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Key highlights of the week include FDA’s acceptance of Regeneron/Sanofi's Dupixent sBLA for asthma, Biogen/AbbVie’s decision to withdraw multiple sclerosis drug, Zinbryta, due to risk of liver failure and Celgene’s completion of Juno acquisition.
Recap of the Week’s Most Important Stories
Regeneron/Sanofi's Dupixent sBLA for Asthma Accepted by FDA: Regeneron (REGN - Free Report) and partner Sanofi (SNY - Free Report) announced that the FDA has accepted for review the supplemental Biologics License Application (sBLA) of Dupixent (dupilumab) as an add-on maintenance treatment in adults and adolescents (12 years of age or older) with moderate-to-severe asthma. The FDA has set a target action date of Oct 20, 2018 per the Prescription Drug User Fee Act. The sBLA was supported by results from the three pivotal trials from the LIBERTY ASTHMA clinical development program. Sanofi and Regeneron are studying dupilumab in a broad range of clinical development programs for diseases driven by Type 2 inflammation, including pediatric atopic dermatitis (phase III), nasal polyps (phase III) and eosinophilic esophagitis (phase III).
Biogen/AbbVie To Withdraw Zinbryta: Biogen (BIIB - Free Report) and partner AbbVie (ABBV - Free Report) announced that both the companies will withdraw multiple sclerosis drug, Zinbryta voluntarily on a worldwide basis due to risk of liver injury. Both companies decided to withdraw the drug on grounds of the complex and evolving benefit/risk profile of Zinbryta, given the limited number of patients being treated. The drug is currently available in Europe and United States, Switzerland, Canada and Australia. While AbbVie distributes Zinbryta in the United States, Biogen distributes the drug in ex-U.S. markets. The European regulatory authorities provisionally restricted the use of Zinbryta in adult patients with highly active relapsing disease despite a full and adequate course of treatment with at least one DMT or with rapidly evolving severe relapsing MS who are unsuitable for treatment with other DMTs following the report of a case of fatal fulminant liver failure, as well as four cases of serious liver injury.
Gilead Reports New Data on Biktarvy: Gilead (GILD - Free Report) announced encouraging results at 48 weeks from a phase III study (Study 1961) among 470 virologically suppressed adult women with HIV infection at the International Workshop on HIV and Women and at the 2018 Conference on Retroviruses and Opportunistic Infections (“CROI”) in Boston (Poster 2539). Biktarvy was found to be statistically non-inferior to regimens containing a bPI or boosted elvitegravir and demonstrated no treatment-emergent resistance at 48 weeks in the ongoing study. Biktarvy, Gilead’s latest triple therapy, was approved by the FDA in February 2018 as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history.
Celgene Completes Juno Acquisition: Celgene Corporation announced that it has completed the previously-announced acquisition of Juno Therapeutics, Inc for $9 billion Juno focuses on the development of CAR (chimeric antigen receptor) T and TCR (T cell receptor) therapeutics with a promising pipeline evaluating multiple targets and cancer indications. The acquisition will add JCAR017 (lisocabtagene maraleucel; liso-cel) to Celgene’s lymphoma pipeline. JCAR017 is a best-in-class CD19-directed CAR-T currently in a pivotal program for relapsed and/or refractory diffuse large B-cell lymphoma (DLBCL). The candidate is expected to obtain regulatory approval in the United States in 2019 with potential global peak sales of approximately $3 billion.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index gained 4.52% over the last five trading sessions. Among major biotech stocks, Regeneron gained 3.93%. Over the last six months, Celgene lost 36.4% while Vertex gained 6.7% (see the last biotech stock roundup here: Biotech Stock Round Up: Celgene Suffers Setback, Gilead Teams Up with Sangamo).
What's Next in the Biotech World?
Stay tuned for more 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 Round Up: Regeneron Submits sBLA, Biogen to Withdraw Zinbryta
Key highlights of the week include FDA’s acceptance of Regeneron/Sanofi's Dupixent sBLA for asthma, Biogen/AbbVie’s decision to withdraw multiple sclerosis drug, Zinbryta, due to risk of liver failure and Celgene’s completion of Juno acquisition.
Recap of the Week’s Most Important Stories
Regeneron/Sanofi's Dupixent sBLA for Asthma Accepted by FDA: Regeneron (REGN - Free Report) and partner Sanofi (SNY - Free Report) announced that the FDA has accepted for review the supplemental Biologics License Application (sBLA) of Dupixent (dupilumab) as an add-on maintenance treatment in adults and adolescents (12 years of age or older) with moderate-to-severe asthma. The FDA has set a target action date of Oct 20, 2018 per the Prescription Drug User Fee Act. The sBLA was supported by results from the three pivotal trials from the LIBERTY ASTHMA clinical development program. Sanofi and Regeneron are studying dupilumab in a broad range of clinical development programs for diseases driven by Type 2 inflammation, including pediatric atopic dermatitis (phase III), nasal polyps (phase III) and eosinophilic esophagitis (phase III).
(Read more: FDA Accepts Regeneron/Sanofi's Dupixent sBLA for Asthma)
Regeneron is a Zacks Rank #1 (Strong Buy) stock. You can see the complete list of today’s Zacks #1 Rank stocks here.
Biogen/AbbVie To Withdraw Zinbryta: Biogen (BIIB - Free Report) and partner AbbVie (ABBV - Free Report) announced that both the companies will withdraw multiple sclerosis drug, Zinbryta voluntarily on a worldwide basis due to risk of liver injury. Both companies decided to withdraw the drug on grounds of the complex and evolving benefit/risk profile of Zinbryta, given the limited number of patients being treated. The drug is currently available in Europe and United States, Switzerland, Canada and Australia. While AbbVie distributes Zinbryta in the United States, Biogen distributes the drug in ex-U.S. markets. The European regulatory authorities provisionally restricted the use of Zinbryta in adult patients with highly active relapsing disease despite a full and adequate course of treatment with at least one DMT or with rapidly evolving severe relapsing MS who are unsuitable for treatment with other DMTs following the report of a case of fatal fulminant liver failure, as well as four cases of serious liver injury.
Gilead Reports New Data on Biktarvy: Gilead (GILD - Free Report) announced encouraging results at 48 weeks from a phase III study (Study 1961) among 470 virologically suppressed adult women with HIV infection at the International Workshop on HIV and Women and at the 2018 Conference on Retroviruses and Opportunistic Infections (“CROI”) in Boston (Poster 2539). Biktarvy was found to be statistically non-inferior to regimens containing a bPI or boosted elvitegravir and demonstrated no treatment-emergent resistance at 48 weeks in the ongoing study. Biktarvy, Gilead’s latest triple therapy, was approved by the FDA in February 2018 as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history.
(Read more: Gilead Announces Positive Data on New HIV Therapy Biktarvy)
Celgene Completes Juno Acquisition: Celgene Corporation announced that it has completed the previously-announced acquisition of Juno Therapeutics, Inc for $9 billion Juno focuses on the development of CAR (chimeric antigen receptor) T and TCR (T cell receptor) therapeutics with a promising pipeline evaluating multiple targets and cancer indications. The acquisition will add JCAR017 (lisocabtagene maraleucel; liso-cel) to Celgene’s lymphoma pipeline. JCAR017 is a best-in-class CD19-directed CAR-T currently in a pivotal program for relapsed and/or refractory diffuse large B-cell lymphoma (DLBCL). The candidate is expected to obtain regulatory approval in the United States in 2019 with potential global peak sales of approximately $3 billion.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index gained 4.52% over the last five trading sessions. Among major biotech stocks, Regeneron gained 3.93%. Over the last six months, Celgene lost 36.4% while Vertex gained 6.7% (see the last biotech stock roundup here: Biotech Stock Round Up: Celgene Suffers Setback, Gilead Teams Up with Sangamo).
What's Next in the Biotech World?
Stay tuned for more 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 >>