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The Zacks Analyst Blog Highlights: Intercept, Clovis, AbbVie, Relypsa and Horizon Pharma

For Immediate Release

Chicago, IL – April 14, 2016 – 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 (ICPT), Clovis (CLVS), AbbVie (ABBV), Relypsa (RLYP) and Horizon Pharma (HZNP).

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Here are highlights from Wednesday’s Analyst Blog:

Biotech Stock Roundup

Key highlights in the biotech sector this week include a couple of FDA advisory panel meetings -- while Intercept (ICPT) got a favorable recommendation, Clovis ( CLVS) did not fare so well and may be looking at a significant delay in the potential approval of its product.

Meanwhile, AbbVie (ABBV) and partner Roche gained accelerated approval for their leukemia treatment. And this week’s rumored takeover target is Relypsa ( RLYP).

Recap of the Week’s Most Important Stories

1. Clovis suffered a huge setback with the company facing a possible delay in the FDA approval of its lead pipeline candidate, rociletinib. The agency’s advisory panel has recommended that the FDA should wait for results from an ongoing late-stage study (TIGER-3) before deciding on the approval status of the experimental lung cancer treatment.

Clovis, which touched a 52-week low earlier this week on the release of unfavorable briefing documents (Read more: Clovis Hits 52-week Low Post Rociletinib Briefing Documents ), expects patient enrollment in the TIGER-3 study to complete in late 2018. While the FDA is not required to follow the advice of its advisory panels, it usually does so. At present, it does not look likely that the FDA will grant approval on the PDUFA date of Jun 28.

2. Intercept, on the other hand, got a favorable recommendation from an FDA advisory panel which voted unanimously (17-0) in favor of granting accelerated approval to the company’s lead pipeline candidate, Ocaliva, for the treatment of a rare chronic liver disease, primary biliary cholangitis (PBC). With the panel voting in its favor, approval should come by May 29(Read more: Intercept's Ocaliva Gets Favorable FDA Panel Vote ).

3. AbbVie and Roche got accelerated approval for their breakthrough therapy cancer drug, Venclexta. Approved for a type of blood cancer in patients with a specific chromosomal abnormality, Venclexta was found to provide 80% overall response rate in a mid-stage study (Read more: Roche/AbbVie's Lymphocytic Leukemia Drug Gets FDA Nod ).

4. This week’s rumored buyout target is Relypsa. The company’s shares shot up 67% on aReuters article saying that Relypsa is exploring the possibility of a potential sale following interest from prospective buyers (Read more: Relypsa Soars 67% in Thursday Trading on Buyout Rumors ).

5. Horizon Pharma’s (HZNP) shares crashed with the company’s detailed guidance for the first two quarters of the year falling short of expectations. With the company expecting a major part of its sales and EBITDA to come in the second half of the year, investors are concerned about the company’s ability to meet targets (Read more: Why is Horizon Pharma Crashing Today?).

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INTERCEPT PHARM (ICPT): Free Stock Analysis Report
 
CLOVIS ONCOLOGY (CLVS): Free Stock Analysis Report
 
ABBVIE INC (ABBV): Free Stock Analysis Report
 
RELYPSA INC (RLYP): Free Stock Analysis Report
 
HORIZON PHARMA (HZNP): Free Stock Analysis Report
 
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