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Mesoblast to File Biologics License Application for Ryoncil® FDA Approval Next Week
GlobeNewswire News Room· 2024-07-01 05:55
About Mesoblast 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 has locations in Australia, the United States and Singapore and is listed on the Austr ...
Mesoblast Corporate Presentation at Investor Conference
Newsfilter· 2024-06-03 00:23
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 potenti ...
Appendix 4c Quarterly Activity Report for Quarter Ended March 31, 2024
Newsfilter· 2024-04-30 01:05
NEW YORK, April 29, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB))), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an activity report for the third quarter ended March 31, 2024. Mesoblast Chief Executive Silviu Itescu said: "We are very pleased with the positive interactions we had last quarter with the FDA, having received clarity on the path to licensure for our product candidates in pediatric acute graft versus host disease and in ischemic pa ...
Mesoblast (MESO) - 2024 Q2 - Quarterly Report
2024-02-29 23:15
mesol February 2024 ASX: MSB; Nasdaq: MESO Global Leader in Allogeneic Cellular M« for Inflammatory Diseases Financial Results and Operational Update for the Half-Year Ended December 31, 2023 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS Extensive patent portfolio with protection extending through 2040 Over 1,100 patents and patent applications (82 patent families) across all major jurisdictions Covers composition of matter, manufacturing, and therapeutic applications of mesenchymal lineage cells Pro ...
Mesoblast (MESO) - 2024 Q2 - Earnings Call Transcript
2024-02-29 23:07
Rexlemestrocel our second generation immuno-selected product being developed for heart disease and for inflammatory back pain. In the field of inflammatory heart failure was low ejection fraction was completed the Phase 3 trial. We have an FDA designated regenerative medicine advanced therapeutics designation for the product in the treatment of the most severe end-stage patients. It's the ejection fraction -- low ejection fraction heart failure and with ventricular assist device. And under the RMAT we had a ...
Mesoblast (MESO) - 2024 Q2 - Earnings Call Presentation
2024-02-29 22:10
Global Leader in Allogeneic Cellular Medicines | --- | --- | |----------------------------------------------|-------| | | | | | | | for Inflammatory Diseases | | | Financial Results and Operational Update for | | | the Half-Year Ended December 31, 2023 | | February 2024 This presentation includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity ...
Mesoblast (MESO) - 2023 Q4 - Annual Report
2023-08-31 12:05
mesoblast Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases August 2023 ASX: MSB; Nasdaq: MESO Financial Results and Operational Update for the Year Ended June 30, 2023 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achieveme ...
Mesoblast (MESO) - 2023 Q4 - Earnings Call Transcript
2023-08-31 02:25
Mesoblast Limited (NASDAQ:MESO) Q4 2023 Results Conference Call August 30, 2023 6:30 PM ET Company Participants Dr. Silviu Itescu - Chief Executive Officer Dr. Eric Rose - Chief Medical Officer Andrew Chaponnel - Interim Chief Financial Officer Dr. Philip Krause - Board Member Conference Call Participants Louise Chen - Cantor Edward Tenthoff - Piper Sandler Sami Corwin - William Blair John Hester - Bell Potter Operator Hello and welcome to the Mesoblast Financial Results for the Period Ended June 30, 2023. ...
Mesoblast (MESO) - 2023 Q4 - Annual Report
2023-08-31 01:06
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ______________________________ FORM 20-F ______________________________ o REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2023 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR o SHELL COMPANY REPORT PUR ...
Mesoblast (MESO) - 2023 Q3 - Earnings Call Transcript
2023-05-26 03:38
Mesoblast Limited (NASDAQ:MESO) Q3 2023 Earnings Conference Call May 25, 2023 6:30 PM ET Silviu Itescu – Chief Executive Officer Eric Rose – Chief Medical Officer Andrew Chaponnel – Interim Chief Financial Officer Edward Tenthoff – Piper Sandler Sami Corwin – William Blair John Hester – Bell Potter Thank you all for standing by. Hello and welcome to the Mesoblast Financial Results for the period ended March 31, 2023. An announcement and presentation have been lodged with the ASX and will also be available o ...