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LGVN 資訊
LGVN 事件
Longeveron Updates ELPIS II Trial Results
Longeveron announced updated results from ELPIS II following planned additional analysis conducted by the company and the National Institutes of Health, or NIH, funded trial investigators. ELPIS II is the company's Phase 2b clinical trial evaluating its investigational stem cell therapy laromestrocel as an adjunct to Stage 2 palliative surgery in 40 infants with hypoplastic left heart syndrome, or HLHS. The ELPIS II trial did not meet the primary efficacy endpoint of change from baseline in right ventricular ejection fraction, or RVEF, at Month 12. Based on the secondary endpoints, laromestrocel was associated with fewer adjudicated clinical and safety events than the standard of care, or SOC, arm. Additional review of the pre-specified secondary endpoint major adverse cardiac events, or MACE, showed statistical significance with 8 events in the SOC arm versus 1 in the laromestrocel treatment arm. Laromestrocel demonstrated a favorable safety and tolerability profile through 12 months, with no treatment-related serious adverse events identified. The company believes the favorable pre-specified secondary endpoint findings suggest that laromestrocel has the potential to meaningfully improve clinical outcomes of children with HLHS undergoing Stage II surgical palliation. The company intends to request a meeting with the FDA to review the results to determine potential next steps for the HLHS development program. Among the 40 randomized infants in the intention-to-treat population, baseline and Month 12 cardiovascular magnetic resonance were available for 28 infants. Mean RVEF decreased by 2.6 percentage points in the SoC group and 3.3 percentage points in the Laromestrocel group, with no statistically significant difference between 2 groups.
Longeveron Shares Drop 55% After Trial Failure
Shares of Longeveron are down 55% after the resumption of trade after the company announced that laromestrocel did not meet primary endpoint in Phase 2b HLHS trial.
Longeveron Initiates Cost Optimization Process
Longeveron has initiated a process of optimizing cost containment and will explore all options with the goal of maximizing shareholder value. The company intends to engage an investment bank to act as a strategic advisor for this process. In conjunction with that process, the company will look to implement cash conservation measures to optimize cost containment.
Longeveron ELPIS II Clinical Trial Results Miss Target
Longeveron announced topline results from ELPIS II, its Phase 2b clinical trial evaluating its investigational stem cell therapy laromestrocel as an adjunct to Stage 2 palliative surgery in 40 infants with hypoplastic left heart syndrome, or HLHS. The ELPIS II trial did not meet the primary efficacy endpoint of change from baseline in right ventricular ejection fraction - RVEF - at Month 12. In the intent-to-treat population, the least-squares mean difference between treatment groups was -0.7 percentage points. Over a 12-month period, there were no deaths in patients that received laromestrocel, compared to one patient in the control group. Hospitalization burden was similar between arms. Adjudicated Major Adverse Cardiovascular Events, or MACE, were approximately 31% fewer in the laromestrocel arm. However, the negative binomial analysis was not statistically significant. A sponsor-defined exploratory hierarchical composite endpoint consisting of all-cause mortality and duration of inpatient hospitalization was not statistically significant in the ITT population. Laromestrocel demonstrated a safety profile generally consistent with prior clinical trials. The company is conducting additional analyses and intends to discuss results with the FDA to determine potential next steps for the HLHS development program. Laromestrocel has shown positive initial results in Aging-related Frailty, including publication of clinical trial results in Cell Stem Cell and selection as a Finalist awardee in the XPRIZE Healthspan global competition.
Longeveron Shares Halted as Trial Fails to Meet Endpoint
Longeveron is scheduled to resume quoting at 5:50 pm ET and to resume trading at 5:55 pm ET, according to Nasdaq. Shares were halted, pending news, ahead of the company announcing that laromestrocel did not meet primary endpoint in Phase 2b HLHS trial.
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