Has the ASX 200 Healthcare Stock Mesoblast Touched a new 52-week high?

Summary

• Australian regenerative medicine company Mesoblast’s share price hit a 52-week high on 27 August following outstanding FY2020 results with revenue up 92%.
• Mesoblast, on 2 September, received ethics approval to include Australian hospitals in the Phase 3 trial of remestemcel-L in ventilator-dependent COVID-19 patients having ARDS.
• Participating hospitals received the approval by the Human Research Ethics Committee of Monash Health. They will join almost 17 leading US medical centres in the Phase 3 trial at present.
• The independent DSMB intends to finalise an interim analysis this month and shall recommend MSB whether to proceed or stop early.
• Earlier, The FDA Oncologic Drugs Advisory Committee (ODAC) voted overwhelmingly in favour that the available information support the efficacy of RYONCIL in SR-aGVHD in children.

ASX 200 healthcare company Mesoblast Limited (ASX:MSB) is gaining investor attention on the back of its progressive movement towards developing a suitable treatment for the deadly infection caused by the novel coronavirus (SARS-Cov-2).

On 27 August 2020, MSB witnessed its 52 weeks high price of A$5.430 post announcement of its impressive annual results for the financial year 2020. The Company has had several important releases in August and has performed exceptionally amid the challenging environment, with the pandemic acting as a boon for Mesoblast.

On 2 September 2020, the share price of MSB was trading at A$5.150 at the end of the trading session. The market capitalisation of MSB is A$3.06 billion. The stock has generated an outstanding return of 129.82% and 33.33% in the last six months and three months, respectively.

Let us discuss what is recent with ASX 200 listed healthcare player Mesoblast-

About Mesoblast Limited

ASX 200 listed healthcare company Mesoblast Limited is a world leader in developing off-the-shelf (allogeneic) cellular medicines. The Company, through its proprietary mesenchymal lineage cell therapy technology program, has formed a broad portfolio of commercial products as well as late-stage product candidates. Mesoblast operates in Australia, Singapore, and the US.

With more than 1,100 patents and patent applications, the Company has protection extending through 2040 in all key markets.

Mesoblast Obtains Ethics Approval to Conduct Phase 3 Trial in Australian Hospitals

On 2 September 2020, Mesoblast disclosed that it had received ethics approval to include hospitals of Australia in the Phase 3 trial (randomised controlled) of remestemcel-L in COVID-19 patients having ARDS and are on a ventilator.

Participating hospitals in Melbourne and Sydney have received approval by the Human Research Ethics Committee of Monash Health. These hospitals shall join more than 17 prominent US medical centres which are already conducting the Phase 3 trial. This study is approved by the US Food and Drug Administration (FDA) and being conducted by the US National Institutes of Health-funded CTSN (Cardiothoracic Surgical Trials Network).

The independent DSMB (Data Safety Monitoring Board) of the trial intends to finalise an interim analysis this month. For interim analysis, data will be collected from the first 90 patients randomised in the United States after they have completed thirty days of follow up.

After the assessment of the safety and efficacy information, the Board shall give a recommendation to Mesoblast on whether the clinical study should go on as it was planned or stop early.

On this approval, Chief Executive of Mesoblast Dr Silviu Itescu commented-

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Mesoblast reported impressive FY20 Results; Revenue increased by 92%

On 27 August 2020, Mesoblast updated the market with its annual financial results and operational highlights for

FY20 highlights (year ended 30 June 2020)

• During FY20, revenues of Mesoblast climbed by 92%, as compared to FY19, to US$32.2 million.
• The Company witnessed a 127% rise in milestone revenues from strategic partnerships to US$25.0 million.
• Commercialisation revenue from TEMCELL sales reported at US$6.6 million, up by 32%.
• As on 30 June 2020, MSB has US$129.3 million worth of cash on hand.
• Loss after tax during the period was lower by 13% to US$77.9 million compared with US$89.8 million for FY19.
• The FDA Oncologic Drugs Advisory Committee (ODAC) voted overwhelmingly in favour that the available information support the efficacy of RYONCIL in SR-aGVHD in children.
• RYONCIL BLA is under Priority Review by the US FDA under the PDUFA with an action date of 30 September 2020.

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A Glance at Phase 3 Trial of Remestemcel-L in COVID-19 induced ARDS

Phase 3 trial of Remestemcel-L is a randomised, controlled, multi-centre blinded clinical trial. This clinical trial will evaluate safety as well as the efficacy of remestemcel-L along with the standard of care (SOC) vs placebo and SOC in human volunteers with moderate or severe ARDS symptoms and are on a ventilator due to COVID-19.

The objective of the Phase 3 clinical trial of remestemcel-L is to reduce mortality within 30 days. Mesoblast stated that recruitment for Phase 3 clinical trial is anticipated to complete during the fourth quarter of the calendar year 2020. The Phase 3 interim analysis is planned and could result in early stoppage for efficacy or futility.

First interim analysis of this trial is due in early September after 30% of patients achieve the primary endpoint.

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