Regeneron’s Lymphoma Drug Odronextamab Receives FDA Priority Review

Regeneron Pharmaceuticals has received priority review status from the U.S. Food and Drug Administration (FDA) for its drug odronextamab. The company is requesting approval to use this treatment for adults with relapsed or refractory follicular lymphoma or diffuse large B-cell lymphoma who have not responded to at least two prior systemic therapies.

Priority review is granted by the FDA to drugs that show potential for significant advancements in treating serious conditions, which streamlines the review process. The FDA has set a target date of March 31, 2024, for their decision on Regeneron’s application.

If approved, odronextamab would become the first bispecific antibody sanctioned for use in both follicular lymphoma and diffuse large B-cell lymphoma, marking a significant step forward in its regulatory journey.

Regeneron Pharmaceuticals is publicly traded and boasts a market capitalization of $87.59 billion with a price-to-earnings ratio of 20.61. The company has shown notable growth in its stock price over the last three months, rising by 17.81%.

According to recent insights, Regeneron is recognized as a key player in the biotechnology sector. Additionally, the company’s management has been actively buying back shares, demonstrating confidence in its prospects. Regeneron also maintains a robust financial profile, with a return on assets of 14.86% over the past year.

The firm is scheduled to report its next earnings on November 7, 2023, and analysts anticipate profitability for the company this year. The estimated fair value of Regeneron’s stock is $874.24, which is marginally above its last recorded closing price of $834.57.

This article has been generated with the assistance of artificial intelligence and reviewed for accuracy.