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Biotech Stock Roundup: FDA Advisory Panels Say Yes to Intercept, No to Clovis

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 a Reuters 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?).


Alexion ALXN gained (3.73%) the most last week among major biotech stocks, while Vertex declined slightly (0.94%). Meanwhile, Vertex VRTX lost 26.38% over the last six months with Amgen recording a gain (4.89%) during this period.

CompanyLast WeekLast 6 Months

The NASDAQ Biotechnology Index was up 2.31% over the last five trading days (See the last biotech stock roundup here: Gilead's HIV Drug Approved, Regeneron Up on Positive Data).

What's Next in the Biotech World?

Watch out for the usual pipeline updates and data presentations from biotech companies.

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