors | Fast-Track designation granted by the FDA |
| RhoVac | RV001 | prostate cancer | Fast-Track designation granted by the FDA |
| Protagonist Therapeutics | PTG-300 | polycythemia vera | Fast-Track designation granted by the FDA |
| Theralase Technologies | Theralase | Bacillus Calmete Guérin unresponsive nonmuscle-invasive bladder cancer carcinoma In situ | Fast-Track designation granted by the FDA |
| Alnylam Pharmaceuticals | Oxlumo (lumasiran) | primary hyperoxaluria type 1 | approved by the FDA |
| Armis Biopharma | VeriFixx Small Bone Implant | fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe | approved by the FDA |
| Cerus Corporation | INTERCEPT Blood System for Cryoprecipitation | treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency | approved by the FDA |
| Eiger Biopharmaceuticals | Zokinvy (lonafarnib) | Hutchinson-Gilford progeria syndrome and processing-deficient progeroid laminopathies | approved by the FDA |
| Genentech | Xofluza (baloxavir marboxil) | post-exposure prevention of influenza for patients 12 years of age and older after contact with an individual who has the flu | approved by the FDA for expanded indication |
| Genentech | Gavreto (pralsetinib) | adults and children over 12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy, or with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory | approved by the FDA |
| Novartis | Xolair (omalizumab) | add-on maintenance treatment of nasal polyps in adults over 18 years of age with inadequate response to nasal corticosteroids | approved by the FDA for expanded indication |
| Profound Medical Group | Sonalleve | osteoid osteoma | approved by the FDA under a Humanitarian Device Exemption |
| Rhythm Pharmaceuticals | Imcivree (setmelanotide) | chronic weight management in adults and pediatrics over the age of six with obesity due to proopiomelanocortin, proprotein convertase subtilisin/kexin type 1 or leptin receptor deficiency confirmed by genetic testing | approved by the FDA |
| Viatris ViiV Healthcare |
pediatric dolutegravir tablets for oral suspension, 10 mg | treatment of HIV-1 infected pediatric patients at least 4 weeks old and weighing at least 6.6 pounds | tentative approval granted by the FDA under the U.S. President's Emergency Plan for AIDS Relief |
| Y-mAbs Therapeutics | Danyleza (naxitamab-gqgk) | patients with relapsed or refractory high-risk neuroblastoma | approved by the FDA |
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