We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Earnings season for the biotech sector has kicked off with two big biotech names, Biogen (BIIB - Free Report) and Gilead (GILD - Free Report) reporting second quarter results. Meanwhile, companies like AbbVie (ABBV - Free Report) and Amgen (AMGN - Free Report) provided updates on their pipeline efforts.
Recap of the Week’s Most Important Stories
1. Two major biotech companies reported second quarter results over the last few days – Biogen and Gilead. First a look at Biogen’s results – Biogen’s second-quarter results were pretty good with the company surpassing earnings expectations by a huge margin and beating on revenues as well.
The company also raised its outlook for the year. However, Biogen’s CEO announced that he will be stepping down once a successor is identified (Read more: Biogen Stock Up on Q2 Earnings Beat, Raised Outlook).
Meanwhile, Gilead’s results were mixed with the company beating on earnings by a penny and revenues falling short of expectations. Moreover, Gilead cut its product sales outlook for the year (Read more: Gilead Beats on Q2 Earnings, Cuts 2016 Sales View) with its hepatitis C virus (HCV) segment under pressure.
2. AbbVie, which will be reporting second quarter results later this week, came out with quite a few updates on the pipeline and regulatory front. The company’s extended release once-daily version of HCV treatment, Viekira Pak, gained FDA approval. Viekira XR is approved for the treatment of patients with chronic genotype 1 (GT1) HCV, including those with compensated cirrhosis (Child-Pugh A).
Additionally, AbbVie is a step closer to gaining EU approval for a 12-week regimen of Viekirax with ribavirin for genotype 4 (GT4) chronic HCV infected adult patients with or without compensated cirrhosis, with the CHMP issuing a positive opinion.
AbbVie also entered into a clinical trial collaboration with Bristol-Myers under which the safety, tolerability and efficacy of AbbVie's investigational biomarker-specific antibody drug conjugate rova-T (rovalpituzumab tesirine) will be evaluated in combination with Bristol-Myers’ Opdivo and Opdivo + Yervoy regimen for the treatment of relapsed extensive-stage small cell lung cancer (SCLC). Rova-T became a part of AbbVie’s pipeline following the recent Stemcentrx acquisition.
3. Celgene has decided it will not seek marketing approval for the expansion of the label of its blockbuster drug, Revlimid, as maintenance treatment in a certain type of diffuse large B-cell lymphoma (DLBCL) patients. The decision is based on data from a phase III study – while patients on Revlimid showed an improvement in progression-free survival, an interim analysis revealed that no benefit was seen in the Revlimid arm where overall survival is concerned.
4. Amgen also provided some updates on the pipeline front. Firstly, the company and its partner, UCB, have filed for FDA approval of their experimental osteoporosis treatment, romosozumab. The other update came from the biosimilar front – Amgen and partner Allergan said that their biosimilar version of cancer treatment, Herceptin (trastuzumab) fared well in a late-stage study. We note that Amgen has nine biosimilars in its pipeline and recently got a favorable FDA advisory panel recommendation for its Humira biosimilar.
The NASDAQ Biotechnology Index was up 3.8% over the last five trading days. The biggest gainer among major biotech stocks was Biogen, which was up 10.5% on strong second quarter results. Gilead declined 5.1% during this period reflecting disappointment regarding the company’s second quarter results and outlook. Over the last six months, Biogen was up 10.5% while Alexion lost 17.0% (See the last biotech stock roundup here: Celgene in Immuno-Oncology Deal, Zafgen Drops Lead Drug).
What's Next in the Biotech World?
Quite a few major biotech companies will be reporting second quarter results over the next few days including Vertex (VRTX - Free Report) , Celgene, AbbVie and Amgen.
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 >>
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Biotech Stock Roundup: Biogen Q2 Results Impress, Gilead HCV Franchise Under Pressure
Earnings season for the biotech sector has kicked off with two big biotech names, Biogen (BIIB - Free Report) and Gilead (GILD - Free Report) reporting second quarter results. Meanwhile, companies like AbbVie (ABBV - Free Report) and Amgen (AMGN - Free Report) provided updates on their pipeline efforts.
Recap of the Week’s Most Important Stories
1. Two major biotech companies reported second quarter results over the last few days – Biogen and Gilead. First a look at Biogen’s results – Biogen’s second-quarter results were pretty good with the company surpassing earnings expectations by a huge margin and beating on revenues as well.
The company also raised its outlook for the year. However, Biogen’s CEO announced that he will be stepping down once a successor is identified (Read more: Biogen Stock Up on Q2 Earnings Beat, Raised Outlook).
Meanwhile, Gilead’s results were mixed with the company beating on earnings by a penny and revenues falling short of expectations. Moreover, Gilead cut its product sales outlook for the year (Read more: Gilead Beats on Q2 Earnings, Cuts 2016 Sales View) with its hepatitis C virus (HCV) segment under pressure.
2. AbbVie, which will be reporting second quarter results later this week, came out with quite a few updates on the pipeline and regulatory front. The company’s extended release once-daily version of HCV treatment, Viekira Pak, gained FDA approval. Viekira XR is approved for the treatment of patients with chronic genotype 1 (GT1) HCV, including those with compensated cirrhosis (Child-Pugh A).
Additionally, AbbVie is a step closer to gaining EU approval for a 12-week regimen of Viekirax with ribavirin for genotype 4 (GT4) chronic HCV infected adult patients with or without compensated cirrhosis, with the CHMP issuing a positive opinion.
AbbVie also entered into a clinical trial collaboration with Bristol-Myers under which the safety, tolerability and efficacy of AbbVie's investigational biomarker-specific antibody drug conjugate rova-T (rovalpituzumab tesirine) will be evaluated in combination with Bristol-Myers’ Opdivo and Opdivo + Yervoy regimen for the treatment of relapsed extensive-stage small cell lung cancer (SCLC). Rova-T became a part of AbbVie’s pipeline following the recent Stemcentrx acquisition.
3. Celgene has decided it will not seek marketing approval for the expansion of the label of its blockbuster drug, Revlimid, as maintenance treatment in a certain type of diffuse large B-cell lymphoma (DLBCL) patients. The decision is based on data from a phase III study – while patients on Revlimid showed an improvement in progression-free survival, an interim analysis revealed that no benefit was seen in the Revlimid arm where overall survival is concerned.
4. Amgen also provided some updates on the pipeline front. Firstly, the company and its partner, UCB, have filed for FDA approval of their experimental osteoporosis treatment, romosozumab. The other update came from the biosimilar front – Amgen and partner Allergan said that their biosimilar version of cancer treatment, Herceptin (trastuzumab) fared well in a late-stage study. We note that Amgen has nine biosimilars in its pipeline and recently got a favorable FDA advisory panel recommendation for its Humira biosimilar.
Performance
MEDICAL-BIOMED/GENETICS Industry Price Index
MEDICAL-BIOMED/GENETICS Industry Price Index
The NASDAQ Biotechnology Index was up 3.8% over the last five trading days. The biggest gainer among major biotech stocks was Biogen, which was up 10.5% on strong second quarter results. Gilead declined 5.1% during this period reflecting disappointment regarding the company’s second quarter results and outlook. Over the last six months, Biogen was up 10.5% while Alexion lost 17.0% (See the last biotech stock roundup here: Celgene in Immuno-Oncology Deal, Zafgen Drops Lead Drug).
What's Next in the Biotech World?
Quite a few major biotech companies will be reporting second quarter results over the next few days including Vertex (VRTX - Free Report) , Celgene, AbbVie and Amgen.
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 >>