Looking to buy Mesoblast shares? Here’s the latest on where the ASX biotech is at with the FDA

With the unwinding of the high-growth/tech trade of the past two years, many biotechnology names suffered equally in nasty selloffs this year.

Shares of Mesoblast Ltd (ASX: MSB) have taken a hit in 2022 having slipped more than 42% into the red this year to date.

Shares of the regenerative medicine player are currently at 84 cents apiece in early trading on Thursday, gaining the 3% they lost in yesterday’s session.

What’s Mesoblast been up to?

It was a busy period in the last financial year for Mesoblast, especially in its liaison with the US Food and Drug Administration (FDA).

Mesoblast has made, and is set to make, a host of submissions to the FDA regarding its lead drug candidates, Remestemcel-L and Rexlemestrocel-L.

It intends to resubmit a biologics license application (BLA) with the FDA this quarter for the approval of Remestemcel-L in treating children with steroid-resistant acute graft-versus-host-disease (SR-aGVHD). It is aiming for this approval in early 2023.

Meanwhile, Mesoblast also plans to meet with the FDA in the next quarter under its existing regenerative medicine advanced therapy (RMAT) designation to discuss Rexlemestrocel-L.

They will look over data from the company’s recent phase 3 trial of 565 patients with heart failure condition HFrEF.

Rexlemestrocel-L also “gained alignment” with the FDA last period on key metrics for a pivotal phase 3 clinical trial in patients with chronic low back pain (CLBP) associated with disc pathology.

This follows on from the first phase 3 trial covering the same condition and Mesoblast hopes to replicate favourable results produced there.

The company also plans to have received clearance from the FDA by the end of 2022 so it can commence the pivotal trial.

As such, it will be a busy few months for Mesoblast as it looks to progress through this next round of trials in both of its leading drug segments.

In the last 12 months, the Mesoblast share price has faltered 54% into the red.

The post Looking to buy Mesoblast shares? Here’s the latest on where the ASX biotech is at with the FDA appeared first on The Motley Fool Australia.

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More reading

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Motley Fool contributor Zach Bristow has no position in any of the stocks mentioned. The Motley Fool Australia’s parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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