Mesoblast gets FDA nod for new potency assay to release Ryoncil batches
The company said the assay, called TIBA, will work alongside existing tests to help confirm product consistency as manufacturing evolves.
SEC filing
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The company said the assay, called TIBA, will work alongside existing tests to help confirm product consistency as manufacturing evolves.
SEC filing
The company said gross profit reached $103.6 million as reported, or $109.7 million excluding amortization, while completing patient treatment in its Phase 3 back pain trial.
SEC filing
The company enrolled and treated 350 patients in the pivotal MSB-DR004 study, setting up a mid-2027 readout.
SEC filing
The cell therapy maker also hit its 300-patient enrollment target in a Phase 3 back pain trial and drew down $50M more from a credit facility.
SEC filing
Silviu Itescu paid A$2,733,734 to exercise options, according to a company filing dated July 21, 2026.
SEC filing
The company said commercial manufacturing is underway in parallel while it awaits results expected in mid-2027.
SEC filing