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Biotech Stock Roundup: Gilead to Get New CEO, Biogen In-Licenses Candidate

It was a pretty ho-hum week for the biotech sector with regular pipeline and regulatory updates. Key news include bigwig Gilead Sciences, Inc. GILD getting a new CEO and shares of Conatus Pharmaceuticals’ CNAT plummeting on the failure of lead candidate in the NASH study.

Recap of the Week’s Top Stories:

Gilead to Get New CEO: Gilead Sciences announced that its board of directors has appointed Daniel O’ Day as the company’s chairman and chief executive officer (CEO). O’Day will take over the reins on Mar 1, 2019. Meanwhile, the board appointed Gregg Alton as interim CEO for the period of Jan 1 to Mar 1, 2019. O’Day is the CEO of the pharmaceutical arm of Roche Holdings (RHHBY) since 2012. The appointment of a veteran leader like O’Day should relieve wary investors as the new CEO will bring leadership experience across multiple therapeutic areas, which is much needed at Gilead. The company has been facing turbulent times lately, and hence O’Day has a tough job in his hands.

Gilead currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Conatus Plummets on Failure of NASH Study: Shares of Conatus Pharmaceuticals plunged after it announced the failure of the phase IIb study, ENCORE, evaluating emricasan for the treatment of nonalcoholic steatohepatitis (NASH). The phase IIb study enrolled two subgroups of patients — one with compensated NASH cirrhosis and the other with early decompensated NASH cirrhosis. The trial mostly enrolled compensated NASH cirrhosis patients. The trial’s primary endpoint was change in mean hepatic venous pressure gradient (HVPG) from baseline to week 24 in any of three emricasan dosing groups compared with placebo. However, the candidate did not meet the primary endpoint. Apart from this, there are two other phase IIb ENCORE studies, which are examining emricasan for the treatment of fibrosis or cirrhosis caused by NASH. The studies are ENCORE-NF (for NASH fibrosis) and ENCORE-LF (for liver function).

Biogen In-Licenses Candidate From Ionis: Biogen Inc. BIIB announced that it exercised its option to obtain a worldwide license to develop and commercialize Ionis Pharmaceuticals’ IONS pipeline candidate, BIIB067 (IONIS-SOD1RX).  BIIB067 is an investigational candidate, currently evaluated for the treatment of amyotrophic lateral sclerosis (ALS) patients with superoxide dismutase 1 (SOD1) mutations. Biogen’s decision was based on positive interim data from a phase I study on the candidate that demonstrated proof-of-biology and proof-of-concept for BIIB067. The study enrolled 70 patients, who were administered with single and multiple-ascending doses of BIIB067. It showed that treatment with the highest dose of BIIB067 over a three-month period led to a statistically significant lowering of SOD1 protein levels in cerebrospinal fluid and slowing of clinical decline as measured by the ALS Functional Rating Scale-Revised compared with placebo.

Exelixis Initiates Liver Cancer Study on Cabometyx: Exelixis, Inc. EXEL along with its French partner, Ipsen, announced the initiation of a pivotal phase III study — COSMIC-312 -to evaluate a Cabometyx (cabozantinib) combination therapy in treatment-naïve advanced hepatocellular carcinoma (“HCC”) patients, a form of liver cancer. Moreover, an exploratory arm will also evaluate Cabometyx monotherapy in the first-line setting for similar patients. The COSMIC-312 study will compare the combination of Cabometyx and Roche’s Tecentriq with Bayer’s Nexavar (sorafenib) in previously untreated patients (n ≈ 640) with advanced HCC. The co-primary endpoints of the study are progression-free survival (“PFS”) and overall survival. Cabometyx is under review in the United States for previously treated advanced HCC patients. A decision is expected by mid-January 2019.


Medical - Biomedical and Genetics Industry 5YR % Return



Medical - Biomedical and Genetics Industry 5YR % Return

The NASDAQ Biotechnology index lost 2.29% in the last five trading sessions. Among the major biotech stocks, Alexion lost 6.11%. Over the past six months, shares of Regeneron have rallied 20.44%, while Celgene has dropped 11.29%. (See the last biotech stock roundup here: Biotech Stock Roundup: ASH Meet in Focus, Gilead's Drugs Get Approval in China).


What's Next in Biotech?

Stay tuned for more regulatory and pipeline updates.

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Conatus Pharmaceuticals Inc. (CNAT) : Free Stock Analysis Report
Exelixis, Inc. (EXEL) : Free Stock Analysis Report
Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report
Biogen Inc. (BIIB) : Free Stock Analysis Report
Ionis Pharmaceuticals, Inc. (IONS) : Free Stock Analysis Report
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