Mesoblast (ASX:MSB) share price surges 5% in early trade today

Mesoblast’s request to meet with United States drug regulators has excited the market.
The post Mesoblast (ASX:MSB) share price surges 5% in early trade today appeared first on The Motley Fool Australia. –

The Mesoblast Limited (ASX: MSB) share price soared earlier today. This came after news the company has requested to meet with the United States Food and Drug Administration (FDA) to discuss its chronic lower back pain medication.

Shortly after the opening bell, Mesoblast shares surged to $2.08 — 5.05% higher than its closing price yesterday. It has since settled lower to $2.01, up 1.52% at the time of writing.

According to Mesoblast, its drug would be an alternative therapy to opioids. This is important because excessive use of opioids is considered a major problem by US policymakers and regulators.

More than 50% of US opioid prescriptions are given to patients with chronic lower back pain.

Let’s take a look at today’s news from Mesoblast.

Mesoblast’s meeting with FDA

According to the release, the company has requested and expects to be granted, a meeting with the FDA in the September quarter.

In the meeting, Mesoblast and the FDA would discuss pathways to have rexlemestrocel-L approved for use in the United States.

The company recently completed a 404 patient phase 3 trial of rexlemestrocel-L. The trial saw rexlemestrocel-L successfully treating patients with chronic inflammatory back pain caused by degenerative disc disease.

According to Mesoblast, it will use the results from a future US-based trial to help achieve product approvals in the United States and the European Union.

To bypass the need for a European Union-based trial, Mesoblast envisages 20% of the trial’s patients will be European. Mesoblast states that including European patients in the trial will provide “regulatory harmonisation”, cost efficiencies, and a faster timeline.

To make it happen, the company has amended its collaboration agreement with Grünenthal, its partner in Europe and Latin America.

Mesoblast is likely to be eligible for payments of up to US$112.5 million before rexlemestrocel-L launches in the European Union. To be eligible, it must pass certain clinical and regulatory milestones and reimbursement targets.

The company states that the payments could reach a combined US$1 billion. However, that figure is dependant on the outcome of phase 3 studies and patient adoption. It will also receive royalties on product sales.

Commentary from management

Mesoblast’s chief medical officer, Dr Fred Grossman was quoted in the company’s release. He said:

We look forward to discussing with the FDA the most efficient path forward given the durable pain reduction for at least two years and the opioid-sparing activity from a single administration of rexlemestrocel-L that was observed in the recent Phase 3 trial.

Mesoblast share price snapshot

The Mesoblast share price needs all the good news it can get to boost its recent poor performance.

Currently, shares in Mesoblast are over 13% lower than they were at the beginning of 2021. They have also fallen around 40% since this time last year.

The company has a market capitalisation of around $1.29 billion, with approximately 647 million shares outstanding.

The post Mesoblast (ASX:MSB) share price surges 5% in early trade today appeared first on The Motley Fool Australia.

Should you invest $1,000 in Mesoblast right now?

Before you consider Mesoblast, you’ll want to hear this.

Motley Fool Investing expert Scott Phillips just revealed what he believes are the 5 best stocks for investors to buy right now… and Mesoblast wasn’t one of them.

The online investing service he’s run for nearly a decade, Motley Fool Share Advisor, has provided thousands of paying members with stock picks that have doubled, tripled or even more.* And right now, Scott thinks there are 5 stocks that are better buys.

*Returns as of May 24th 2021

More reading

ASX 200 Weekly Wrap: Share market breaks 5 week winning streak

These were the worst-performing ASX 200 shares last week

ASX 200 Weekly Wrap: ASX edges even higher, led by tech rebound

These were the best performing ASX 200 shares last week

The Mesoblast (ASX:MSB) share price has rocketed 18% this week

Motley Fool contributor Brooke Cooper 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 Bruce Jackson.

Trade The World Anywhere & Anytime!

Mobile app platform with over 50,000 global listed securities across 12 markets (over 70% global market capitalisation), right from your Android or iOS device.

Integrated with exclusive trading idea and investment analysis tools to help you find actionable insight on virtually every financial instrument across our 12 global markets, to help you optimise your trading strategies.

Refer Your Friends

Tell your friends about Monex and gift them FREE access to our trading tools.

We respect your privacy and will only send this one email notification to your friends. 

Share With Your Friends

Share on facebook
Share on twitter
Share on linkedin

Monex Trading Tools Access and Usage Terms

The Monex Trading Tools (referred to as ‘tools’ hereafter) are available to you inside your client portal;

To activate access to the tools, you must have a verified and approved trading account and have made a deposit of at least AUD $1000.

An active and funded account with a positive trading balance is required to continue to have access to the tools;

Although the tools are available to you indefinitely, Monex Securities may at it’s discretion disable access to the tools in the future;

Monex securities reserves the right to change these terms and conditions from time to time, as it sees fit, without notice.

Important Notice
iOS & Android App - 12 International Markets & Over 70% Global Market Cap. $0 Brokerage On US Trades. Click Here!