Why Is Regeneron Pharmaceuticals Stock Trading Lower On Tuesday?

Chief District Judge Thomas Kleeh denied Regeneron Pharmaceuticals, Inc.‘s REGN effort to prevent the sale of Amgen Inc‘s AMGN Eylea biosimilar.

Regeneron filed a notice of its appeal to the U.S. Court of Appeals for the Federal Circuit.

The appeal is from the Order issued on September 23, 2024, which denied Regeneron’s request for a preliminary injunction, along with any related orders, decisions, rulings, findings, or conclusions connected to that Order.

Reuters highlighted that an Amgen spokesperson expressed the company’s satisfaction with the decision. Amgen will reveal the timeline for launching its biosimilar Pavblu “in due course.”

Regeneron sued Amgen in January, alleging that it was developing a biosimilar that violated key patent protections for Eylea. The lawsuit claims the infringement of over 30 patents, which the pharma claims will “irreparably” harm its business if Amgen is not “enjoined” from violating these protections.

The lawsuit also notes, “Amgen’s commercial manufacture, use, offer for sale, and/or sale within the United States, or importation into the United States, of ABP 938 before the expiration of the '106 patent will cause Regeneron injury, entitling Regeneron to damages and/or other monetary relief.”

In October 2023, Amgen said the FDA accepted its abbreviated Biologics Drug Application for ABP 938, a biosimilar copy of Eylea.

Stat News noted that the judge’s decision came as a surprise, given that this same judge had previously approved Regeneron’s requests for injunctions against other pharmaceutical companies attempting to release Eylea biosimilars.

In December, a court ruling found that Viatris Inc’s VTRS replica of Regeneron’s Eylea violated patent rights.

Price Action: REGN stock is down 6% at $1,025.44 at last check Tuesday.

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