By Don Nico Forbes

Share in Longeveron rose after the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy designation to its Lomecel-B treatment for mild Alzheimer's Disease.

Shares more than doubled in premarket trading to $6.85.

The biotechnology company said Lomecel-B is currently being evaluated for multiple conditions, including Alzheimer's Disease, aging-related frailty and hypoplastic left heart syndrome.

On Oct. 5, a Phase 2a Alzheimer's trial for the treatment demonstrated an overall slowing of disease worsening compared to placebo, achieving the primary safety and secondary efficacy targets.

"We look forward to meeting with the FDA to discuss the path forward and the development plans for Alzheimer's Disease in the very near future," said Chief Medical Officer Nataliya Agafonova.

RMAT designation is designed to expedite the drug development and review processes for promising pipeline regenerative medicine products.

Write to Don Nico Forbes at

(END) Dow Jones Newswires

07-10-24 0910ET