The FDA cleared Anavex's application to test its drug in people with Fragile X

Anavex completed ADME and DDI studies for blarcamesine, with 65 and 8 healthy volunteers respectively, and no serious adverse events reported. The FDA cleared the IND for Fragile X syndrome, and a meeting is scheduled to discuss adding pediatric participants to the Phase 3 Rett syndrome trial.

ANAVEX LIFE SCIENCES CORP. (AVXL) filed an SEC Form 8-K — Other Events. EXHIBIT 99.1 Anavex Provides Corporate Update, Announces Completion of Clinical Conduct of ADME and DDI Clinical Studies Clinical conduct of both blarcamesine (ANAVEX®2-73) studies in healthy volunteers is now complete, data are expected to support clinical pharmacology character

Anavex Life Sciences (AVXL) received FDA clearance to start a Phase 2a trial for blarcamesine in Fragile X syndrome, expanding its clinical development. The trial will involve 60 adult males and assess safety, tolerability, and pharmacokinetics. Blarcamesine has Orphan Drug Designation but is not yet proven effective.

Anavex Life Sciences (AVXL) received FDA clearance for its Investigational New Drug Application to study blarcamesine in Fragile X syndrome. The Phase 2a trial will assess safety, tolerability, and pharmacokinetics in adult males. Blarcamesine previously received FDA Orphan Drug Designation. AVXL shares closed at $1.48, down 0.67%.

The US FDA cleared Anavex Life Sciences' Investigational New Drug application for blarcamesine to treat Fragile X Syndrome. According to interim CEO Terrie Kellmeyer, this allows a phase 2a clinical trial to proceed.

Anavex Life Sciences received FDA clearance for its Investigational New Drug (IND) application for blarcamesine in Fragile X syndrome. The company plans a Phase 2a study to evaluate the drug's safety, tolerability, and pharmacokinetics in approximately 60 adult males. Blarcamesine has previously received FDA Orphan Drug designation for this indication.