Longeveron, Inc. (NASDAQ: LGVN) is engaged as a clinical-stage biotechnology company, which is specifically focused on the research, development and testing of cell therapies to treat age-related and life-threatening illnesses. Shares of the biotech company are soaring 175% through early trading on Thursday, November 18, 2021. Over the past three months, Longeveron has seen average daily volume of 121,990 shares. However, volume of 170.64 million shares or dollar volume of around $1.37 billion, has already exchanged hands through early trading Thursday.
Shares of Longeveron are surging after the company announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation for its Lomecel-B candidate for the treatment of Hyproplastic Left Heart Syndrome (HLHS). HLHS is a rare and life-threatening congenital heart defect found in infants. Phase 2 clinical trials are underway for Lomecel-B.
Around 1,000 babies in the U.S. are born with HLHS every year. Phase 2 clinical trials are underway for Lomecel-B. HLHS leads to an underdeveloped left ventricle, which limits the heart’s ability to pump blood throughout the body. In order to treat HLHS, three surgical procedures are required over a period of five years. The procedures configure the right ventricle to pump blood throughout the body.
Longeveron’s clinical testing is evaluating the safety and efficicay of its Lomecel-B candidate, which is an injection into the right ventricle during the second surgery. The clinical trials are also testing Lomecel-B’s effect on cardiac function and other health endpoints.
Phase 1 trials have already shown strong promise. Every single infant enrolled during the Phase 1 trials were alive and did not require a transplant between 2-3.5 years post-surgery. The infants’ height, weight and growth patterns were also a match to those of healthy babies.
“We are pleased by FDA’s acknowledgment of the urgent need for a safe and effective treatment for children born with this rare and devastating congenital heart defect,” stated Longeveron co-founder and Chief Science Officer Joshua M. Hare, M.D. “We are encouraged by our Phase 1 clinical data, and the progress being made in the ongoing Phase 2 trial. Lomecel-B represents a unique cell therapy approach that could potentially be administered at the same time as surgery in these critically impacted infants.”
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