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Mesoblast Reports First Quarter Ended September 30, 2018 Financial Results and Operational Highlights
Nov. 16, 2018 08:43AM PST
Genetics InvestingMesoblast (ASX:MSB; NASDAQ:MESO) today reported strong financial results and provided operational highlights for the first quarter ended September 30, 2018. As quoted in the press release: The trial succeeded in achieving the clinically meaningful outcome of reduction in gastrointestinal (GI) bleeding and related hospitalizations Results confirm the previous pilot trial, which also demonstrated significant reduction …
Mesoblast (ASX:MSB; NASDAQ:MESO) today reported strong financial results and provided operational highlights for the first quarter ended September 30, 2018.
As quoted in the press release:
The trial succeeded in achieving the clinically meaningful outcome of reduction in gastrointestinal (GI) bleeding and related hospitalizations
Results confirm the previous pilot trial, which also demonstrated significant reduction in GI bleeding and related hospitalizations in MPC-150-IM treated LVAD patients
Pilot trial results formed the basis for the FDA Regenerative Medicine Advanced Therapy (RMAT) designation granted in December 2017
The RMAT designation under the 21st Century Cures Act aims to expedite the development of regenerative medicine therapies intended for the treatment of serious diseases and life-threatening conditions
Company intends to meet with the FDA in 1H CY2019 to provide full study data and discuss pathway to potential Biologics License Application (BLA) filing using reduction in GI bleeding and related hospitalizations as an approvable regulatory endpoint