The Zacks Analyst Blog Highlights: Bristol-Myers Squibb, Biogen, Actelion and Horizon Pharma - Press Releases
For Immediate Release
Chicago, IL – May 04, 2015 – 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 the Bristol-Myers Squibb Company (BMY), Biogen Inc. (BIIB), Actelion Ltd. (ALIOF) and Horizon Pharma plc (HZNP).
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Here are highlights from Friday’s Analyst Blog:
Bristol-Myers Supplemental BLA Accepted by FDA
Updates on the regulatory front are eagerly awaited by investors in the pharma/biotech sector as they impact the share price of the concerned company. Regulatory updates include events like filing of marketing applications, acceptance of these applications for review by the regulatory agencies, reviews by advisory panels and, finally, a response from the regulatory agency regarding the approval status.
Earlier this week, Bristol-Myers Squibb Company (BMY) announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Opdivo for treatment-naive patients suffering from unresectable or metastatic melanoma.
In the sBLA, the company provided data on Opdivo compared to dacarbazine chemotherapy for previously untreated patients with BRAF wild-type advanced melanoma. The FDA also granted priority review status for this application. An action from the FDA is expected by Aug 27, 2015.
We note that Opdivo is already approved in the U.S. for the treatment of patients with unresectable or metastatic melanoma who are suffering from disease progression following treatment with Yervoy, and a BRAF inhibitor if they are BRAF V600 mutation positive. In Mar 2015, the drug also received approval in the U.S. for the treatment of patients with advanced squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy.
Opdivo is one of the key products in Bristol-Myers’ portfolio and following its launch in Dec 2014 the drug generated revenues of $40 million in the first quarter of 2015. Label expansion efforts by the company for Opdivo are encouraging since we believe that widening the eligible patient population should open new channels of revenue generation.
Meanwhile, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended Opdivo’s approval for use in treatment-naive as well as treatment-experienced patients suffering from advanced unresectable or metastatic melanoma earlier in the month. This increases the likelihood of the candidate to receive approval from the European Commission (EC) since the EC takes the CHMP’s opinion into account while reviewing candidates.
Bristol-Myers carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Biogen Inc. (BIIB), Actelion Ltd. (ALIOF) and Horizon Pharma plc (HZNP). All these stocks carry a Zacks Rank #1 (Strong Buy).
Today, Zacks is promoting its ''Buy'' stock recommendations. Get #1Stock of the Day pick for free.
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BRISTOL-MYERS (BMY): Free Stock Analysis Report
BIOGEN IDEC INC (BIIB): Free Stock Analysis Report
ACTELION LTD (ALIOF): Free Stock Analysis Report
HORIZON PHARMA (HZNP): Free Stock Analysis Report
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