Multi-Billion-Dollar Battle for the Future of Depression Treatment Has Begun Creating a Huge Opportunity

NEW YORK, June 30, 2026 (GLOBE NEWSWIRE) -- Market News Updates News Commentary - The way Major Depressive Disorder (MDD) is treated is changing faster than it has in years. For decades, most patients relied on traditional antidepressants that often took several weeks to start working—and didn't always help everyone. Today, drug developers are introducing a new wave of treatments designed to work faster, target different areas of the brain, and offer hope to people with treatment-resistant depression. Researchers are also exploring innovative approaches, including NMDA receptor therapies, orexin-targeting drugs, and other next-generation medicines that could significantly improve patient outcomes. Active Companies in the biotech space current developments include: Helus PharmaTM (NASDAQ:HELP) (Cboe CA: HELP), Definium Therapeutics, Inc. (NASDAQ:DFTX), Compass Pathways plc (NASDAQ:CMPS), GH Research PLC (NASDAQ:GHRS), Johnson & Johnson (NYSE:JNJ).

The opportunity is also attracting billions of dollars in investment. As more people seek treatment and awareness of mental health continues to grow, the global Major Depressive Disorder treatment market is expected to increase from about $20 billion in 2026 to nearly $36 billion by 2033, reflecting strong long-term demand. At the same time, the broader global depression drugs market is projected to grow from roughly $20 billion today to more than $25 billion by 2034, fueled by new drug approvals, expanding insurance coverage, and continued innovation across the pharmaceutical industry.

For investors and healthcare companies, this is one of the most exciting areas in biotechnology today. Pharmaceutical companies are racing to develop treatments that can provide faster relief, fewer side effects, and better long-term results than older antidepressants. As more breakthrough therapies move through clinical trials and toward regulatory approval, the MDD market is expected to remain a major growth opportunity for years to come.

Helus Pharma Reports Recent Business Highlights and Fiscal Year 2026 Financial Results

• Recently closed $50 million underwritten offering reinforces strong institutional investor conviction and bolsters balance sheet for execution of second Phase 3 HLP003 trial
• EMBRACE, for potential U.S. FDA New Drug Application in 2028
• Phase 3 APPROACH pivotal study of HLP003 in Major Depressive Disorder ("MDD") has surpassed 88% enrollment and is on track for topline data readout in Q4 2026
• HLP003 Phase 2 data demonstrated durability at 12 months following two 16mg doses, with 100% response and 71% remission based on a MADRS benchmark of ≤10, with remission rising to 100% based on recent peer benchmarks of ≤124
• Reported topline results in Phase 2 signal detection study for HLP004 in Generalized Anxiety Disorder ("GAD") showing ~10-point improvement from baseline in HAM-A on top of Standard of Care at 6 weeks
• The Company intends to complete design of next HLP004 study by the end of Q3 2026
• Strengthened scientific and medical leadership with addition of globally recognized experts in clinical development, translational science, and medical affairs
  
  
  
  

Helus PharmaTM (NASDAQ:HELP) (Cboe CA: HELP) ("Helus"), a clinical stage pharmaceutical company committed to helping minds heal by developing novel serotonergic agonists ("NSAs"), reported audited financial results for its fiscal year ended March 31, 2026, and recent business highlights. Unless otherwise noted, all dollar amounts are expressed in United States dollars.

"Over the past year, Helus Pharma has strengthened its position as a segment-leading, clinical-stage pharmaceutical company, advancing HLP003 toward a critical Phase 3 readout in Q4 2026 and progressing HLP004 to its next study design by the end of Q3 2026," said Eric So, Interim Chief Executive Officer of Helus Pharma.

"We are pleased to report that our Phase 3 APPROACH study has surpassed 88% enrollment, with recruited participants at approximately the same level of baseline severity as in Phase 2," continued Mr. So. "With topline data anticipated later this year, Helus Pharma is at an inflection point as we move toward commercialization, subject to regulatory approval. Our recently closed $50 million underwritten offering represents a strong vote of confidence in our clinical strategy from top-tier institutional investors and bolsters our balance sheet for execution of our second Phase 3 HLP003 trial, EMBRACE, with potential U.S. FDA New Drug Application in 2028."

Previously reported Phase 2 data for HLP003 demonstrated a durable and clinically meaningful treatment effect, including a ~23-point reduction in MADRS score from baseline at 12 months after two 16 mg doses administered three weeks apart, with response and remission rates improving to 100% and 71% respectively at 12 months based on a MADRS scale threshold for remission of ≤10. Based on recent peer remission criteria of MADRS ≤121, both response and remission rates were 100% at 12 months. These results reinforce the potential of HLP003 to address a significant unmet need and deliver a transformative treatment for patients with MDD.

Helus Pharma is focused on transforming patient outcomes, with remission, response rate and durability serving as key measures of clinical success. Sustained remission has the potential to improve patient quality of life while potentially reducing the long-term burden on healthcare systems and payers. The Company believes HLP003's positioning as an adjunctive therapy—and, to its knowledge, the only late-stage adjunctive potential treatment in this emerging class—may better integrate into existing standards of care and support broader adoption in real-world settings.

"As we advance our clinical trials, we continue to expand our roster of globally recognized scientific leaders and network of strategic partnerships to bring these therapies to patients," added Mr. So. "Amid growing clinical need and increasing regulatory support, our late-stage programs are poised to potentially transform the mental health treatment landscape. This is an exciting time at Helus Pharma as we execute toward key clinical, regulatory and strategic milestones."

Recent Business and Pipeline Highlights:

HLP003: Continued to progress enrollment in Phase 3 PARADIGM program.

• APPROACH has surpassed 88% enrollment, and the study is on track for topline data readout in Q4 2026.
• Enrollment is underway in EMBRACE, the second pivotal study.
• Participant rollover is ongoing into the EXTEND study to generate long-term safety and durability data.
  
  
  
  

Partnered with TARA Mind to advance veteran access to mental health treatment. Collaboration with leading mental health organizations to support HLP003 Phase 3 recruitment and expand outreach in veteran communities.

HLP004: Reported topline results from Phase 2 signal detection study in patients with GAD.

• Statistically significant (p<0.0001) within subject, and clinically meaningful improvement from baseline in Hamilton Anxiety Rating Scale ("HAM-A") of ~10 points on top of Standard of Care at 6 weeks.
• In Phase 1 trial, 100% of participants were ready for discharge within 3 hours6; acute effects lasted ~90 minutes.
• Durable effects sustained through at least six months, with the pooled study population showed 67% responders and 39% of patients were in remission.
• Generally well-tolerated, adverse events were transient, with no drug-related serious adverse events recorded.
  
  
  
  

The Company intends to complete the design of the next HLP004 study by the end of Q3 2026. Continued… Read this full release with full notes and additional news for Helus PharmaTM by visiting: https://ir.helus.com/news

Key Market Highlights Investors are Watching in the Industry:

• Major Depressive Disorder treatment market: projected to grow from ~$20.3 billion (2026) to ~$35.9 billion (2033).
• Global depression drugs market: expected to increase from $19.7 billion (2025) to $25.4 billion (2034).
• Rapid-acting antidepressants, NMDA receptor modulators, orexin-targeted therapies, and psychedelic-inspired medicines are among the fastest-growing areas of research.
• Expanding clinical pipelines, increased mental health awareness, and growing diagnosis rates continue to drive investment and long-term market growth.
  
  
  
  

Next-Wave Mental Health and Other Biotech Drugs may also include:

Definium Therapeutics, Inc. (NASDAQ:DFTX), a late-stage clinical biopharmaceutical company developing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders, recently announced positive topline results from Emerge, its first randomized, double-blind, placebo-controlled Phase 3 study evaluating a single dose of DT120 (lysergide) ODT 100 µg in adults with major depressive disorder (MDD).

Emerge met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement from baseline compared with placebo, as measured by the change in MADRS total score at week 6. The Least Squares (LS) mean change from baseline in MADRS total score at Week 6 in participants who received DT120 ODT 100 µg was -13.3 compared with -5.2 for patients who received placebo, a LS mean difference of -8.1 points (p<0.0001). Beyond the primary endpoint, the effect was rapid with a placebo-adjusted LS mean reduction in MADRS total score at Week 1 of -14.2 (p<0.0001) and durable with a placebo-adjusted LS mean reduction in MADRS total score of -7.3 at Week 12 (p<0.0001).

Compass Pathways plc (NASDAQ:CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced earlier this month that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to seventeen newly hired non-executive employees. The equity awards were granted on June 1, 2026 and consisted of options to purchase an aggregate of 157,000 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 74,700 shares. The options have an exercise price per share equal to $14.19, the closing price of the Company's American Depositary Shares on the Nasdaq Global Select Market on the grant date, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in equal monthly installments over the three-year period thereafter, subject to each employee's continued employment. The restricted share units and nominal cost options will vest in four equal annual installments, subject to each employee's continued employment.

GH Research PLC (NASDAQ:GHRS) earlier this month announced the publication of the full results from its Phase 2a trial in postpartum depression (PPD) and the acceptance of two oral presentations at the 37th World Congress of Neuropsychopharmacology (CINP 2026).

The peer-reviewed article, titled "Inhaled Mebufotenin (GH001) for Adult Patients with Postpartum Depression: A Phase 2a Open-Label Clinical Trial," has been published in The Journal of Clinical Psychiatry (DOI: 10.4088/JCP.25m16284). The article reports the full results from the Phase 2a, single-arm, open-label trial, which enrolled 10 adult women with PPD.

Johnson & Johnson (NYSE:JNJ) recently announced new data across 12 abstracts at the European Academy of Neurology (EAN) 2026 Congress that offer additional insight into the use of IMAAVY® (nipocalimab-aahu) throughout clinically relevant points in the generalized myasthenia gravis (gMG) treatment journey. The analyses include adults with anti-AChRa or anti-MuSKb antibody-positive gMG who were early in their disease course or had lower baseline symptom burden – providing insight into the potential importance of addressing pathogenic immunoglobulin G (IgG) early in disease progression where use of advanced therapies may be less common. Additional research to be shared include outcomes shortly after common infections, which are a known cause of disease exacerbations in gMG, and plans to address evidence gaps in use of IMAAVY during pregnancy.

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