By Colin Kellaher
Shares of Longeveron Inc. more than doubled on Thursday after the clinical-stage biotechnology company received a key U.S. Food and Drug Administration designation for its lead program.
The Miami company said the FDA granted rare-pediatric-disease designation to Lomecel-B for the treatment of a rare congenital heart defect in infants known as hypoplastic left-heart syndrome.
Drugmakers who eventually win FDA approval of a drug granted the rare-pediatric-disease designation receive priority-review vouchers, which they can use to obtain priority review for another drug or sell to other companies.
Mirum Pharmaceuticals Inc., which in September won a priority-review voucher upon FDA approval of its cholestatic pruritus drug Livmarli for patients with Alagille syndrome, on Wednesday said it agreed to sell the voucher for $110 million.
Longeveron is currently conducting a Phase 2 trial of Lomecel-B in hypoplastic left-heart syndrome and is also studying the drug in aging frailty, Alzheimer's disease and flu- and Covid-related acute respiratory distress syndrome.
Longeveron went public in February at $10 a share, and the stock rose as high as $12.48 in March after the FDA approved Lomecel-B for compassionate use for the treatment of a child with hypoplastic left heart syndrome.
However, the shares had fallen back since then amid disappointing study results, hitting a 52-week low of $2.84 on Wednesday.
In recent trading Thursday, Longeveron shares were up 120% to $6.42.
Write to Colin Kellaher at firstname.lastname@example.org
(END) Dow Jones Newswires