LONDON, UK / ACCESSWIRE / September 11, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Regeneron Pharmaceuticals Inc. (NASDAQ: REGN), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=REGN. The Company along with its partner Sanofi (NYSE: SNY) declared on September 08, 2017, that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation status to its experimental candidate Cemiplimab (REGN2810) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC. For immediate access to our complimentary reports, including today's coverage, register for free now at:
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About Cutaneous Squamous Cell Carcinoma
CSCC has become the second most common type of skin cancer in the United States, after melanoma. An important thing to note about CSCC is that it has a good prognosis if it is caught early. However, if it progresses to advanced stages, it becomes particularly difficult to treat. Patients in the advanced stage can be disfigured due to multiple surgeries to remove CSCC tumors on the head, neck as well as other parts of the body. CSCC is known to be the major cause of death among non-melanoma skin cancer patients.
Hence, Cemiplimab is anticipated to provide Regeneron access to a promising market with a huge potential.
About Cemiplimab
Cemiplimab is an investigational human, monoclonal antibody targeting PD-1 (programmed death 1). However, it is currently under clinical development. Its safety and efficacy have not yet been fully evaluated by any regulatory authority.
Cemiplimab was discovered leveraging Regeneron Pharma's proprietary VelocImmune® technology, which yields optimized fully human antibodies. Regeneron Pharma and Sanofi are jointly developing it under a global collaboration agreement, entered in July 2015.
Successfully Phase-1 Study Completion; Phase-2 is in Progress
- Regeneron Pharma and Sanofi have successfully completed the Phase-1 study for Cemiplimab covering around 400 patients. They reported positive, preliminary results for Cemiplimab from two expansion cohorts involving 26 advanced CSCC patients from the Phase-1 study at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2017.
- Currently, EMPOWER-CSCC 1, a Phase-2, potentially pivotal, single-arm, open-label clinical trial of Cemiplimab is enrolling patients with metastatic CSCC and locally advanced and unresectable CSCC.
- Although the data results are still pending, Regeneron Pharma and Sanofi intend to submit a Biologics License Application for Cemiplimab with the FDA in the first quarter of 2018.
What Does the "Breakthrough Therapy Designation" Signify?
The Breakthrough Therapy designation helps expedite the development and review of drugs meant for targeting serious or life-threatening conditions. Drugs that qualify for this designation should note credible evidence of a considerable improvement on a clinically significant endpoint over available therapies or over placebo if there is no available therapy.
The Breakthrough Therapy designation comprises all Fast Track program features, with more intensive FDA guidance and discussion. This designation is different from accelerated approval as well as priority review which can also be granted to the same drug if relevant criteria are met.
About Regeneron Pharmaceuticals Inc.
Regeneron Pharma is a prominent biotechnology Company which devises life-transforming medicines for people with serious diseases. Physician-scientists founded this Company about 30 years ago, and it now has the unique ability to consistently translate science into medicine. Regeneron Pharma has six FDA-approved treatments and over a dozen product candidates, all of which were homegrown in its laboratories. Its medicines are designed to help patients with eye disease, heart disease, allergic and inflammatory diseases, pain, cancer, infectious diseases, and rare diseases.
About Sanofi
Sanofi is a global healthcare leader, which discovers, develops, as well as distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular; General Medicines and Emerging Markets; Sanofi Genzyme; Sanofi Pasteur; and Consumer Healthcare. Of these, Sanofi Genzyme particularly focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.
Last Close Stock Review
On Friday, September 8, 2017, the stock closed the trading session at $471.49, marginally dropping 0.09% from its previous closing price of $471.92. A total volume of 765.62 thousand shares have exchanged hands. Regeneron Pharma's stock price surged 21.45% in the past six months, and 17.34% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have rallied 28.44%. The stock is trading at a PE ratio of 47.33. At Friday's closing price, the stock's net capitalization stands at $49.53 billion.
Sanofi's share price finished last Friday's trading session at $49.37, slightly advancing 0.10%. A total volume of 1.31 million shares have exchanged hands, which was higher than the 3-month average volume of 1.28 million shares. The Company's stock price surged 2.43% in the last three months, 12.43% in the past six months, and 23.15% in the previous twelve months. Additionally, the stock rallied 22.08% since the start of the year. Shares of the Company have a PE ratio of 22.44 and have a dividend yield of 3.32%. The stock currently has a market cap of $123.37 billion.
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