Longeveron Inc. (LGVN) on Friday announced it held a constructive Type C meeting with the U.S. FDA regarding its ongoing Phase 2b ELPIS II trial of laromestrocel (Lomecel-B) in hypoplastic left heart syndrome (HLHS).
The FDA acknowledged HLHS is a rare disease with high unmet need but advised that the trial's primary endpoint, right ventricular ejection fraction (RVEF), is not sufficient to demonstrate efficacy.
The company noted that while it agreed with the FDA's concerns, changes to the primary endpoint cannot be made mid-trial due to NIH-mandated interim analysis. As a result, the FDA no longer considers ELPIS II pivotal, but confirmed willingness to revisit the program once results are available.
Longeveron intends to submit a Sponsor Statistical Analysis Plan (SAP) with a composite primary endpoint and secondary endpoints for the FDA's review and approval. Longeveron remains optimistic that the ELPIS II results together with other available evidence will be sufficient to support a Biologics License Application (BLA) following the readout.
Topline results from the 40-patient, multicentre study are anticipated in August 2026. The trial is capturing objective measures such as mortality, transplant-free survival, and major adverse cardiac events to support efficacy assessment.
Laromestrocel has received Orphan Drug, Fast Track, and Rare Pediatric Disease designations for HLHS, making Longeveron eligible for a Priority Review Voucher if approved.
HLHS is a congenital defect where the left ventricle is severely underdeveloped or absent, requiring complex staged surgeries. Despite surgical advances, early mortality remains high, underscoring the need for new therapies.
The company has scheduled its Q1 2026 earnings call on May 13, 2026.
LGVN has traded between $0.47 and $1.80 over the past year. The stock closed Friday's trading (May 8, 2026) at $0.84, down 0.77%. During overnight trading, the stock is at $0.77, down 7.99%.
For comments and feedback contact: editorial@rttnews.com
Business News
May 08, 2026 15:50 ET Manufacturing and services sector survey results and labor market data from main economies were the highlight on the economics news front this week. Factory orders and jobs report dominated the news flow in the U.S. Similarly, industrial production data from German garnered attention in Europe. In Asia, purchasing managers’ survey results from China and the central bank decision from Australia were in focus.