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Biotech Stock Roundup: Cara Plunges on Study Data, Regulatory Updates & More
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It’s been a pretty slow week for the biotech sector with not too many major updates being provided. Among key news, Cara Therapeutics (CARA - Free Report) saw its shares declining on mixed data on its experimental pain treatment. Meanwhile, companies like BioMarin (BMRN - Free Report) and Acorda provided regulatory updates.
Recap of the Week’s Most Important Stories
Cara Down on Mixed Results: Cara Therapeutics’ shares plunged 39.7% on mixed results from a mid-stage study in chronic pain patients with osteoarthritis of the hip or knee. Top-line results from a phase IIb study of an oral tablet formulation of the company's peripherally selective kappa opioid agonist, CR845, showed a statistically significant 39% reduction in mean joint pain score in hip patients and a 35% reduction in mean joint pain score for all patients at eight weeks with the highest dose (5 mg). However, patients on lower doses (1 mg and 2.5 mg) failed to show significant reductions in mean joint pain scores compared to placebo.
Cara intends to conduct a phase II adaptive study with increased tablet strength of 5mg-10mg. The company also intends to request a Type C meeting with the FDA to outline the path forward.
Cara’s shares are up 76.9% year-to-date (YTD), outperforming the Zacks-categorized Medical-Biomedical/Genetics industry.
BioMarin Submits PKU Drug Application to FDA: Rare-disease focused BioMarin has submitted a regulatory application to the FDA for pegvaliase to reduce blood phenylalanine (Phe) levels in adult patients with PKU who have uncontrolled blood Phe levels on existing management. The company intends to submit an application in the EU by year end.
PKU is a genetic disorder affecting about 50,000 diagnosed patients in the developed world. BioMarin already has a PKU product in its portfolio in the form of Kuvan (Read more: BioMarin Files BLA for Phenylketonuria Candidate Pegvaliase).
Amgen’s Vectibix Label Expanded: Amgen’s (AMGN - Free Report) Vectibix gained FDA approval for the first-line treatment of patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC) in combination with FOLFOX and as monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy. This makes Vectibix the first-and-only fully human monoclonal anti-EGFR antibody to be approved by the FDA for this patient population (Read more: Amgen's Colorectal Cancer Drug Gets FDA Nod to Expand Label). Amgen is a Zacks Rank #3 (Hold) stock -- you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Acorda Files Inbrija Regulatory Application in the U.S.: Acorda is seeking approval for Inbrija (CVT-301, levodopa inhalation powder) in the U.S. as a treatment for symptoms of OFF periods in people with Parkinson’s taking a carbidopa / levodopa regimen. Acorda will get to know if the NDA, which has been submitted as a 505(b)(2) application, will be deemed complete by the end of September.
According to information provided by the company, about 1 million people in the U.S. and 1.2 million in Europe suffer from Parkinson’s disease with OFF periods being experienced by approximately 350,000 and 420,000 patients in the U.S. and Europe, respectively. Timely review and approval would allow the company to launch the product in 2018. Acorda expects annual peak net revenues of more than $500 million in the U.S. alone. The company intends to file for approval in Europe by year end.
Alkermes Schizophrenia Drug Scores in First Phase III Study: Alkermes (ALKS - Free Report) provided positive preliminary topline results on its experimental schizophrenia treatment, ALKS 3831 from the first of two key late stage studies – ENLIGHTEN-1. The once-daily, oral atypical antipsychotic drug’s efficacy was found to be statistically superior to placebo and similar to Zyprexa (olanzapine). The secondary endpoint was also achieved. ALKS 3831 is expected to provide the efficacy of Zyprexa without the severe weight gain and metabolic side effects commonly associated with its use. An antipsychotic with these properties would have strong demand in the schizophrenia market.
While the ENLIGHTEN-1 results are encouraging, all eyes will remain on results from the six-month phase III ENLIGHTEN-2 study which is evaluating the weight gain profile of Zyprexa versus ALKS 3831. Results from this study are expected next year (Read more: Alkermes Presents Phase III Data on Schizophrenia Candidate).
Opexa Soars on Merger Agreement: Opexa’s shares shot up 76.9% on the announcement of a merger agreement with privately-held pharma company Acer Therapeutics Inc. The merger, slated to go through in the third quarter of 2017, is expected to lead to the creation of a pre-NDA-stage, NASDAQ-listed, pharma company focused on the development and commercialization of therapies for serious rare diseases with critical unmet medical need.
The combined company is expected to submit Acer’s lead pipeline candidate, Edsivo, a potential life-saving therapy for patients with vascular Ehlers-Danlos Syndrome (vEDS) in the first half of 2018.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index was up marginally (0.2%) over the last four trading sessions. Among major biotech stocks, Amgen gained 1.1% while Regeneron lost 2.9%. Over the last six months, Vertex was up 71.2% while Biogen (BIIB - Free Report) was down 6.6% (See the last biotech stock roundup here: EU Nod for Regeneron RA Drug, Portola Soars on FDA Nod).
What's Next in the Biotech World?
Watch out for the usual pipeline updates and data presentations from biotech companies.
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Biotech Stock Roundup: Cara Plunges on Study Data, Regulatory Updates & More
It’s been a pretty slow week for the biotech sector with not too many major updates being provided. Among key news, Cara Therapeutics (CARA - Free Report) saw its shares declining on mixed data on its experimental pain treatment. Meanwhile, companies like BioMarin (BMRN - Free Report) and Acorda provided regulatory updates.
Recap of the Week’s Most Important Stories
Cara Down on Mixed Results: Cara Therapeutics’ shares plunged 39.7% on mixed results from a mid-stage study in chronic pain patients with osteoarthritis of the hip or knee. Top-line results from a phase IIb study of an oral tablet formulation of the company's peripherally selective kappa opioid agonist, CR845, showed a statistically significant 39% reduction in mean joint pain score in hip patients and a 35% reduction in mean joint pain score for all patients at eight weeks with the highest dose (5 mg). However, patients on lower doses (1 mg and 2.5 mg) failed to show significant reductions in mean joint pain scores compared to placebo.
Cara intends to conduct a phase II adaptive study with increased tablet strength of 5mg-10mg. The company also intends to request a Type C meeting with the FDA to outline the path forward.
Cara’s shares are up 76.9% year-to-date (YTD), outperforming the Zacks-categorized Medical-Biomedical/Genetics industry.
BioMarin Submits PKU Drug Application to FDA: Rare-disease focused BioMarin has submitted a regulatory application to the FDA for pegvaliase to reduce blood phenylalanine (Phe) levels in adult patients with PKU who have uncontrolled blood Phe levels on existing management. The company intends to submit an application in the EU by year end.
PKU is a genetic disorder affecting about 50,000 diagnosed patients in the developed world. BioMarin already has a PKU product in its portfolio in the form of Kuvan (Read more: BioMarin Files BLA for Phenylketonuria Candidate Pegvaliase).
Amgen’s Vectibix Label Expanded: Amgen’s (AMGN - Free Report) Vectibix gained FDA approval for the first-line treatment of patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC) in combination with FOLFOX and as monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy. This makes Vectibix the first-and-only fully human monoclonal anti-EGFR antibody to be approved by the FDA for this patient population (Read more: Amgen's Colorectal Cancer Drug Gets FDA Nod to Expand Label). Amgen is a Zacks Rank #3 (Hold) stock -- you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Acorda Files Inbrija Regulatory Application in the U.S.: Acorda is seeking approval for Inbrija (CVT-301, levodopa inhalation powder) in the U.S. as a treatment for symptoms of OFF periods in people with Parkinson’s taking a carbidopa / levodopa regimen. Acorda will get to know if the NDA, which has been submitted as a 505(b)(2) application, will be deemed complete by the end of September.
According to information provided by the company, about 1 million people in the U.S. and 1.2 million in Europe suffer from Parkinson’s disease with OFF periods being experienced by approximately 350,000 and 420,000 patients in the U.S. and Europe, respectively. Timely review and approval would allow the company to launch the product in 2018. Acorda expects annual peak net revenues of more than $500 million in the U.S. alone. The company intends to file for approval in Europe by year end.
Alkermes Schizophrenia Drug Scores in First Phase III Study: Alkermes (ALKS - Free Report) provided positive preliminary topline results on its experimental schizophrenia treatment, ALKS 3831 from the first of two key late stage studies – ENLIGHTEN-1. The once-daily, oral atypical antipsychotic drug’s efficacy was found to be statistically superior to placebo and similar to Zyprexa (olanzapine). The secondary endpoint was also achieved. ALKS 3831 is expected to provide the efficacy of Zyprexa without the severe weight gain and metabolic side effects commonly associated with its use. An antipsychotic with these properties would have strong demand in the schizophrenia market.
While the ENLIGHTEN-1 results are encouraging, all eyes will remain on results from the six-month phase III ENLIGHTEN-2 study which is evaluating the weight gain profile of Zyprexa versus ALKS 3831. Results from this study are expected next year (Read more: Alkermes Presents Phase III Data on Schizophrenia Candidate).
Opexa Soars on Merger Agreement: Opexa’s shares shot up 76.9% on the announcement of a merger agreement with privately-held pharma company Acer Therapeutics Inc. The merger, slated to go through in the third quarter of 2017, is expected to lead to the creation of a pre-NDA-stage, NASDAQ-listed, pharma company focused on the development and commercialization of therapies for serious rare diseases with critical unmet medical need.
The combined company is expected to submit Acer’s lead pipeline candidate, Edsivo, a potential life-saving therapy for patients with vascular Ehlers-Danlos Syndrome (vEDS) in the first half of 2018.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index was up marginally (0.2%) over the last four trading sessions. Among major biotech stocks, Amgen gained 1.1% while Regeneron lost 2.9%. Over the last six months, Vertex was up 71.2% while Biogen (BIIB - Free Report) was down 6.6% (See the last biotech stock roundup here: EU Nod for Regeneron RA Drug, Portola Soars on FDA Nod).
What's Next in the Biotech World?
Watch out for the usual pipeline updates and data presentations from biotech companies.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +18.8% from 2016 - Q1 2017, our top stock-picking screens have returned +157.0%, +128.0%, +97.8%, +94.7%, and +90.2% respectively.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - Q1 2017, the composite yearly average gain for these strategies has beaten the market more than 11X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation. See Them Free>>