MESO - Mesoblast Corporate Presentation at Investor Conference | Benzinga
NEW YORK, June 02, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB)), Chief Executive Silviu Itescu provided a corporate update at the Bell Potter Emerging Leaders Conference.
Dr. Itescu reiterated that the Company expects to file this quarter the Biologics License Application (BLA) resubmission with the United States Food and Drug Administration (FDA) for its lead product candidate Ryoncil®(remestemcel-L) in the treatment of steroid-refractory acute graft versus host disease, with potential approval in the second half of CY2024.
Dr. Itescu additionally highlighted the heart failure and back pain programs in Phase 3, and the recent feedback from FDA regarding an accelerated approval pathway for the heart failure product Revascor® (rexlemestrocel).
The presentation also highlighted Mesoblast's strong United States intellectual property position, with granted patents through 2032 covering mesenchymal stem cell compositions of matter, irrespective of source, and their broad uses, including for GVHD. On RYONCIL approval, the granted patents may be extended up to 2037. Additional patent filings may extend the commercial barrier to entry through 2043.
The presentation materials have been lodged with the ASX and are available on the investor page of the company's website www.mesoblast.com.
About Mesoblast
Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of late-stage product candidates which respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.
Mesoblast has a strong and extensive global intellectual property portfolio with protection extending through to at least 2041 in all major markets. The Company's proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.
Mesoblast is developing product candidates ...