Pipeline

April 22, 2019
Company Drug/Device Medical Condition Status
Vaxart, Inc. bivalent norovirus vaccine norovirus Phase Ib trial initiated
Zymeworks, Inc. ZW25 HER2-positive metastatic gastric, gastroesophageal junction, and esophageal adenocarcinomas Phase II trial initiated
Cortexyme, Inc. COR388 mild to moderate Alzheimer’s disease (AD) Phase II/III trial initiated enrolling more than 570 subjects at more than 90 sites across the U.S. and Europe
CStone Pharmaceuticals CS1001 in combination with oxaliplatin and capecitabine (XELOX) chemotherapy unresectable, locally advanced, or metastatic gastric adenocarcinoma (GC) and gastro-esophageal junction (GEJ) adenocarcinoma Phase III trial initiated in China
Alnylam Pharmaceuticals, Inc. lumasiran primary hyperoxaluria type 1 (PH1) Phase III trial initiated enrolling 8 subjects aged 6 years and younger
Ultragenyx Pharmaceutical Inc. UX007 long-chain fatty acid oxidation disorders (LC-FAOD) Rare Pediatric Disease designation granted by the FDA
Elucent Medical EnVisio Surgical Navigation System breast tumors 510(k) clearance granted by the FDA
Aprea Therapeutics APR-246 Myelodysplastic Syndromes (MDS) Fast Track designation granted by the FDA
Ultragenyx Pharmaceutical Inc. UX007 long-chain fatty acid oxidation disorders (LC-FAOD) Fast Track designation granted by the FDA
Janssen Pharmaceuticals Balversa (erdafitinib) locally advanced or metastatic bladder cancer Breakthrough Therapy designation granted by the FDA
Viracta Therapeutics, Inc. nanatinostat in combination with valganciclovir post-transplant lymphoproliferative disorder (PTLD), plasmablastic lymphoma, and angioimmunoblastic T cell lymphoma Orphan Drug designation granted by the FDA
Aprea Therapeutics APR-246 Myelodysplastic Syndromes (MDS) Orphan Drug designation granted by the FDA
Gelesis PLENITY (Gelesis100) weight management Clearance to market granted by the FDA
Circassia Pharmaceuticals, Inc. DUAKLIR PRESSAIR (aclidinium bromide and formoterol fumarate) chronic obstructive pulmonary disease (COPD) Approval granted by the FDA
Intact Vascular, Inc. Tack Endovascular System (6F) peripheral arterial disease (PAD) Approval granted by the FDA

 

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