Longeveron Inc. LGVN
Longeveron Inc. (Nasdaq: LGVN) is a cardio-renal-metabolic drug developer. Its lead program, laromestrocel (Lomecel-B; allogeneic mesenchymal stem cell therapy), is in Phase 2 for Hypoplastic Left Heart Syndrome (ELPIS II). Its next catalyst on record is laromestrocel (pediatric DCM): Start single Phase 2 registrational trial (subject to financing) (2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: laromestrocel (pediatric DCM) — Start single Phase 2 registrational trial (subject to financing) (2027). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| laromestrocel - ELPIS II (Phase 2b) | Hypoplastic Left Heart Syndrome | cell therapy | Phase 2 |
| laromestrocel - planned Phase 2/3 adaptive trial | Mild Alzheimer's disease | cell therapy | Phase 2 |
| laromestrocel | Aging-related frailty | cell therapy | Phase 2 |
| laromestrocel - planned Phase 2 registrational trial | Pediatric dilated cardiomyopathy | cell therapy | Pre-clinical |
Recent results and decisions
- Sep 16, 2026missed ELPIS II missed primary endpoint of RVEF change at Month 12 (LS mean difference -0.7 points, 95% CI -7.3 to 5.9, p=0.8336); exploratory MACE ~31% fewer events (12 vs 19) not significant.
The ELPIS II trial did not meet the primary efficacy endpoint of change from baseline in right ventricular ejection fraction (RVEF) at Month 12.
Filing - May 8, 2026negative FDA Type C meeting: RVEF primary endpoint not appropriate to show efficacy, so FDA no longer calls ELPIS II pivotal; new endpoint cannot be agreed while trial ongoing.
the FDA no longer refers to the ELPIS II trial as pivotal, as had been specifically discussed in the Company’s Type C meeting in 2024.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 cardio-renal-metabolic companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.