Biotech Stock Roundup: Amgen, Gilead Report 4Q Results, ARIAD Seeks EU Nod for Brigatinib

Major biotech stocks like Amgen AMGN and Gilead GILD reported fourth quarter results -- while both topped estimates, revenue outlook fell short of expectations.

Recap of the Week’s Most Important Stories

Amgen Delivers Strong Quarter but Sales Guidance Falls Short: Amgen’s fourth quarter results were better-than-expected with the company beating on all fronts. The company also came out with highly awaited cardiovascular outcomes data on its PCSK9 inhibitor, Repatha (Read more: Amgen Q4 Earnings Top; Repatha Positive in CV Study). While Amgen’s results impressed, concerns remain about the sustainability of the performance considering the challenges being faced by the company’s mature brands. Volume growth of recently launched products may not be enough to offset the decline in mature brands. Neulasta could start facing biosimilar competition in the fourth quarter of the year. Over the last one year, Amgen has significantly outperformed the Zacks-categorized Medical-Biomedical/Genetics industry with shares gaining 16.7% during this period compared to the industry decline of 0.2%.

Gilead’s Sales Outlook Disappoints: Although Gilead’s 4Q results topped estimates, the company’s sales outlook for 2017 disappointed. Hepatitis C virus (HCV) franchise sales continued declining and will remain under pressure in 2017 given the changing dynamics in HCV markets across the world. Gilead expects fewer patient starts in 2017. Gilead’s shares were down in pre-market trading. Over the last one year, the company has significantly underperformed the Zacks-categorized Medical-Biomedical/Genetics industry with shares declining almost 18% during this period. Gilead is a Zacks Rank #3 (Hold) stock.You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

GW Pharma to Advance Cancer R&D Efforts: GW Pharmaceuticals GWPH, which is often in the news related to the development of treatments based on its proprietary cannabinoid product platform, announced positive top-line data from an exploratory phase II study of a proprietary combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) in patients with recurrent glioblastoma multiforme (GBM). The results support the potential use of cannabinoids in the field of oncology. The company has orphan drug status in the U.S. and the EU for the THC:CBD combination in glioma. GBM, a particularly aggressive brain tumor with a poor prognosis, is one of the most common primary brain tumors.

Stemline Provides Update on SL-401: Stemline Therapeutics STML provided an update on its ongoing pivotal phase II study on SL-401 for blastic plasmacytoid dendritic cell neoplasm (BPDCN). The company said that it got to know about a patient death in the study on Jan 18. The company said that the patient had developed capillary leak syndrome (CLS). The company noted that CLS is a known, sometimes fatal, and well-documented side effect of SL-401 and that earlier too, deaths were reported in patients with CLS in the study. Stemline pointed out that these deaths were disclosed in public presentations.

Although the latest patient death raises concerns about the experimental treatment’s safety profile, Stemline said that it remains on track for a BLA submission as announced earlier -- the company expects to file a BLA in the second half of the year and potentially launch the product in 2018, if all goes as per schedule.

ARIAD Files for EU Approval of Brigatinib: ARIAD ARIA, which is set to be acquired by Takeda for $5.2 billion, said that it has submitted a regulatory application in the EU for its investigational ALK inhibitor, brigatinib, for the treatment of adult patients with ALK+ non-small cell lung cancer (NSCLC) who have been previously treated with Xalkori (crizotinib). Brigatinib is currently under FDA review with a response expected by Apr 29, 2017 (Read more: ARIAD Files for EU Approval of Lung Cancer Drug Brigatinib).

Performance

Medical - Biomedical and Genetics Industry 5YR % Return

Medical - Biomedical and Genetics Industry 5YR % Return

The NASDAQ Biotechnology Index gained 1.5% over the last five trading days. Among major biotech stocks, Amgen was up 6.5% on Q4 results while Biogen BIIB declined 4%. Over the last six months, Celgene was up 0.6% while Biogen lost 15.8%. (See the last biotech stock roundup here: Celgene, Biogen, ABBV Post Q4 Results, Catabasis Falls on DMD Data).

What's Next in the Biotech World?

Watch out for earnings results from companies like Regeneron REGN this week and the usual pipeline and regulatory updates.

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Regeneron Pharmaceuticals, Inc. (REGN): Free Stock Analysis Report
 
Gilead Sciences, Inc. (GILD): Free Stock Analysis Report
 
Amgen Inc. (AMGN): Free Stock Analysis Report
 
Biogen Inc. (BIIB): Free Stock Analysis Report
 
Stemline Therapeutics, Inc. (STML): Free Stock Analysis Report
 
ARIAD Pharmaceuticals, Inc. (ARIA): Free Stock Analysis Report
 
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