Mesoblast Limited ( (AU:MSB) ) has issued an update.
Mesoblast Limited has filed a request for a Type B meeting with the FDA to discuss the accelerated approval pathway for its product Revascor, intended for treating ischemic chronic heart failure with reduced ejection fraction and inflammation. This meeting, expected to occur this quarter, aims to obtain FDA feedback on chemistry, manufacturing, and controls, as well as alignment on potency assays and the design of a confirmatory trial. The outcome of this meeting could significantly impact Mesoblast’s operations by potentially expediting the approval process for Revascor, thereby enhancing its industry positioning and offering new treatment options for patients with heart failure.
More about Mesoblast Limited
Mesoblast Limited is a global leader in the development of allogeneic cellular medicines aimed at treating severe and life-threatening inflammatory conditions. The company utilizes its proprietary mesenchymal lineage cell therapy technology platform to create therapies that respond to severe inflammation by releasing anti-inflammatory factors, significantly reducing damaging inflammatory processes. Mesoblast’s product portfolio includes RYONCIL, approved for treating steroid-refractory acute graft versus host disease in pediatric patients, and is being developed for other inflammatory diseases. The company has established commercial partnerships in Japan, Europe, and China, and holds a strong intellectual property portfolio with over 1,000 patents.
YTD Price Performance: -37.73%
Average Trading Volume: 293,355
Technical Sentiment Signal: Sell
Current Market Cap: $1.57B
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