Lomecel-B is a allogeneic, bone marrow-derived medicinal signaling cell (MSC) product in development to treat Hypoplastic Left Heart Syndrome (HLHS) in infants. This is a rare, life-threatening heart defect that affects roughly 1,000 infants per year.
Longeveron notes that Lomecel-B is currently in a Phase 2a clinical trial. It seeks to address the poor blood pumping ability of a heart affected by HLHS. The condition is fatal without treatment, which can include three reconstructive heart surgeries in the first five years of life, or a heart transplant.
Chris Min, M.D., Ph.D., interim CEO and CMO of Longeveron, said the following about today’s news.
“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.”
Heavy trading of LGVN stock follows the fast-track news today. This has more than 2 million shares on the move as of this writing. For comparison, the company’s daily average trading volume is closer to 171,000 shares.
LGVN stock started off up this morning but is down 6.2% as of Wednesday afternoon.
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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.