Biotech Stock Roundup: CBAY Falls, CCXI Gains, Amgen Acquires Otezla & More
Zacks Investment Research | Nov 26, 2019 10:09PM ET
It was a busy week for the biotech sector with updates from quite a few companies. While Intercept Pharmaceuticals (NASDAQ:ICPT) obtained Priority Review for its New Drug Application (NDA) for NASH drug, CymaBay (NASDAQ:CBAY) plunged on termination of NASH study. Amgen (NASDAQ:AMGN) upped its guidance after buying Otezla whereas Global Blood Therapeutics (NASDAQ:GBT) obtained FDA approval for its SCD drug. Meanwhile, ChemoCentryx (NASDAQ:CCXI) soared after it announced positive data from a late-stage study on its rare disease candidate.
Recap of the Week’s Most Important Stories:
Intercept NDA for NASK Drug Gets Priority Review: Intercept Pharmaceuticals announced that the FDA has approved its lead product candidate Oxbryta (voxelotor) as an oral, once-daily treatment for sickle cell disease (SCD) in patients aged 12 years and above. The approval comes almost three months ahead of the scheduled action date of Feb 26, 2020. SCD is a chronic, inherited blood disorder that affects hemoglobin levels. Following this nod, Oxbryta became the first approved therapy that directly inhibits sickle hemoglobin polymerization, a major cause for SCD.
ChemoCentryx Gains on Study Results: ChemoCentryx surged significantly after it announced encouraging top-line data from the phase III study ADVOCATE evaluating its orally-administered selective complement 5a receptor inhibitor, avacopan. The pivotal study evaluated avacopan in patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA vasculitis), a rare disease affecting small blood vessels. Data from the study showed that patients in the study treated with avacopan achieved both primary endpoints of clinical remission at weeks 26 and 52. Clinical remission was statistically superior in the avacopan arm compared to SOC at 52 weeks. The company is planning to file a regulatory application seeking approval for avacopan to treat ANCA vasculitis in the United States and Europe next year.
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