Mesoblast Ltd (ASX: MSB) shares are at it again today.

And by 'it', I mean racing higher.

Shares in the ASX biotech company closed yesterday trading for 79.5 cents. In afternoon trade on Tuesday, shares are swapping hands for 86 cents apiece, up 8.2%.

While that's a very tidy intraday gain, it pales in comparison to the 160.6% gains delivered by Mesoblast shares over the past month.

That's right.

One month ago today, you could have snapped up the stock for 33 cents a share.

Meaning a $6,000 investment last month would now be worth a whopping $15,636.

Here's what's been going right for the company.

The big moves higher for Mesoblast shares really commenced on 26 March.

That day saw the ASX biotech stock gain 45.5%, ending the day trading for 48 cents a share.

Shares gained 3.1% the next day and another 12.1% on Thursday 28 March, before the ASX closed for the four-day Easter holiday.

Apparently investor enthusiasm only increased over the holiday break, with Mesoblast shares soaring an eye-watering 71.2% on 2 April to finish the day at 95 cents.

Investors began sending the biotech stock soaring following promising news from the US Food and Drug Administration (FDA) about the company's remestemcel-L treatment.

Mesoblast is developing remestemcel-L to treat inflammatory diseases including steroid-refractory acute graft versus host disease and biologic-resistant inflammatory bowel disease in children and adults.

On 26 March the FDA said that after examining additional clinical data from Mesoblast's phase 3 study, there appeared to be sufficient results to support the resubmission of the company's proposed Biologics License Application (BLA) for remestemcel-L.

Mesoblast CEO Silviu Itescu said at the time, "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 shares look to be getting ongoing support, as the company said it plans to file the resubmission in the upcoming quarter.

After soaring 161% in a month, can Mesoblast shares keep delivering?

According to the analysts at Bell Potter, very much so.

Bell Potter has a 'speculative buy' rating on the ASX biotech stock.

And on 5 April, the broker increased its target price to $1.40 from its previous target of 58 cents.

That's some 63% above the current Mesoblast share price.

According to Bell Potter:

Our best estimate for approval of Remestemcel is mid-August 2024. The planned adult study in GvHD has for the moment been postponed pending the outcome of the resubmitted BLA.

 Valuation is increased from $0.58 to $1.40 reflecting significant changes to revenue forecasts bought about by renewed confidence for a prospective approval for Remestemcel in Paediatric GvHD later this year.

A first approval may represent a gateway to a series of label expansions in the ensuing period as reflected in the share price movement in recent days.