Revascor (rexlemestrocel-L) / Mesoblast, Grunenthal - LARVOL DELTA

Mesoblast Files Request for Type B Meeting with FDA to Discuss Accelerated Approval Pathway for Revascor in Ischemic Heart Failure (GlobeNewswire) - "Mesoblast...provided an update on its plans to meet with the United States Food and Drug Administration (FDA) to discuss the accelerated approval pathway for Revascor (rexlemestrocel-L) in the treatment of patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammation. Mesoblast filed a request for a Type B meeting during the last quarter, in line with previous guidance, and expects to have the meeting during this quarter....The key objectives of the meeting are to obtain FDA feedback on relevant chemistry, manufacturing & controls (CMC), alignment on potency assays for commercial product release, and Mesoblast’s proposed design and primary endpoint for the confirmatory trial."

FDA event • Heart Failure

HyaluronicAcid: Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: Mesoblast, Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Back Pain • Lumbar Back Pain • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

HyaluronicAcid: Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: Mesoblast, Ltd.

New P3 trial • Back Pain • Lumbar Back Pain • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

Appendix 4C Quarterly Activity Report (GlobeNewswire) - "Mesoblast has previously gained alignment with the FDA on key metrics for a pivotal Phase 3 study of rexlemestrocel-L in patients with chronic low back pain (CLBP) with degenerative disc disease which seeks to replicate the significant reduction in pain seen in the first Phase 3 trial. FDA has confirmed that 12-month reduction in pain is an approvable indication, with key secondary measures of improvement in function and reduction in opioid usage."

FDA event • Back Pain • CNS Disorders • Pain

Mesoblast Key Opinion Leader Event Series for Investors & Analysts (GlobeNewswire) - "Mesoblast Limited...will host a webinar focused on the current treatment landscape and unmet medical need for patients with chronic low back pain (CLBP) due to degenerative disc disease...Mesoblast’s Chief Executive Silviu Itescu will provide an overview of the three-year outcomes from the completed 404 patient randomized controlled Phase 3 trial of rexlemestrocel-L in patients with CLBP due to degenerative disc disease and regulatory pathway to market."

Clinical • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

Mesoblast Stem Cell Therapy for Patients With Single Ventricle and Borderline Left Ventricle (clinicaltrials.gov) - P1/2; N=19; Active, not recruiting; Sponsor: Boston Children's Hospital; Recruiting ➔ Active, not recruiting; Trial primary completion date: Jan 2022 ➔ Jan 2023

Clinical • Enrollment closed • Trial primary completion date • Cardiovascular

FDA’s OTAT in Agreement With 12-Month Reduction in Pain as Primary Endpoint for Chronic Low Back Pain Program (GlobeNewswire) - "Mesoblast Limited...today announced that it has received feedback from the US Food & Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) on the Phase 3 program of rexlemestrocel-L in patients with chronic low back pain (CLBP) due to degenerative disc disease (DDD) refractory to available therapies, including opioids. Mesoblast plans to conduct an additional US Phase 3 trial which may support submissions for potential approval in both the US and EU. The trial will include at least 20% of subjects from the EU to support global submission plans. Following review of the completed Phase 3 trial data, OTAT agreed with Mesoblast’s proposal for pain reduction at 12 months as the primary endpoint of the next trial, with functional improvement and reduction in opioid use as secondary endpoints."

FDA event • New P3 trial • Back Pain • CNS Disorders • Pain

Mesoblast Provides Update on Program for Chronic Low Back Pain Due to Degenerative Disc Disease (GlobeNewswire) - "Mesoblast Limited...today provided an update on the strategy for bringing rexlemestrocel-L to patients in the United States (US) with chronic low back pain (CLBP) due to degenerative disc disease (DDD) refractory to available therapies, including opioids....Mesoblast has filed a request and expects to hold a Type C meeting with the US Food & Drug Administration (FDA) during the current quarter to discuss the pathway to US regulatory approval for rexlemestrocel-L following the recently completed 404 patient Phase 3 trial in patients with chronic inflammatory back pain due to degenerative disc disease...Grünenthal, have amended their collaboration agreement, with Mesoblast being eligible to receive payments up to US$112.5 million prior to product launch in the EU, inclusive of US$17.5 million already received, if certain clinical and regulatory milestones are satisfied and reimbursement targets are achieved."

FDA event • Licensing / partnership • Back Pain • Lumbar Back Pain • Pain

Mesoblast Stem Cell Therapy for Patients With Single Ventricle and Borderline Left Ventricle (clinicaltrials.gov) - P1/2; N=24; Recruiting; Sponsor: Boston Children's Hospital; Trial completion date: Nov 2022 ➔ Jan 2024

Clinical • Trial completion date • Cardiovascular

Operational Highlights and Financial Results for the Year Ended June 30, 2021 (GlobeNewswire) - "Mesoblast expects to receive feedback from the FDA in the next quarter on the potential pathways to US regulatory approval for its rexlemestrocel-L technology platform following the recently completed Phase 3 trials in patients with chronic heart failure and chronic low back pain (CLBP) due to degenerative disc disease....Research and Development expenses decreased from US$56.2 million in FY2020 to US$53.0 million in FY2021, due to a reduction in third party clinical trial costs; 54% (US$28.5 million) of total spend related to remestemcel-L development, including clinical, medical & regulatory support ($14.8 million), process development (including potency assays & support costs) (US$9.5 million)..."

Commercial • FDA event • Back Pain • Crohn's disease • Immunology • Inflammatory Bowel Disease • Lumbar Back Pain • Pain • Ulcerative Colitis

MSB-DR003: Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyaluronic Acid in Subjects With Chronic Low Back Pain (clinicaltrials.gov) - P3; N=404; Completed; Sponsor: Mesoblast, Ltd.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Mesoblast Operational Highlights and Upcoming Milestones (GlobeNewswire) - "Mesoblast intends to meet with FDA to discuss a potential pathway for approval of rexlemestrocel-L in patients with chronic discogenic lower back pain based on the observed durable reduction in pain and opioid sparing activity in the CLBP Phase 3 trial."

FDA event • Back Pain • Lumbar Back Pain • Pain

Mesoblast Phase 3 Trial Shows That a Single Injection of Rexlemestrocel-L + Hyaluronic Acid Carrier Results in at Least Two Years of Pain Reduction With Opioid Sparing Activity in Patients With Chronic Low Back Pain Due to Degenerative Disc Disease (GlobeNewswire) - P3, N=404; NCT02412735; Sponsor: Mesoblast, Ltd.; "Mesoblast...announced results from the Phase 3 randomized controlled trial of its allogeneic mesenchymal precursor cell (MPC) therapy rexlemestrocel-L in 404 enrolled patients with chronic low back pain (CLBP) due to degenerative disc disease (DDD) refractory to conventional treatments....Significant reduction in opioid use over 24 months in patients treated with MPC + HA, while increased opioid use occurred in saline controls. Treatment with MPC + HA resulted in nearly four times more opioid users achieving 50% reduction in pain as well as reduction in opioid use by 24 months than those treated with saline."

P3 data • Back Pain • Pain

DREAM HF-1: Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure. (clinicaltrials.gov) - P3; N=566; Completed; Sponsor: Mesoblast, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Cardiovascular • Congestive Heart Failure • Heart Failure

Mesoblast Stem Cell Therapy for Patients With Single Ventricle and Borderline Left Ventricle (clinicaltrials.gov) - P1/2; N=24; Recruiting; Sponsor: Boston Children’s Hospital; Trial completion date: Nov 2021 ➔ Nov 2022; Trial primary completion date: Nov 2020 ➔ Nov 2021

Clinical • Trial completion date • Trial primary completion date

Mesoblast provides corporate update and financial results for the first quarter ended September 30, 2016 (GlobeNewswire) - "With respect to other indications of the MPC-300-IV product candidate, positive results from the randomized, placebo-controlled Phase 2 trial of MPC-300-IV in patients with diabetic nephropathy were published in the peer-reviewed journal EBioMedicine."

P2 data • Renal Disease

DREAM HF-1: Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure. (clinicaltrials.gov) - P3; N=566; Active, not recruiting; Sponsor: Mesoblast, Inc.; Trial completion date: Dec 2019 ➔ May 2020; Trial primary completion date: Dec 2019 ➔ May 2020

Clinical • Trial completion date • Trial primary completion date

".@US_FDA Orphan Status For @Mesoblast’s Revascor - subscribe to Biotech Daily https://t.co/4E9331THtC" (@biotech_daily)

Mesoblast Reports Financial Results and Operational Highlights for the Period Ended March 31, 2019 (GlobeNewswire, Mesoblast Limited) - "28% increase in royalty income on sales of TEMCELL for aGVHD in Japan...US$4.3 million royalties and milestones revenue recognized in the nine months of FY2019 from sales of TEMCELL by our licensee in Japan, JCR, compared with US$3.6 million in the nine months of FY2018, an increase of US$0.7 million. Royalty income from TEMCELL increased by 28% for the nine months of FY2019."

Clinical • Commercial

DREAM HF-1: Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure. (clinicaltrials.gov) - P3; N=566; Active, not recruiting; Sponsor: Mesoblast, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Memorandum of Understanding for Confirmatory Trial to Support Marketing Approval of Revascor for Reduction of Gastrointestinal Bleeding in LVAD Patients (GlobeNewswire, Mesoblast Limited) - "Mesoblast Limited...today announced that the International Center for Health Outcomes and Innovation Research (InCHOIR)...and Mesoblast have entered into a Memorandum of Understanding (MOU) to conduct a confirmatory clinical trial using Mesoblast’s product candidate Revascor (MPC-150-IM) for reduction of gastrointestinal (GI) bleeding in end-stage heart failure patients implanted with a left ventricular assist device (LVAD)....Mesoblast plans to meet with the FDA in the upcoming quarter to discuss an approval pathway for Revascor under its existing RMAT designation, which provides eligibility for priority review and accelerated approval."

FDA event • New trial