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Wired News – EMA to Review Regeneron’s Marketing Authorization Application for Cemiplimab

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LONDON, UK / ACCESSWIRE / April 05, 2018 / Active-Investors.com has just released a free research report on Regeneron Pharma, Inc. (NASDAQ: REGN). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=REGN as the Company's latest news hit the wire. On April 03, 2018, the Company, which is a leading biotechnology organization that invents life-transforming medicines for people with serious diseases, along with the global pharmaceutical Company, Sanofi, declared that the European Medicines Agency (EMA) has accepted for review their Marketing Authorization Application (MAA) for Cemiplimab, used for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC), or patients with locally advanced CSCC who are not candidates for surgery. Register today and get access to over 1000 Free Research Reports by joining our site below:


Active-Investors.com is currently working on the research report for Navidea Biopharmaceuticals, Inc. (NYSE AMER: NAVB), which also belongs to the Healthcare sector as the Company Regeneron Pharma. Do not miss out and become a member today for free to access this upcoming report at:


Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Regeneron Pharma most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:


Advanced CSCC, the Deadliest Non-Melanoma Skin Cancer

CSCC is the second most common type of skin cancer worldwide. In fact, the number of newly diagnosed CSCC cases is expected to rise annually.

CSCC has a good prognosis when is diagnosed early but the cancer can prove to be very difficult to treat when it is in an advanced stage. Advanced CSCC is the deadliest non-melanoma skin cancer, and patients with advanced CSCC experience reduced quality of life due to its extreme symptoms. However, so far, there are no EMA-approved treatments for advanced CSCC.

Cemiplimab for the Treatment of CSCC

Cemiplimab is an investigational human monoclonal antibody that targets the checkpoint inhibitor programmed cell death protein-1 (PD-1).

At present, Regeneron and Sanofi are jointly developing Cemiplimab under a global collaboration agreement. Regeneron developed this drug using its proprietary VelocImmune® technology that yields optimized fully human antibodies.

Cemiplimab is currently under clinical development but no regulatory authority has fully evaluated its safety and efficacy as yet.

MAA Based on Results of Recent Trials

The marketing authorization application for Cemiplimab is based on results from recent trials - the Phase-2 pivotal, single-arm, and open label clinical trial of Cemiplimab for advanced CSCC (EMPOWER-CSCC 1), and the Phase-1 data from two advanced CSCC expansion cohorts.

Both these trials enrolled patients with metastatic CSCC and patients with locally-advanced CSCC who were not candidates for surgery. Regeneron shared top-line results from the EMPOWER-CSCC 1 trial on December 13, 2017, and presented results from the Phase-1 expansion cohort at the 2017 American Society of Clinical Oncology Annual Meeting on June 04, 2017. Now, the Company is submitting the updated results from both these clinical trials for presentation at upcoming medical congresses.

EMA to Review Application for DUPIXENT

Additionally, Regeneron and Sanofi declared on April 03, 2018, that the EMA has also accepted to review their application for DUPIXENT (dupilumab), as an add-on maintenance treatment in certain adults and adolescents (12 years of age and older) with inadequately controlled moderate-to-severe asthma.

Stock Performance Snapshot

April 04, 2018 - At Wednesday's closing bell, Regeneron Pharma's stock climbed 1.55%, ending the trading session at $337.35.

Volume traded for the day: 813.66 thousand shares.

Stock performance in the last month – up 1.03%

After yesterday's close, Regeneron Pharma's market cap was at $35.71 billion.

Price to Earnings (P/E) ratio was at 25.68.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 1.4% at the end of the session.


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