Neuphoria Therapeutics Achieves Target Enrollment for Phase 3 AFFIRM-1 Study of BNC-210 in Treating Social Anxiety Disorder (SAD)
Neuphoria's Clinical Trial Milestone: Neuphoria Therapeutics has achieved target enrollment of 332 participants in the AFFIRM-1 Phase 3 trial for BNC-210, a fast-acting treatment for social anxiety disorder (SAD), with Phase 3 data expected in early Q4 2025.
About BNC-210: BNC-210 is an oral medication designed as a selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor, showing rapid anti-anxiety effects without sedation or addiction potential, and has received FDA Fast Track designation for SAD and PTSD treatment.
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- Trial Termination Reason: Merck decided to halt the mid-stage study of MK-1167 after an early planned review indicated the drug did not meet performance standards for continuation, although no safety concerns were identified, highlighting the drug's ineffectiveness in improving memory and cognition in Alzheimer's patients.
- Market Reaction: Following the trial termination, Merck's shares fell over 2%, while its partner Neuphoria Therapeutics saw a 19% drop in stock price, reflecting investor disappointment and underscoring the market's keen interest in Alzheimer's treatment developments.
- Ongoing Research: Despite the halt of MK-1167, Merck remains active in Alzheimer's research, continuing to test another experimental drug, MK-2214, with results expected in 2029, indicating the company's long-term commitment to this therapeutic area.
- Analyst Ratings: According to Koyfn data, 19 out of 29 analysts covering Merck rated it as 'Buy' or 'Strong Buy', demonstrating confidence in the company's future potential, despite short-term stock price fluctuations due to trial results.
- Development Halted: Merck has terminated the development of MK-1167, an oral positive allosteric modulator of the alpha-7 nicotinic acetylcholine receptor, in phase 2 for Alzheimer's disease, citing business reasons, indicating a strategic shift in the company's approach to Alzheimer's treatment.
- Partnership Impact: The asset was developed in collaboration with Neuphoria Therapeutics under a licensing agreement, and the termination may affect future collaborations and resource allocation between the two companies, highlighting the fragility of partnerships in the pharmaceutical industry.
- Ongoing Research: Despite the halt of MK-1167, Merck continues to advance MK-2214, an antibody targeting phosphorylated serine 413 (pS413) tau in phase 2 trials, suggesting that the company still has other potential treatment options in the Alzheimer's space.
- Market Reaction: Following the announcement, Merck's stock declined, ending a six-day rally, reflecting investor uncertainty regarding the company's research direction and concerns about future profitability.
- Merger Negotiation Confirmation: Neuphoria Therapeutics has confirmed it is in discussions with London-listed Scancell Holdings plc regarding a potential merger, which, if successful, would see Scancell become a Nasdaq-listed entity, indicating a strategic intent for consolidation in the biotech sector.
- Clinical Stage Progress: Neuphoria focuses on developing therapies for neuropsychiatric disorders, particularly its lead drug BNC210 aimed at treating PTSD, although it missed primary and secondary endpoints in the AFFIRM-1 trial, the company is conducting a strategic review to optimize its product offerings.
- Market Potential Assessment: Neuphoria's pipeline includes early-stage clinical trial drugs for Alzheimer's disease and other CNS conditions, highlighting the company's potential to meet market demands and enhance shareholder value, especially against the backdrop of rapid growth in the neuropsychiatric drug market.
- Cautious Future Outlook: While negotiations with Scancell present potential growth opportunities, Neuphoria emphasizes that the completion of any deal is uncertain, and future announcements will comply with SEC and Nasdaq regulations, reflecting the company's commitment to transparency and compliance.
- Shareholder Voting Recommendation: Neuphoria Therapeutics Inc. urges shareholders to support its director nominees, particularly Peter Miles Davies and David Wilson, to ensure maximum shareholder value during the strategic review process.
- ISS Recommendation: Institutional Shareholder Services (ISS) issued a report recommending shareholders vote for Neuphoria's nominees, noting that the board acted appropriately in response to the clinical trial failure and capital raise efforts.
- Successful Capital Raise: The board proactively raised capital ahead of the Phase 3 trial data readout, strengthening the company's balance sheet and providing a solid financial foundation for the upcoming strategic review.
- Commitment to Transparency: Neuphoria's board has committed to maintaining transparency throughout the strategic review process and has provided recent updates to shareholders, aiming to bolster confidence in the company's future direction.
U.S. Stock Market Performance: U.S. stocks opened higher, with the Nasdaq Composite gaining 1% and the Dow and S&P 500 also showing positive movements. Information technology shares rose by 1.3%, while materials stocks fell by 0.3%.
Procter & Gamble Earnings Report: Procter & Gamble reported better-than-expected earnings and sales for Q3, raising its fiscal 2026 guidance for adjusted EPS and sales, surpassing analyst estimates.
Notable Stock Movements: Wellgistics Health saw a significant increase of 183% after a partnership announcement, while Genenta Science surged 145% due to a collaboration expansion. Conversely, Picard Medical's shares dropped 72%.
Global Market Overview: European shares were mixed, with slight gains in some indices, while Asian markets mostly closed higher. Economic indicators showed an increase in the S&P Global services and manufacturing PMIs for October.
Stock Market News Overview: Tuesday features a wealth of stock market news that traders should monitor closely.
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