Biotech Stock Roundup: Amgen Reiterates 2017 Outlook, Intercept Hit By Ocaliva Safety Issues

Biotech stocks like Amgen (NASDAQ:AMGN) and Intercept Pharmaceuticals (NASDAQ:ICPT) were in the news with Amgen providing an update on the impact of Hurricane Maria while Intercept continues to be impacted by Ocaliva safety concerns.

Recap of the Week’s Most Important Stories

Amgen Maintains 2017 Outlook: Amgen, which provided an update on the impact of Hurricane Maria's impact on the company's manufacturing facilities in Puerto Rico, maintained its outlook for 2017. The company said that no product or in-process inventory was lost and the company has enough stock to meet patient demand. At the time of releasing second quarter results, Amgen had guided toward earnings of $12.15-$12.65 per share on total revenues of $22.5-$23.0 billion.

Ocaliva Safety Issues Continue to Hit Intercept: Intercept continues to be impacted by the safety issues surrounding its sole marketed product, Ocaliva. The company’s shares, which were initially hit by a “Dear Doctor” letter earlier this month, saw its shares fall almost 25% on a drug safety communication issued by the FDA last week. Both communications laid emphasis on the importance of the use of the recommended dosage on the label as liver injury, liver decompensation, liver failure, and death were reported when Ocaliva was dosed more frequently than recommended. Ocaliva is approved for use in primary biliary cholangitis (“PBC”) patients. The company is working with the FDA to ensure the appropriate and safe use of Ocaliva. Ocaliva, approved in May 2016, brought in sales of $30.4 million in the second quarter of 2017.

Intercept’s shares are down 43.6% year to date, compared to the industry’s 15.6% rally.

Infinity-Bristol-Myers Clinical Trial Collaboration Expanded: Infinity Pharmaceuticals's (NASDAQ:INFI) existing clinical collaboration with Bristol-Myers Squibb for IPI-549 (a PI3K-gamma inhibitor) plus Opdivo (a PD-1 immune checkpoint inhibitor) has been expanded to include patients with triple negative breast cancer (“TNBC”) who have not been previously exposed to anti-PD-1 or anti-PD-L1 therapy. IPI-549 is currently in a phase I/Ib study in patients with advanced solid tumors.

AbbVie-Bristol-Myers in Clinical Trial Collaboration: AbbVie (NYSE:ABBV) is collaborating with Bristol-Myers Squibb for evaluating a combination of AbbVie's investigational antibody drug conjugate ABBV-399 and Bristol-Myers's immunotherapy Opdivo in c-met overexpressing non-small cell lung cancer (NSCLC). A phase Ib study is ongoing. With cancer remaining a challenging medical condition, several companies are entering into clinical trial collaborations to evaluate different combinations to address the disease.

AbbVie is a Zacks Rank #3 (Hold) stock - you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Performance

Medical - Biomedical and Genetics Industry 5YR % Return

The Nasdaq Biotechnology Index gained 0.4% over the last four trading sessions. Among major biotech stocks, Gilead (NASDAQ:GILD) was up 1.6% while Vertex lost 2.6%. Over the last six months, Vertex (NASDAQ:VRTX) was up 65.7% (See the last biotech stock roundup here: FDA Nod for First Cancer Biosimilar, HALO up on Deals, Raised Outlook).

What's Next in the Biotech World?

Watch out for the usual regulatory and pipeline updates.

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