The market may be tumbling on Monday but the same cannot be said for the Mesoblast Ltd (ASX: MSB) share price.
In early trade, the biotechnology company's shares jumped 16% to 36.5 cents.
Mesoblast's shares have eased back a touch since then but remain up approximately 7% at the time of writing.
Why is the Mesoblast share price jumping?
Investors have been bidding the company's shares higher this morning after it released an update on its rexlemestrocel-L therapy.
It is Mesoblast's allogeneic mesenchymal precursor cell (MPC) product for patients with end-stage ischemic heart failure with reduced ejection fraction (HFrEF) and a left ventricular assist device (LVAD).
According to the release, following a meeting with the U.S. Food and Drug Administration (FDA) in February, it has been advised that the federal agency will support an accelerated approval pathway for rexlemestrocel-L under the existing Regenerative Medicine Advanced Therapy (RMAT) designation.
The company highlights that the FDA's comments indicated that the presented results may support a reasonable likelihood of clinical benefit of MPCs against mortality in LVAD patients, consistent with the criteria for accelerated approval.
Mesoblast CEO, Dr. Silviu Itescu, commented:
We are very pleased with FDA's feedback that the presented results from our pivotal study of rexlemestrocel-L in end-stage HFrEF patients with LVADs may support an accelerated approval. We intend to request a pre-Biologics License Application (BLA) meeting to discuss data presentation, timing and FDA expectations for an accelerated approval filing.
This certainly could be good news for both the company and sufferers. Mesoblast notes that every year in the United States over 100,000 patients progress to end-stage HFrEF. In these patients, more than 2,500 life-prolonging LVADs are implanted in the US annually, of whom approximately 80% undergo the procedure as destination or permanent therapy.
The Mesoblast share price is now up approximately 25% since this time last month. Though, it remains down by a sizeable 63% on a 12-month basis.
