Ann: Trading Halt, page-199

In the AFR
Mesoblast in trading halt pending FDA review

Robert Guy

Mesoblast has requested a trading halt pending a United States Food and Drug Administration review of its biologics licence application for its Ryoncil drug treatment.

The review is based on the use of the treatment in paediatric patients with steroid-refractory acute graft versus host disease.

Including a potential treatment for hospitalised COVID-19 patients, Mesoblast has four phase three product candidates at the trial stage. All of them use donated bone marrow cells to regenerate damaged tissue or modulate immune responses in patients.

The Australian Financial Review's Tom Richardson and Carrie LaFrenz took a deep dive look at a company they said has long been one of the sharemarket's most polarising companies.

The wrote how the Melbourne-based biotech is also hopeful of a regulatory breakthrough in the US which could see its treatment for a life-threatening inflammatory condition in children approved by the US Food and Drug Administration (FDA).

According to experts and analysts, Mesoblast may be close to transforming itself from a speculative biotech research company into a credible operating business.

Mesoblast shares last traded at $5.08, down from a record high of $5.50 touched on September 28.