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The Zacks Analyst Blog Highlights: Intercept, CymaBay, Amgen, Global Blood Therapeutics and ChemoCentryx

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For Immediate Release

Chicago, IL –November 29, 2019 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Intercept Pharmaceuticals (ICPT - Free Report) , CymaBay (CBAY - Free Report) , Amgen (AMGN - Free Report) , Global Blood Therapeutics (GBT - Free Report) and ChemoCentryx (CCXI - Free Report) .

Here are highlights from Wednesday’s Analyst Blog:

Biotech Stock Roundup: CBAY, CCXI, AMGN and More

It was a busy week for the biotech sector with updates from quite a few companies. While Intercept Pharmaceuticals obtained Priority Review for its New Drug Application (NDA) for NASH drug, CymaBay plunged on termination of NASH study. Amgen upped its guidance after buying Otezla whereas Global Blood Therapeutics obtained FDA approval for its SCD drug.  Meanwhile, ChemoCentryx 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 accepted its New Drug Application (NDA) for obeticholic acid (OCA) seeking accelerated nod for the treatment of fibrosis due to nonalcoholic steatohepatitis (NASH). The agency also granted a Priority Review to the same. Notably, the regulatory authority generally grants priority review to drugs with potential to treat a serious condition and if approved, would provide a significant improvement in safety or effectiveness. The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of Mar 26, 2020, for the NDA. The agency indicated that it currently plans to hold an advisory committee meeting to discuss the application. However, the date for the meet has not been finalized and the timeline for the NDA review is subject to change.

CymaBay Plunges on Termination of NASH Study: Shares of CymaBay plummeted significantly after the company announced that it was terminating its phase IIb study of seladelpar in patients with NASH and its recently initiated phase II study of the drug in patients with primary sclerosing cholangitis (PSC). Moreover, it is putting a hold on all studies of seladelpar in patients with primary biliary cholangitis (PBC). The decision to terminate these studies was based on initial histological findings observed in the phase IIb study of seladelpar for NASH after data showed some patients experiencing some liver damage. These planned, blinded, histological assessments of the first tranche of liver biopsies in the study showed atypical histological findings including histology characterized as an interface hepatitis presentation with or without biliary injury.

You can seethe complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Amgen Buys Otezla, Lifts Outlook: Amgen announced that it has completed the previously-declared acquisition of Celgene’s blockbuster psoriasis drug Otezla, which the latter had to divest in order to complete its merger with Bristol-Myers.  Amgen had to pay Celgene $13.4 billion in cash or approximately $11.2 billion net of anticipated future cash tax benefits for Otezla and certain related assets and liabilities. Otezla is approved to treat psoriasis, psoriatic arthritis and oral ulcers associated with Behçet's disease

Following this buyout, the company raised its overall guidance for 2019. Amgen now expects total revenues in the range of $23.1-$23.3 billion, previously expected within $22.8-$23.0 billion. Adjusted EPS is expected in the band of $14.5 -$14.7 compared with the previous range of $14.20-14.45.

Global Blood Gets FDA Approval for SCD Drug:  Global Blood Therapeutics 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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