Pipeline

May 18, 2020
Company Drug/Device Medical Condition Status
COVID-19 Trials and Actions
Enlivex Therapeutics Allocetra COVID-19 initiation of phase 2 trial
Bellerophon Therapeutics INOpulse inhaled nitric oxide COVID-19 IND approved by the FDA
Moderna Therapeutics mRNA-1273 COVID-19 vaccine IND approved by the FDA; Fast Track designation granted by the FDA
Pluristem PLX cells severe COVID-19 cases complicated by Acute Respiratory Distress Syndrome (ARDS) IND approved by the FDA
Redhill Biosciences opaganib (Yeliva, ABC294640) moderate-to-severe SARS-CoV-2 infection IND approved by the FDA
Abbott SARS-CoV-2 IgG lab-based serology blood test COVID-19 antibody detection test Emergency Use Authorization (EUA) granted by the FDA
Applied DNA Sciences Linea COVID-19 RT-PCR test SARS-CoV-2 detection EUA granted by the FDA
Quidel the Sofia 2 SARS Antigen FIA rapid detection of SARS-Cov-2 antigens EUA granted by the FDA
Rutgers Clinical Genomics Laboratory Spectrum Solutions LLC SDNA-1000 Saliva Collection Device COVID-19 antibody detection test EUA granted by the FDA
Sherlock Biosciences Sherlock CRISPR SARS-CoV-2 kit rapid detection of SARS-Cov-2 antigens EUA granted by the FDA
Zymo Research Quick SARS-CoV-2 rRT-PCR Kit rapid detection of SARS-Cov-2 antigens EUA granted by the FDA
Other Trials and Actions
Ocular Therapeutix OTX-CSI (cyclosporine intracanalicular insert) dry eye disease dosing of first patient in phase 1 trial
I-Mab Biopharma TJ004309 advanced solid tumors dosing of first patients in phase 1/2 trial
Rubius Therapeutics RTX-240 relapsed/refractory or locally advanced solid tumors dosing of first patients in phase 1/2 trial
Strongbridge Biopharma Recorlev (levoketoconazole) endogenous Cushing’s syndrome completion of patient enrollment in phase 3 trial
AgenTus Therapeutics agenT-797 cancer IND approved by the FDA
Histogen HST 001 androgenic alopecia in men IND approved by the FDA
SciMount Pharmatech SMP-100 Irritable Bowel Syndrome with diarrhea IND approved by the FDA
Amgen

Cytokinetics		 omecamtiv mecarbil chronic heart failure with reduced ejection fraction Fast Track designation granted by the FDA
AstraZeneca

Daichi Sankyo		 Enhertu (fam-trastuzumab deruxtecan-nxki) patients with HER2 positive unresectable or metastatic gastric cancer who have received two or more prior regimens including trastuzumab Breakthrough Therapy designation granted by the FDA
CRISPR Therapeutics

Vertex Pharmaceuticals 		CTX001 severe sickle cell disease and transfusion-dependent beta thalassemia Regenerative Medicine Advanced Therapy designation granted by the FDA
Eli Lilly Retevmo (selpercatinib) adults with metastatic RET fusion-positive non-small cell lung cancer and adult and pediatric patients <12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer or advanced or metastatic RET fusion-positive thyroid cancer approved by the FDA
AstraZeneca

Merck		 Lynparza (olaparib) in combination with bevacizumab first-line maintenance treatment for HRD-positive advanced ovarian cancer approved by the FDA

 

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