Longeveron Shares Ascend As FDA Grants Fast Track Status To Congenital Heart Disease Candidate

Longeveron LGVN received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for its lead drug Lomecel-B for the treatment of Hypoplastic Left Heart Syndrome (HLHS).

Lomecel-B is being evaluated in ELPIS II, Phase 2a clinical trial intended to evaluate the safety and efficacy of intramyocardial (directly into the heart) injection in infants with HLHS who are undergoing Stage II reconstructive cardiac surgery.

In ELPIS, a Phase 1trial in ten HLHS patients, Lomecel-B was  well tolerated with no major adverse cardiac events one-year post-surgery, and/or treatment-related infections.

Chris Min, Interim Chief Executive Officer and Chief Medical Officer, stated, "Fast Track Designation represents a significant milestone in our efforts to develop Lomecel-B as a treatment for infants with HLHS. Fast Track Designation underscores the urgent need in HLHS, and we look forward to continuing to work closely with the FDA to bring this potential new therapy to infants as expeditiously as possible."

HLHS is a rare congenital heart defect that affects approximately 1,000 babies per year in the U.S. Infants born with HLHS have an underdeveloped or absent left ventricle, which impairs the heart's ability to pump adequate amounts of blood throughout the body.

FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.

Price Action : Longeveron shares are trading around 7 percent higher at $5.57 on Wednesday during pre-market session.