Mesoblast Stock Price, News & Analysis

Mesoblast (Nasdaq:MESO) reported real-world pediatric outcomes for Ryoncil (remestemcel-L-rknd) since commercial launch in March 2025. Of the first 25 children treated post-launch, 21 (84%) completed the FDA-label 28-day regimen and were alive; four patients who did not complete treatment died within 28 days. Mesoblast has onboarded 45 transplant centers toward a 64-center target covering 94% of U.S. transplants, and reports payer coverage for over 260 million U.S. lives. A CMS HCPCS J-Code issued Oct 1, 2025 increased CMS usage in the last quarter. A pivotal adult trial with BMT-CTN is expected to begin site enrollment this quarter to seek FDA label expansion.

Mesoblast (NASDAQ:MESO) reported FDA feedback after a Type B meeting on a potential BLA for rexlemestrocel-L in chronic discogenic low back pain (CLBP). FDA acknowledged that pain-intensity results from the MSB-DR003 Phase 3 trial favor rexlemestrocel-L versus placebo and confirmed a clinically meaningful 12-month pain reduction can support product efficacy. FDA also said robust opioid-reduction results from at least one adequate and well-controlled trial could be included in product labeling. A second Phase 3 study, MSB-DR004, is >50% enrolled across 40 U.S. sites and aims for a 300-patient enrollment target within about three months. Rexlemestrocel-L holds RMAT designation for CLBP.

Mesoblast (Nasdaq:MESO) reported Ryoncil sales of US$35.1 million for the quarter ended December 31, 2025, a 60% increase versus the prior quarter. The company said Ryoncil is the first FDA-approved MSC product and will be evaluated in a pivotal adult second-line SR-aGvHD trial, targeting a market roughly three times larger than the pediatric market. Mesoblast also entered a US$125 million five-year interest-only facility with its largest shareholder that lowered its cost of capital, allowed repayment in full of its prior senior secured loan, and enabled partial repayment of a subordinated royalty facility, which the company expects to be fully repaid by mid-CY2026. The facility reportedly has no exit fees, no encumbrance of material assets or IP, and permits additional unsecured debt and licensing.

Mesoblast (Nasdaq: MESO) announced board leadership changes effective Jan 1, 2026 as the company shifts from development to revenue-generating commercialization.

Key points: Jane Bell will retire as Chair and remain on the board as a non-executive director; Philip Facchina is unanimously appointed non-executive Chair; Lyn Cobley is appointed Chair of the Audit and Risk Committee; William Burns remains Vice-Chair and Chair of Nomination and Remuneration. The board said the changes follow a periodic composition review and the company plans to strengthen U.S. commercial expertise over the next twelve months.

Mesoblast (Nasdaq:MESO) drew down US$75 million from a new five-year credit facility provided by director and shareholder Dr Gregory George and repaid its senior secured loan to Oaktree and part of a NovaQuest subordinated royalty facility on Dec 29, 2025.

Mesoblast may draw an additional US$50 million until June 30, 2026. The facility carries a fixed 8.00% annual rate, a five-year interest-only period, is initially unsecured until NovaQuest debt is repaid (no later than July 8, 2026), and thereafter will be secured solely by the Temcell royalty. Facility terms include no prepayment or exit fees, no encumbrance of material assets or IP, and 5-year warrants for ~323,000 ADS at US$21.51 per ADS subject to shareholder approval.

Mesoblast (Nasdaq:MESO) announced an independent peer‑reviewed meta‑analysis presented at the 67th ASH Annual Meeting showing remestemcel‑L had superior complete and overall remission versus ruxolitinib for steroid‑refractory acute graft versus host disease (SR‑aGvHD).

The meta‑analysis included 2,732 patients across 11 studies (644 received remestemcel‑L; 1,349 received ruxolitinib). Authors reported differences in hematology, cardiac, and hepatic adverse events and concluded both therapies improved quality of life but safety profiles differ. Ryoncil is noted as the first FDA‑approved mesenchymal stromal cell product and the only product approved for children under 12 with SR‑aGvHD.

Mesoblast (Nasdaq: MESO) will participate at the Piper Sandler 37th Annual Healthcare Conference in New York on December 2–4, 2025. Silviu Itescu, Chief Executive, is scheduled for a fireside chat at 12:00 p.m. ET on Thursday, December 4, 2025. A live webcast will be available at the provided event link, and a replay will be posted for up to 30 days on Mesoblast’s investor events page.

Mesoblast (Nasdaq: MESO) issued a trading update at its Annual General Meeting, reporting expected Ryoncil gross revenue of more than US$30.0 million for the quarter ending Dec 31, 2025. The company said this represents a >37% increase versus US$21.9 million in Ryoncil gross revenue for the prior quarter ended Sep 30, 2025. The AGM address included a comprehensive operational overview alongside the trading update.

Mesoblast (Nasdaq: MESO) and the NIH-funded BMT CTN will launch a pivotal Phase 3 trial of Ryoncil (remestemcel-L-rknd) as part of a first-line regimen for adults with severe acute graft versus host disease refractory to corticosteroids (SR-aGvHD).

The randomized trial will compare ruxolitinib alone versus ruxolitinib plus Ryoncil, with the protocol to be submitted to FDA and enrollment targeted to begin in Q1 2026. Background data cited include 44–58% non-response to ruxolitinib at Day 28 in supportive studies and 20–30% 100-day survival after ruxolitinib failure; Mesoblast reported 76% Day-100 survival in its Expanded Access program for patients ≥12 who failed ruxolitinib or other second-line agents.