Neuphoria Therapeutics' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Neuphoria Therapeutics (NEUP).
Over the past two years, Neuphoria Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
BNC-210. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
BNC-210 FDA Regulatory Events
BNC-210 is a drug developed by Neuphoria Therapeutics for the following indication: Social Anxiety Disorder (SAD).
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:
- BNC-210
- Announced Date:
- September 4, 2025
- Indication:
- Social Anxiety Disorder (SAD)
Announcement
Neuphoria Therapeutics Inc announced the achievement of target enrollment of 332 participants in the AFFIRM-1 Phase 3 trial evaluating lead candidate BNC-210 as a first-in-class, acute, "as needed", fast-acting treatment for social anxiety disorder (SAD).
AI Summary
Neuphoria Therapeutics Inc. has reached its target enrollment of 332 participants in the AFFIRM-1 Phase 3 trial of BNC-210, a first-of-its-kind, as-needed, fast-acting treatment for social anxiety disorder. This milestone moves the study toward its first Phase 3 results, expected in early fourth quarter.
BNC-210 is an oral, proprietary modulator of the α7 nicotinic acetylcholine receptor. It has FDA Fast Track designation for acute social anxiety disorder and PTSD. Earlier trials showed it produces rapid, broad anti-anxiety effects without sedation, cognitive impairment, or addiction potential.
The AFFIRM-1 study is multicenter, double-blind, and placebo-controlled. Participants receive a single 225 mg dose of BNC-210 or placebo one hour before a public speaking challenge. The main outcome measures changes in distress using the Subjective Units of Distress Scale (SUDS) during the speech and related anxiety scales.
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Neuphoria Therapeutics FDA Events - Frequently Asked Questions
As of now, Neuphoria Therapeutics (NEUP) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Neuphoria Therapeutics (NEUP) has reported FDA regulatory activity for BNC-210.
The most recent FDA-related event for Neuphoria Therapeutics occurred on September 4, 2025, involving BNC-210. The update was categorized as "Enrollment Update," with the company reporting: "Neuphoria Therapeutics Inc announced the achievement of target enrollment of 332 participants in the AFFIRM-1 Phase 3 trial evaluating lead candidate BNC-210 as a first-in-class, acute, "as needed", fast-acting treatment for social anxiety disorder (SAD)."
Currently, Neuphoria Therapeutics has one therapy (BNC-210) targeting the following condition: Social Anxiety Disorder (SAD).
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:NEUP) was last updated on 9/26/2025 by MarketBeat.com Staff
