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Biotech Stock Roundup: Amgen Down on Repatha Data, Nektar Surges on Pain Results
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Biotech stocks were hit by the release of the Budget Blueprint for 2018 which could require companies to shell out higher fees for regulatory reviews. Moreover, the budget proposes a reduction of $5.8 billion in the National Institutes of Health’s (NIH) spending. Other key updates include Amgen’s (AMGN - Free Report) data on its PCSK9 inhibitor, Repatha, and a couple of analyst downgrades for Biogen (BIIB - Free Report) .
Recap of the Week’s Most Important Stories
Amgen Presents Data on PCSK9 Inhibitor: Although Amgen presented positive data from an outcomes study (FOURIER) on its PCSK9 inhibitor, Repatha, shares were down as some of the data fell short of expectations. Repatha is one of the most watched new product launches though sales are yet to ramp up (Read more: Amgen: Repatha Outcomes Data Disappoint, Shares Drop).
Meanwhile, Amgen is facing a lawsuit from French pharma giant Sanofi and partner Regeneron (REGN - Free Report) related to their eczema drug Dupixent, which could gain FDA approval later this month. The companies have filed a lawsuit seeking a court order that their drug does not infringe a patent held by Amgen. The lawsuit is a proactive move by Sanofi and Regeneron to prevent Amgen from initiating a patent infringement lawsuit like it had related to Sanofi and Regeneron’s PCSK9 inhibitor Praluent.
Biogen Hit by Analyst Downgrades but Bounces Back on Patent Ruling: Biogen, known for its presence in the multiple sclerosis (MS) market, suffered a blow with a couple of analysts downgrading their rating on the stock. Investors are concerned about the performance of the company’s new product launch, spinal muscular atrophy treatment, Spinraza, as well as increasing competition in the MS space. While Biogen was down on the analyst downgrades, shares popped on news that the company got a favorable ruling related to inter partes reviews for its oral MS drug, Tecfidera. Tecfidera brought in sales of almost $4 billion last year and is a key revenue generator at Biogen. Biogen is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Array Withdraws Binimetinib Regulatory Application: Array’s (ARRY - Free Report) shares were down on news that the company has withdrawn its regulatory application in the U.S. for its experimental cancer treatment, binimetinib. The company was looking to get binimetinib approved for NRAS-mutant melanoma, a rare type of skin cancer. However, following discussions with the FDA and a late cycle review meeting, Array said that the NEMO study data would not be enough to gain approval.
Array pointed out that the decision to submit the regulatory application would not affect ongoing studies with binimetinib. Moreover, the company remains on track to seek FDA approval for binimetinib plus encorafenib for BRAF-mutant melanoma in mid-2017.
Nektar Jumps on Pain Drug Data: Nektar’s (NKTR - Free Report) shares shot up 42.6% on positive data from a late-stage study on the company’s first-in-class opioid analgesic, NKTR-181. NKTR-181, which has fast track designation in the U.S. for the treatment of moderate to severe chronic pain, is the first full mu-opioid agonist designed to provide potent pain relief without the high levels of euphoria that can lead to abuse and addiction with standard opioids. NKTR-181’s efficacy along with significantly lower abuse potential than oxycodone could help it change the way of treating patients with chronic pain conditions (Read more: Nektar's Pain Drug Positive in Phase III Study; Shares Gain).
CytomX-Bristol-Myers Expand Deal: CytomX’s (CTMX - Free Report) shares gained 24.4% on the company’s expansion of its 2014 agreement with Bristol-Myers related to the use of CytomX's proprietary Probody platform. The expanded deal not only validates CytomX’s technology, it will also provide the company with a source of funds.
While under the initial agreement, Bristol-Myers had selected four oncology targets, the company will get exclusive global rights to develop and commercialize Probody therapeutics for up to six additional oncology targets and two non-oncology targets. CytomX will get an upfront payment of $200 million as well as research funding over the course of the research term. Moreover, CytomX could receive up to $448 million on the achievement of development, regulatory and sales milestones and tiered royalties on commercialized products. So far in 2017, CytomX has outperformed the Zacks-categorized Medical-Biomedical/Genetics industry with the company soaring 66.1% compared to the industry gain of 8.2% (Read more: Bristol-Myers Squibb and CytomX Therapeutics Extend Deal).
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index declined 3.3% over the last five trading sessions with the sector being hit by the budget blueprint and other developments. Among major biotech stocks, Amgen declined 7.4% on Repatha data while Biogen was down 5.7% on the analyst downgrades. Over the last six months, Celgene was up 13% while Gilead (GILD - Free Report) was down 17.1% (See the last biotech stock roundup here: Amgen's Data on Repatha, Catalyst Soars on Firdapse Data).
What's Next in the Biotech World?
Watch out for the usual pipeline and regulatory updates. Regeneron and partner Sanofi will get to know about the approval status of their eczema treatment, Dupixent, by Mar 29, 2017.
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Biotech Stock Roundup: Amgen Down on Repatha Data, Nektar Surges on Pain Results
Biotech stocks were hit by the release of the Budget Blueprint for 2018 which could require companies to shell out higher fees for regulatory reviews. Moreover, the budget proposes a reduction of $5.8 billion in the National Institutes of Health’s (NIH) spending. Other key updates include Amgen’s (AMGN - Free Report) data on its PCSK9 inhibitor, Repatha, and a couple of analyst downgrades for Biogen (BIIB - Free Report) .
Recap of the Week’s Most Important Stories
Amgen Presents Data on PCSK9 Inhibitor: Although Amgen presented positive data from an outcomes study (FOURIER) on its PCSK9 inhibitor, Repatha, shares were down as some of the data fell short of expectations. Repatha is one of the most watched new product launches though sales are yet to ramp up (Read more: Amgen: Repatha Outcomes Data Disappoint, Shares Drop).
Meanwhile, Amgen is facing a lawsuit from French pharma giant Sanofi and partner Regeneron (REGN - Free Report) related to their eczema drug Dupixent, which could gain FDA approval later this month. The companies have filed a lawsuit seeking a court order that their drug does not infringe a patent held by Amgen. The lawsuit is a proactive move by Sanofi and Regeneron to prevent Amgen from initiating a patent infringement lawsuit like it had related to Sanofi and Regeneron’s PCSK9 inhibitor Praluent.
Biogen Hit by Analyst Downgrades but Bounces Back on Patent Ruling: Biogen, known for its presence in the multiple sclerosis (MS) market, suffered a blow with a couple of analysts downgrading their rating on the stock. Investors are concerned about the performance of the company’s new product launch, spinal muscular atrophy treatment, Spinraza, as well as increasing competition in the MS space. While Biogen was down on the analyst downgrades, shares popped on news that the company got a favorable ruling related to inter partes reviews for its oral MS drug, Tecfidera. Tecfidera brought in sales of almost $4 billion last year and is a key revenue generator at Biogen. Biogen is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Array Withdraws Binimetinib Regulatory Application: Array’s (ARRY - Free Report) shares were down on news that the company has withdrawn its regulatory application in the U.S. for its experimental cancer treatment, binimetinib. The company was looking to get binimetinib approved for NRAS-mutant melanoma, a rare type of skin cancer. However, following discussions with the FDA and a late cycle review meeting, Array said that the NEMO study data would not be enough to gain approval.
Array pointed out that the decision to submit the regulatory application would not affect ongoing studies with binimetinib. Moreover, the company remains on track to seek FDA approval for binimetinib plus encorafenib for BRAF-mutant melanoma in mid-2017.
Nektar Jumps on Pain Drug Data: Nektar’s (NKTR - Free Report) shares shot up 42.6% on positive data from a late-stage study on the company’s first-in-class opioid analgesic, NKTR-181. NKTR-181, which has fast track designation in the U.S. for the treatment of moderate to severe chronic pain, is the first full mu-opioid agonist designed to provide potent pain relief without the high levels of euphoria that can lead to abuse and addiction with standard opioids. NKTR-181’s efficacy along with significantly lower abuse potential than oxycodone could help it change the way of treating patients with chronic pain conditions (Read more: Nektar's Pain Drug Positive in Phase III Study; Shares Gain).
CytomX-Bristol-Myers Expand Deal: CytomX’s (CTMX - Free Report) shares gained 24.4% on the company’s expansion of its 2014 agreement with Bristol-Myers related to the use of CytomX's proprietary Probody platform. The expanded deal not only validates CytomX’s technology, it will also provide the company with a source of funds.
While under the initial agreement, Bristol-Myers had selected four oncology targets, the company will get exclusive global rights to develop and commercialize Probody therapeutics for up to six additional oncology targets and two non-oncology targets. CytomX will get an upfront payment of $200 million as well as research funding over the course of the research term. Moreover, CytomX could receive up to $448 million on the achievement of development, regulatory and sales milestones and tiered royalties on commercialized products. So far in 2017, CytomX has outperformed the Zacks-categorized Medical-Biomedical/Genetics industry with the company soaring 66.1% compared to the industry gain of 8.2% (Read more: Bristol-Myers Squibb and CytomX Therapeutics Extend Deal).
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index declined 3.3% over the last five trading sessions with the sector being hit by the budget blueprint and other developments. Among major biotech stocks, Amgen declined 7.4% on Repatha data while Biogen was down 5.7% on the analyst downgrades. Over the last six months, Celgene was up 13% while Gilead (GILD - Free Report) was down 17.1% (See the last biotech stock roundup here: Amgen's Data on Repatha, Catalyst Soars on Firdapse Data).
What's Next in the Biotech World?
Watch out for the usual pipeline and regulatory updates. Regeneron and partner Sanofi will get to know about the approval status of their eczema treatment, Dupixent, by Mar 29, 2017.
5 Trades Could Profit "Big-League" from Trump Policies
If the stocks above spark your interest, wait until you look into companies primed to make substantial gains from Washington's changing course.
Today Zacks reveals 5 tickers that could benefit from new trends like streamlined drug approvals, tariffs, lower taxes, higher interest rates, and spending surges in defense and infrastructure. See these buy recommendations now >>