Mesoblast (ASX:MSB) shares closed 23.4% higher at A$2.32 on Thursday 29 October 2026, the best performance in the ASX 200, according to IBTimes. The cell therapy company’s quarterly report showed a sharp fall in cash burn, record patient starts for Ryoncil and a positive meeting with the US Food and Drug Administration (FDA).
What Mesoblast reported
According to Mesoblast’s quarterly activities report for the three months to 30 September:
| Metric | Sep quarter 2026 | Sep quarter 2025 |
|---|---|---|
| Ryoncil net revenue | US$28M | US$19M |
| Net operating cash spend | US$2.1M | US$14.9M |
| Cash at 30 September | US$98.5M | n/a |
Ryoncil revenue was first flagged on 16 October, and the shares then fell about 11% because sales were below the June quarter and analyst forecasts. Thursday’s report added more detail:
- Cash burn: down 86% to US$2.1 million for the quarter
- Patient starts: September was Ryoncil’s best month for new patients
- Adult trial: a registration trial to expand Ryoncil to adults is enrolling, with up to 40 US sites expected this year
CEO Silviu Itescu said the first-quarter results “show continued momentum for Ryoncil” sales.
The FDA meeting
Mesoblast said that following an FDA meeting, it may proceed with a Biologics License Application (BLA) for rexlemestrocel-L. The application would cover life-threatening gastrointestinal bleeding in end-stage heart failure patients with a left ventricular assist device. Formal meeting minutes are expected shortly, and no filing date was given.
Mesoblast also completed treatment of all 350 patients in its Phase 3 trial of rexlemestrocel-L for chronic low back pain. Results are expected next year.
The insider angle: a director’s US$28M bet
Non-executive director Greg George, who is also listed as a 10% owner in his US filings, has been one of Mesoblast’s biggest buyers this year. Through related parties, he bought:
- March 2026: about US$16.4 million of shares and ADSs on the market, according to TipRanks
- 9 and 10 April 2026: about US$11.4 million more, with ADSs bought at about US$14.10 to US$14.40 each, according to his Form 4 filing
Mesoblast’s Nasdaq ADSs traded at about US$15.68 early Thursday, up 17%, according to IBTimes, putting George’s April purchases back in profit.
State Street also became a substantial holder with 5.15% on 23 October, according to a substantial holder notice. Our Applied Digital report explains how to read Form 4 filings.
What Mesoblast investors should watch
- The FDA minutes and timing of the BLA filing
- Ryoncil sales in the December quarter
- Back pain trial results next year
- Director trades in Appendix 3Y notices and Form 4 filings
Bottom line
Mesoblast is now burning very little cash, Ryoncil demand is building and a new FDA filing is in sight. With a director spending about US$28 million on shares this year, insiders are clearly backing the turnaround, but the company is still loss-making and sales growth must continue.
