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Mesoblast Limited

MESO
OvervaluedBiotech · Commercial
FDA catalysts, PDUFA dates & pipeline intelligence
$14.28
▲ +0.52 · +3.78%

Financials

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52W LOW $13.0552W HIGH $21.50
Volume
113.01 K
Value Traded
4.93 M
Short % Float
2.58%
+1.78%Week
-11.21%1 Month
-7.19%3 Month
-4.47%6 Month
+2.01%5 Year
+220%All Time

Cash Data

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  • SEC Filing

Key Stats

Market Cap
1.85 B
EPS (TTM)
-0.74
P/E Ratio
-
Ent. Value
1.96 B
Total Shares
129.87 M
Float Shares
128.29 M
Insiders
-
Institutions
3.02%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
Phase 3 topline data readout
rexlemestrocel-L
Chronic low back pain (CLBP)
RMAT
Phase 3Cell TherapiesMusculoskeletal System
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

MESO Catalyst Timeline

Dated clinical, regulatory and corporate events for Mesoblast Limited

Catalyst Timeline

Dated clinical, regulatory & corporate events for Mesoblast Limited

1098Total events
15Upcoming
351Tier-1 (high impact)
2014 to 2044Coverage

Upcoming catalysts 2

T2Quarterly Update
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Rexlemestrocel-LFiled
T1BLA Submission
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Rexlemestrocel-LFiled

Event history 50

▲Manufacturing MilestoneRyoncilApprovedCMC / Inspection
FDA approves new potency assay TIBA for release and stability monitoring of commercial Ryoncil lots
steroid-refractory acute graft versus host disease (SR-aGvHD)source ↗
▲Trial CompletionRexlemestrocel-LFiledTrial
Completed 350 patients treated in pivotal Phase 3 trial of rexlemestrocel-L for CLBP
chronic low back pain (CLBP) associated with inflammatory degenerative disc diseasesource ↗
▲Trial InitiationRyoncilApprovedTrial
Registration trial for RYONCIL label extension into adults with SR-aGvHD commenced and enrolling
adults with SR-aGvHD as part of second-line regimen with ruxolitinibsource ↗
▲IND ClearanceRyoncilApprovedIND
FDA IND clearance to proceed directly to registrational trial for RYONCIL in DMD
ambulatory children aged 5-9 years with Duchenne muscular dystrophy (DMD)source ↗
●BLA SubmissionRexlemestrocel-LFiledRegulatory Filing
Received BLA filing number from FDA for rexlemestrocel-L in LVAD-associated GI bleeding
prevention of life-threatening gastrointestinal bleeding due to right ventricular dysfunction in end-stage heart failure patients with a left ventricular assist device (LVAD)source ↗
▲Quarterly UpdateCorporate
Reported FY2026 financial results with total revenue of US$120.3 million
▲Partnership / LicenseCorporate
Exclusively licensed oncolytic virus technology platform from Baylor College of Medicine
▲Enrollment CompleteRexlemestrocel-LFiledTrial
Completed patient treatment in pivotal Phase 3 trial with 350 patients
chronic low back pain associated with degenerative disc diseasesource ↗
●Enrollment UpdateRyoncilApprovedTrial
Adult SR-aGvHD registration trial currently enrolling patients
steroid-refractory acute graft versus host disease in adultssource ↗
▲Enrollment CompleteRexlemestrocel-LFiledTrial
Target of 300 treated patients achieved in pivotal Phase 3 trial
chronic low back pain associated with degenerative disc diseasesource ↗
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Past FDA Catalysts and PDUFA Decisions

How MESO actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2025-12-31Revascor® (rexlemestrocel-L) BLA Submission pendingBLA
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

C41 / 100
Pipeline Score
$458M
Pipeline Value
$277M
Commercial Value
Overvalued
Valuation Signal
6
Drugs Scored
0.3x
rNPV / MCap
Top 37%
Micro Cap
(rank 244 of 658)
Percentile Rank
Mesoblast Limited carries a moderate pipeline score (41/100), with $1.2B risk-adjusted pipeline value, led by Prochymal adult human mesenchymal stem cells in Crohn's Disease (Phase 3).
Commercial products (revenue basis: latest annual revenue in its 20-F, to Jun 2026; product lines from the latest annual filing) Revenue $120.3M x 2.3 = $277M
ProductRevenuePrior periodChange
Ryoncil$115M$11M+922.4%
Showing 1 of 6 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
Prochymal adult human mesenchymal stem cells Cell therapyCompletedNCT00294112Crohn's DiseasePhase 3 COMPLETED 108Jul 21, 2006
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Clinical Trial Results

Readouts, endpoints and source filings for every MESO program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
Ryoncil
BreakthroughPriorityOrphan
steroid-refractory acute graft-versus-host disease (SR-aGvHD)Phase 32026-02-1215% died before being able to complete a full treatment course of Ryoncil compared with only 2% of patients who received Ryoncil as second-line in the Phase 3 trial MSB-GVHD001; adult patients in the EIND program of Ryoncil had at least as favorable day 100 survival as children in the EIND programRead Moreryoncileindatt HIGH SURVIVAL RATES WITH RYONCIL IN EIND PROGRAM EMPHASIZE IMPORTANCE OF EARLIER USE IN BOTH CHILDREN AND ADULTS WITH SR-aGvHD New York, USA: February 11 and Melbourne, AustraliaRead More
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Inside Trades

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InsiderSideSharesPriceValueDate
George GregoryDirector, 10% OwnerBuy 2,324,072 8,324,072 held$1.48 04/10/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
AFFINITY ASSET ADVISORS, LLC 2.2 % (2,100 %) 16.60 M 838.60 K 109.65% ( 438.60 K)
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MESO Institutional Ownership Trends

Options Data

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Option Volume
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Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2026-10-16
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Real-Time Option Chain

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Competitive positioning

How MESO ranks across every disease it competes in

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MESO News

MESO
Sep 24, 2026
MESOFDA Updates

Mesoblast Receives FDA Approval for New Potency Assay to Release Commercial Ryoncil Product

Mesoblast Limited has received FDA approval for a new potency assay, the T-cell Proliferation Inhibition BioAssay (TIBA), to monitor its Ryoncil product. This assay will help ensure the product's potency and consistency during manufacturing. Ryoncil is the first FDA-approved mesenchymal stromal cell therapy for pediatric patients with steroid-refractory acute graft versus host disease.

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MESO
Aug 27, 2026
MESOGeneral
▲ +8%on this news

Mesoblast Reports Substantial Revenue Growth to US$120M

Mesoblast Limited reported significant financial growth for FY2026, with total revenue reaching US$120.3 million, driven by the successful launch of RYONCIL. The company also completed patient treatment in a Phase 3 trial for rexlemestrocel-L, indicating potential for a large market opportunity. Despite a reduced net loss, increased R&D expenses remain a concern.

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MESO
Aug 24, 2026
MESOConferences/Events

Mesoblast Financial Results and Corporate Update Webcast

Mesoblast Limited will host a webcast on August 26, 2026, to discuss its operational highlights and financial results for the fiscal year ending June 30, 2026. The company is recognized for its innovative allogeneic cellular medicines targeting severe inflammatory diseases. Ryoncil, its leading therapy, is FDA-approved for treating steroid-refractory acute graft versus host disease in pediatric patients. Mesoblast continues to expand its therapeutic applications and maintain a robust intellectual property portfolio.

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MESO
Aug 17, 2026
MESOPhases
▲ +9.1%on this news

Mesoblast Achieves Major Milestone Completing Patient Treatment in Pivotal Phase 3 Trial for Chronic Low Back Pain

Mesoblast Limited has completed patient treatment in its pivotal Phase 3 trial for rexlemestrocel-L, aimed at chronic low back pain linked to degenerative disc disease. The trial involved 350 patients and focuses on confirming pain reduction after 12 months. The treatment has significant revenue potential and has received RMAT designation from the FDA, paving the way for priority review.

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MESO
Jul 30, 2026
MESOGeneral

Mesoblast Reports Ryoncil® Net Revenues of US$36M for the Quarter and US$115M for First Full Year of Product Launch

Mesoblast Limited reported strong financial results for Ryoncil, generating US$115 million in net revenue during its first year post-FDA approval. The company is expanding Ryoncil's indications to include adults with steroid-refractory acute graft versus host disease (SR-aGvHD). Additionally, Mesoblast achieved its target in a pivotal Phase 3 trial for rexlemestrocel-L for chronic low back pain.

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MESO
Jul 14, 2026
MESOPhases

Mesoblast Achieves Target of 300 Treated Patients in Pivotal Phase 3 Trial for Chronic Low Back Pain

Mesoblast Limited has successfully treated over 300 patients in its pivotal Phase 3 trial for rexlemestrocel-L, targeting chronic low back pain linked to degenerative disc disease. The trial aims to confirm previous findings of pain reduction from a single injection. The FDA has granted RMAT designation, allowing for priority review following the trial's results, expected in mid-2027.

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MESO
Jul 10, 2026
MESOGeneral

Ryoncil® Delivers Net Revenue of US$36M for the Fourth Quarter Ended 30 June 2026

Mesoblast Limited reported a net revenue of US$36 million for Ryoncil in Q4 2026, totaling US$115 million for the fiscal year. The company anticipates ongoing revenue growth driven by strong demand in U.S. pediatric centers. Ryoncil is the first FDA-approved MSC therapy for children with steroid-refractory acute graft-versus-host disease.

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MESO
Jul 1, 2026
MESOFDA Updates

Mesoblast Receives BLA Filing Number and Requests Modular Review for Rexlemestrocel-L in Patients with End-Stage Heart Failure and LVADs

Mesoblast Limited has received a Biologics License Application (BLA) filing number from the FDA and has requested a modular review for its product rexlemestrocel-L. This therapy aims to prevent life-threatening gastrointestinal bleeding in end-stage heart failure patients with LVADs. The product has received Orphan Drug and RMAT designations, allowing for priority review. The FDA's recent guidance indicates a flexible approach to products for rare diseases.

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MESO
Jun 25, 2026
MESOGeneral
▼ -6.8%on this news

Mesoblast Draws US$50 Million from Five-Year Non-Dilutive Facility

Mesoblast Limited has drawn US$50 million from a five-year non-dilutive facility provided by Dr. Gregory George. This funding will help the company retire short-term high-cost debt and strengthen its balance sheet. With US$122 million cash on hand, Mesoblast is positioned to invest in its commercial operations and growth pipeline.

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MESO
Jun 10, 2026
MESOConferences/Events

This presentation includes forward-looking statements and forecasts that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our

Mesoblast recently presented a compelling overview of its forward-looking strategies and expectations regarding future financial performance. The presentation highlighted their foundational successes, including the successful commercialization of Ryoncil, their first FDA-approved product, which has generated significant revenue. Mesoblast is focused on expanding its pipeline with advanced cellular therapies for various severe conditions, leveraging their proprietary technology in stem cell medicine. However, the company acknowledges inherent risks and uncertainties in clinical trials, regulatory approvals, and market dynamics.

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MESO
Apr 30, 2026
MESOPhases

Mesoblast Reports Ryoncil Net Revenues of US$30.3m and Improved Net Operating Cash Spend for the Quarter to US$4.1 Million

Mesoblast Limited reported strong financial performance with net revenues of US$30.3 million for the quarter and total Ryoncil sales nearing US$100 million since its launch. The company achieved its patient recruitment target for a pivotal phase 3 trial on chronic low back pain, signaling progress in clinical development. Additionally, Mesoblast has improved its net operating cash spend and secured an exclusive license for a new CAR technology to enhance therapeutic offerings. These advancements mark significant milestones for the company in the biopharma sector.

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MESO
Apr 30, 2026
MESOPhases

Other Fees to Non-Executive Directors were US$156,048, consulting payments to Non-Executive Directors were US$150,000, and salary payments to full-time Executive Directors were US$399,070, detailed in Item 6 of the Appen

Mesoblast Limited has reported significant financial progress for the third fiscal quarter ended March 31, 2026, with Ryoncil revenues nearing US$100 million since its launch. The company also achieved its patient recruitment target for a pivotal Phase 3 trial aimed at treating chronic low back pain. Furthermore, Mesoblast has made advancements in its cellular therapy technologies, acquiring a patented CAR technology platform to enhance its product efficacy. The reduction in net operating cash expenditure indicates improved financial management.

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MESO
Apr 29, 2026
MESOPhases

About Chronic Low Back Pain Back pain is the leading cause of disability in Americans under 45 years,1 with an annual prevalence in the general US adult population of 10-30%.2 CLBP caused by inflammation and degenerative

Mesoblast Limited has successfully reached its patient recruitment target for the pivotal Phase 3 trial of rexlemestrocel-L in treating chronic low back pain (CLBP) related to degenerative disc disease. This achievement is a critical step toward commercializing the therapy, which aims to offer a non-opioid alternative for patients suffering from CLBP—a condition affecting over 7 million individuals in the U.S. With positive results expected to support regulatory filing in 2027, Mesoblast is on track to address a significant unmet medical need in this patient population.

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MESO
Apr 29, 2026
MESOPhases

Mesoblast Achieves Patient Recruitment Target in Pivotal Phase 3 Trial for Chronic Low Back Pain

Mesoblast Limited has successfully met its patient recruitment target for a pivotal Phase 3 trial of rexlemestrocel-L, aimed at treating chronic low back pain due to degenerative disc disease. The trial will involve over 300 patients and seeks to confirm earlier positive results regarding pain reduction and opioid usage. Top-line results are anticipated in mid-2027, with a regulatory filing expected in Q3 2027.

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MESO
Apr 17, 2026
MESOGeneral

Appendix 3Y Change of Director's Interest Notice + See chapter 19 for defined terms. 01/01/2011 Appendix 3Y Page 2 3437-3947-1947, v. 1 Class See above Number acquired 70,000 ADS, each representing 10 ordinary shares; an

Gregory George, a director of Mesoblast Limited, has reported a change in his interest regarding securities of the company. He acquired a total of 70,000 American Depositary Shares (ADSs) and over 7 million ordinary shares, with a total consideration of approximately $11.4 million. This acquisition suggests a strong belief in the company's potential and may have an impact on market perception. No securities were disposed of during this reporting period.

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MESO
Apr 15, 2026
MESOGeneral
▲ +7.8%on this newsshared move

Mesoblast Acquires Chimeric Antigen Receptor (CAR) Platform Technology for Precision-Enhanced Cell Products

Mesoblast Limited has acquired an exclusive worldwide license for a patented chimeric antigen receptor (CAR) technology platform. This acquisition aims to enhance the effectiveness of Mesoblast's mesenchymal lineage stromal cell (MSC) products, particularly for inflammatory diseases. The technology, developed by Mayo Clinic, is expected to improve targeting and potency of treatments for conditions like ulcerative colitis and Lupus Nephritis.

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MESO
Apr 15, 2026
MESOGeneral
▲ +7.8%on this newsshared move

About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of

Mesoblast Limited has acquired an exclusive worldwide license for a patented chimeric antigen receptor (CAR) technology platform aimed at enhancing the potency of its mesenchymal lineage stromal cell (MSC) products. This technology is set to improve targeted homing to inflamed tissues, with applications for inflammatory diseases such as ulcerative colitis and Lupus Nephritis. Mesoblast's strong intellectual property portfolio, comprising over 1,000 patents, will provide commercial protection for its innovative therapies well into the future. The Mayo Clinic, which developed the foundational CAR technology, will support Mesoblast in advancing this promising platform.

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MESO
Apr 10, 2026
MESOFDA Updates

Mesoblast Receives IND Clearance From FDA to Directly Proceed to Registrational Trial for Approval of Ryoncil in Duchenne Muscular Dystrophy - CORRECTION

Mesoblast Limited has received Investigational New Drug (IND) clearance from the FDA to start a registrational clinical trial for Ryoncil in treating Duchenne muscular dystrophy (DMD). This trial involves randomizing 76 patients aged 5 to 9 years who will receive either Ryoncil or a placebo in addition to standard care, with the primary endpoint being time-to-stand at nine months. The initiative aims to leverage Ryoncil's anti-inflammatory properties to preserve muscle function and slow disease progression in affected children.

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MESO
Apr 8, 2026
MESOFDA Updates

Mesoblast Receives IND Clearance from FDA to Directly Proceed to Registrational Trial for Approval of Ryoncil® in Duchenne Muscular Dystrophy

Mesoblast Limited has received FDA clearance to proceed with a registrational trial for Ryoncil® in treating Duchenne muscular dystrophy (DMD). This trial will evaluate the efficacy of Ryoncil® in children aged 5 to 9 years, aiming to leverage its anti-inflammatory properties to slow disease progression. The company is partnering with Parent Project Muscular Dystrophy to facilitate patient engagement and trial awareness.

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About Mesoblast Limited

108 employees mesoblast.com
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