FDA Events for Bright Minds Biosciences (DRUG)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Bright Minds Biosciences (DRUG).
Over the past two years, Bright Minds Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BMB-101. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
BMB-101 - FDA Regulatory Timeline and Events
BMB-101 is a drug developed by Bright Minds Biosciences for the following indication: In adult patients with classic Absence Epilepsy and Developmental Epileptic Encephalopathy (DEE).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BMB-101
- Announced Date:
- September 12, 2024
- Indication:
- In adult patients with classic Absence Epilepsy and Developmental Epileptic Encephalopathy (DEE).
Announcement
Bright Minds Biosciences Inc. announced the initiation of the BREAKTHROUGH Study, an open-label Phase 2 clinical trial evaluating the safety, tolerability, and efficacy of BMB-101, a highly selective 5-HT2C receptor agonist, in adult patients with classic Absence Epilepsy and Developmental Epileptic Encephalopathy (DEE).
AI Summary
Bright Minds Biosciences has initiated the BREAKTHROUGH Study, an open-label Phase 2 clinical trial to assess BMB-101 in adults with refractory forms of epilepsy, including classic Absence Epilepsy and Developmental Epileptic Encephalopathy (DEE). BMB-101 is a novel, highly selective 5-HT2C receptor agonist that uses a G-protein biased mechanism, aiming to offer improved efficacy and reduced tolerance issues compared to existing treatments. The study will enroll approximately 20 adult participants, who will first undergo a 4‑week baseline period to document seizure activity. Participants will then receive treatment for 8 to 12 weeks, followed by a 4‑week follow-up phase to assess lasting effects. The trial’s primary goals are to evaluate the safety, tolerability, and efficacy of BMB-101 by monitoring changes in seizure frequency and EEG patterns, potentially offering a new treatment option for patients with drug-resistant epilepsy disorders.
Read Announcement
Bright Minds Biosciences FDA Events - Frequently Asked Questions
As of now, Bright Minds Biosciences (DRUG) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Bright Minds Biosciences (DRUG) has reported FDA regulatory activity for BMB-101.
The most recent FDA-related event for Bright Minds Biosciences occurred on September 12, 2024, involving BMB-101. The update was categorized as "Study Initiation," with the company reporting: "Bright Minds Biosciences Inc. announced the initiation of the BREAKTHROUGH Study, an open-label Phase 2 clinical trial evaluating the safety, tolerability, and efficacy of BMB-101, a highly selective 5-HT2C receptor agonist, in adult patients with classic Absence Epilepsy and Developmental Epileptic Encephalopathy (DEE)."
Currently, Bright Minds Biosciences has one therapy (BMB-101) targeting the following condition: In adult patients with classic Absence Epilepsy and Developmental Epileptic Encephalopathy (DEE)..
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:DRUG) was last updated on 7/10/2025 by MarketBeat.com Staff
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