The Mesoblast Ltd (ASX: MSB) share price is blasting off in early afternoon trade on Tuesday.
Shares in the ASX biotech company closed yesterday trading for 33 cents per share.
The company requested a trading pause this morning pending a further announcement.
That announcement was just released.
And investors have responded by sending the Mesoblast share price soaring to 45 cents per share, up 36.4%.
Here's what the company reported.
Mesoblast share price lifts off on FDA news
Mesoblast is enjoying a big lift after reporting on encouraging communications with the US Food and Drug Administration (FDA).
After additional consideration of the clinical data from Mesoblast's phase 3 study, the FDA said there appear to be sufficient results to support the submission of the company's proposed Biologics License Application (BLA) for its remestemcel-L medicine to treat paediatric patients with steroid-refractory acute graft versus host disease.
Remestemcel-L is being developed for inflammatory diseases in children and adults, including steroid-refractory acute graft versus host disease, and biologic-resistant inflammatory bowel disease.
Commenting on the FDA's guidance that's sending the Mesoblast share price soaring this afternoon, CEO Silviu Itescu said, "We thank the agency for their collaborative approach."
Silviu added, "The responses and guidance from FDA are clear and provide us with a high level of confidence to refile our BLA for remestemcel-L in children with SR-aGVHD."
Mesoblast said it plans to file the resubmission during the next quarter. The ASX biotech stock aims to address the remaining product characterization issues.
How has the ASX biotech stock been tracking?
The Mesoblast share price has seen some big moves higher and lower over the past year.
With today's intraday moves factored in, the ASX biotech share is up 45% in 2024.
