Cellectar Biosciences Receives European Medicines Agency Priority Medicines Designation For Iopofosine For Waldenstrom's Macroglobulinemia
Portfolio Pulse from Benzinga Newsdesk
Cellectar Biosciences, Inc. (NASDAQ:CLRB) has received Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) for its lead small-molecule drug candidate, iopofosine I 131, for Waldenstrom's macroglobulinemia (WM) in patients who have received two or more prior treatment regimens. The company expects to release top-line data from the CLOVER-WaM pivotal trial in Q4 2023 and submit its NDA in March 2024. The U.S. FDA has also granted Fast Track Designation for the drug for WM patients, as well as for multiple myeloma and diffuse large B-cell lymphoma (DLBCL).
September 18, 2023 | 12:42 pm
News sentiment analysis
Sort by:
Ascending
POSITIVE IMPACT
Cellectar Biosciences has received PRIME designation from the EMA for its lead drug candidate, potentially speeding up its development and evaluation. This, along with the FDA's Fast Track Designation, could lead to earlier patient access and potentially increased revenues for the company.
The PRIME designation from the EMA and the Fast Track Designation from the FDA are both significant regulatory milestones that could speed up the development and evaluation of Cellectar's lead drug candidate. This could lead to earlier patient access and potentially increased revenues for the company, positively impacting its stock price in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100