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Biotech Stock Roundup: Biogen Gains on Strong Q1, NASH Data on Gilead Drug
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Earnings season for the biotech sector is off to a promising start with Biogen (BIIB - Free Report) reporting better-than-expected first quarter results. While focus remained on Biogen’s results, companies like Gilead (GILD - Free Report) were also in the news on the presentation of pipeline data.
Recap of the Week’s Most Important Stories
Biogen Up on Q1 Results: Biogen’s shares were up 3.6% on strong first quarter results with both revenues and earnings surpassing expectations. Recently launched Spinraza (spinal muscular atrophy) is off to a promising start with the company working on expanding access to all patients. Spinraza got a positive opinion in Europe this week -- Biogen is working on pre-launch activities and intends to file for approval in at least 10 additional countries this year. On the Alzheimer’s disease front, Biogen said that it expects both the ENGAGE and EMERGE studies on aducanumab to be 50% enrolled by mid-May (Read more: Biogen Q1 Earnings & Sales Top, Spinraza Sales Strong). Biogen is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Regeneron, Sanofi Face Patent Infringement Lawsuit for Dupixent: Regeneron (REGN - Free Report) and partner Sanofi are facing a patent infringement lawsuit filed by Amgen’s (AMGN - Free Report) Immunex Corporation related to their recently approved eczema treatment, Dupixent. We note that Sanofi and Regeneron had already filed a lawsuit prior to the approval of Dupixent seeking a court order that their drug does not infringe a patent held by Amgen. The lawsuit was a proactive move by the companies to prevent Amgen from initiating a patent infringement lawsuit like it had related to Sanofi and Regeneron’s PCSK9 inhibitor Praluent. We note that the FDA recently gave its nod for a once-monthly formulation of Praluent.
The companies also announced that they got a positive opinion from the European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for the approval of their experimental rheumatoid arthritis drug, Kevzara (sarilumab). A final decision regarding approvability should be out in the coming months.
Gilead Presents NASH Data: Gilead presented promising data from an open-label, proof-of-concept study evaluating GS-0976, an investigational inhibitor of ACC, in patients with nonalcoholic steatohepatitis (NASH). Although a small study, the data showed statistically significant improvements in liver fat content and noninvasive markers of fibrosis. The candidate is currently in a mid-stage, double-blind, placebo-controlled study.
Gilead is among the many companies developing treatments for NASH. The company is currently planning or conducting mid- as well as late-stage studies evaluating single-agent and combination therapy approaches against multiple core pathways associated with NASH. NASH is an increasingly common, progressive form of fatty-liver disease which is becoming a significant and growing health issue given the rising obesity epidemic. With no treatments currently approved for this disease, the market opportunity is significant.
Amgen-Novartis Collaboration Update: Amgen expanded its commercial collaboration with Novartis for experimental migraine drug, erenumab. The companies’ initial collaboration dates back to 2015 covering Alzheimer's disease and migraine. The companies have now agreed to combine capabilities to co-commercialize erenumab in the U.S. while Amgen retains exclusive commercialization rights in Japan. Novartis, which retains its existing commercialization rights in rest of the world, gains exclusive rights to commercialize erenumab in Canada under the expanded deal. Amgen and Novartis hope to file for approval in the second quarter of 2017.
Achillion Down on HCV Data: Achillion’s shares touched a 52-week low on the presentation of additional phase II data on its experimental hepatitis C virus (HCV) treatment, JNJ-4178. Updated results from the ongoing study were presented at the European Association for the Study of the Liver (EASL) 2017 International Liver Congress.
Although data showed that JNJ-4178, a three-drug combination of simeprevir, odalasvir and AL-335, was highly effective in treatment naïve patients with HCV genotype 1 infection without cirrhosis, results for the three-drug regimen in HCV genotype 3 patients without cirrhosis were not promising enough to warrant continued development for this category. The regimen will be investigated further for HCV genotypes 1, 2, 4, 5, and 6. Meanwhile, a two-drug regimen of odalasvir and AL-335 will also not be moving forward in patients with HCV genotype 1 without cirrhosis. Achillion’s shares have underperformed the Zacks-categorized Medical-Biomedical/Genetics industry year-to-date with shares declining 15.7% compared to the industry gain of 3.2%.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index gained 2.8% over the last five trading sessions. All major biotech stocks were up with Biogen jumping 5.8% on Q1 results. Over the last six months, Vertex (VRTX - Free Report) was up 48.9% while Gilead was down 9.8% (See the last biotech stock roundup here: FDA CRL Hits Incyte, Pipeline Setbacks Weigh on OncoMed).
What's Next in the Biotech World?
Watch out for earnings results of companies like Amgen, Vertex, Celgene and Gilead among others in the next few days. Meanwhile, BioMarin (BMRN - Free Report) should get a response from the FDA regarding the approval status of Brineura for the treatment of CLN2 disease, a form of Batten disease, this week.
Zacks' Hidden Trades
While we share many recommendations and ideas with the public, certain moves are hidden from everyone but selected members of our portfolio services. Would you like to peek behind the curtain today and view them?
Starting now, for the next month, I invite you to follow all Zacks' private buys and sells in real time from value to momentum...from stocks under $10 to ETF to option movers...from insider trades to companies that are about to report positive earnings surprises (we've called them with 80%+ accuracy). You can even look inside portfolios so exclusive that they are normally closed to new investors.
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Biotech Stock Roundup: Biogen Gains on Strong Q1, NASH Data on Gilead Drug
Earnings season for the biotech sector is off to a promising start with Biogen (BIIB - Free Report) reporting better-than-expected first quarter results. While focus remained on Biogen’s results, companies like Gilead (GILD - Free Report) were also in the news on the presentation of pipeline data.
Recap of the Week’s Most Important Stories
Biogen Up on Q1 Results: Biogen’s shares were up 3.6% on strong first quarter results with both revenues and earnings surpassing expectations. Recently launched Spinraza (spinal muscular atrophy) is off to a promising start with the company working on expanding access to all patients. Spinraza got a positive opinion in Europe this week -- Biogen is working on pre-launch activities and intends to file for approval in at least 10 additional countries this year. On the Alzheimer’s disease front, Biogen said that it expects both the ENGAGE and EMERGE studies on aducanumab to be 50% enrolled by mid-May (Read more: Biogen Q1 Earnings & Sales Top, Spinraza Sales Strong). Biogen is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Regeneron, Sanofi Face Patent Infringement Lawsuit for Dupixent: Regeneron (REGN - Free Report) and partner Sanofi are facing a patent infringement lawsuit filed by Amgen’s (AMGN - Free Report) Immunex Corporation related to their recently approved eczema treatment, Dupixent. We note that Sanofi and Regeneron had already filed a lawsuit prior to the approval of Dupixent seeking a court order that their drug does not infringe a patent held by Amgen. The lawsuit was a proactive move by the companies to prevent Amgen from initiating a patent infringement lawsuit like it had related to Sanofi and Regeneron’s PCSK9 inhibitor Praluent. We note that the FDA recently gave its nod for a once-monthly formulation of Praluent.
The companies also announced that they got a positive opinion from the European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for the approval of their experimental rheumatoid arthritis drug, Kevzara (sarilumab). A final decision regarding approvability should be out in the coming months.
Gilead Presents NASH Data: Gilead presented promising data from an open-label, proof-of-concept study evaluating GS-0976, an investigational inhibitor of ACC, in patients with nonalcoholic steatohepatitis (NASH). Although a small study, the data showed statistically significant improvements in liver fat content and noninvasive markers of fibrosis. The candidate is currently in a mid-stage, double-blind, placebo-controlled study.
Gilead is among the many companies developing treatments for NASH. The company is currently planning or conducting mid- as well as late-stage studies evaluating single-agent and combination therapy approaches against multiple core pathways associated with NASH. NASH is an increasingly common, progressive form of fatty-liver disease which is becoming a significant and growing health issue given the rising obesity epidemic. With no treatments currently approved for this disease, the market opportunity is significant.
Amgen-Novartis Collaboration Update: Amgen expanded its commercial collaboration with Novartis for experimental migraine drug, erenumab. The companies’ initial collaboration dates back to 2015 covering Alzheimer's disease and migraine. The companies have now agreed to combine capabilities to co-commercialize erenumab in the U.S. while Amgen retains exclusive commercialization rights in Japan. Novartis, which retains its existing commercialization rights in rest of the world, gains exclusive rights to commercialize erenumab in Canada under the expanded deal. Amgen and Novartis hope to file for approval in the second quarter of 2017.
Achillion Down on HCV Data: Achillion’s shares touched a 52-week low on the presentation of additional phase II data on its experimental hepatitis C virus (HCV) treatment, JNJ-4178. Updated results from the ongoing study were presented at the European Association for the Study of the Liver (EASL) 2017 International Liver Congress.
Although data showed that JNJ-4178, a three-drug combination of simeprevir, odalasvir and AL-335, was highly effective in treatment naïve patients with HCV genotype 1 infection without cirrhosis, results for the three-drug regimen in HCV genotype 3 patients without cirrhosis were not promising enough to warrant continued development for this category. The regimen will be investigated further for HCV genotypes 1, 2, 4, 5, and 6. Meanwhile, a two-drug regimen of odalasvir and AL-335 will also not be moving forward in patients with HCV genotype 1 without cirrhosis. Achillion’s shares have underperformed the Zacks-categorized Medical-Biomedical/Genetics industry year-to-date with shares declining 15.7% compared to the industry gain of 3.2%.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index gained 2.8% over the last five trading sessions. All major biotech stocks were up with Biogen jumping 5.8% on Q1 results. Over the last six months, Vertex (VRTX - Free Report) was up 48.9% while Gilead was down 9.8% (See the last biotech stock roundup here: FDA CRL Hits Incyte, Pipeline Setbacks Weigh on OncoMed).
What's Next in the Biotech World?
Watch out for earnings results of companies like Amgen, Vertex, Celgene and Gilead among others in the next few days. Meanwhile, BioMarin (BMRN - Free Report) should get a response from the FDA regarding the approval status of Brineura for the treatment of CLN2 disease, a form of Batten disease, this week.
Zacks' Hidden Trades
While we share many recommendations and ideas with the public, certain moves are hidden from everyone but selected members of our portfolio services. Would you like to peek behind the curtain today and view them?
Starting now, for the next month, I invite you to follow all Zacks' private buys and sells in real time from value to momentum...from stocks under $10 to ETF to option movers...from insider trades to companies that are about to report positive earnings surprises (we've called them with 80%+ accuracy). You can even look inside portfolios so exclusive that they are normally closed to new investors.
Click here for Zacks' secret trade>>