CervoMed (NASDAQ:CRVO) announced that the FDA has granted orphan drug designation (ODD) to its lead investigational therapy, neflamapimod, for the treatment of frontotemporal dementia (FTD). Following the announcement, the company’s stock price rose by 14.6%, increasing from $7.98 at market close on November 26 to $9.15 at market close yesterday.
The company stated that it remains on track to report topline data from its RewinD-LB Phase 2 clinical trial in early-stage dementia with Lewy bodies (DLB) next month.
“We are pleased to have received Orphan Drug Designation as it implicitly recognizes the scientific rationale and potential for neflamapimod to treat this debilitating condition. Patients diagnosed with frontotemporal dementia have no available treatment options, and this rare condition is extremely burdensome to patients and caregivers alike,” said John Alam, MD, CEO of CervoMed.
“Within this year, there have been multiple scientific presentations and publications that indicate neflamapimod targets specific pathogenic mechanisms associated with FTD. We are in active discussions with clinical thought leaders regarding the design of a proof-of-principle study in FTD, while continuing to prepare to advance neflamapimod into a Phase 3 trial in DLB in mid-2025,” Dr. Alam added.
