Mesoblast Limited Sponsored ADR (MESO)
Mesoblast shares surge on strong Ryoncil launch, tapering off after Friday rally
Shares in Mesoblast Ltd (NASDAQ:MESO, ASX:MSB) surged by nearly 38% following Friday’s successful commercial launch of its FDA-approved treatment, Ryoncil®, for steroid-refractory acute graft-versus-host disease (SR-aGvHD) in children. The Melbourne-based biotechnology company reported a strong start to the first quarter post-launch, with gross revenue of US$13.2 million for the period ending June 30, 2025. The stock gained almost 35% over the week to reach $2.41, buoyed by the positive update. However, the momentum appears to be tapering off this week, with shares falling by 3.7% today to A$2.32. The release of Ryoncil® marked a significant milestone for Mesoblast, as it is the first and only FDA-approved mesenchymal stromal cell (MSC) product for the treatment of SR-aGvHD in pediatric patients. Mesoblast’s solid financial standing remains a key asset, with US$162 million (A$247 million) in cash on hand at the end of the quarter, positioning the company for continued expansion. In addition to the strong initial sales of Ryoncil®, the company also received US$1.6 million in royalties from the sale of TEMCELL® HS Inj. in Japan, through its licensing agreement. The company also received seven years of orphan-drug exclusivity from the US Food and Drug Administration (FDA) for Ryoncil® for SR-aGvHD in pediatric patients, protecting it from competition in the US market during that period. In addition, Mesoblast holds biologic exclusivity preventing competitors from referencing Ryoncil®'s biologic license application (BLA) until December 2036, effectively barring biosimilars from entering the market for more than a decade. “We are pleased with the commercial launch activities of Ryoncil® in the first quarter post-launch and look forward to updating on the current quarter’s progress now that mandatory state CMS coverage has become effective as of July 1, and we complete onboarding of the remaining major US transplant centres,” said Mesoblast CEO Dr Silviu Itescu. The company has onboarded more than 25 transplant centres, with plans to complete onboarding at 45 priority centres this quarter. The company also highlighted the expanding coverage for the product, now insured for more than 250 million US lives through both commercial and government payers, including federal Medicaid, which became effective from July 1. Looking ahead, Mesoblast remains focused on expanding the use of Ryoncil® in adults with SR-aGvHD. In July, the company met with the FDA to discuss a pivotal trial for Ryoncil® in this adult population, in collaboration with the National Institutes of Health-funded Bone Marrow Transplant Clinical Trials Network. Meanwhile, the company is continuing its work with rexlemestrocel-L, its second-generation allogeneic MSC therapy, for the treatment of chronic inflammatory diseases like ischemic heart failure and chronic low back pain. Recent meetings with the FDA on the latter have aligned the company and regulators on the pathway to filing for biologics license approval (BLA), which could pave the way for accelerated approval under the existing Regenerative Medicine Advanced Therapy (RMAT) designation. Despite a promising week for Mesoblast, investor sentiment appears to have moderated as the stock price has slightly retreated from its Friday highs. As of 4:30 pm AEST on Friday, Mesoblast shares were trading at A$2.32, down 3.73%. However, the company’s long-term prospects, buoyed by Ryoncil®'s commercial launch and a robust cash position, provide strong fundamentals as the stock enters the next phase of growth. The market will likely continue to monitor the progress of the company’s US product rollout and upcoming clinical trials for both Ryoncil® and rexlemestrocel-L, with potential catalysts on the horizon. Helix Exploration PLC (AIM:HEX, OTCQB:HHEXF) CEO Bo Sears talked with Proactive about the latest developments at the Rudyard Field, where the Inez #1 well has confirmed helium-bearing zones across a broader area. Sears explained that the logs from Inez #1 look identical to the earlier Linda #1 well, underlining the field’s large aerial extent. "The PSA is effectively finished. There's just some minor piping to be done," Sears said. He noted that once the concrete pad is completed, membrane units will be installed and the equipment will be moved onsite. These steps are expected to lead to first helium production on schedule. Sears also highlighted how Helix aims to become Montana’s first helium producer, supported by a strong local team and backing from the state. He emphasised that wireline logging is already complete and well completion operations are underway. The next phase involves perforating the target zones to commence flow testing, which will help further de-risk the Rudyard project and define its production profile. Proactive: Bo, very good to speak with you. With Inez #1 confirming helium-bearing zones across a wider area, how does this impact your estimates for the Rudyard Field’s total reserves and long-term production potential? Bo Sears: Yeah. With this new well, with the Inez #1, it just further highlights the aerial extent of this field. It’s quite large. We just ran logs. The logs look identical to the Linda #1 well. So we are really pleased with the results here. Proactive: Can you share some more about the timeline from completing the PSA plant installation to achieving first helium production, and what milestones investors should be watching out for? Bo Sears: Yeah. So the PSA is effectively finished. There’s just some minor piping to be done. We’re waiting on the delivery of the membrane units. Once the concrete pad is built on the pad site that we’ve already begun construction on, we’ll just start moving that equipment up there. So everything is right on time. We’re really excited. The teams that have been working on this have been outstanding. So we couldn’t be happier. Proactive: Bo, how do you see Helix differentiating itself as the first helium producer in Montana, especially in terms of cost efficiency and speed to market compared to other North American projects? Bo Sears: It’s exciting. Even I almost can’t believe it, Stephen. We have really assembled a great team over here on the US side, specifically in Montana, and everything has just gone so well that we couldn’t be happier. To be the first helium producer in Montana is very exciting. We’re getting a lot of support from the state. So I think the entire state is very excited about the prospects of helium exploration and production in the state. Proactive: And what role will the upcoming wireline logging and flow testing play in de-risking the Rudyard project? When do you expect to have those results? Bo Sears: Logging is complete. We are actually completing the well right now, setting casing and submitting that to surface. Once we are ready, we will go in there with perforating guns and perforate the zones of interest, and we’ll get going. Proactive: Well, Bo, I hope you’ll continue to keep us updated with progress. Thank you very much for speaking with us today.
Bullish On Mesoblast: Shifting To Commercial Stage With Ryoncil Approval And Revascor Trials
MESO's Off-the-shelf MSC/MPC platform treats severe inflammatory diseases without donor–recipient matching. This alleviates the typical need for immunosuppression. The FDA recently approved Ryoncil, which achieved as much as 70% response in pediatric SR-aGVHD patients. And it has adult SR-aGVHD and Crohn's Phase 3 trials underway. MESO's Revascor is also in trials for chronic low back pain and heart failure, and its accelerated BLA could position it as another revenue vertical in the next couple of.
Mesoblast Limited (MESO) Q2 2025 Earnings Call Transcript
Mesoblast Limited (NASDAQ:MESO ) Q2 2025 Earnings Conference Call February 26, 2025 5:00 PM ET Company Participants Silviu Itescu - Chief Executive Officer & Managing Director Andrew Chaponnel - Interim Chief Financial Officer Marcelo Santoro - Chief Commercial Officer Conference Call Participants Edward Tenthoff - Piper Sandler Michael Okunewitch - Maxim Group Silviu Itescu Good morning, everybody. I'm Silviu Itescu.
Mesoblast Limited (MESO) Could Find a Support Soon, Here's Why You Should Buy the Stock Now
Mesoblast Limited (MESO) witnesses a hammer chart pattern, indicating support found by the stock after losing some value lately. This coupled with an upward trend in earnings estimate revisions could mean a trend reversal for the stock in the near term.
MESO Stock Surges 80% in a Month After FDA Approval of GVHD Drug
Mesoblast stock climbs 80% in a month following the FDA's approval of Ryoncil as the only approved therapy for SR-aGVHD in children aged two months and older.
MESO Stock Up as FDA Approves Ryoncil for Graft Versus Host Disease
The FDA approves Mesoblast's Ryoncil (remestemcel-L) for treating pediatric patients with steroid-refractory acute graft versus host disease. Shares rise.
Mesoblast's Cell Therapy Treatment For Graft Versus Host Disease Gets FDA Approval, Stock Surges
On Wednesday, the FDA approved Mesoblast Limited's MESO Ryoncil (remestemcel-L) as the first mesenchymal stromal cell (MSC) therapy in the U.S.
Top-Notch Biotech Mesoblast Skyrockets 29% On Immune Condition Approval
Mesoblast snagged FDA approval late Wednesday for the first-ever treatment for children with a form of GVHD. The biotech stock rocketed.
US FDA approves Mesoblast's cell therapy for graft-versus-host disease
The U.S. Food and Drug Administration on Wednesday approved Mesoblast's cell therapy for treating a type of complication that occurs after a stem cell or bone marrow transplant called graft-versus-host disease.
Mesoblast: Undervalued Due To Remestemcel-L's Substantial Growth Potential
Mesoblast Limited is advancing innovative cellular therapies, with Remestemcel-L for pediatric SR-aGVHD nearing FDA approval and a PDUFA date set for January 2025. Positive Phase 3 results indicate that Remestemcel-L significantly improves response rates and survival in pediatric patients. Additionally, Mesoblast's pipeline includes late-stage therapies for chronic low back pain and heart failure, both of which are showing promising results and are nearing regulatory approval.
Mesoblast Limited (MESO) Q4 2024 Earnings Call Transcript
Mesoblast Limited (NASDAQ:MESO ) Q4 2024 Earnings Conference Call August 28, 2024 6:30 PM ET Company Participants Silviu Itescu - Chief Executive Officer and Managing Director Andrew Chaponnel - Interim Chief Financial Officer Conference Call Participants Edward Tenthoff - Piper Sandler Operator Hello and welcome to the Mesoblast Financial Results for the Full Year ended June 30, 2024. An announcement and presentation have been lodged with the ASX and are available on the home and investor pages at www.
Mesoblast (MESO) Soars 208% YTD on Positive Regulatory Updates
Mesoblast (MESO) skyrockets 208.2% year to date on encouraging progress with its pipeline candidates.
