The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Longeveron Inc (NASDAQ: LGVN) Lomecel-B for the treatment of Hypoplastic Left Heart Syndrome (HLHS).

HLHS is a rare and life-threatening congenital heart defect affecting approximately 1,000 infants per year.

Lomecel-B is an investigational allogeneic, bone marrow-derived medicinal signaling cell (MSC) product that is currently in a Phase 2a trial for HLHS.

The fast-track designation will help Longeveron facilitate development and expedite the review of drugs that treat serious conditions and fill an unmet medical need, so a product can potentially be approved and reach patients more quickly.

It will enable the company to have more frequent interactions with the FDA throughout the drug development process and allows for eligibility for priority review and accelerated approval subject to certain conditions.

Also Read: EXCLUSIVE: Longeveron’s Heart Disease Cell Therapy Poised To Secure European Patent

“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,” said Chris Min, M.D., Ph.D., Longeveron’s Interim Chief Executive Officer, and Chief Medical Officer.

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. The condition requires three reconstructive heart surgeries within the first five years of life, and many require a heart transplant.

Longeveron is evaluating Lomecel-B in ELPIS II, an ongoing 38-patient, randomized (1:1), blinded, controlled Phase 2a clinical trial intended to evaluate the safety and efficacy of intramyocardial (directly into the heart) injection of the Lomecel-B therapy in infants with HLHS who are undergoing Stage II reconstructive cardiac surgery.

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

Price Action: LGVN shares closed 2.26% lower at $5.19 on Tuesday.

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