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4-Traders Homepage  >  Equities  >  Nasdaq  >  Regeneron Pharmaceuticals    REGN

REGENERON PHARMACEUTICALS (REGN)
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Regeneron Pharmaceuticals : EMA to Review Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma

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04/12/2018 | 08:25pm CEST

By a News Reporter-Staff News Editor at Biotech Week -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery. Advanced CSCC is the deadliest non-melanoma skin cancer. Cemiplimab is an investigational human monoclonal antibody targeting the checkpoint inhibitor PD-1 (programmed cell death protein-1) (see also Regeneron Pharmaceuticals Inc.).

The MAA for cemiplimab is based on a Phase 2 pivotal, single-arm, open-label clinical trial of cemiplimab for advanced CSCC (EMPOWER-CSCC 1) in addition to Phase 1 data from two advanced CSCC expansion cohorts. Both clinical trials enrolled patients with metastatic CSCC and patients with locally advanced CSCC who were not candidates for surgery. Topline results from EMPOWER-CSCC 1 were previously announced in December 2017, and Phase 1 expansion cohort results were presented at the 2017 American Society of Clinical Oncology Annual Meeting. Updated results from both clinical trials are being submitted for presentation at upcoming medical congresses.

Cemiplimab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement, and was invented by Regeneron using the company's proprietary VelocImmune® technology that yields optimized fully-human antibodies.

Cemiplimab is currently under clinical development, and its safety and efficacy has not been fully evaluated by any regulatory authority.

Keywords for this news article include: Regeneron Pharmaceuticals Inc., Business, Oncology, Clinical Research, Health and Medicine, Squamous Cell Carcinoma, Biopharmaceutical Companies, Clinical Trials and Studies, Healthcare Biotechnology Companies.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2018, NewsRx LLC

(c) 2018 NewsRx LLC, source Health Newsletters

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Financials ($)
Sales 2018 6 389 M
EBIT 2018 2 477 M
Net income 2018 1 709 M
Finance 2018 3 045 M
Yield 2018 -
P/E ratio 2018 21,38
P/E ratio 2019 18,32
EV / Sales 2018 4,94x
EV / Sales 2019 4,19x
Capitalization 34 613 M
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Mean consensus OUTPERFORM
Number of Analysts 27
Average target price 416 $
Spread / Average Target 32%
EPS Revisions
Managers
NameTitle
Leonard S. Schleifer President, Chief Executive Officer & Director
P. Roy Vagelos Chairman
Robert E. Landry Chief Financial Officer & Senior VP-Finance
George Damis Yancopoulos Director & Chief Scientific Officer
Charles A. Baker Independent Director
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