Regeneron Provides Update on Biologics License Application for Odronextamab - Seite 2
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
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or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,”
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“Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation odronextamab; the likelihood, timing, and scope of possible regulatory
approval and commercial launch of Regeneron’s Product Candidates (such as odronextamab, including any potential regulatory approval of odronextamab by the U.S. Food and Drug Administration (the
“FDA”) based on the Biologics License Application discussed in this press release (the “odronextamab BLA”) or the regulatory review by the European Medicines Agency referenced in this press
release) and new indications for Regeneron’s Products; the impact of the Complete Response Letters for the odronextamab BLA discussed in this press release (the “CRLs”) on the timing of the
potential regulatory approval of odronextamab by the FDA and whether and how timely Regeneron is able to resolve the issues identified in the CRLs (including Regeneron’s ability to enroll patients
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