Longeveron Announces FDA Grants Type C Meeting Ahead of Data Readout for Pivotal Phase 2 Clinical Trial (ELPIS II) Evaluating Treatment for Hypoplastic Left Heart Syndrome (HLHS)
Rhea-AI Summary
Longeveron (NASDAQ: LGVN) announced the U.S. FDA has granted a Type C meeting at the end of March 2026 to align on clinical efficacy endpoints and the statistical analysis plan to support a potential BLA for laromestrocel (LOMECEL-B) in Hypoplastic Left Heart Syndrome (HLHS).
ELPIS II topline results are anticipated in Q3 2026. ELPIS II is a Phase 2b trial that enrolled 40 pediatric patients at 12 centers, conducted in collaboration with NHLBI through NIH grants. Laromestrocel holds Rare Pediatric Disease, Orphan Drug, and Fast Track designations.
Positive
- FDA granted a Type C meeting to align on endpoints and SAP
- ELPIS II topline results expected in Q3 2026
- Laromestrocel has Rare Pediatric Disease, Orphan Drug, and Fast Track designations
- ELPIS II enrolled 40 patients across 12 U.S. centers
- Collaboration with NHLBI/NIH supporting the trial
Negative
- ELPIS II is Phase 2b with only 40 patients, limiting immediate approval certainty
- BLA submission contingent on positive results, creating regulatory outcome risk
- Disease context: only ~50% of infants survive to adolescence despite current care
News Market Reaction
On the day this news was published, LGVN gained 6.17%, reflecting a notable positive market reaction. Argus tracked a peak move of +11.1% during that session. Argus tracked a trough of -11.4% from its starting point during tracking. Our momentum scanner triggered 11 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $770K to the company's valuation, bringing the market cap to $13M at that time. Trading volume was very high at 4.2x the daily average, suggesting strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
LGVN was up 6.6% while close peers showed mixed moves (e.g., EDSA +0.69%, PULM +1.85%, NBY -10.63%). The action appears stock-specific rather than a sector-wide biotech move.
Previous Clinical trial,fda approval Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jul 08 | IND approval | Positive | +28.7% | FDA approved IND for Phase 2 pivotal laromestrocel trial in pediatric DCM. |
| Jul 17 | Fast Track win | Positive | +10.8% | FDA granted Fast Track for Lomecel‑B in mild Alzheimer’s after RMAT designation. |
For prior clinical trial/FDA milestones, LGVN saw consistently positive reactions, with same-tag events averaging a 19.74% gain and all recorded moves aligning with the constructive news.
Over the past 18 months, Longeveron has repeatedly advanced its cell therapy platform through regulatory milestones. A July 2025 FDA IND approval enabled a Phase 2 pivotal registration study in pediatric DCM, which saw a 28.68% gain. In July 2024, Fast Track designation for Lomecel‑B in mild Alzheimer’s drove a 10.8% move. Today’s Type C meeting for HLHS and alignment on endpoints fits this pattern of FDA engagement across multiple pediatric and neuro indications.
Historical Comparison
LGVN’s prior FDA/clinical milestones averaged a 19.74% move, with both same-tag events trading higher. Today’s HLHS Type C meeting continues that pattern of value-driving regulatory steps.
Across indications, laromestrocel has moved from Fast Track and RMAT designations to pivotal Phase 2 planning and now an HLHS Type C meeting focused on BLA-supportive endpoints.
Market Pulse Summary
The stock moved +6.2% in the session following this news. A strong positive reaction aligns with Longeveron’s history of outsized moves on FDA milestones, where similar clinical/FDA events averaged 19.74% gains. The Type C meeting signals FDA engagement on HLHS endpoints ahead of the Q3 2026 readout. However, prior filings flagged much lower revenue of $137k, a $7.221M quarterly loss, and going concern language, so funding needs and ATM usage could temper follow‑through.
Key Terms
biologics licensing application (bla) regulatory
rare pediatric disease designation regulatory
orphan drug designation regulatory
fast track designation regulatory
phase 2b medical
investigational new drug (ind) regulatory
regenerative medicine advanced therapy (rmat) regulatory
atm facility financial
AI-generated analysis. Not financial advice.
- ELPIS II top-line trial results are anticipated in the third quarter of 2026
- Laromestrocel Biological License Application (BLA) submission for full traditional approval for HLHS anticipated if ELPIS II results are positive
- U.S. FDA has awarded laromestrocel HLHS program Rare Pediatric Disease designation, Orphan Drug designation, and Fast Track designation
- Laromestrocel HLHS program has the potential to address an unmet medical need with significant U.S. market opportunities
- Even with current standard of care surgeries, only
50% of infants survive to adolescence due to right ventricular failure
MIAMI, Jan. 26, 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 U.S. Food and Drug Administration (FDA) has granted Longeveron a Type C meeting at the end of March to prepare for the anticipated third quarter data readout of ELPIS II, the pivotal Phase 2 clinical trial evaluating the Company’s proprietary stem cell therapy, laromestrocel (LOMECEL-B®), as a potential treatment for Hypoplastic Left Heart Syndrome (HLHS), a rare pediatric and orphan-designated disease. The primary purpose of the meeting is to gain alignment on the clinical efficacy data endpoints and statistical analysis plan (SAP) to support a Biologics Licensing Application (BLA).
The Company expects to provide a regulatory update after the receipt of the official meeting minutes.
ELPIS II is a Phase 2b clinical trial evaluating laromestrocel as a potential adjunct therapy for HLHS. The clinical trial enrolled 40 pediatric patients at twelve premiere infant and children’s treatment institutions across the country. ELPIS II is being conducted in collaboration with the National Heart, Lung, and Blood Institute (NHLBI) through grants from the National Institutes of Health (NIH).
About Hypoplastic Left Heart Syndrome (HLHS)
HLHS is a congenital birth defect in which the left ventricle (one of the pumping chambers of the heart) is either severely underdeveloped or missing. As a consequence, infants born with this condition have severely diminished systemic blood flow, which requires them to undergo a complex, three stage heart reconstruction surgery process over the course of the first 5 years of their lives. Although surgical advances have enabled survival into adulthood for some patients, early mortality remains substantial in this population, due to right ventricular failure. As such, there remains an important unmet medical need to improve right ventricular function in these patients in order to support both short-term and long-term outcomes.
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
FAQ
When will Longeveron (LGVN) report ELPIS II topline results?
When is the FDA Type C meeting for Longeveron (LGVN) scheduled?
What regulatory designations does laromestrocel (LGVN) have for HLHS?
How large is the ELPIS II trial for LGVN's laromestrocel and who supports it?
Does Longeveron plan a BLA submission for laromestrocel (LGVN)?
