Longeveron (LGVN) Stock: Why The Price Surged

By Amit Chowdhry ● Nov 23, 2021
  • The stock price of Longeveron Inc (NASDAQ: LGVN) increased by 181.16% in the most recent trading session. This is why it happened.

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.

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. And 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. And HLHS is often fatal without surgical intervention, in which 3 surgical procedures are performed over the period of about 5 years, to allow 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.

The FDA may grant RPD designation for diseases that primarily affect children ages 18 years old or younger, and fewer than 200,000 individuals in the U.S. Under this program (if the FDA approves Lomecel-B for the treatment of HLHS), Longeveron may be eligible to receive a priority review voucher (PRV) if the application submitted for the product satisfies certain conditions, and under current law, is approved prior to September 30, 2026.

Drug companies receiving a PRV can have any subsequent drug or biologic application reviewed and a decision made in six months as opposed to the standard 10 months, potentially accelerating the time to market or they can sell the PRV to another company. And the PRV accelerated review is for patients with serious conditions providing access to a potentially lifesaving or -changing treatment sooner. For companies, it means they can potentially go to market with their product more quickly, and potentially begin generating product revenue.

Infants with HLHS are currently being enrolled in ELPIS II, a 38-subject, phase 2 randomized, double-blind, controlled clinical trial. And ELPIS II is being funded in part by a grant from the National Institute of Health’s National Heart, Lung, and Blood Institute (NHLBI; Grant number 1UG3HL148318), in collaboration with Longeveron, and is led by Principal Investigator Sunjay Kaushal, MD, PhD, Division Head, Cardiovascular-Thoracic Surgery, Ann and Robert H. Lurie Children’s Hospital of Chicago. The other participating clinical sites currently open for enrollment are Advocate Children’s Hospital, Park Ridge, IL; Primary Children’s Hospital/University of Utah, Salt Lake City, UT; Children’s Hospital Los Angeles, Los Angeles, CA; and Cincinnati Children’s Hospital Medical Center, Cincinnati, OH.

Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.