FDA Supports Accelerated Approval Pathway for Rexlemestrocel-L in End-Stage Heart Failure Patients following the Type B Meeting

March 11, 2024

DENVER, Colo., Mar 11, 2024 (247marketnews.com)- Mesoblast Limited (NASDAQ:MESO) reported, on Sunday, that the U.S. FDA supports an accelerated approval pathway for rexlemestrocel-L, Mesoblast’s allogeneic mesenchymal precursor cell (MPC) product, in patients with end-stage ischemic heart failure with reduced ejection fraction (HFrEF) and a left ventricular assist device (LVAD).

Mesoblast is trading at $2.47, up $0.32 (+14.88%), on 3.5M shares.

Its 52-week range is $1.61 to $10.24. Not that it’s going to challenge this today, but it has a very attractive gap from the mid-threes to mid-sevens.

The FDA feedback was provided in formal minutes to the company following their February 21, 2024 Type B meeting with FDA for rexlemestrocel-L (Revascor®) under the existing Regenerative Medicine Advanced Therapy (RMAT) designation.

“We are very pleased with FDA’s feedback that the presented results from our pivotal study of rexlemestrocel-L in end-stage HFrEF patients with LVADs may support an accelerated approval,” said Mesoblast CEO Dr. Silviu Itescu. “We intend to request a pre-Biologics License Application (BLA) meeting to discuss data presentation, timing and FDA expectations for an accelerated approval filing.”

More than 100,000 patients, per year, progress to end-stage HFrEF, in the United States. Of which, more than 2,500 life prolonging LVADs are implanted in the US annually and approximately 80% undergo the procedure as destination or permanent therapy.

About 24/7 Market News
As a pioneer in digital financial market media, 24/7 Market News (24/7MN) is dedicated to the swift distribution of financial market news and information. 24/7 MN incorporates comprehensive corporate communications resources and tools to engage the investment community. Visit 24/7 Market News website here.

24/7 MARKET NEWS, INC Disclaimer
Please go to https://247marketnews.com/disclaimer/ for disclaimer information.

CONTACT:
24/7 Market News
Editor@247marketnews.com

Related news for (MESO)

NASDAQ and NYSE quotes and data are delayed 15 minutes unless indicated otherwise. Market data and exchange information are provided for informational purposes only and is not intended for trading purposes. Neither 24/7 Market News Editors, 247 Market News, or data and content providers shall be liable for any errors or omissions, delays, misquotes or other market information relayed in any press materials. You should Use Realtime data to conduct due diligence before investing or trading, and trading in any stock is risky you could lose all your money.