New Pipeline Updates from Daiichi Sankyo, Precigen and Altavant Sciences

August 12, 2019

Company Drug/Device Medical Condition Status
Precigen, Inc. PRGN-3005 UltraCAR-T advanced, recurrent platinum resistant ovarian, fallopian tube or primary peritoneal cancer Phase 1 trial initiated
Soricimed Biopharma, Inc. SOR-C13 late stage pancreatic cancer Phase 1b trial initiated enrolling 36 subjects with advanced solid tumor cancers at The University of Texas MD Anderson Cancer Center (MDACC)
89Bio Ltd. BIO89-100 nonalcoholic steatohepatitis (NASH) or nonalcoholic fatty liver disease (NAFLD) and high risk of NASH Phase 1b/2a trial initiated enrolling 83 subjects
Provention Bio, Inc. PRV-3279 lupus Phase 1b/2a trial initiated enrolling 16 healthy volunteers
Eureka Therapeutics, Inc. ET140202 ARTEMIS T-Cell therapy advanced hepatocellular carcinoma (HCC) liver cancer Phase 1/2 trial initiated enrolling subjects with metastatic or locally advanced, inoperable liver cancer and have progressed or have not been able to tolerate at least one line of treatment at City of Hope in Duarte, CA
RegeneRx Biopharmaceuticals, Inc. RGN-137 epidermolysis bullosa (EB) Phase 2 trial initiated
POXEL SA PXL770 NASH Phase 2a trial initiated enrolling 100 subjects with nonalcoholic fatty liver disease (NAFLD) who likely have NASH at sites in the U.S.
Altavant Sciences rodatristat ethyl pulmonary arterial hypertension (PAH) Phase 2a trial initiated enrolling 36 subjects
Astellas Pharma, Inc. fezolinetant moderate-to-severe vasomotor symptoms (VMS) Phase 3 trial initiated enrolling 450 subjects at 20 sites in the U.S., Canada and Europe
Apyx Medical Corporation next-generation J-Plasma Precise Handpiece open and laparoscopic surgical procedures 510(k) clearance granted by the FDA
Alnylam Pharmaceuticals, Inc. givosiran acute hepatic porphyria (AHP) Priority Review granted by the FDA
Provention Bio, Inc. teplizumab (PRV-031) prevention or delay of clinical type 1 diabetes (T1D) in at-risk individuals Breakthrough Therapy designation granted by the FDA
Inotrem S.A. nangibotide (LR12) septic shock IND approval granted by the FDA
Daiichi Sankyo Turalio (pexidartinib) capsules subjects with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery Approval granted by the FDA
Bracco Diagnostics, Inc. VARIBAR THIN LIQUID (barium sulfate) for oral suspension dysphagia Approval granted by the FDA