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Mesoblast Receives FDA Green Flag for COVID-19 Drug Application, Share Price Skyrockets~35 per cent

  • April 06, 2020 07:42 PM AEST
  • Team Kalkine
Mesoblast Receives FDA Green Flag for COVID-19 Drug Application, Share Price Skyrockets~35 per cent

In the past few weeks, markets have been unpredictable, witnessing sharp movements in both directions as agencies throughout the world disclosed massive amounts of stimulus to stem the economic impact of the COVID-19. This pandemic has shattered medical systems and packed the hospitals. According to the International Monetary Fund (IMF), the COVID-19 pandemic has struck the economies hard with the world falling in a recession, one which could even worse than the GFC of 2009 according to the Director of IMF, Ms Kristalina Georgieva.

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Do Read: Medical Developments in Race Against COVID-19

As per the World Health Organization (WHO), the total number of incidents around the world has surpassed 1.1 million, while the number of deaths has almost touched the 63,000-markacross 208 nations and territories.The global healthcare sector is under limelight amid the turmoil created by the coronavirus pandemic with numerous players tapping the market opportunity to look into the treatment and prevention of the same.

On 6 April 2020, the S&P/ASX 200 Index closed at 5,286.8 points, up by 4.33 per cent from its previous close. The S&P/ASX 200 Health Care sector index traded higher at 43,722.8 points, with a rise of 4.87 per cent compared to the last close.

There are a few health sector companies that generated profitsby challenging the crisis of coronavirus in a commercial sense, and these stocks are catching investors’ eyes these days amid the COVID-19 outbreak. The profitable Australian healthcare sector often grabs the attention of investorswith the potential of delivering significant earnings and returns.

Numerous variables are accountable for increasing investors’concern in the healthcare sector, including new drug discoveries, Food and Drug Administration (FDA) approvals, demographics, patents and patent application and ongoing clinical studies and more.

The approval process from the FDA is an essential aspect that provides a decent impression on the fate of any healthcare stock. In general, FDA approval indicates an increasing share price for the Company. However, investors should consider each Company and each approval separately.

One healthcare sector player Mesoblast Limited is focused on achieving its established objectives and received approvals from the FDA for its drug candidates. Moreover, it is noteworthy thaton 6 April 2020, Mesoblast received an IND application approval for using Remestemcel-L in COVID-19 patients for treating acute respiratory distress syndrome (ARDS).

Let us deep dive and talk about the recent updates of the ASX-listed, regenerative medicine Company, Mesoblast.

Mesoblast Limited’s (ASX:MSB) share price up by ~35 per cent

On 6 April 2020, MSB stock closed the day’s trade at$1.815, going up by 34.944 per centwith a market capitalisation of approximately $722.63 million. With nearly 537.27 million shares outstanding, the MSB stock has a fifty-two weeks high and the low price reported at$3.210 and $1.020, respectively.

About the Company

A Melbourne, Australia headquartered healthcare sector player Mesoblast Limited is a leader in developing innovative cellular medicines across the globe. The Company has a robust emerging drug pipeline for follow-on indications with three programs currently undergoing Phase III clinical studies. The lead product candidates of the Company that are under clinical research include remestemcel-L, revascor, MPC-06-ID and MPC-300-IV.

Mesoblast has filed a BLA (biologics license application) to the FDA for approval of its drug candidate RYONCIL™ for the treatment of steroid-refractory acute GvHD (graft versus host disease). If approved, RYONCIL is anticipated to be introduced for pediatric steroid-refractory aGVHD in the US in 2020.

MSB has a robust and extensive international IP portfolio with protection extending through to at least 2040 in all key markets.

Source: Company's Presentation

FDA clearance for IND for Mesoblast to use Remestemcel-L

In an ASX announcement dated 6 April 2020, Mesoblast revealed that the US Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application for drug candidate remestemcel-L to treat patients with acute respiratory distress syndrome triggered by coronavirus infection with intravenous infusions of its allogeneic mesenchymal stem cell (MSC).

Remestemcel-L is being developed for several inflammatory diseases and is supposed to counteract the inflammatory procedures implicated in these diseases by increasing production of anti-inflammatory cytokines and down-regulating the production of pro-inflammatory cytokines and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues. The safety and therapeutic effects of intravenous infusions of remestemcel-L have been assessed in more than 1,100 patients in numerous clinical studies.

The drug was successful in a Phase III clinicalstudy for steroid-refractory aGVHDin children, a potentially fatal inflammatory condition due to a similar cytokine storm process as is observed in acute respiratory distress syndrome (ARDS) in COVID-19 patients.

Furthermore, a posthoc analysis of a randomised, placebo-controlled clinical trial in 60 patients with chronic obstructive pulmonary disease (COPD) established that remestemcel-L significantly improved respiratory function in patients with the same elevated inflammatory biomarkers that are also observed in patients with COVID-19 acute respiratory distress syndrome. Collectively, these findings provide the rationale for assessingremestemcel-L in patients with COVID-19 ARDS.

CMO of Mesoblast, Dr Fred Grossman stated that the clearance for the use of remestemcel-L from Food and Drug Administration (FDA) provides a pathway in the US for use of drug in patients with COVID-19 ARDS, where the projection is very miserable, under both expanded access compassionate use as well as planned randomised controlled clinical study.

Biologics licence application for RYONCIL™ accepted by FDA

On 1 April 2020, Mesoblast disclosed that the US FDA had accepted for priority review the Company’s Biologics License Application filing for RYONCILTM (remestemcel-L), its allogeneic cell therapy, for treating children having SR-aGVHD (steroid-refractory acute graft versus host disease).

Moreover, the company highlighted that the FDA established a prescription drug user fee act, or PDUFA, action date of 30 September 2020, and immediately after approval, the Company will make available RYONCIL in the US.

Despite the Coronavirus outbreak, Mesoblast has continued its operations. The Company has a strong product pipeline with some of the drug candidates in late-stage clinical studies andthus, is well-positioned to develop a treatment for COVID-19. And the recently received green light from the FDA for its drug candidate Remestemcel-L for treatment of acute respiratory distress syndrome (ARDS) in coronavirus infected individuals seems to strengthen MSB’s position further.

Interesting Read: How FDA approvals can change the fate of healthcare stocks?


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