Melbourne, Australia; August 11, 2020; and New York, USA; August 10, 2020
Mesoblast's lead product candidate, RYONCIL (remestemcel-L), is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. Another key feature of Mesoblast’s cells is they can be administered to patients without the need for donor–recipient matching or recipient immune suppression. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Remestemcel-L is also being developed for other Mesoblast Chief Executive Dr Silviu Itescu stated: … Get the latest Mesoblast Limited (MESO) stock news and headlines to help you in your trading and investing decisions.
RYONCIL is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in steroid- refractory acute graft versus host disease by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues. For further information, please contact: Uncertainties and risks that may cause Mesoblast's actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. Mesoblast Provides Remestemcel-L Update and Quarterly Activity Report Editorial & Advertiser Disclosure Global Banking And Finance Review is an independent publisher which offers News, information, Analysis, Opinion, Press Releases, Reviews, Research reports covering various economies, industries, products, services and companies. RYONCIL is under Priority Review by the FDA with an action date of September 30, 2020, under the Prescription Drug User Fee Act (PDUFA). Forward- looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. UPDATE ON SCHEDULED FDA ADVISORY COMMITTEE MEETING The morning session will be non-voting and will discuss issues related to the characterization and critical quality attributes of remestemcel-L. It is administered to patients in a series of intravenous infusions. The Company's proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of September 30, 2020, and if approved, Mesoblast will make RYONCIL immediately available in the United States.The Company also has a promising emerging pipeline and next generation technologies.Mesoblast’s novel allogeneic product candidates are based on rare (approximately 1:100,000 in bone marrow) mesenchymal lineage cells that respond to tissue damage, secreting mediators that promote tissue repair and modulate immune responses.Mesenchymal lineage cells are collected from the bone marrow of healthy adult donors and proprietary processes are utilized to expand them to a uniform, well characterized, and highly reproducible cell population. Briefing materials and webcast information have been made publicly available and can be found on the FDA website at: These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide. ... Latest News. Forward- looking statements include, but are not limited to, statements about: the timing, progress and results of Mesoblast's preclinical and clinical studies; Mesoblast's ability to advance product candidates into, enroll and successfully complete, clinical studies; the timing or likelihood of regulatory filings and approvals; and the pricing and reimbursement of Mesoblast's product candidates, if approved; Mesoblast's ability to establish and maintain intellectual property on its product candidates and Mesoblast's ability to successfully defend these in cases of alleged infringement. This session will discuss the Phase 3 trial results and supporting clinical data included in the BLA. Mesoblast has extensively prepared for this meeting and has provided a publicly available briefing book.