Longeveron® Granted Japan Patent for Potency Assay Methods for Assessing Human Mesenchymal Stem Cells (MSCs)
Rhea-AI Summary
Longeveron (NASDAQ: LGVN) announced that the Japan Patent Office granted Japan Patent No. 2022-563984 for potency assay methods to assess human mesenchymal stem cells (MSCs), with protection through April 20, 2041 assuming annuity payments.
The patent expands Longeveron's international IP to 33 issued patents and supports development of laromestrocel (Lomecel-B). A pivotal Phase 2b trial in Hypoplastic Left Heart Syndrome (HLHS) is ongoing, with results expected in Q3 2026, which may enable a U.S. BLA submission depending on outcomes.
Positive
- Japan patent (No. 2022-563984) for MSC potency assays through April 20, 2041
- Global intellectual property expanded to 33 issued patents
- Patent covers potency assays for MSCs from multiple tissue sources, supporting product regulatory readiness
- Ongoing pivotal Phase 2b trial in HLHS with data expected in Q3 2026
Negative
- Regulatory progress is contingent on Phase 2b results; approval pathway is not guaranteed
- Japan patent term depends on timely payment of annuity fees
Key Figures
Market Reality Check
Peers on Argus
LGVN was up 2.52% while momentum scanners showed peers like EDSA and MTVA moving up, but sector_momentum is flagged as company-specific and no same-direction correlation with LGVN is established.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jan 26 | FDA meeting granted | Positive | +6.2% | FDA Type C meeting to align on endpoints and BLA path for HLHS. |
| Dec 29 | Investor outreach news | Positive | -2.9% | Selection for StartUp Health Alzheimer’s Moonshot and JPM Apollo House. |
| Dec 17 | U.S. patent granted | Positive | +7.8% | U.S. patent on MSC methods to treat female sexual dysfunction. |
| Dec 3 | Conference speaking roles | Neutral | -1.2% | Executives speaking on cell therapy topics at CVCT Forum panels. |
| Dec 2 | Canadian patent grant | Positive | +2.2% | Canadian patent for MSC therapy in aging-related frailty and NIDCM. |
Recent IP and regulatory milestones, especially patents and FDA interactions, often coincided with positive price reactions, while conference or networking news saw more muted or negative moves.
Over the last few months, Longeveron has built a pattern of value-driving catalysts around its stem cell platform. A Jan 26, 2026 FDA Type C meeting announcement for the HLHS Phase 2b trial saw shares rise. Earlier, Canadian and U.S. patents in Dec 2025 for aging-related frailty, cardiomyopathy, and female sexual dysfunction also drew positive reactions. By contrast, general visibility events and networking news produced modest or negative moves, highlighting investor focus on IP and clinical/regulatory milestones.
Market Pulse Summary
This announcement expands Longeveron’s intellectual property with a Japan patent for MSC potency assays and highlights progress toward pivotal HLHS data in Q3 2026. Recent history shows investors reacting most to concrete clinical and regulatory milestones, such as FDA meetings and new patents. Against a backdrop of low share price versus the 52-week high, investors may focus on how this patent supports laromestrocel’s path toward potential BLA-enabling data.
Key Terms
mesenchymal stem cells medical
induced pluripotent stem cells medical
phase 2b medical
biologics license application regulatory
AI-generated analysis. Not financial advice.
- The patent relates to potency assay methods for assessing human mesenchymal stem cells (MSCs) derived from bone marrow, adipose tissue, peripheral blood, a lung, a heart, amniotic fluid, inner organs, an amniotic membrane, an umbilical cord or a placenta or differentiated from induced pluripotent stem cells (IPSCs)
- Patent issuance contributes to Longeveron’s growing international patent portfolio protecting its clinical programs and products
- Laromestrocel, Longeveron’s proprietary mesenchymal stem cell therapy, has delivered positive initial results across five clinical trials in three indications, including Hypoplastic Left Heart Syndrome, Alzheimer’s disease and Aging-related Frailty
MIAMI, Jan. 29, 2026 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapy for life-threatening, rare pediatric and chronic aging-related conditions, today announced that the Japan Patent Office (JPO) has granted a patent covering potency assay methods for assessing human mesenchymal stem cells (MSCs) derived from bone marrow, adipose tissue, peripheral blood, a lung, a heart, amniotic fluid, inner organs, an amniotic membrane, an umbilical cord or a placenta or differentiated from induced pluripotent stem cells (IPSCs).
Japan Patent No. 2022-563984, entitled “Potency Assay,” provides Longeveron with patent rights in Japan through April 20, 2041, assuming all annuity fees are paid. Potency assays are a crucial element for approved cell-based therapy products.
“We are extremely encouraged by our growing portfolio of international patents protecting the novelty of our cell-based therapeutic products,” said Dr. Joshua M. Hare, Executive Chairman and Chief Science Officer of Longeveron. “This issuance brings Longeveron’s global intellectual property portfolio to 33 issued patents.”
Longeveron has previously conducted clinical trials with laromestrocel (Lomecel-B™) in Alzheimer’s disease (Phase 1 & 2), Aging-related Frailty (Phase 1 & 2), and Hypoplastic Left Heart Syndrome (HLHS) (Phase 1), a rare pediatric and orphan-designated disease. Longeveron is currently conducting a pivotal Phase 2b clinical trial evaluating laromestrocel in HLHS, with trial results anticipated in the third quarter of 2026. These data may allow Longeveron to proceed to a Biologics License Application (BLA) with the U.S. FDA for this indication, subject to the results of the study.
About laromestrocel (Lomecel-B®)
Laromestrocel is a living cell product made from specialized cells isolated from the bone marrow of young healthy adult donors. These specialized cells, known as mesenchymal stem cells (MSCs), are essential to our endogenous biological repair mechanism. MSCs have been shown to perform a number of complex functions in the body, including the formation of new tissue. They also have been shown to respond to sites of injury or disease and secrete bioactive factors that are immunomodulatory and regenerative. We believe that laromestrocel MSCs may have multiple potential mechanisms of action that may lead to anti-inflammatory, pro-vascular regenerative responses, and therefore may have broad application for a range of rare and aging related diseases.
About Longeveron Inc.
Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is laromestrocel (LOMECEL-B®), an allogeneic mesenchymal stem cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Laromestrocel has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease (AD), and Pediatric Dilated Cardiomyopathy (DCM). Laromestrocel development programs have received five distinct and important FDA designations: for the HLHS program - Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program - Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram.
Forward-Looking Statements
Certain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve known and unknown risks, uncertainties, and other important factors that could cause actual results, performance, or achievements to differ materially from those anticipated, expressed, or implied by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expects,” “intend,” “looks to,” “may,” “on condition,” “plan,” “potential,” “predict,” “preliminary,” “project,” “see,” “should,” “target,” “will,” “would,” or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, our cash position and need to raise additional capital, the difficulties we may face in obtaining access to capital, and the dilutive impact it may have on our investors; our financial performance, and ability to continue as a going concern; the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; the timing and focus of our ongoing and future preclinical studies and clinical trials, and the reporting of data from those studies and trials; the size of the market opportunity for certain of our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting; our ability to scale production and commercialize the product candidate for certain indications; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates in the U.S. and other jurisdictions; our plans relating to the further development of our product candidates, including additional disease states or indications we may pursue; our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others; the need to hire additional personnel and our ability to attract and retain such personnel; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.
Further information relating to factors that may impact the Company’s results and forward-looking statements are disclosed in the Company’s filings with the Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on February 28, 2025, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The Company operates in highly competitive and rapidly changing environment; therefore, new factors may arise, and it is not possible for the Company’s management to predict all such factors that may arise nor assess the impact of such factors or the extent to which any individual factor or combination thereof, may cause results to differ materially from those contained in any forward-looking statements. The forward-looking statements contained in this press release are made as of the date of this press release based on information available as of the date of this press release, are inherently uncertain, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Investor and Media Contact:
Derek Cole
Investor Relations Advisory Solutions
derek.cole@iradvisory.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f106bde7-972a-4687-a91e-03e924f409fc
FAQ
What does the Japan patent mean for Longeveron (LGVN)?
Which MSC sources are covered by Longeveron's Japan Patent No. 2022-563984?
How does the patent affect laromestrocel (Lomecel-B) development for HLHS?
When will Longeveron (LGVN) report results from the HLHS Phase 2b trial?
Does the Japan patent require any conditions to remain in force?
