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Biotech Stock Roundup: Amgen Down on Enbrel Sales, Regeneron's Sarilumab Faces Delay
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Third quarter earnings season is in full flow with several major biotech companies including Gilead (GILD - Free Report) and Amgen (AMGN - Free Report) reporting results. Meanwhile, companies like TESARO and Regeneron (REGN - Free Report) provided regulatory updates -- while TESARO submitted a regulatory application for its PARP inhibitor, Regeneron is facing a delay in the U.S. approval of its experimental rheumatoid arthritis treatment.
Recap of the Week’s Most Important Stories
A Look at Earnings Results: Gilead’s third quarter earnings fell short of expectations while revenues just about surpassed expectations. The company’s hepatitis C virus (HCV) franchise sales remain under pressure (Read more: Gilead Misses Q3 Earnings Estimates, Retains View). Gilead also said that it would not be continuing with the development of simtuzumab which was being evaluated for non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC). Moreover, the company will not pursue the development of GS-5745 for ulcerative colitis or Crohn's disease and eleclazine for ventricular tachycardia/ventricular fibrillation.
AbbVie’s results were also disappointing -- though earnings were in line with expectations, revenues fell short with flagship product, Humira, missing estimates. Meanwhile, Celgene’s third quarter results were strong with the company beating on both earnings and revenues and raising its outlook for the year (Read more: Celgene Beats on Q3 Earnings, Raises '16 Outlook). Even though Amgen topped estimates, shares declined reflecting concerns regarding Enbrel’s performance (Read more: Amgen Q3 Earnings & Sales Top; Enbrel Hurts Stock).
Sarilumab Approval Delayed on Manufacturing Issues: Regeneron and partner Sanofi are facing a delay in their plans for experimental rheumatoid arthritis treatment, sarilumab. The companies got a Complete Response Letter (CRL) from the FDA for the IL-6R antibody, which has blockbuster potential. While the CRL did not raise any issues regarding sarilumab’s efficacy or safety, the agency cited certain deficiencies observed during a routine good manufacturing practice inspection of the Sanofi Le Trait facility in France where sarilumab is filled and finished. Sanofi has submitted a comprehensive corrective action plan to the FDA and is working on implementing corrective actions.
TESARO Finishes Rolling NDA Submission for Niraparib: TESARO finished submitting the rolling NDA for its PARP inhibitor, niraparib, for platinum sensitive, recurrent ovarian cancer. TESARO, an oncology-focused company, is also seeking marketing approval from the European Medicines Agency (EMA) for niraparib -- the marketing application was accepted for review in late October. We remind investors that TESARO had presented impressive data on niraparib at the congress of the European Society for Medical Oncology (ESMO) last month. With ovarian cancer being the fifth most frequent cause of cancer death among women, there is significant need for new therapeutic options that prolong response.
Celldex to Acquire Kolltan: Celldex (CLDX - Free Report) , another cancer-focused company, announced that it will be acquiring Kolltan Pharmaceuticals, Inc., a privately held clinical-stage company focused on the discovery and development of novel, antibody-based drugs targeting receptor tyrosine kinases (RTKs). The acquisition, slated to close by year-end, will strengthen Celldex’s immuno-oncology pipeline. Kolltan’s pipeline candidates could have the potential to help overcome tumor resistance mechanisms associated with current tyrosine kinase inhibitors and seen in patients who have failed other cancer therapies.
The stock-for-stock transaction includes an upfront payment representing an equity value of about $62.5 million with Kolltan shareholders eligible to receive additional payments of up to $172.5 million on the achievement of certain development, regulatory and commercial milestones. Celldex is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Performance
Medical - Biomedical and Genetics Industry Price Index
The NASDAQ Biotechnology Index declined 4.1% over the last five trading days. Among major biotech stocks, Amgen declined 12.8% while Alexion was up 5.1%. Over the last six months, Gilead lost 28.4% (See the last biotech stock roundup here: Clinical Holds Hit Inovio & Aduro, Vertex Q3 Results Miss Estimates).
What's Next in the Biotech World?
Watch out for earnings reports from companies like Regeneron, Kite and Juno in the coming days. Moreover, a response from the FDA regarding the approval status of Gilead's TAF for hepatitis B virus (HBV) should be out shortly.
Where Do Zacks' Investment Ideas Come From?
You are welcome to download the full, up-to-the-minute list of 220 Zacks Rank #1 "Strong Buy" stocks free of charge. There is no better place to start your own stock search. Plus you can access the full list of must-avoid Zacks Rank #5 "Strong Sells" and other private research. See the stocks free >>
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Biotech Stock Roundup: Amgen Down on Enbrel Sales, Regeneron's Sarilumab Faces Delay
Third quarter earnings season is in full flow with several major biotech companies including Gilead (GILD - Free Report) and Amgen (AMGN - Free Report) reporting results. Meanwhile, companies like TESARO and Regeneron (REGN - Free Report) provided regulatory updates -- while TESARO submitted a regulatory application for its PARP inhibitor, Regeneron is facing a delay in the U.S. approval of its experimental rheumatoid arthritis treatment.
Recap of the Week’s Most Important Stories
A Look at Earnings Results: Gilead’s third quarter earnings fell short of expectations while revenues just about surpassed expectations. The company’s hepatitis C virus (HCV) franchise sales remain under pressure (Read more: Gilead Misses Q3 Earnings Estimates, Retains View). Gilead also said that it would not be continuing with the development of simtuzumab which was being evaluated for non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC). Moreover, the company will not pursue the development of GS-5745 for ulcerative colitis or Crohn's disease and eleclazine for ventricular tachycardia/ventricular fibrillation.
AbbVie’s results were also disappointing -- though earnings were in line with expectations, revenues fell short with flagship product, Humira, missing estimates. Meanwhile, Celgene’s third quarter results were strong with the company beating on both earnings and revenues and raising its outlook for the year (Read more: Celgene Beats on Q3 Earnings, Raises '16 Outlook). Even though Amgen topped estimates, shares declined reflecting concerns regarding Enbrel’s performance (Read more: Amgen Q3 Earnings & Sales Top; Enbrel Hurts Stock).
Sarilumab Approval Delayed on Manufacturing Issues: Regeneron and partner Sanofi are facing a delay in their plans for experimental rheumatoid arthritis treatment, sarilumab. The companies got a Complete Response Letter (CRL) from the FDA for the IL-6R antibody, which has blockbuster potential. While the CRL did not raise any issues regarding sarilumab’s efficacy or safety, the agency cited certain deficiencies observed during a routine good manufacturing practice inspection of the Sanofi Le Trait facility in France where sarilumab is filled and finished. Sanofi has submitted a comprehensive corrective action plan to the FDA and is working on implementing corrective actions.
TESARO Finishes Rolling NDA Submission for Niraparib: TESARO finished submitting the rolling NDA for its PARP inhibitor, niraparib, for platinum sensitive, recurrent ovarian cancer. TESARO, an oncology-focused company, is also seeking marketing approval from the European Medicines Agency (EMA) for niraparib -- the marketing application was accepted for review in late October. We remind investors that TESARO had presented impressive data on niraparib at the congress of the European Society for Medical Oncology (ESMO) last month. With ovarian cancer being the fifth most frequent cause of cancer death among women, there is significant need for new therapeutic options that prolong response.
Celldex to Acquire Kolltan: Celldex (CLDX - Free Report) , another cancer-focused company, announced that it will be acquiring Kolltan Pharmaceuticals, Inc., a privately held clinical-stage company focused on the discovery and development of novel, antibody-based drugs targeting receptor tyrosine kinases (RTKs). The acquisition, slated to close by year-end, will strengthen Celldex’s immuno-oncology pipeline. Kolltan’s pipeline candidates could have the potential to help overcome tumor resistance mechanisms associated with current tyrosine kinase inhibitors and seen in patients who have failed other cancer therapies.
The stock-for-stock transaction includes an upfront payment representing an equity value of about $62.5 million with Kolltan shareholders eligible to receive additional payments of up to $172.5 million on the achievement of certain development, regulatory and commercial milestones. Celldex is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Performance
Medical - Biomedical and Genetics Industry Price Index
Medical - Biomedical and Genetics Industry Price Index
The NASDAQ Biotechnology Index declined 4.1% over the last five trading days. Among major biotech stocks, Amgen declined 12.8% while Alexion was up 5.1%. Over the last six months, Gilead lost 28.4% (See the last biotech stock roundup here: Clinical Holds Hit Inovio & Aduro, Vertex Q3 Results Miss Estimates).
What's Next in the Biotech World?
Watch out for earnings reports from companies like Regeneron, Kite and Juno in the coming days. Moreover, a response from the FDA regarding the approval status of Gilead's TAF for hepatitis B virus (HBV) should be out shortly.
Where Do Zacks' Investment Ideas Come From?
You are welcome to download the full, up-to-the-minute list of 220 Zacks Rank #1 "Strong Buy" stocks free of charge. There is no better place to start your own stock search. Plus you can access the full list of must-avoid Zacks Rank #5 "Strong Sells" and other private research. See the stocks free >>