New Pipeline Updates from Allergan, Bayer, Genentech and Pfizer

December 3, 2018

Company Drug/Device Medical Condition Status
GlycoMimetics Uproleselan (GMI-1271) Relapsed/refractory acute myeloid leukemia First patient enrolled in global Phase III trial
Sollis Therapeutics Clonidine micropellet Sciatica pain First patient enrolled in the RePRIEVE-CM trial
Stallergenes Greer Sublingual allergy immunotherapy tablet STAGR320 House dust mite (HDM)-induced allergic rhinitis Phase III trial met its primary endpoint with statistical significance in patients treated with STAGR320 compared to patients on placebo
Rocket Pharmaceuticals RP-L201 Severe Leukocyte Adhesion Deficiency-I FDA approved IND for Phase I trial
Pliant Therapeutics PLN-74809 Primary sclerosing cholangitis Granted Orphan Drug designation by FDA
Allergan Avycaz Complicated urinary tract infections and complicated intra-abdominal infections FDA accepted for review sNDA to expand label indication
NovImmune S.A. Gamifant® (emapalumab-lzsg) Primary hemophagocytic lymphohistiocytosis Granted approval by FDA
Pfizer Daurismo™ (glasdegib), to be used in combination with low-dose cytarabine (LDAC) Newly diagnosed acute myeloid leukemia in adults 75 years or older Granted approval by FDA
AbbVie and Genentech Venclexta® (venetoclax) Newly diagnosed acute myeloid leukemia in adults 75 years or older who cannot tolerate intensive chemotherapy Granted accelerated approval by FDA
Synthetic Biologics Synthetic Biologics Antibiotic-mediated Clostridium difficile infection Successfully completed End-of-Phase II meeting; Phase III go-ahead from FDA
Bayer and Loxo Oncology Vitrakvi (larotrectinib) Solid tumors with NTRK gene fusion Granted approval by FDA
HighTide Therapeutics HTD1801 Nonalcoholic steatohepatitis Fast Track designation granted by FDA