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Biotech Stock Roundup: Earnings in Focus, AbbVie Takes Steps to Block Humira Copycat
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Several small and mid-sized as well as big biotech companies like Regeneron (REGN - Free Report) and BioMarin (BMRN - Free Report) reported second quarter results last week. Meanwhile, among other major updates, AbbVie (ABBV - Free Report) filed a patent infringement lawsuit against Amgen (AMGN - Free Report) . Amgen is seeking FDA approval for its biosimilar version of Humira.
Recap of the Week’s Most Important Stories
1. First a look at earnings results of companies like BioMarin and Regeneron. BioMarin once again reported better-than-expected results and raised its revenue guidance with both Kuvan and Vimizim performing well (Read more: BioMarin Posts Narrower Q2 Loss, Sales View Upped). Regeneron’s earnings also surpassed expectations with Eylea continuing to perform well (Read more: Regeneron Tops Q2 Earnings, Keeps '16 Eylea View).
2. Medivation also reported second quarter results this week. While revenues just fell short of expectations, earnings were better-than-expected. Investor focus remains on the performance of prostate cancer drug, Xtandi. The company reported that the mean duration of treatment for Xtandi based on patient discontinuation, which is a retrospective analysis, reached an all-time high of nine months. Xtandi is in several studies for additional indications.
3. Biogen’s (BIIB - Free Report) partner Eisai said that their experimental treatment for early Alzheimer’s disease, BACE inhibitor E2609, has got the green signal from the FDA for advancement into phase III studies. Biogen also announced the name of the new hemophilia-focused company that will be created through the spin-off of the company’s hemophilia franchise currently comprising marketed products like Eloctate and Alprolix. The company will be named Bioverativ and will trade under the symbol BIVV on the NASDAQ Stock Market. The spin-off is scheduled to be completed early next year.
Meanwhile, rumors surfaced last week that Biogen could be acquired by companies like Allergan or Merck. But, according to sources, the biotech company is not interested in a takeover.
4. AbbVie has initiated a patent infringement lawsuit against Amgen to protect its flagship product, Humira, from biosimilar competition. The move was largely expected considering Humira accounts for a major part of AbbVie’s sales (61.4% of total sales in 2015) and the earlier-than-expected entry of biosimilars would have a huge impact on the company’s financials. Amgen’s biosimilar version got the support of an FDA advisory panel. A final decision regarding the approval status of the product is expected by Sep 25, 2016.
5. Momenta announced that it has stopped enrolling patients in a phase II study evaluating necuparanib in combination with Abraxane and Gemzar (gemcitabine) in patients with advanced metastatic pancreatic cancer. The decision was taken following an interim futility analysis – while no new safety signals were observed and the toxicity profile was considered manageable, the independent Data Safety Monitoring Board determined that the treatment did not show a sufficient level of efficacy to warrant continued enrollment.
The NASDAQ Biotechnology Index was down 3% over the last five trading days. While all the major biotechs declined during this period, Regeneron lost 5.9% over the last five trading days. Over the last six months, Biogen was up 22.5% while Gilead lost 10.1%.
What's Next in the Biotech World?
With second quarter earnings season coming to an end, watch out for the usual pipeline and regulatory updates.
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Biotech Stock Roundup: Earnings in Focus, AbbVie Takes Steps to Block Humira Copycat
Several small and mid-sized as well as big biotech companies like Regeneron (REGN - Free Report) and BioMarin (BMRN - Free Report) reported second quarter results last week. Meanwhile, among other major updates, AbbVie (ABBV - Free Report) filed a patent infringement lawsuit against Amgen (AMGN - Free Report) . Amgen is seeking FDA approval for its biosimilar version of Humira.
Recap of the Week’s Most Important Stories
1. First a look at earnings results of companies like BioMarin and Regeneron. BioMarin once again reported better-than-expected results and raised its revenue guidance with both Kuvan and Vimizim performing well (Read more: BioMarin Posts Narrower Q2 Loss, Sales View Upped). Regeneron’s earnings also surpassed expectations with Eylea continuing to perform well (Read more: Regeneron Tops Q2 Earnings, Keeps '16 Eylea View).
2. Medivation also reported second quarter results this week. While revenues just fell short of expectations, earnings were better-than-expected. Investor focus remains on the performance of prostate cancer drug, Xtandi. The company reported that the mean duration of treatment for Xtandi based on patient discontinuation, which is a retrospective analysis, reached an all-time high of nine months. Xtandi is in several studies for additional indications.
3. Biogen’s (BIIB - Free Report) partner Eisai said that their experimental treatment for early Alzheimer’s disease, BACE inhibitor E2609, has got the green signal from the FDA for advancement into phase III studies. Biogen also announced the name of the new hemophilia-focused company that will be created through the spin-off of the company’s hemophilia franchise currently comprising marketed products like Eloctate and Alprolix. The company will be named Bioverativ and will trade under the symbol BIVV on the NASDAQ Stock Market. The spin-off is scheduled to be completed early next year.
Meanwhile, rumors surfaced last week that Biogen could be acquired by companies like Allergan or Merck. But, according to sources, the biotech company is not interested in a takeover.
4. AbbVie has initiated a patent infringement lawsuit against Amgen to protect its flagship product, Humira, from biosimilar competition. The move was largely expected considering Humira accounts for a major part of AbbVie’s sales (61.4% of total sales in 2015) and the earlier-than-expected entry of biosimilars would have a huge impact on the company’s financials. Amgen’s biosimilar version got the support of an FDA advisory panel. A final decision regarding the approval status of the product is expected by Sep 25, 2016.
5. Momenta announced that it has stopped enrolling patients in a phase II study evaluating necuparanib in combination with Abraxane and Gemzar (gemcitabine) in patients with advanced metastatic pancreatic cancer. The decision was taken following an interim futility analysis – while no new safety signals were observed and the toxicity profile was considered manageable, the independent Data Safety Monitoring Board determined that the treatment did not show a sufficient level of efficacy to warrant continued enrollment.
Performance
MEDICAL-BIOMED/GENETICS Industry Price Index
MEDICAL-BIOMED/GENETICS Industry Price Index
The NASDAQ Biotechnology Index was down 3% over the last five trading days. While all the major biotechs declined during this period, Regeneron lost 5.9% over the last five trading days. Over the last six months, Biogen was up 22.5% while Gilead lost 10.1%.
What's Next in the Biotech World?
With second quarter earnings season coming to an end, watch out for the usual pipeline and regulatory updates.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>