The Mesoblast Limited (ASX: MSB) share price could be set to surge after the Aussie biotech company had a huge regulatory breakthrough.
What was the big breakthrough?
Investors were holding out ahead of the US Oncologic Drugs Adviosry Committee (ODAC) meeting to vote on Mesoblast’s remestemcel-L treatment (Ryoncil) for paediatric patients with acute-graft versus host disease (aGHVD).
According to an article in the Australian Financial Review (AFR), the ODAC meeting voted 8 to 2 in favour of the Mesoblast drug this morning.
That’s good news for the Mesoblast share price, which had tumbled 37% in just 2 days earlier this week.
Investors were pessimistic on the ODAC meeting after a US Food and Drug Administration (FDA) briefing note on Tuesday.
That note questioned how strong the evidence of the treatment’s effectiveness was. That caused many to believe the ODAC would come to a similar conclusion.
However, today’s news could mean the Mesoblast share price rockets higher. According to the article, the final decision on the Ryoncil drug for marketing is expected to be made by the FDA before 30 September.
That looms as another important milestone, but todaý’s vote should boost investors’ confidence.
How has the Mesoblast share price performed?
This week alone has been a wild ride for investors.
The Mesoblast share price climbed 9.9% on Monday before freefalling 30.60% on the back of Tuesday’s news.
Wednesday saw a further decline of 9.5% before tactical investors picked up the stock cheaply, sparking a 10.1% rally in yesterday’s trade.
Despite the volatility, the Mesoblast share price has jumped 64.9% higher in 2020. That’s a significant outperformance against the S&P/ASX 200 Index (ASX: XJO), which is down 9.0% this year.
Mesoblast’s fellow ASX biotech shares have also had a strong year in the Aussie share market.
Polynovo Ltd (ASX: PNV) shares are up 15.1% this year while the CSL Limited (ASX: CSL) share price has edged 1.0% higher.
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Ken Hall has no position in any of the stocks mentioned. The Motley Fool Australia’s parent company Motley Fool Holdings Inc. owns shares of CSL Ltd. and POLYNOVO FPO. 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.
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