Search ASX code:
Generic filters

Search ASX code:
Generic filters

Search ASX code:
Generic filters

Search ASX code:
Generic filters

Mesoblast (ASX:MSB) share price plunges on FDA decision

The Mesoblast Limited (ASX: MSB) share price is down 38% in early trading after the FDA’s decision about remestemcel-L.

What happened?

Mesoblast has been waiting for approval for remestemcel-L from the FDA.

The biotech business announced today that the FDA has issued a ‘complete response letter’ to its application for remestemcel-L for treating pediatric steroid-refractory acute graft versus host disease (SR-aGVHD).

While the Oncologic Drugs Advisory Commitee (ODAC) of the FDA voted 9 to 1 that the available data supported the effectiveness of of remestemcel-L in patients, the FDA has recommended that Mesoblast conduct “at least” one additional randomised, controlled study in adults and/or children to provide further evidence.

Mesoblast said it would urgently request a Type A meeting with the FDA to discuss a potential accelerated approval with a post-approval condition for an additional study considering there are no approved treatments for this condition.

The FDA also identified a need for further scientific rationale to demonstrate the relationship of potency measurements to the product’s biological activity. Mesoblast said assays (testing) measuring the potency of remestemcel-L will continue to be refined to provide further scientific rationale for its use in severe inflammatory diseases with high mortality risk.

Mesoblast CEO Dr Silviu Itescu said: “We are working tirelessly to bring remestemcel-L to patients with life threatening inflammatory conditions including SR-aGVHD and COVID-19 ARDS”. 

Summary

This is disappointing news for Mesoblast and delays things for the company. However, it’s not as though the FDA denied remestemcel-L completely. I don’t know enough about the company or the sector, it seems like a binary (yes/no) outcome – which isn’t how I like to invest. With the prior 9 to 1 recommendation, I’d guess it will get through, so this could be an opportunity. But I prefer the idea of other ASX growth shares like Pushpay Holdings Ltd (ASX: PPH) which I wrote about here.

Are you stuck wondering where to invest right now? Have you got cash 'sitting on the sidelines'? Are you looking for dividend income AND growth but don't know where to start? Rask's expert ASX analyst team has just released a full report, detailing where we'd invest $10,000 right now.

Not only are we offering these 11 investment ideas completely FREE, we've also released an in-depth podcast to go with the report!

So, whether you have $2,000 or $50,000, our brand new analyst report could help transform your watchlist. Right now, you can get the full analyst report emailed to you for FREE by CLICKING HERE NOW or simply entering your email below.

Unsubscribe anytime. Read our TermsFinancial Services GuidePrivacy Policy. We’ll never sell your email address. Our company is Australian owned.

Are you stuck wondering where to invest right now? Have you got cash 'sitting on the sidelines'? Are you looking for dividend income AND growth but don't know where to start? Rask's expert ASX analyst team has just released a full report, detailing where we'd invest $10,000 right now.

Not only are we offering these 11 investment ideas completely FREE, we've also released an in-depth podcast to go with the report!

So, whether you have $2,000 or $50,000, our brand new analyst report could help transform your watchlist. Right now, you can get the full analyst report emailed to you for FREE by CLICKING HERE NOW.

At the time of publishing, the author of this article does not have a financial or commercial interest in any of the companies mentioned.

Information warning: The information on this website is published by The Rask Group Pty Ltd (ABN: 36 622 810 995) is limited to factual information or (at most) general financial advice only. That means, the information and advice does not take into account your objectives, financial situation or needs. It is not specific to you, your needs, goals or objectives. Because of that, you should consider if the advice is appropriate to you and your needs, before acting on the information. If you don’t know what your needs are, you should consult a trusted and licensed financial adviser who can provide you with personal financial product advice. In addition, you should obtain and read the product disclosure statement (PDS) before making a decision to acquire a financial product. Please read our Terms and Conditions and Financial Services Guide before using this website. The Rask Group Pty Ltd is a Corporate Authorised Representative (#1280930) of AFSL #383169.

LIVE ASX Chat - Join in!

Play Video

Keep reading:

Rask Analyst’s $10,000 Hypothetical Portfolio 

Rask Australia’s expert analysts have just released 11 stock & ETF positions they’d buy right now as part of a $10,000 hypothetical portfolio. 

Completely free, this report comes with the exact ticker codes, how much the analysts would invest and a detailed over the company and why we like it. Plus a 60-min podcast! 

Simply enter your email address and we’ll send you the report.

Unsubscribe anytime. Read our TermsFinancial Services GuidePrivacy Policy. We’ll never sell your email address. Our company is Australian owned.