The stock price of Longeveron Inc (NASDAQ: LGVN) – a clinical-stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions – increased by 181.16% in the most recent trading session. This is a continuation of momentum as the company stock price is up 749.4% over the past week.
Among speculative biotech stocks, Longeveron continues to outperform the market by a wide margin. Trading at only $3 per share a week ago, shares of LGVN stock have skyrocketed to more than $40 per share today.
Lomecel-B has been designated for treating Hypoplastic Left Heart Syndrome (HLHS), a rare and life-threatening heart defect in infants. The treatment is currently undergoing a Phase 2 trial following a positive Phase 1 trial.
“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,” said Longeveron co-founder and Chief Science Officer Joshua Hare.
The surge in the stock price is being driven by news from last week. Longeveron had announced last week that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation for Lomecel-B for the treatment of Hypoplastic Left Heart Syndrome (HLHS), a rare and life-threatening congenital heart defect in infants.
Lomecel-B, an investigational allogeneic, bone marrow-derived medicinal signaling cell (MSC) product, is currently being evaluated in a Phase 2 trial.
About 1,000 babies are born with HLHS each year in the U.S. HLHS babies have an underdeveloped left ventricle – which impairs the heart’s ability to pump blood throughout the body. HLHS is often fatal without surgical intervention, in which 3 surgical procedures are performed over the period of about 5 years. It allows the right ventricle to be configured to pump blood to the body.
Longeveron is evaluating the safety of Lomecel-B injection into the right ventricle during the second surgery (4 – 6 months of age), and the effect on cardiac function and other health status endpoints.
Longeveron had recently reported clinical results from its safety-focused Phase I clinical study of Lomecel-B in HLHS patients. When cardiac surgeons injected Lomecel-B directly into the babies’ hearts at the time of surgery, the cells were well-tolerated with no major adverse cardiac events and no infections considered to be related to the investigational treatment.
100% of infants enrolled in the Phase 1 trial (n=10) were alive and had not required a transplant between 2 – 3.5 years post-surgery. And other measurements of the babies’ health like weight gain and growth pattern matched that of normal healthy babies.
Whats’s Next :
Riding a short squeeze can result in significant returns very quickly if you jump aboard early enough. The problem is that these squeezes typically don’t last long. When a short squeeze ends, stocks usually fall nearly as rapidly as they rose.
Anyone considering buying shares of Longeveron at this point should exercise caution. The stock could soon give up much of its gains from the past few days.
It’s certainly good news that the FDA granted Rare Pediatric Disease designation to Lomecel-B. This puts Longeveron in a position to potentially receive a priority review voucher. Using a priority review voucher cuts the FDA’s review time for an approval filing from 10 months to six months. However, Lomecel-B is still only in phase 2 testing.