The Mesoblast Ltd (ASX: MSB) share price is on form again on Thursday.
In morning trade, the biotechnology company's shares are up 11% to a 52-week high of $1.33.
This means the Mesoblast share price is now up over 50% since the start of the year, as you can see on the chart below.
Why is the Mesoblast share price charging higher today?
Investors have been buying Mesoblast shares again on Thursday after the company made another positive announcement.
According to the release, the United States Food and Drug Administration's (FDA) Office of Tissues and Advanced Therapies has granted Mesoblast Regenerative Medicine Advanced Therapy (RMAT) designation to rexlemestrocel-L.
This is for the treatment of chronic low back pain (CLBP) associated with disc degeneration, in combination with hyaluronic acid (HA) as the delivery agent for injection into the lumbar disc.
What does this mean?
RMAT designations are good news for Mesoblast as they aim to expedite the development of regenerative medicine therapies that are treating serious or life-threatening disease or conditions where preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs.
The release notes that RMAT designation for rexlemestrocel-L provides all the benefits of breakthrough and fast track designations, including rolling review and eligibility for priority review when filing a Biologics License Application (BLA).
Management highlights that there is a significant need for a safe, effective, and durable opioid-sparing treatment in patients with CLBP associated with degenerative disc disease.
The good news is that a completed 404-patient randomised, blinded placebo-controlled Phase 3 trial of rexlemestrocel-L combined with HA has delivered promising results. It was for this reason that the FDA granted its RMAT designation.
Mesoblast's Chief Executive, Silviu Itescu, commented:
We are pleased to receive RMAT designation for our cellular therapy to treat CLBP due to disc degeneration. We look forward to working closely with FDA to efficiently generate the additional data needed to support marketing approval of rexlemestrocel-L for the treatment of this serious and debilitating condition.
Mesoblast highlights that CLBP is a serious condition with an annual prevalence of low back pain in the general US adult population of 10% to 30% and a lifetime prevalence in US adults as high as 65% to 80%. This makes it a potentially lucrative market for Mesoblast to target.
