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The Zacks Analyst Blog Highlights: Biogen, Vertex, Amgen, Alexion and Achillion Pharmaceuticals
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For Immediate Release
Chicago, IL – October 24, 2019 – 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: Biogen (BIIB - Free Report) , Vertex (VRTX - Free Report) , Amgen (AMGN - Free Report) , Alexion and Achillion Pharmaceuticals, Inc. .
Here are highlights from Wednesday’s Analyst Blog:
Biotech Stock Roundup: Biogen’s (BIIB - Free Report) Big Jump, & More
It was a busy week for the biotech sector with updates from quite a few bigwigs. Biogen topped third-quarter estimates and reported positive data on AD drug. Vertex got FDA approval for a new CF medicine, while Amgen got a positive opinion for Evenity. Further, Alexion is set to buy a clinical-stage biopharmaceutical company to broaden its PNH portfolio.
Recap of the Week’s Most Important Stories:
Biogen Up on Positive AD Drug Data, Beats on Q3 Earnings: Shares of Biogen surged significantly after it announced new data on aducanumab in patients with early Alzheimer’s disease (AD). The company released results from a new analysis of a larger dataset of the discontinued ENGAGE and EMERGE phase III studies on aducanumab in patients with early AD. This analysis was conducted in consultation with the FDA. Biogen and Japanese partner Eisai had discontinued ENGAGE and EMERGE studies, following a futility analysis. Nevertheless, the new data showed that aducanumab reduced clinical decline of Alzheimer’s disease in such patients as measured by the pre-specified primary and secondary endpoints. Based on this data, the company plans to submit a biologics license application seeking approval of the drug to the FDA in early 2020.
Concurrently, the company also reported better-than-expected results for the third quarter of 2019, driven by higher sales of key multiple sclerosis drugs and continued global launch of spinal muscular atrophy drug, Spinraza.
Amgen Gets Positive CHMP Opinion for Evenity: Amgen and partner UCB announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has given a positive opinion for Evenity (romosozumab) following a re-examination procedure. The committee recommended Marketing Authorization for the drug for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture and with no history of myocardial infarction or stroke. The recommendation will now be reviewed by the European Commission and a decision is expected by year-end. The committee had earlier given a negative opinion on the same. We note that Evenity is already approved in the United States for the treatment of osteoporosis in postmenopausal women at high risk for fracture.
Additionally, Amgen announced that the FDA has approved its Supplemental Biologics License Application for Nplate (romiplostim) to include new data in its U.S. prescribing information showing sustained platelet responses in adults with immune thrombocytopenia.
Alexion to Buy Achillion for $930M: Alexion announced that it has entered a definitive agreement to acquire a clinical-stage biopharmaceutical company, Achillion Pharmaceuticals, Inc., for $930 million. Achillion primarily focuses on the development of oral small molecule Factor D inhibitors to treat people with complement alternative pathway-mediated rare diseases, such as paroxysmal nocturnal hemoglobinuria (PNH) and C3 glomerulopathy (C3G). The acquisition will add two clinical-stage candidates to Alexion’s pipeline — lead candidate, danicopan (ACH-4471), in phase II and ACH-5228 in phase I. Achillion’s shareholders will get $6.30 per share as an initial consideration. Alexion will also be acquiring Achillion’s cash balance. The transaction is expected to close in the first half of 2020. Alexion is looking to strengthen its PNH franchise with this acquisition.
Additionally, the company announced that the FDA approved a label expansion of its long-acting C5 complement inhibitor, Ultomiris (ravulizumab-cwvz). The drug has been approved for the treatment of atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy in adult and pediatric (one month or older) patients. Ultomiris is already approved for the treatment of adults with PNH in the United States.
Vertex Gets FDA Approval for Trikafta: Vertex Pharmaceuticals announced that the FDA has approved Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of cystic fibrosis (CF) in patients aged 12 years or above, who have at least one F508del mutation. As a result of this approval, approximately 6,000 patients with one minimal function mutation and one F508del mutation have access to a drug that can treat the underlying cause of their disease. Moreover, approximately 12,000 people with one or two F508del mutations, who are currently eligible for one of Vertex’s three other FDA-approved CF medicines, are now eligible for Trikafta. Additional studies are ongoing for this combination.
Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit http://www.zacks.com/performance for information about the performance numbers displayed in this press release.
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The Zacks Analyst Blog Highlights: Biogen, Vertex, Amgen, Alexion and Achillion Pharmaceuticals
For Immediate Release
Chicago, IL – October 24, 2019 – 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: Biogen (BIIB - Free Report) , Vertex (VRTX - Free Report) , Amgen (AMGN - Free Report) , Alexion and Achillion Pharmaceuticals, Inc. .
Here are highlights from Wednesday’s Analyst Blog:
Biotech Stock Roundup: Biogen’s (BIIB - Free Report) Big Jump, & More
It was a busy week for the biotech sector with updates from quite a few bigwigs. Biogen topped third-quarter estimates and reported positive data on AD drug. Vertex got FDA approval for a new CF medicine, while Amgen got a positive opinion for Evenity. Further, Alexion is set to buy a clinical-stage biopharmaceutical company to broaden its PNH portfolio.
Recap of the Week’s Most Important Stories:
Biogen Up on Positive AD Drug Data, Beats on Q3 Earnings: Shares of Biogen surged significantly after it announced new data on aducanumab in patients with early Alzheimer’s disease (AD). The company released results from a new analysis of a larger dataset of the discontinued ENGAGE and EMERGE phase III studies on aducanumab in patients with early AD. This analysis was conducted in consultation with the FDA. Biogen and Japanese partner Eisai had discontinued ENGAGE and EMERGE studies, following a futility analysis. Nevertheless, the new data showed that aducanumab reduced clinical decline of Alzheimer’s disease in such patients as measured by the pre-specified primary and secondary endpoints. Based on this data, the company plans to submit a biologics license application seeking approval of the drug to the FDA in early 2020.
Concurrently, the company also reported better-than-expected results for the third quarter of 2019, driven by higher sales of key multiple sclerosis drugs and continued global launch of spinal muscular atrophy drug, Spinraza.
Amgen Gets Positive CHMP Opinion for Evenity: Amgen and partner UCB announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has given a positive opinion for Evenity (romosozumab) following a re-examination procedure. The committee recommended Marketing Authorization for the drug for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture and with no history of myocardial infarction or stroke. The recommendation will now be reviewed by the European Commission and a decision is expected by year-end. The committee had earlier given a negative opinion on the same. We note that Evenity is already approved in the United States for the treatment of osteoporosis in postmenopausal women at high risk for fracture.
Additionally, Amgen announced that the FDA has approved its Supplemental Biologics License Application for Nplate (romiplostim) to include new data in its U.S. prescribing information showing sustained platelet responses in adults with immune thrombocytopenia.
Alexion to Buy Achillion for $930M: Alexion announced that it has entered a definitive agreement to acquire a clinical-stage biopharmaceutical company, Achillion Pharmaceuticals, Inc., for $930 million. Achillion primarily focuses on the development of oral small molecule Factor D inhibitors to treat people with complement alternative pathway-mediated rare diseases, such as paroxysmal nocturnal hemoglobinuria (PNH) and C3 glomerulopathy (C3G). The acquisition will add two clinical-stage candidates to Alexion’s pipeline — lead candidate, danicopan (ACH-4471), in phase II and ACH-5228 in phase I. Achillion’s shareholders will get $6.30 per share as an initial consideration. Alexion will also be acquiring Achillion’s cash balance. The transaction is expected to close in the first half of 2020. Alexion is looking to strengthen its PNH franchise with this acquisition.
Additionally, the company announced that the FDA approved a label expansion of its long-acting C5 complement inhibitor, Ultomiris (ravulizumab-cwvz). The drug has been approved for the treatment of atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy in adult and pediatric (one month or older) patients. Ultomiris is already approved for the treatment of adults with PNH in the United States.
Vertex Gets FDA Approval for Trikafta: Vertex Pharmaceuticals announced that the FDA has approved Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of cystic fibrosis (CF) in patients aged 12 years or above, who have at least one F508del mutation. As a result of this approval, approximately 6,000 patients with one minimal function mutation and one F508del mutation have access to a drug that can treat the underlying cause of their disease. Moreover, approximately 12,000 people with one or two F508del mutations, who are currently eligible for one of Vertex’s three other FDA-approved CF medicines, are now eligible for Trikafta. Additional studies are ongoing for this combination.
Vertex currently carries a Zacks Rank #1 (Strong Buy). You can seethe complete list of today’s Zacks #1 Rank stocks here.
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Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit http://www.zacks.com/performance for information about the performance numbers displayed in this press release.