The Mesoblast limited (ASX: MSB) share price is racing higher on Tuesday morning.
At the time of writing, the biotech company's shares are up 14% to 97.5 cents.
Why is the Mesoblast share price racing higher?
Investors have been bidding the Mesoblast share price higher on Tuesday following the release of a positive update on the biotech company's rexlemestrocel-L product candidate.
According to the release, rexlemestrocel-L delivered an improvement in left ventricular ejection fraction (LVEF) at 12 months after a single intervention in the 565-patient randomised controlled trial in New York Heart Association (NYHA) class II/III chronic heart failure (CHF) with reduced ejection fraction (HFrEF).
The release highlights that the improvement in LVEF was most pronounced in the setting of inflammation and preceded a long-term reduction in major adverse cardiovascular events (MACE) and associated recurrent hospitalisations for non-fatal heart attack or stroke.
In respect to the latter, the trial reported a 68% reduction in the rate of recurrent hospitalisations from non-fatal heart attacks or strokes compared with controls.
Management also notes that the effects on LVEF and MACE outcomes were even more pronounced in 301 HFrEF patients with high baseline levels of inflammation.
Another positive was that the results confirmed the observed reduction in major gastrointestinal bleeding events seen in an earlier 30-patient randomised study.
This is good news for Mesoblast, as the US FDA has previously indicated that a reduction in life-threatening mucosal bleeding events is an important clinical outcome in patients implanted with a left ventricular assist device.
What's next?
Mesoblast intends to meet with US FDA under the regenerative medicine advanced therapy framework.
It will discuss the totality of the data, the evidence of a common mechanism of action across the broad HFrEF spectrum, and how the outcomes from each trial may support the regulatory approval pathway for rexlemestrocel-L.
