Bright Minds Stock Soars 23% on Positive Epilepsy Drug Trial Data
FDA & Biotech

Bright Minds Stock Soars 23% on Positive Epilepsy Drug Trial Data

Phase 2 study shows significant seizure reduction in rare epilepsy syndromes, setting the stage for pivotal trials and hitting a new 52-week high.

Shares of Bright Minds Biosciences (NASDAQ: DRUG) surged in heavy trading Tuesday, closing up 22.83% after the company announced positive topline results from a Phase 2 trial of its novel epilepsy drug, BMB-101.

The stock finished the session at $98.275, a new 52-week high, boosting the company's market capitalization to approximately $650 million as investors reacted to data suggesting the drug could become a promising new treatment for severe and rare forms of epilepsy.

The Phase 2 BREAKTHROUGH trial evaluated BMB-101 in patients with drug-resistant forms of Developmental and Encephalopathic Epilepsies (DEE), including the notoriously difficult-to-treat Dravet syndrome, as well as in patients with Absence Seizures. According to the official company announcement, the drug met its primary endpoints, demonstrating significant anti-seizure activity.

In one cohort, patients with Absence Seizures experienced a median reduction of 73.1% in the frequency of seizures lasting three seconds or longer, a result that was statistically significant (p = 0.012). In a second cohort of patients with DEE, treatment with BMB-101 led to a 63.3% median reduction in major motor seizures. The company reported that BMB-101 exhibited a favorable safety and tolerability profile, with the majority of adverse events being mild to moderate and no serious adverse events attributed to the treatment.

Beyond the primary endpoints, Bright Minds reported an unexpected secondary finding: patients with Absence Seizures showed a mean 90% increase in REM sleep without an increase in total sleep time, suggesting a potential ancillary benefit for sleep architecture, which is often disrupted in epilepsy patients.

The strong data provides a major validation for the clinical-stage biotechnology company, which currently generates no revenue as it focuses on its development pipeline. The successful outcome of the Phase 2 study is a critical de-risking event, significantly increasing the probability of BMB-101 eventually reaching the market. Developmental and Encephalopathic Epilepsies represent an area of high unmet medical need, with many patients failing to achieve seizure control despite multiple available therapies.

Buoyed by the results, Bright Minds announced it has already initiated preparations for global registrational trials, the large-scale studies typically required for seeking regulatory approval from the FDA and other health authorities. The company also signaled confidence in BMB-101's broader potential, stating plans to initiate a study for the drug in Prader Willi Syndrome during the first quarter of 2026.

Wall Street's reaction builds on what was already a bullish stance on the company. Prior to Tuesday's announcement, Bright Minds was covered by seven analysts, with six holding 'Buy' ratings and one a 'Strong Buy'. The consensus analyst price target stood at $104.77, suggesting that some on the Street already anticipated positive developments and still see further upside even after the significant stock price appreciation.