Regeneron Gets FDA Nod for Odronextamab Resubmission

Regeneron Pharmaceuticals (REGN) has received FDA acceptance for the BLA resubmission of odronextamab targeting R/R follicular lymphoma. This could positively impact stock prices given the favorable trial results.

Date: 26-02-2025

AI Rating: 7

FDA Acceptance of Resubmission: Regeneron Pharmaceuticals has made a significant step forward as the FDA accepted the resubmission of the Biologics License Application (BLA) for odronextamab, aimed at treating relapsed/refractory follicular lymphoma. This response follows the company meeting FDA-enforced enrollment criteria for Phase 3 trials.

Overall Response Rate: The report indicated that data from Phase 1 and pivotal Phase 2 trials showed an impressive overall response rate of 80%, with 74% of patients achieving a complete response. Such promising results typically correlate with a favorable outlook from investors, thus potentially affecting Regeneron's stock price positively.

The approval of odronextamab as Ordspono in the European Union demonstrates further validation of the drug's effectiveness, which might enhance investor confidence and valuation of the company.

Stocks: REGN