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Biotech Stock Roundup: FDA Nod for Biogen/Ionis Drug, Seattle Genetics Hit by Clinical Hold
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Biogen (BIIB - Free Report) and Ionis (IONS - Free Report) got an early Christmas gift with the FDA approving their spinal muscular atrophy (SMA) treatment Spinraza three months within the filing of the regulatory application. Meanwhile, Seattle Genetics has been hit by clinical holds on several early-stage studies evaluating an experimental cancer treatment.
Recap of the Week’s Most Important Stories
Christmas Cheer for Biogen and Ionis: Biogen and Ionis got a boost with the FDA approving their SMA treatment Spinraza just before Christmas. Spinraza has been approved to treat a broad range of SMA patients. With the drug being the first treatment to be approved for SMA, a leading genetic cause of death in infants and toddlers that is marked by progressive, debilitating muscle weakness, the market potential is huge.
The approval, which came within three months of the regulatory filing, is important for both companies. While Ionis could well find itself on the path to profitability on Spinraza sales, Biogen needed this boost considering the challenges the company has been facing with growing its multiple sclerosis (MS) franchise sales and pipeline setbacks. The FDA has also granted a rare pediatric disease priority review voucher which can used later to get priority review for some other product (Read more: Ionis/Biogen Spinraza Approved For Spinal Muscular Atrophy).
Meanwhile, AveXis, which is developing an SMA treatment, saw its shares decline 5.9% on Spinraza’s approval.
Sleepless Times for Seattle Genetics? Seattle Genetics' investors received a jolt with the company saying that the FDA has placed a clinical hold or partial clinical on several early stage studies on SGN-CD33A (vadastuximab talirine) in acute myeloid leukemia (AML). However, other studies including a phase III study (CASCADE) in older AML patients and a phase I/II study in myelodysplastic syndrome, remain unaffected by the holds.
The holds were put in place to evaluate the potential risk of hepatotoxicity in patients who were treated with SGN-CD33A and received allogeneic stem cell transplant either before or after treatment. While six patients were identified with hepatotoxicity, including several cases of veno-occlusive disease, there were four deaths. Seattle Genetics is working with the FDA to determine whether there is any link between hepatotoxicity and treatment with SGN-CD33A. Seattle Genetics’ shares were down 15.4% on the news.
Anthera Drug Misses Primary Endpoint in Late-Stage Study: Anthera (ANTH - Free Report) suffered a setback with one of its pipeline candidates failing in a late-stage study in cystic fibrosis patients with exocrine pancreatic insufficiency (EPI). While Sollpura missed the primary endpoint for change in the coefficient of fat absorption (CFA) non-inferiority margin, it demonstrated non-inferiority in the per protocol CFA analysis and coefficient of nitrogen absorption (CNA) analyses. The company now intends to start a new study in the first quarter of 2017 with a BLA filing planned for the first quarter of 2018.
Synergy Up on Positive Plecanatide Data: Synergy’s shares were up on positive top-line data from a couple of pivotal studies on plecanatide in adult patients with irritable bowel syndrome with constipation (IBS-C). Plecanatide is currently under FDA review for the treatment of chronic idiopathic constipation (CIC) with a response expected by Jan 29, 2017. Depending on the FDA’s decision regarding the CIC indication, Synergy will seek approval for the IBS-C indication in the first quarter of 2017 (Read more: Synergy Reports Positive Top-Line Phase III Data on IBS Drug).
NICE Recommendation for Celgene’s Otezla: Celgene’s Otezla got a positive recommendation from the National Institute for Health and Care Excellence (NICE) for the treatment of adult patients with active psoriatic arthritis who have responded inadequately to or have been unable to tolerate disease modifying anti-rheumatic drugs (DMARDs). The recommendation represents the reversal of earlier negative guidance issued by NICE in Sep 2015. Otezla, one of the most promising products in Celgene’s portfolio, has immense potential with sales being driven by demand, growing market share and an expanding global footprint. The product is comfortably on track to achieve blockbuster status in 2016.
The NASDAQ Biotechnology Index gained slightly (0.2%) over the last four trading days. Among major biotech stocks, Alexion gained 8% while Vertex (VRTX - Free Report) declined 1.6%. Over the last six months, Biogen was up 29.6% while Vertex lost 5.8%. Vertex has underperformed the Zacks-categorized Medical-Biomedical and Genetics industry year-to-date (YTD) with shares declining 40.9% during this period compared to the industry decline of 25.2% (See the last biotech stock roundup here: Conatus Soars on Novartis Deal, Early FDA Nod for Clovis Drug).
What's Next in the Biotech World?
Watch out for the usual pipeline and regulatory updates from biotech companies.
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Biotech Stock Roundup: FDA Nod for Biogen/Ionis Drug, Seattle Genetics Hit by Clinical Hold
Biogen (BIIB - Free Report) and Ionis (IONS - Free Report) got an early Christmas gift with the FDA approving their spinal muscular atrophy (SMA) treatment Spinraza three months within the filing of the regulatory application. Meanwhile, Seattle Genetics has been hit by clinical holds on several early-stage studies evaluating an experimental cancer treatment.
Recap of the Week’s Most Important Stories
Christmas Cheer for Biogen and Ionis: Biogen and Ionis got a boost with the FDA approving their SMA treatment Spinraza just before Christmas. Spinraza has been approved to treat a broad range of SMA patients. With the drug being the first treatment to be approved for SMA, a leading genetic cause of death in infants and toddlers that is marked by progressive, debilitating muscle weakness, the market potential is huge.
The approval, which came within three months of the regulatory filing, is important for both companies. While Ionis could well find itself on the path to profitability on Spinraza sales, Biogen needed this boost considering the challenges the company has been facing with growing its multiple sclerosis (MS) franchise sales and pipeline setbacks. The FDA has also granted a rare pediatric disease priority review voucher which can used later to get priority review for some other product (Read more: Ionis/Biogen Spinraza Approved For Spinal Muscular Atrophy).
Meanwhile, AveXis, which is developing an SMA treatment, saw its shares decline 5.9% on Spinraza’s approval.
Sleepless Times for Seattle Genetics? Seattle Genetics' investors received a jolt with the company saying that the FDA has placed a clinical hold or partial clinical on several early stage studies on SGN-CD33A (vadastuximab talirine) in acute myeloid leukemia (AML). However, other studies including a phase III study (CASCADE) in older AML patients and a phase I/II study in myelodysplastic syndrome, remain unaffected by the holds.
The holds were put in place to evaluate the potential risk of hepatotoxicity in patients who were treated with SGN-CD33A and received allogeneic stem cell transplant either before or after treatment. While six patients were identified with hepatotoxicity, including several cases of veno-occlusive disease, there were four deaths. Seattle Genetics is working with the FDA to determine whether there is any link between hepatotoxicity and treatment with SGN-CD33A. Seattle Genetics’ shares were down 15.4% on the news.
Anthera Drug Misses Primary Endpoint in Late-Stage Study: Anthera (ANTH - Free Report) suffered a setback with one of its pipeline candidates failing in a late-stage study in cystic fibrosis patients with exocrine pancreatic insufficiency (EPI). While Sollpura missed the primary endpoint for change in the coefficient of fat absorption (CFA) non-inferiority margin, it demonstrated non-inferiority in the per protocol CFA analysis and coefficient of nitrogen absorption (CNA) analyses. The company now intends to start a new study in the first quarter of 2017 with a BLA filing planned for the first quarter of 2018.
Synergy Up on Positive Plecanatide Data: Synergy’s shares were up on positive top-line data from a couple of pivotal studies on plecanatide in adult patients with irritable bowel syndrome with constipation (IBS-C). Plecanatide is currently under FDA review for the treatment of chronic idiopathic constipation (CIC) with a response expected by Jan 29, 2017. Depending on the FDA’s decision regarding the CIC indication, Synergy will seek approval for the IBS-C indication in the first quarter of 2017 (Read more: Synergy Reports Positive Top-Line Phase III Data on IBS Drug).
NICE Recommendation for Celgene’s Otezla: Celgene’s Otezla got a positive recommendation from the National Institute for Health and Care Excellence (NICE) for the treatment of adult patients with active psoriatic arthritis who have responded inadequately to or have been unable to tolerate disease modifying anti-rheumatic drugs (DMARDs). The recommendation represents the reversal of earlier negative guidance issued by NICE in Sep 2015. Otezla, one of the most promising products in Celgene’s portfolio, has immense potential with sales being driven by demand, growing market share and an expanding global footprint. The product is comfortably on track to achieve blockbuster status in 2016.
Celgene 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 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index gained slightly (0.2%) over the last four trading days. Among major biotech stocks, Alexion gained 8% while Vertex (VRTX - Free Report) declined 1.6%. Over the last six months, Biogen was up 29.6% while Vertex lost 5.8%. Vertex has underperformed the Zacks-categorized Medical-Biomedical and Genetics industry year-to-date (YTD) with shares declining 40.9% during this period compared to the industry decline of 25.2% (See the last biotech stock roundup here: Conatus Soars on Novartis Deal, Early FDA Nod for Clovis Drug).
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What's Next in the Biotech World?
Watch out for the usual pipeline and regulatory updates from biotech companies.
Zacks' Best Investment Ideas for Long-Term Profit
Today you can gain access to long-term trades with double and triple-digit profit potential rarely available to the public. Starting now, you can look inside our stocks under $10, home run and value stock portfolios, plus more. Want a peek at this private information? Click here >>