On July 2, Regeneron Pharmaceuticals rose 3.1% in regular trading, trading at $644.35/share, with turnover of approximately $90.06 million. The stock was boosted by multiple positive catalysts on the news front.
On June 29, the U.S. FDA announced that Regeneron was selected for its newly launched PreCheck production pilot program, which provides earlier regulatory engagement to enhance predictability for domestic drug manufacturing facilities. Eli Lilly, Fujifilm, and several other major companies were also selected as inaugural participants in this initiative aimed at streamlining new facility approvals.
Additionally, on June 22, Regeneron's novel drug Cemdisiran received FDA priority review designation for its new drug application targeting generalized myasthenia gravis, with a target action date set for November. The European Medicines Agency has also accepted the regulatory filing, with a decision expected in H2 of the following year. Cemdisiran, an siRNA therapy targeting complement C5, could become the first approved siRNA drug for the treatment of generalized myasthenia gravis globally if approved.
(The above content is based on publicly available market information, generated by a program or algorithm, and is intended solely as a stock movement alert. It does not constitute investment advice or a basis for trading decisions.)
Comments