Why Is Depression Focused Seelos Therapeutics Stock Plunging Today?

Seelos Therapeutics Inc SEEL announced topline data from Part 2 of its Phase 2 study of SLS-002 (intranasal racemic ketamine) for Acute Suicidal Ideation and Behavior (ASIB) in adults with Major Depressive Disorder (MDD). 

The company says that the target enrollment of this study was 220 patients. However, due to financial constraints, only 147 patients diagnosed with MDD requiring psychiatric hospitalization due to significant risk of suicide were randomized. 

Due to the limited sample size, the study did not meet the pre-defined primary endpoint (MADRS ANCOVA at 24 hours post-dosing). 

However, assuming the same treatment difference and standard deviation, analyses showed that the study would have achieved statistical significance for the primary endpoint had the study reached full enrollment (220 patients). 

The company said the study demonstrated clinically meaningful treatment effects across multiple endpoints and a well-tolerated safety profile, and no deaths were reported in the study.

Clinically meaningful reduction in acute suicidality was demonstrated with SLS-002 over placebo. Both groups continued to improve over time.

Price Action: SEEL shares are down 75.90% at $0.24 on the last check Wednesday.