Mesoblast share price rockets 57% higher on FDA breakthrough

309

 

thumbs up

The Mesoblast limited (ASX: MSB) share price has been the best performer on the S&P/ASX 200 Index (ASX: XJO) on Friday.

In morning trade the biotechnology company’s shares rocketed as much as 57% higher to a record high of $5.30.

Why is the Mesoblast share price rocketing higher?

Investors have been fighting to get hold of the company’s shares after a very successful outcome from its meeting with the Oncologic Drugs Advisory Committee (ODAC) overnight.

That meeting was to discuss its remestemcel-L (RYONCIL) product candidate as a treatment for paediatric steroid-resistance acute graft versus host disease (paediatric SR-aGvHD).

The ODAC is an independent panel of experts that evaluates efficacy and safety of data and makes appropriate recommendations to the United States Food and Drug Administration (FDA).

What happened at the meeting?

This morning the company revealed that the ODAC voted overwhelmingly in favour that the available data supports the efficacy of remestemcel-L in paediatric patients with SR-aGvHD.

Mesoblast’s Chief Medical Officer, Dr Fred Grossman, commented: “Steroid-refractory acute graft versus host disease is an area of extreme need, especially in vulnerable children under 12 years old where there is no approved therapy.”

“We are very encouraged by today’s outcome and are committed to working closely with the FDA as they complete their review of our submission regarding approval of RYONCIL for this life-threatening complication of an allogeneic bone marrow transplant.”

What now?

While the FDA will seriously consider the recommendation of the panel, the final decision regarding the approval of the product is made solely by the regulator. This means the recommendations by the panel are non-binding.

The RYONCIL product has been accepted for Priority Review by the FDA, with an action date of 30 September 2020. If approved, Mesoblast plans to launch RYONCIL in the United States in 2020.

Paediatric transplant physician Dr Joanne Kurtzberg appears hopeful this will go to plan. She sees a major need for a treatment for this condition.

Dr Kurtzberg commented: “This devastating condition has an extremely poor prognosis and there are no FDA-approved options for children under the age of 12. The clinical studies I have directed have demonstrated the potential for this treatment to fill a significant unmet medical need.”

The post Mesoblast share price rockets 57% higher on FDA breakthrough appeared first on Motley Fool Australia.

Man who said buy Kogan shares at $3.63 says buy these 3 ASX stocks now

When investing expert Scott Phillips has a stock tip, it can pay to listen. After all, the flagship Motley Fool Share Advisor newsletter he has run for more than eight years has provided thousands of paying members with stock picks that have doubled, tripled or even more.*

In this FREE STOCK REPORT, Scott just revealed what he believes are the 3 ASX stocks for the post COVID world that investors should buy right now while they still can. These stocks are trading at dirt-cheap prices and Scott thinks these could really go gangbusters as we move into ‘the new normal’.

*Returns as of 6/8/2020

More reading

Motley Fool contributor James Mickleboro has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

The Motley Fool’s purpose is to help the world invest, better. Click here now for your free subscription to Take Stock, The Motley Fool’s free investing newsletter. Packed with stock ideas and investing advice, it is essential reading for anyone looking to build and grow their wealth in the years ahead. This article contains general investment advice only (under AFSL 400691). Authorised by Bruce Jackson. 2020

Contributors to this article may own shares in some of the companies mentioned in this article. The Capital Club has a thorough disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Bruce Jackson.
James Mickleboro
James Mickleboro studied economics in the United Kingdom before coming to Australia and landing a job at a fund manager. He is part of the CFA Institute's Chartered Financial Analyst program. He loves researching and writing about Australian equities.