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Home » Pipeline

Pipeline

June 1, 2020
Company Drug/Device Medical Condition Status
COVID-19 Trials and Actions
Novavax NVX CoV2373 coronavirus vaccine initiation of phase 1/2 trial
RE-Stem Biotech umbilical cord mesenchymal stem cells severe cases of COVID-19 initiation of phase 1/2 trial
ORYZON Genomics vafidemstat severe cases of COVID-19 enrollment of first patient in phase 2 trial
SaNOtize Research and Development Nitric Oxide Releasing Solution prevention and early treatment of COVID-19 enrollment of first patient in phase 2 trial
Genentech

Gilead
Actemra (tocilizumab) plus remdesivir hospitalized patients with severe COVID-19 pneumonia initiation of phase 3 trial
Covis Pharma Alvesco (ciclesonide) non-hospitalized patients 12 years of age and older with symptomatic COVID-19 initiation of phase 3 trial
BioSig Technologies and ViralClear Pharmaceuticals merimepodib oral solution adults with COVID-19 who are hospitalized and either require supplemental oxygen or are on non-invasive ventilation or high-flow oxygen devices IND approved by the FDA
Leading Biosciences LB1148 pulmonary dysfunction associated with COVID-19 pneumonia IND approved by the FDA
NantKwest BM-Allo.MSC acute respiratory distress syndrome (ARDS) caused by COVID-19 IND approved by the FDA
Octapharma USA Octagam 10% [Immune Globulin Intravenous (Human)] COVID-19 patients with severe disease progression IND approved by the FDA
Color LAMP technology Covid-19 testing Emergency Use Authorization (EUA) granted by the FDA
Fulgent Therapeutics RT-PCR test detection of SARS-CoV-2 EUA granted by the FDA
G Medical Innovations Holdings Vital Signs Monitoring System ECG Patch remote monitoring of the QT interval of an ECG for hospitalized patients with COVID-19 being treated with drugs that can prolong QT intervals and may cause fatal arrhythmias EUA granted by the FDA
Hologic Aptima SARS-CoV-2 assay detection of SARS-CoV-2 EUA granted by the FDA
Other Trials and Actions
Anavex Life Sciences ANAVEX 3-71 (AF710B) neurodegenerative diseases initiation of phase 1 trial
Vir Biotechnology VIR-3434 hepatitis B virus initiation of phase 1 trial
Daiichi Sankyo DS-6157 patients with advanced gastrointestinal stromal tumor who have progressed on, or are intolerant to, standard treatment first patient dosed in phase 1 trial
Innovent IBI939 advanced malignancies first patient dosed in phase 1 trial
Poseida Therapeutics P-PSMA-101 metastatic castration-resistant prostate cancer first patient dosed in phase 1 trial
Heron Therapeutics HTX-034 postoperative pain initiation of phase 1/2 trial
Apollomics APL-101 non-small cell lung cancer MET exon 14 skipping mutation, and tumors with MET amplification or fusions initiation of phase 2 trial
Arena Pharma etrasimod moderate-to-severe atopic dermatitis completion of patient enrollment in phase 2b trial
Amplyx Pharmaceuticals fosmanogepix (APX001) Candida infections completion of patient enrollment in phase 2 trial
KBP Biosciences KBP-5074 patients with moderate-to-severe chronic kidney disease and uncontrolled hypertension completion of patient enrollment in phase 2b trial
Cidara Therapeutics rezafungin prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation first patient dosed in phase 3 trial
Oncopeptides AB Melflufen (melphalan flufenamide) relapsed refractory multiple myeloma completion of patient enrollment in phase 3 trial
BioXcel Therapeutics BXCL501 agitation in patients with schizophrenia and bipolar disorder completion of patient enrollment in phase 3 trial
Alethia Biotherapeutics AB-16B5 in combination with docetaxel previously treated subjects with metastatic non-small cell lung cancer with disease progression following treatment with a platinum-containing doublet treatment and an anti-PD1 or PD-L1 immune checkpoint antibody IND approved by the FDA
CARsgen Therapeutics CT041 claudin18.2-targeted CAR-T cell therapy claudin18.2-positive adenocarcinoma of the stomach, gastroesophageal junction or pancreas IND approved by the FDA
Expression Therapeutics ET3 hemophilia A IND approved by the FDA
Novaremed NRD135S.E1 painful diabetic peripheral neuropathy IND approved by the FDA
Qurient Q702 patients with advanced solid tumors for whom standard of care therapies are currently ineffective IND approved by the FDA
Sorrento Therapeutics STI-6129 advanced relapsed and/or refractory systemic amyloid light chain (AL) amyloidosis IND approved by the FDA
Passage Bio PBGM01 GM1 gangliosidosis Rare Pediatric Disease designation granted by the FDA
Azitra ATR-12 Netherton syndrome Rare Pediatric Disease designation granted by the FDA
Seelos Therapeutics SLS-005 Sanfilippo syndrome Rare Pediatric Disease Designation granted by the FDA
Daiichi Sankyo

AstraZeneca
ENHERTU (fam-trastuzumab deruxtecan-nxki) gastric cancer, including gastroesophageal junction cancer Orphan Drug designation granted by the FDA
Daiichi Sankyo

AstraZeneca
ENHERTU (fam-trastuzumab deruxtecan-nxki) patients with metastatic non-small cell lung cancer whose tumors have a HER2 mutation and with disease progression on or after platinum-based therapy Breakthrough Therapy designation granted by the FDA
Orphayzme arimoclomol amyotrophic lateral sclerosis Fast Track designation granted by the FDA
Protara Therapeutics intravenous Choline Chloride intestinal failure-associated liver disease Fast Track designation granted by the FDA
Neuraptive Therapeutics NTX-001 peripheral nerve injuries Fast Track designation granted by the FDA
AstraZeneca

Merck
Lynparza adults with deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer who have progressed following prior treatment with enzalutamide or abiraterone approved by the FDA for additional indication
Bristol-Myers Squibb Pomalyst (pomalidomide) patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy or patients with Kaposi sarcoma who are HIV-negative approved by the FDA
Bristol-Myers Squibb Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) first-line treatment of adults with metastatic non-small cell lung cancer whose tumors express PD-L1with no EGFR or ALK genomic tumor aberrations approved by the FDA for new indication
Clovis Oncology Rubraca (rucaparib) patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy approved by the FDA for new indication
Deciphera Pharmaceuticals QINLOCK (ripretinib) fourth line treatment for adults with advanced gastrointestinal stromal tumor who have received prior treatment with three or more kinase inhibitors, including imatinib approved by the FDA
Genentech Tecentriq (atezolizumab) first-line treatment for metastatic non-small cell lung cancer tumors with high PD-L1 expression or PD-L1 stained tumor-infiltrating with no EGFR or ALK genomic tumor aberrations approved by the FDA for additional indication
Amivas artesunate for injection severe malaria approved by the FDA
Astellas Pharma VESIcare LS (solifenacin succinate) oral suspension neurogenic detrusor overactivity in children <2 years of age approved by the FDA
Chiesi Group Ferriprox (deferiprone) twice daily tablets patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate approved by the FDA for new formulation
Evofem Biosciences Phexxi (lactic acid, citric acid and potassium bitartrate) vaginal gel prevention of pregnancy in females for use as on-demand contraception approved by the FDA
Microbion inhaled pravibismane (BisEDT antimicrobial suspension) pulmonary infections in patients with cystic fibrosis approved by the FDA
Sanofi

Regeneron
Dupixent (dupilumab) children ages 6 to 11 years with moderate-to-severe atopic dermatitis approved by the FDA
Sunovion Pharma Kynmobi (apomorphine HCl) acute, intermittent treatment of OFF episodes in Parkinson’s patients approved by the FDA
Takeda ALUNBRIG (brigatinib) adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer approved by the FDA

 

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