financetom
Business
financetom
/
Business
/
Regeneron Says US FDA Accepts for Review Resubmission of Application for Follicular Lymphoma Drug
News World Market Environment Technology Personal Finance Politics Retail Business Economy Cryptocurrency Forex Stocks Market Commodities
Regeneron Says US FDA Accepts for Review Resubmission of Application for Follicular Lymphoma Drug
Feb 26, 2025 6:05 AM

08:48 AM EST, 02/26/2025 (MT Newswires) -- Regeneron Pharmaceuticals ( REGN ) said Wednesday that the US Food and Drug Administration has accepted for review the resubmission of its biologics license application for odronextamab drug, a treatment for relapsed/refractory follicular lymphoma after two or more lines of systemic therapy.

The target action date for the agency's decision is July 30, the company said.

The acceptance of the resubmission follows the achievement of target mandated by the agency in a confirmatory trial. The resubmission is supported by data from two trials, which showed that the drug had an overall response rate of 80% and a 74% complete response rate, the company said.

Follicular lymphoma is one of the most common subtypes of B-cell non-Hodgkin lymphoma.

Comments
Welcome to financetom comments! Please keep conversations courteous and on-topic. To fosterproductive and respectful conversations, you may see comments from our Community Managers.
Sign up to post
Sort by
Show More Comments
Related Articles >
Most Asian Markets Fall Tuesday as Investors Assess China's December Manufacturing Activity
Most Asian Markets Fall Tuesday as Investors Assess China's December Manufacturing Activity
Dec 31, 2024
05:52 AM EST, 12/31/2024 (MT Newswires) -- Most Asian markets were down at the end of Tuesday trading as investors assessed China's manufacturing activity in December. Hong Kong closed in the green, while Shanghai was down at the last trading day of the year. Stock markets in Japan, South Korea, and Thailand were closed for the New Year holiday. The...
FibroBiologics Closes Second $5 Million Tranche of $25 Million Equity Purchase Agreement
FibroBiologics Closes Second $5 Million Tranche of $25 Million Equity Purchase Agreement
Dec 31, 2024
05:12 AM EST, 12/31/2024 (MT Newswires) -- FibroBiologics ( FBLG ) said late Monday it has closed the second $5 million tranche of its standby equity purchase agreement with YA II PN, an investment fund managed by Yorkville Advisors Global. The biotech company said it expects to use net proceeds from the financing tranche for general corporate purposes. The equity...
Digital Ally Files Registration Statement on Behalf of Selling Shareholders
Digital Ally Files Registration Statement on Behalf of Selling Shareholders
Dec 31, 2024
05:35 AM EST, 12/31/2024 (MT Newswires) -- Digital Ally ( DGLY ) filed a registration statement Monday covering the potential sale of up to 808,377 shares of its common stock on behalf of selling shareholders. The filing covers the sale of shares issued pursuant to a securities purchase agreement with selling shareholders dated Nov. 6. The company said it will...
Stocks and dollar end 2024 steady, 2025 all about Trump
Stocks and dollar end 2024 steady, 2025 all about Trump
Dec 31, 2024
SINGAPORE/LONDON (Reuters) -World stocks held steady on Tuesday in cautious year-end trading that has seen investors bracing for the incoming Donald Trump administration by scaling back bets on deep U.S. interest rate cuts in 2025, helping the dollar stand tall against most other currencies. Volumes were light with a holiday for the New Year looming, with the Santa-rally largely failing...
Copyright 2023-2026 - www.financetom.com All Rights Reserved