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Biotech Stock Roundup: Amgen, Gilead, Celgene Q1 Earnings, Sunesis Down on Vosaroxin Update
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It was all about earnings this week with companies like Amgen (AMGN - Free Report) , Celgene , Vertex, AbbVie, Alexion, and Gilead (GILD - Free Report) reporting results. So far, it looks like a mixed quarter for quite a few companies with earnings topping expectations while revenues fell short.
Amgen’s shares were down after the earnings report mainly due to concerns regarding the slowdown in sales of legacy brands as well as Enbrel’s performance. Meanwhile, Gilead topped earnings estimates but missed on sales with hepatitis C virus (HCV) market dynamics once again weighing on the company’s performance. Gilead is a Zacks Rank #2 (Buy) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Sunesis Hit by Vosaroxin Update: Sunesis’ shares plunged on news that the company will be withdrawing its European Marketing Authorization Application (MAA) for vosaroxin as a treatment for relapsed/refractory acute myeloid leukemia (AML) in patients aged 60 years and above. The company’s decision was based on interactions with the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) -- although a CHMP opinion was not provided, the company learned that the committee was likely to formally adopt a negative opinion for the MAA.
We note that the company had faced a similar setback for vosaroxin in the U.S. in Jul 2015 when Sunesis was informed by the FDA that it did not support a filing and encouraged the company to provide additional clinical evidence to support a future regulatory submission.
With vosaroxin facing a similar fate in the EU, Sunesis has decided to significantly cut down its investment in the AML program and shift more of its resources to its kinase inhibitor pipeline. Sunesis, however, has not given up totally on vosaroxin -- the company said the development of vosaroxin will continue through a modest investment in investigator-sponsored group studies though it will carefully evaluate business development alternatives before another pivotal study is conducted to support regulatory approval of the drug.
Year-to-date, Sunesis has underperformed the Zacks-categorized Medical-Biomedical/Genetics industry with shares declining 18% compared to the industry gain of 5.5%.
May 2017 Response Date for Regeneron RA Drug: Regeneron (REGN - Free Report) and partner Sanofi announced that their BLA resubmission for their experimental rheumatoid arthritis (RA) drug Kevzara (sarilumab) has been accepted for review by the FDA with a response now expected on May 22, 2017. The companies had got a complete response letter (CRL) for the IL-6R antibody in Oct 2016 with the agency citing certain deficiencies observed during a routine good manufacturing practice inspection of the Sanofi Le Trait facility in France where sarilumab is filled and finished.
Bluebird Signs License Agreements with Glaxo & Novartis: bluebird bio (BLUE - Free Report) announced a couple of licensing agreements for its proprietary lentiviral vector platform -- one with Glaxo and the other with Novartis. Under the Glaxo deal, the company will non-exclusively license certain bluebird patent rights related to lentiviral vector technology for the development and commercialization of gene therapies for two rare genetic diseases -- Wiscott-Aldrich syndrome and metachromatic leukodystrophy. The Novartis deal also provides the company with a non-exclusive license to certain bluebird patent rights related to lentiviral vector technology for the development and commercialization of chimeric antigen receptor T cell (CAR T) therapies for oncology, including CTL019, Novartis’s anti-CD19 CAR T investigational therapy.
Financial terms for both deals include an upfront payment to bluebird as well as milestone and royalty payments.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index was up slightly (0.9%) over the last five trading sessions. Among major biotech stocks, Biogen declined 5.4% while Alexion gained 10.7% on Q1 results. Over the last six months, Vertex was up 51.9% while Gilead was down 5.4% (See the last biotech stock roundup here: Biogen Gains on Strong Q1, NASH Data on Gilead Drug).
What's Next in the Biotech World?
Watch out for earnings results from companies like BioMarin (BMRN - Free Report) and Regeneron in the next few days.
Will You Make a Fortune on the Shift to Electric Cars?
Here's another stock idea to consider. Much like petroleum 150 years ago, lithium power may soon shake the world, creating millionaires and reshaping geo-politics. Soon electric vehicles (EVs) may be cheaper than gas guzzlers. Some are already reaching 265 miles on a single charge.
With battery prices plummeting and charging stations set to multiply, one company stands out as the #1 stock to buy according to Zacks research.
Image: Bigstock
Biotech Stock Roundup: Amgen, Gilead, Celgene Q1 Earnings, Sunesis Down on Vosaroxin Update
It was all about earnings this week with companies like Amgen (AMGN - Free Report) , Celgene , Vertex, AbbVie, Alexion, and Gilead (GILD - Free Report) reporting results. So far, it looks like a mixed quarter for quite a few companies with earnings topping expectations while revenues fell short.
Recap of the Week’s Most Important Stories
A Look at Earnings Results: While companies like Amgen (Read more: Amgen Q1 Earnings Top, Sales Miss, Shares Decline) and Celgene (Read more: Celgene Tops on Q1 Earnings, Sales Miss, Raises View) topped on earnings but missed revenue expectations, both AbbVie (Read more: AbbVie Q1 Earnings Beat Estimates, Revenues Up Y/Y) and Alexion (Read more: Alexion Tops Q1 Earnings, Revenues; Ups '17 View) surpassed estimates on the top- and bottom-line. Cystic fibrosis focused Vertex also topped earnings and revenue expectations (Read more: Vertex Q1 Earnings Top, CF Products Sales Strong).
Amgen’s shares were down after the earnings report mainly due to concerns regarding the slowdown in sales of legacy brands as well as Enbrel’s performance. Meanwhile, Gilead topped earnings estimates but missed on sales with hepatitis C virus (HCV) market dynamics once again weighing on the company’s performance. Gilead is a Zacks Rank #2 (Buy) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Sunesis Hit by Vosaroxin Update: Sunesis’ shares plunged on news that the company will be withdrawing its European Marketing Authorization Application (MAA) for vosaroxin as a treatment for relapsed/refractory acute myeloid leukemia (AML) in patients aged 60 years and above. The company’s decision was based on interactions with the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) -- although a CHMP opinion was not provided, the company learned that the committee was likely to formally adopt a negative opinion for the MAA.
We note that the company had faced a similar setback for vosaroxin in the U.S. in Jul 2015 when Sunesis was informed by the FDA that it did not support a filing and encouraged the company to provide additional clinical evidence to support a future regulatory submission.
With vosaroxin facing a similar fate in the EU, Sunesis has decided to significantly cut down its investment in the AML program and shift more of its resources to its kinase inhibitor pipeline. Sunesis, however, has not given up totally on vosaroxin -- the company said the development of vosaroxin will continue through a modest investment in investigator-sponsored group studies though it will carefully evaluate business development alternatives before another pivotal study is conducted to support regulatory approval of the drug.
Year-to-date, Sunesis has underperformed the Zacks-categorized Medical-Biomedical/Genetics industry with shares declining 18% compared to the industry gain of 5.5%.
May 2017 Response Date for Regeneron RA Drug: Regeneron (REGN - Free Report) and partner Sanofi announced that their BLA resubmission for their experimental rheumatoid arthritis (RA) drug Kevzara (sarilumab) has been accepted for review by the FDA with a response now expected on May 22, 2017. The companies had got a complete response letter (CRL) for the IL-6R antibody in Oct 2016 with the agency citing certain deficiencies observed during a routine good manufacturing practice inspection of the Sanofi Le Trait facility in France where sarilumab is filled and finished.
Bluebird Signs License Agreements with Glaxo & Novartis: bluebird bio (BLUE - Free Report) announced a couple of licensing agreements for its proprietary lentiviral vector platform -- one with Glaxo and the other with Novartis. Under the Glaxo deal, the company will non-exclusively license certain bluebird patent rights related to lentiviral vector technology for the development and commercialization of gene therapies for two rare genetic diseases -- Wiscott-Aldrich syndrome and metachromatic leukodystrophy. The Novartis deal also provides the company with a non-exclusive license to certain bluebird patent rights related to lentiviral vector technology for the development and commercialization of chimeric antigen receptor T cell (CAR T) therapies for oncology, including CTL019, Novartis’s anti-CD19 CAR T investigational therapy.
Financial terms for both deals include an upfront payment to bluebird as well as milestone and royalty payments.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index was up slightly (0.9%) over the last five trading sessions. Among major biotech stocks, Biogen declined 5.4% while Alexion gained 10.7% on Q1 results. Over the last six months, Vertex was up 51.9% while Gilead was down 5.4% (See the last biotech stock roundup here: Biogen Gains on Strong Q1, NASH Data on Gilead Drug).
What's Next in the Biotech World?
Watch out for earnings results from companies like BioMarin (BMRN - Free Report) and Regeneron in the next few days.
Will You Make a Fortune on the Shift to Electric Cars?
Here's another stock idea to consider. Much like petroleum 150 years ago, lithium power may soon shake the world, creating millionaires and reshaping geo-politics. Soon electric vehicles (EVs) may be cheaper than gas guzzlers. Some are already reaching 265 miles on a single charge.
With battery prices plummeting and charging stations set to multiply, one company stands out as the #1 stock to buy according to Zacks research.
It's not the one you think.
See This Ticker Free >>