Neuphoria Therapeutics (NEUP) FDA Approvals

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.

Enrollment Update - September 4,2025

• Drug: BNC-210
• Announced Date: September 4, 2025
• Indication: Social Anxiety Disorder (SAD)

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).

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.

Neuphoria Therapeutics FDA Events - Frequently Asked Questions

Has Neuphoria Therapeutics received FDA approval?

As of now, Neuphoria Therapeutics (NEUP) has not received any FDA approvals for its therapy in the last two years.

What drugs has Neuphoria Therapeutics submitted to the FDA?

In the past two years, Neuphoria Therapeutics (NEUP) has reported FDA regulatory activity for BNC-210.

What is the most recent FDA event for Neuphoria Therapeutics?

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)."

What conditions do Neuphoria Therapeutics' current drugs treat?

Currently, Neuphoria Therapeutics has one therapy (BNC-210) targeting the following condition: Social Anxiety Disorder (SAD).