World News – AU – Mesoblast (ASX: MSB) share price jumps 19% after FDA update

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Motley Fool Australia »Stock Winners» Mesoblast (ASX: MSB) share price jumps 19% on FDA update

James Mickleboro | 2. December 2020, 10:16 am | More on: MSB

Mesoblast Limited (ASX: MSB) stock price has started the day strong and is racing significantly higher.

At the time of writing, the biotech company’s shares are up 12% to $ 4. 62. But at some point they even went up 19% to $ 4. 90.

Investors bought the company’s stock this morning after positive announcement was made regarding its Remestemcel-L product.

According to the press release, the US Food and Drug Administration (FDA) has granted the fast-track designation for Remestemcel-L in the treatment of acute respiratory distress syndrome (ARDS) due to COVID-19 infection.

Fast-track designation is given when a therapy demonstrates the potential to meet unmet medical needs for a serious or life-threatening illness. Given that ARDS is the leading cause of death in patients with COVID-19, it was no surprise the FDA gave it that designation.

The company notes that the clinical data made available to the FDA included results from a pilot study of Remestemcel-L that was used compassionately in an emergency at New York’s Mt Sinai Hospital from March to April this year.

In this study, nine of 12 ventilator-dependent patients with moderate to severe COVID-19 ARDS were successfully discharged from the hospital a median 10 days after receiving two intravenous doses of Remestemcel-L.

A larger phase 3 study with up to 300 ventilator-dependent patients is ongoing and around two-thirds will be carried out.

Two independent interim analyzes were performed by the independent Data Safety Monitoring Board (DSMB) after 90 and 135 patients were included. After this analysis, the DSMB recommended that the study continue as planned.

A third and final interim analysis should be carried out by the DSMB when 180 patients have completed 30 days of follow-up.

One company that appears optimistic about treatment is Novartis. The two parties recently entered into a licensing and collaboration agreement to develop, manufacture and commercialize Remestemcel-L with an initial focus on the treatment of ARDS, including COVID-19 ARDS.

Novartis prepaid $ 50 million and agreed to pay more than $ 1. Milestone payments of 25 billion depending on success.

A little-known Australian IPO has doubled since January, and renowned Australian moonshot stock picker Anirban Mahanti sees a potential millionaire waiting. . .

With ‘Doc’ Mahanti believing this fast-growing company has all the hallmarks of real moonshot potential, forget ‘buy now, pay later’, this stock could be the next hot stock on the ASX.

James Mickleboro, a contributor to the Motley Fool, 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 agree, but we all believe that taking different insights into account makes us better investors. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). . Authorized by Scott Phillips.

In this FREE SHARE REPORT, Scott Phillips just revealed what he thinks are the 3 ASX stocks for the post-COVID world that investors should buy now while they still can.

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Mesoblast, ASX, Fast Track, Food and Drug Management, ASX: MSB, Share Price, Cell Therapy

World News – AU – Mesoblast (ASX: MSB) share price jumps 19% on FDA- Update

Ref: https://www.fool.com.au

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