Mesoblast Shares Halted: A Look At The Biopharma's Upcoming Catalysts

Trading in shares of Australian biopharma Mesoblast limited MESO was halted on the Nasdaq exchange Wednesday pending the release of material news.

The Mesoblast Trading Halt: Earlier, the Australian stock exchange made an announcement regarding the halt, stating that trading in Mesoblast stock was halted at the request of the company.

"Unless ASX decides otherwise, the securities will remain in trading halt until the earlier of the commencement of normal trading on Monday, 5 October 2020 or when the announcement is released to the market," the statement said. 

Mesoblast Has Long-Awaited Binary Event: Mesoblast is awaiting an FDA decision on its lead stem cell therapy candidate remestemcel-L — trade name Rynocil — for treating steroid-refractory acute graft versus host disease, or SR-aGVHD, in pediatric patients.

The PDUFA date is set for Oct. 30; the trading halt is likely to be related to the pending decision.

The disease is a complication arising from donor cells attacking the organs and tissues of the patient who received them.

FDA's Oncologic Drugs Advisory Committee, which met in mid-August to discuss the BLA, voted 9-1 that the available data supports the efficacy of Rynocil in pediatric patients with SR-aGVHD.

The FDA, though it considers panel recommendations, is not bound to them. 

Mesoblast is planning on a commercial launch of Ryoncil contingent upon FDA approval. 

Ryoncil is likely to generate risk-adjusted U.S. revenues of $150 million by 2030, according to H.C. Wainwright analyst Swayampakula Ramakanth's estimates.

Cantor Fitzgerald Bullish On Mesoblast: Mesoblast is Cantor Fitzgerald's top smid-cap idea into the end of 2020, analyst Louise Chen said in a Thursday note. 

"MESO has several catalysts that could drive the stock higher, including the U.S. approval of Ryoncil as well as positive data for COVID-19 ARDS, chronic low back pain and heart failure," the analyst said.

Mesoblast's Upcoming Catalysts: Mesoblast is expected to complete enrollment in a Phase 3 trial of remestemcel-L in patients with moderate to severe acute respiratory distress syndrome due to COVID-19 infection in the fourth quarter.

The company is also due to report results in the fourth quarter from a Phase 3 study of Revascor in advanced heart failure and analysis of data from a Phase 3 trial in MPC-06-ID for chronic low back pain.

MESO Price Action: Mesoblast was trading down 3.15% at $18.58 before the stock was halted. 

The stock has gained over 150% in the year-to-date period.

Related Links:

The Week Ahead In Biotech: FDA Decisions For Mesoblast And Eton, Coronavirus Vaccine Updates

Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates