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Home » Pipeline

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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