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Biotech Stock Roundup: FDA Nod for Amgen PCSK9 Inhibitor, Revance Up on RT002 Data
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This week, companies like Amgen (AMGN - Free Report) , Revance Therapeutics, Inc. (RVNC - Free Report) and AbbVie (ABBV - Free Report) were in the news. While Amgen got FDA approval for the inclusion of cardiovascular outcomes data for its PCSK9 inhibitor, AbbVie and Revance provided data on their pipeline candidates.
Recap of the Week’s Most Important Stories
Revance Soars on RT002 Data: Revance’s shares shot up 33.7% on positive top-line data from late-stage studies evaluating the company’s next-generation neuromodulator RT002. RT002 met the primary as well as all secondary endpoints in the studies that were conducted for the reduction of moderate-to-severe glabellar lines (the frown lines or wrinkles between the brows).
A long-term safety study is currently ongoing with the study scheduled to complete in the second half of 2018. The successful completion of this study would allow Revance to file for FDA approval in the first half of 2019 and potentially launch the product in 2020. The company believes that FDA approval would make RT002 the first neuromodulator with a long-acting duration of six months as currently marketed neuromodulators have shown duration of three to four months in treating glabellar lines. RT002’s approval could well change the neuromodulator treatment landscape as it would be needed only twice a year.
According to information provided by the company, the treatment of glabellar lines is the most popular aesthetic procedure for an injectable neuromodulator with almost a third of the $3.6 billion in global neuromodulator sales in 2016 coming from this area. Currently approved treatments include Botox and Dysport.
Amgen’s PCSK9 Inhibitor Label Approved for Cardiovascular Outcomes Data: Amgen’s PCSK9 inhibitor, Repatha, got a bit of a boost with the FDA granting approval to the company’s request to add cardiovascular outcomes data to the drug’s label. This makes Repatha the first PCSK9 inhibitor to prevent heart attacks, strokes and coronary revascularizations in adults with established cardiovascular disease. Repatha was also approved for use as an adjunct to diet, alone or in combination with other lipid-lowering therapies like statins, for the treatment of adults with primary hyperlipidemia to reduce low density lipoprotein cholesterol (LDL-C).
The updated label will provide physicians with a new treatment option to prevent cardiovascular events by dramatically lowering LDL cholesterol with Repatha, especially in the case of patients who are already on maximally-tolerated statin therapy and need to lower their LDL cholesterol level further.
The cardiovascular outcomes data should help drive Repatha sales which are yet to take off as expected with factors like strict utilization management criteria and processes employed by insurers and pharmacy benefit managers (PBMs) impacting sales. However, Amgen has been working with payers to improve access for appropriate patients and Repatha remains a growth brand for the company (Read more: Amgen's PCSK9 Inhibitor Gets FDA Nod for Stroke Prevention). Amgen is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Positive Data on AbbVie’s Risankizumab and Imbruvica: AbbVie’s risankizumab met the primary endpoint in the fourth pivotal phase III study conducted for the treatment of patients with moderate to severe plaque psoriasis. After 16 weeks of treatment, almost half (47%) of risankizumab patients achieved complete skin clearance (PASI 100) compared to 1% of patients on placebo. Risankizumab is being developed in collaboration with Boehringer Ingelheim (Read more: AbbVie Psoriasis Candidate Succeeds in 4th Phase III Study).
AbbVie also presented data on a combination of its BTK inhibitor, Imbruvica, and Rituxan for the treatment of both newly and previously-treated patients with Waldenström's macroglobulinemia (“WM”). The primary endpoint of progression-free survival (“PFS”) was achieved in the late-stage study. Imbruvica is approved for different indications including chronic lymphocytic leukemia, previously treated mantle cell lymphoma and WM as well as chronic graft-versus-host-disease. AbbVie expects Imbruvica revenues of $5 billion in 2020.
Priority Review for Clovis sNDA: Clovis Oncology’s supplemental New Drug Application (sNDA) for the use of its PARP inhibitor, Rubraca (rucaparib), has been granted priority review status by the FDA. The company is looking to get Rubraca approved for use as maintenance treatment for women with recurrent ovarian cancer who are platinum sensitive, and in complete or partial response to platinum chemotherapy, with no requirement for diagnostic testing. With the FDA granting priority review, a response should be out on Apr 6, 2018.
Clovis’s shares are up 29.9% year to date, compared to the 1.3% gain recorded by the industry it belongs to.
Galectin Down on NASH Data: Galectin Therapeutics Inc.’s shares fell 30.7% on data from a phase IIb study on GR-MD-02. Although the candidate showed statistically significant and clinically meaningful results in a sub-group of non-alcoholic steatohepatitis (“NASH”) cirrhosis patients, it failed to achieve statistical significance in the total group of patients.
Positive 48-Week Data on Ultragenyx Drug: Ultragenyx Pharmaceutical Inc. (RARE - Free Report) and partner Kyowa Kirin announced positive 48-week data from a late-stage study of burosumab (KRN23) in adults with X-linked hypophosphatemia (“XLH”). The companies said that further improvement in disease symptoms and fracture healing were observed through 48 weeks of treatment with burosumab. Burosumab is currently under priority review for the treatment of pediatric and adult patients with XLH with a response from the FDA expected on Apr 17, 2018.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index declined slightly (0.5%) over the last five trading sessions. Among major biotech stocks, Amgen was up 4.9% while Vertex declined 6.1%. Over the last six months, Biogen (BIIB - Free Report) was up 23.7% while Regeneron (REGN - Free Report) lost 22.5% (See the last biotech stock roundup here: Regeneron Down on Eylea Data, Biogen-Alkermes in MS Deal).
What's Next in the Biotech World?
Watch out for the usual pipeline and regulatory updates.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
Image: Bigstock
Biotech Stock Roundup: FDA Nod for Amgen PCSK9 Inhibitor, Revance Up on RT002 Data
This week, companies like Amgen (AMGN - Free Report) , Revance Therapeutics, Inc. (RVNC - Free Report) and AbbVie (ABBV - Free Report) were in the news. While Amgen got FDA approval for the inclusion of cardiovascular outcomes data for its PCSK9 inhibitor, AbbVie and Revance provided data on their pipeline candidates.
Recap of the Week’s Most Important Stories
Revance Soars on RT002 Data: Revance’s shares shot up 33.7% on positive top-line data from late-stage studies evaluating the company’s next-generation neuromodulator RT002. RT002 met the primary as well as all secondary endpoints in the studies that were conducted for the reduction of moderate-to-severe glabellar lines (the frown lines or wrinkles between the brows).
A long-term safety study is currently ongoing with the study scheduled to complete in the second half of 2018. The successful completion of this study would allow Revance to file for FDA approval in the first half of 2019 and potentially launch the product in 2020. The company believes that FDA approval would make RT002 the first neuromodulator with a long-acting duration of six months as currently marketed neuromodulators have shown duration of three to four months in treating glabellar lines. RT002’s approval could well change the neuromodulator treatment landscape as it would be needed only twice a year.
According to information provided by the company, the treatment of glabellar lines is the most popular aesthetic procedure for an injectable neuromodulator with almost a third of the $3.6 billion in global neuromodulator sales in 2016 coming from this area. Currently approved treatments include Botox and Dysport.
Amgen’s PCSK9 Inhibitor Label Approved for Cardiovascular Outcomes Data: Amgen’s PCSK9 inhibitor, Repatha, got a bit of a boost with the FDA granting approval to the company’s request to add cardiovascular outcomes data to the drug’s label. This makes Repatha the first PCSK9 inhibitor to prevent heart attacks, strokes and coronary revascularizations in adults with established cardiovascular disease. Repatha was also approved for use as an adjunct to diet, alone or in combination with other lipid-lowering therapies like statins, for the treatment of adults with primary hyperlipidemia to reduce low density lipoprotein cholesterol (LDL-C).
The updated label will provide physicians with a new treatment option to prevent cardiovascular events by dramatically lowering LDL cholesterol with Repatha, especially in the case of patients who are already on maximally-tolerated statin therapy and need to lower their LDL cholesterol level further.
The cardiovascular outcomes data should help drive Repatha sales which are yet to take off as expected with factors like strict utilization management criteria and processes employed by insurers and pharmacy benefit managers (PBMs) impacting sales. However, Amgen has been working with payers to improve access for appropriate patients and Repatha remains a growth brand for the company (Read more: Amgen's PCSK9 Inhibitor Gets FDA Nod for Stroke Prevention). Amgen is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Positive Data on AbbVie’s Risankizumab and Imbruvica: AbbVie’s risankizumab met the primary endpoint in the fourth pivotal phase III study conducted for the treatment of patients with moderate to severe plaque psoriasis. After 16 weeks of treatment, almost half (47%) of risankizumab patients achieved complete skin clearance (PASI 100) compared to 1% of patients on placebo. Risankizumab is being developed in collaboration with Boehringer Ingelheim (Read more: AbbVie Psoriasis Candidate Succeeds in 4th Phase III Study).
AbbVie also presented data on a combination of its BTK inhibitor, Imbruvica, and Rituxan for the treatment of both newly and previously-treated patients with Waldenström's macroglobulinemia (“WM”). The primary endpoint of progression-free survival (“PFS”) was achieved in the late-stage study. Imbruvica is approved for different indications including chronic lymphocytic leukemia, previously treated mantle cell lymphoma and WM as well as chronic graft-versus-host-disease. AbbVie expects Imbruvica revenues of $5 billion in 2020.
Priority Review for Clovis sNDA: Clovis Oncology’s supplemental New Drug Application (sNDA) for the use of its PARP inhibitor, Rubraca (rucaparib), has been granted priority review status by the FDA. The company is looking to get Rubraca approved for use as maintenance treatment for women with recurrent ovarian cancer who are platinum sensitive, and in complete or partial response to platinum chemotherapy, with no requirement for diagnostic testing. With the FDA granting priority review, a response should be out on Apr 6, 2018.
Clovis’s shares are up 29.9% year to date, compared to the 1.3% gain recorded by the industry it belongs to.
Galectin Down on NASH Data: Galectin Therapeutics Inc.’s shares fell 30.7% on data from a phase IIb study on GR-MD-02. Although the candidate showed statistically significant and clinically meaningful results in a sub-group of non-alcoholic steatohepatitis (“NASH”) cirrhosis patients, it failed to achieve statistical significance in the total group of patients.
Positive 48-Week Data on Ultragenyx Drug: Ultragenyx Pharmaceutical Inc. (RARE - Free Report) and partner Kyowa Kirin announced positive 48-week data from a late-stage study of burosumab (KRN23) in adults with X-linked hypophosphatemia (“XLH”). The companies said that further improvement in disease symptoms and fracture healing were observed through 48 weeks of treatment with burosumab. Burosumab is currently under priority review for the treatment of pediatric and adult patients with XLH with a response from the FDA expected on Apr 17, 2018.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index declined slightly (0.5%) over the last five trading sessions. Among major biotech stocks, Amgen was up 4.9% while Vertex declined 6.1%. Over the last six months, Biogen (BIIB - Free Report) was up 23.7% while Regeneron (REGN - Free Report) lost 22.5% (See the last biotech stock roundup here: Regeneron Down on Eylea Data, Biogen-Alkermes in MS Deal).
What's Next in the Biotech World?
Watch out for the usual pipeline and regulatory updates.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
Click for details >>