Regeneron (NASDAQ:REGN) Pharmaceuticals' application for its drug odronextamab has been granted priority review by the U.S. Food and Drug Administration (FDA) on Friday. The biotechnology company is seeking approval for the use of this drug in treating adults with relapsed/refractory follicular lymphoma or diffuse large B-cell lymphoma who have progressed after at least two prior systemic therapies.
The FDA grants priority review to medicines that could potentially provide significant improvements in treating a serious disease. This designation shortens the review period for the drug, expediting its potential approval process. The FDA has set a target action date of March 31, 2024, for Regeneron's application.
The Tarrytown, N.Y. based firm stated that if odronextamab receives approval from the FDA, it would be the only bispecific antibody approved in both follicular lymphoma and diffuse large B-cell lymphoma. This step moves odronextamab closer to regulatory approval, marking an important milestone in its development.
Regeneron Pharmaceuticals is listed on NASDAQ under the ticker symbol REGN. As of the latest InvestingPro data, the company has a market cap of $87.59 billion and a P/E ratio of 20.61. In addition, the company has demonstrated a strong return over the last three months with a 17.81% increase in its stock price.
Regeneron has also been identified by InvestingPro as a prominent player in the Biotechnology industry. A couple of InvestingPro Tips further highlight the company's financial stability. Firstly, Regeneron's management has been aggressively buying back shares, indicating confidence in the company's future. Secondly, it operates with a high return on assets, as evidenced by a 14.86% return on assets in the last twelve months. These insights, along with many others, can be found on InvestingPro, which offers a total of 17 additional tips for REGN.
The company's next earnings date is set for November 7, 2023, and analysts predict the company will be profitable this year, according to InvestingPro Tips. The InvestingPro Fair Value for Regeneron stands at $874.24, slightly higher than its previous closing price of $834.57.
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