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Sanofi's (SNY) Skin Cancer Candidate Filing Accepted in EU
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Sanofi (SNY - Free Report) has announced that the regulatory application for its PD-1 antibody, cemiplimab, has been accepted for review by the European Medicines Agency (EMA). The company is seeking approval for the candidate to treat patients with metastatic cutaneous squamous cell carcinoma (CSCC), a type of skin cancer.
Notably, cemiplimab is being jointly developed by Sanofi and Regeneron (REGN - Free Report) post a global collaboration agreement, signed in July 2015.
Shares of Sanofi have lost 13.2% in a year against the industry’s 5% increase.
The marketing application for cemiplimab in the EU includes positive top-line efficacy results from a pivotal phase II EMPOWER-CSCC 1 study and data from two advanced CSCC expansion cohorts. Last December, the company produced data from the phase II study, which demonstrated an overall response rate of 46.3%.
Moreover, the safety profile of cemiplimab in the study was generally consistent with approved anti-PD-1 agents.
Note that, in February 2018, both companies filed a regulatory application for cemiplimab in the United States for treatment of CSCC.
Per the company’s press release, CSCC is the second most common and deadliest skin cancer after melanoma in the United States. The disease is also responsible for the largest number of deaths among non-melanoma skin cancer patients. Although it is easier to apprehend the condition in early stages, it’s quite difficult to treat once it has progressed to advanced stages. Hence, the candidate is expected to provide the company with access to a market promising huge potential.
In a separate release, Sanofi announced that its regulatory application for the label expansion of its marketed drug, Dupixent, has also been accepted by the EMA as an add-on maintenance treatment of adults and adolescents (12 years of age or older) with moderate-to-severe asthma.
Notably, Dupixent is under review in the United States for the same indication with a response expected on Oct 20, 2018. It is presently approved in both the United States and the EU for the treatment of adults with moderate-to-severe atopic dermatitis. The drug is also being developed by Sanofi in collaboration with Regeneron.
This January, both companies announced that they will increase their investment in the label expansion of Dupixent for Type II allergic diseases and cemiplimab in oncology. The inflated investment in the Dupixent development program will enable the companies to expedite the planned new studies on chronic obstructive pulmonary disease, peanut allergy, grass allergy as well as on patients with multiple allergic conditions.
Ligand’s earnings per share estimates have moved up from $3.78 to $4.20 for 2018 and from $4.75 to $5.32 for 2019 in the last 60 days. The company delivered a positive surprise in three of the trailing four quarters with an average beat of 24.88%. Share price of the company has soared 51.6% over a year.
Enanta Pharma came up with a positive surprise in three of the last four quarters with an average beat of 373.1%. Share price of the company has skyrocketed 166.3% over a year.
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
Sanofi's (SNY) Skin Cancer Candidate Filing Accepted in EU
Sanofi (SNY - Free Report) has announced that the regulatory application for its PD-1 antibody, cemiplimab, has been accepted for review by the European Medicines Agency (EMA). The company is seeking approval for the candidate to treat patients with metastatic cutaneous squamous cell carcinoma (CSCC), a type of skin cancer.
Notably, cemiplimab is being jointly developed by Sanofi and Regeneron (REGN - Free Report) post a global collaboration agreement, signed in July 2015.
Shares of Sanofi have lost 13.2% in a year against the industry’s 5% increase.
The marketing application for cemiplimab in the EU includes positive top-line efficacy results from a pivotal phase II EMPOWER-CSCC 1 study and data from two advanced CSCC expansion cohorts. Last December, the company produced data from the phase II study, which demonstrated an overall response rate of 46.3%.
Moreover, the safety profile of cemiplimab in the study was generally consistent with approved anti-PD-1 agents.
Note that, in February 2018, both companies filed a regulatory application for cemiplimab in the United States for treatment of CSCC.
Per the company’s press release, CSCC is the second most common and deadliest skin cancer after melanoma in the United States. The disease is also responsible for the largest number of deaths among non-melanoma skin cancer patients. Although it is easier to apprehend the condition in early stages, it’s quite difficult to treat once it has progressed to advanced stages. Hence, the candidate is expected to provide the company with access to a market promising huge potential.
In a separate release, Sanofi announced that its regulatory application for the label expansion of its marketed drug, Dupixent, has also been accepted by the EMA as an add-on maintenance treatment of adults and adolescents (12 years of age or older) with moderate-to-severe asthma.
Notably, Dupixent is under review in the United States for the same indication with a response expected on Oct 20, 2018. It is presently approved in both the United States and the EU for the treatment of adults with moderate-to-severe atopic dermatitis. The drug is also being developed by Sanofi in collaboration with Regeneron.
This January, both companies announced that they will increase their investment in the label expansion of Dupixent for Type II allergic diseases and cemiplimab in oncology. The inflated investment in the Dupixent development program will enable the companies to expedite the planned new studies on chronic obstructive pulmonary disease, peanut allergy, grass allergy as well as on patients with multiple allergic conditions.
Sanofi Price
Sanofi Price | Sanofi Quote
Zacks Rank & Key Picks
Sanofi carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the health care sector are Ligand Pharmaceuticals Inc. (LGND - Free Report) and Enanta Pharmaceuticals, Inc. (ENTA - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Ligand’s earnings per share estimates have moved up from $3.78 to $4.20 for 2018 and from $4.75 to $5.32 for 2019 in the last 60 days. The company delivered a positive surprise in three of the trailing four quarters with an average beat of 24.88%. Share price of the company has soared 51.6% over a year.
Enanta Pharma came up with a positive surprise in three of the last four quarters with an average beat of 373.1%. Share price of the company has skyrocketed 166.3% over a year.
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 >>