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Biotech Stock Roundup: Regeneron Drops RSV Antibody, Gilead HIV Drug Gets Priority Review
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With earnings season drawing to a close, focus is back on pipeline and regulatory updates. While Regeneron Pharmaceuticals (REGN - Free Report) , which has several pipeline catalysts lined up for the second half of the year, reported data on one of its late-stage pipeline candidates, Gilead Sciences (GILD - Free Report) got priority review for its investigational HIV treatment.
Recap of the Week’s Most Important Stories
Regeneron Shelves RSV Antibody on Study Failure: Regeneron’s investigational antibody, suptavumab (REGN2222), for respiratory syncytial virus (RSV), failed to meet the primary endpoint in a late-stage study conducted in infants. Regeneron has decided that it will not continue with the development of this candidate. Regeneron has several pipeline catalysts lined up for the second half of the year. Later this quarter, the company expects to report top-line phase III data on Dupixent for asthma – positive data would allow the company to go ahead with a U.S. filing in the fourth quarter. Another important data readout scheduled for the second half of the year is on the company’s PD-1 antibody REGN2810, for cutaneous squamous cell carcinoma (CSCC), the second most common skin cancer after basal cell carcinoma and the second deadliest skin cancer after melanoma. Meanwhile, Eylea is being evaluated in combination with nesvacumab with top-line data from two phase II studies (wet age-related macular degeneration and diabetic macular edema) expected in the fourth quarter of the year.
Priority Review for Gilead HIV Drug: Gilead gained priority review in the U.S. for its investigational, fixed-dose combination of bictegravir (50mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF), a dual-NRTI backbone, for the treatment of HIV. Gilead had used a Priority Review voucher at the time of filing the regulatory application. With the combination gaining priority review, a response from the FDA should be out by Feb 12, 2018. The combination is under review in the EU as well. Gilead’s HIV franchise is a major contributor to sales with approved drugs like Genvoya, Truvada, Atripla, Stribild, Descovy, Odefsey and Complera bringing in sales of $6.2 billion in the first half of 2017. Gilead’s shares are up 2.1% year to date, lagging the industry’s 7.4% rally (Also read: Gilead NDA for HIV Combo Regimen Gets Priority Review).
Another Late-Stage Failure for Ophthotech Eye Drug: Ophthotech , which is focused on the development of treatments for eye diseases, announced that Fovista failed to meet the primary endpoint in another late-stage study. The superiority study was evaluating Fovista anti-PDGF therapy in combination with Eylea (aflibercept) or Avastin (bevacizumab) anti-VEGF therapy compared to Eylea or Avastin monotherapy for the treatment of wet age-related macular degeneration (AMD). The study failed to achieve the primary endpoint. The company had anyway attributed a low likelihood of success to the study given Fovista's earlier failure in two phase III studies as well as the failure of a mid-stage study conducted by a competitor on a PDGF inhibitor and a VEGF inhibitor combination for AMD.
Ionis Retains Full Rights to Inotersen and IONIS-FB-LRx: Ionis Pharmaceuticals (IONS - Free Report) said that Glaxo has declined its options for two drugs, inotersen and IONIS-FB-LRx, in keeping with its decision to reprioritize its pipeline and review its Rare Diseases business. The company, however, will continue to collaborate with Ionis for IONIS-HBVRx and IONIS-HBV-LRx, which are being evaluated for hepatitis B virus (HBV) infection.
With Ionis retaining rights to these two investigational drugs, the company laid out its plans and said that it will be filing for approval of inotersen in 2017 followed by launch in 2018. The initial indication for inotersen, which has been designed to treat patients with TTR amyloidosis (ATTR), is expected to be for the treatment of patients with polyneuropathy due to hereditary TTR amyloidosis (hATTR-PN).
Ionis said that it is considering setting up a commercial subsidiary to commercialize or co-commercialize inotersen in North America. The company is evaluating other options as well including a partnership deal.
Galapagos Up on IPF Data: Galapagos NV’s (GLPG - Free Report) shares were up 10.8% on positive data from a mid-stage study on the company’s investigational idiopathic pulmonary fibrosis (IPF) drug. GLPG1690 halted disease progression in IPF patients in the study and is the first autotaxin inhibitor to show effect in an IPF study. Galapagos now intends to move the candidate into a late-stage study and is already in discussions with regulators regarding the study design.
Galapagos’s data comes shortly after FibroGen’s investigational IPF drug, pamrevlumab, fared well in a mid-stage study as well as two combination safety sub-studies. Pamrevlumab is an anti-connective tissue growth factor (CTGF) antibody.
The IPF market represents huge commercial potential – IPF or abnormal scarring of the lungs is a rare and serious lung disease with survival rates comparable to those of some of the deadliest cancers. Currently approved IPF drugs include Esbriet and Ofev.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index declined 1.6% over the last five trading sessions. Among major biotech stocks, Regeneron was up slightly (0.6%) while Celgene lost 2.9%. Over the last six months, Vertex (VRTX - Free Report) was up 70.9% while Biogen slipped 1.6% (See the last biotech stock roundup here: Q2 Earnings from Regeneron, Kite & More, FibroGen Up on IPF Data).
What's Next in the Biotech World?
With second quarter earnings season coming to an end, watch out for the usual regulatory and pipeline updates.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
Image: Bigstock
Biotech Stock Roundup: Regeneron Drops RSV Antibody, Gilead HIV Drug Gets Priority Review
With earnings season drawing to a close, focus is back on pipeline and regulatory updates. While Regeneron Pharmaceuticals (REGN - Free Report) , which has several pipeline catalysts lined up for the second half of the year, reported data on one of its late-stage pipeline candidates, Gilead Sciences (GILD - Free Report) got priority review for its investigational HIV treatment.
Recap of the Week’s Most Important Stories
Regeneron Shelves RSV Antibody on Study Failure: Regeneron’s investigational antibody, suptavumab (REGN2222), for respiratory syncytial virus (RSV), failed to meet the primary endpoint in a late-stage study conducted in infants. Regeneron has decided that it will not continue with the development of this candidate. Regeneron has several pipeline catalysts lined up for the second half of the year. Later this quarter, the company expects to report top-line phase III data on Dupixent for asthma – positive data would allow the company to go ahead with a U.S. filing in the fourth quarter. Another important data readout scheduled for the second half of the year is on the company’s PD-1 antibody REGN2810, for cutaneous squamous cell carcinoma (CSCC), the second most common skin cancer after basal cell carcinoma and the second deadliest skin cancer after melanoma. Meanwhile, Eylea is being evaluated in combination with nesvacumab with top-line data from two phase II studies (wet age-related macular degeneration and diabetic macular edema) expected in the fourth quarter of the year.
Regeneron is a Zacks Rank #1 (Strong Buy) stock -- you can see the complete list of today’s Zacks #1 Rank stocks here.
Priority Review for Gilead HIV Drug: Gilead gained priority review in the U.S. for its investigational, fixed-dose combination of bictegravir (50mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF), a dual-NRTI backbone, for the treatment of HIV. Gilead had used a Priority Review voucher at the time of filing the regulatory application. With the combination gaining priority review, a response from the FDA should be out by Feb 12, 2018. The combination is under review in the EU as well. Gilead’s HIV franchise is a major contributor to sales with approved drugs like Genvoya, Truvada, Atripla, Stribild, Descovy, Odefsey and Complera bringing in sales of $6.2 billion in the first half of 2017. Gilead’s shares are up 2.1% year to date, lagging the industry’s 7.4% rally (Also read: Gilead NDA for HIV Combo Regimen Gets Priority Review).
Another Late-Stage Failure for Ophthotech Eye Drug: Ophthotech , which is focused on the development of treatments for eye diseases, announced that Fovista failed to meet the primary endpoint in another late-stage study. The superiority study was evaluating Fovista anti-PDGF therapy in combination with Eylea (aflibercept) or Avastin (bevacizumab) anti-VEGF therapy compared to Eylea or Avastin monotherapy for the treatment of wet age-related macular degeneration (AMD). The study failed to achieve the primary endpoint. The company had anyway attributed a low likelihood of success to the study given Fovista's earlier failure in two phase III studies as well as the failure of a mid-stage study conducted by a competitor on a PDGF inhibitor and a VEGF inhibitor combination for AMD.
Ionis Retains Full Rights to Inotersen and IONIS-FB-LRx: Ionis Pharmaceuticals (IONS - Free Report) said that Glaxo has declined its options for two drugs, inotersen and IONIS-FB-LRx, in keeping with its decision to reprioritize its pipeline and review its Rare Diseases business. The company, however, will continue to collaborate with Ionis for IONIS-HBVRx and IONIS-HBV-LRx, which are being evaluated for hepatitis B virus (HBV) infection.
With Ionis retaining rights to these two investigational drugs, the company laid out its plans and said that it will be filing for approval of inotersen in 2017 followed by launch in 2018. The initial indication for inotersen, which has been designed to treat patients with TTR amyloidosis (ATTR), is expected to be for the treatment of patients with polyneuropathy due to hereditary TTR amyloidosis (hATTR-PN).
Ionis said that it is considering setting up a commercial subsidiary to commercialize or co-commercialize inotersen in North America. The company is evaluating other options as well including a partnership deal.
Meanwhile, IONIS-FB-LRx is slated to move into a mid-stage study in patients with dry age-related macular degeneration (AMD) later this year (Also read: Ionis Pharmaceuticals Retains Rights to Inotersen, Stock Up).
Galapagos Up on IPF Data: Galapagos NV’s (GLPG - Free Report) shares were up 10.8% on positive data from a mid-stage study on the company’s investigational idiopathic pulmonary fibrosis (IPF) drug. GLPG1690 halted disease progression in IPF patients in the study and is the first autotaxin inhibitor to show effect in an IPF study. Galapagos now intends to move the candidate into a late-stage study and is already in discussions with regulators regarding the study design.
Galapagos’s data comes shortly after FibroGen’s investigational IPF drug, pamrevlumab, fared well in a mid-stage study as well as two combination safety sub-studies. Pamrevlumab is an anti-connective tissue growth factor (CTGF) antibody.
The IPF market represents huge commercial potential – IPF or abnormal scarring of the lungs is a rare and serious lung disease with survival rates comparable to those of some of the deadliest cancers. Currently approved IPF drugs include Esbriet and Ofev.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index declined 1.6% over the last five trading sessions. Among major biotech stocks, Regeneron was up slightly (0.6%) while Celgene lost 2.9%. Over the last six months, Vertex (VRTX - Free Report) was up 70.9% while Biogen slipped 1.6% (See the last biotech stock roundup here: Q2 Earnings from Regeneron, Kite & More, FibroGen Up on IPF Data).
What's Next in the Biotech World?
With second quarter earnings season coming to an end, watch out for the usual regulatory and pipeline updates.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>