Mesoblast

Mesoblast generated US$115 million in revenue in fiscal year 2026 following the launch of RYONCIL, including US$36 million in the fourth quarter. Gross profit on total revenue was US$110 million, and net loss narrowed 44% to US$57.5 million. Management expects double-digit revenue growth for RYONCIL over the next 12 months and sees profitability from FY2027, while cash burn is declining. The stock fell slightly in regular trading and recovered marginally after hours; the balance sheet shows US$103 million in cash and a US$125 million credit facility. » Altro su de.investing.com

Mesoblast shares rose about 9.5% after announcing completion of patient treatment in the approval-relevant, randomized phase 3 study MSB-DR004 with Rexlemestrocel-L. A total of 350 patients were treated (originally planned 300) with intradiscal injection versus sham injection; the primary endpoint is intended to confirm sustained pain reduction at 12 months. Top-line results are expected mid-2027 after the last patient completes 12 months of follow-up. Rexlemestrocel-L has received RMAT designation from the FDA, which enables priority review upon submission of the marketing application. » Altro su de.investing.com

Mesoblast has completed patient dosing in the randomized, placebo‑controlled Phase 3 study of rexlemestrocel‑L for chronic back pain due to degenerative disc disease. A total of 350 patients were enrolled, compared with the originally planned 300, and were either treated intradiscally or given a sham injection. The primary endpoint is durable pain reduction at 12 months; top‑line results are expected in mid‑2027 after completion of the 12‑month follow‑up. Rexlemestrocel‑L has FDA Regenerative Medicine Advanced Therapy status, which enables priority review if a BLA is submitted. » Altro su de.investing.com