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Reunion Neuroscience Announces Program Updates and Highlights Anticipated 2026 Milestones

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-- Aligned with U.S. Food and Drug Administration (FDA) on Registrational Path for RE104 in Postpart...

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AI Summary

Reunion aligns with FDA for RE104's PPD trial. RE104 shows promise in anxiety and mood disorders. Phase 3 trial for PPD expected to start in 2026. Initial data for REKINDLE and RECLAIM trials expected in 2027. Reunion aims to disrupt mental health disorder treatments.

Sentiment Rationale

The progression of RE104 through trials may attract investor interest. Historical data shows successful clinical trials often lead to stock price increases.

Trading Thesis

Results from Phase 3 trials in 2026 could significantly impact future stock performance. Successful trial outcomes historically lead to market-wide interest in biotech stocks.

Market-Moving

  • Reunion aligns with FDA for RE104's PPD trial.
  • RE104 shows promise in anxiety and mood disorders.
  • Phase 3 trial for PPD expected to start in 2026.

Key Facts

  • Reunion aligns with FDA for RE104's PPD trial.
  • RE104 shows promise in anxiety and mood disorders.
  • Phase 3 trial for PPD expected to start in 2026.
  • Initial data for REKINDLE and RECLAIM trials expected in 2027.
  • Reunion aims to disrupt mental health disorder treatments.

Companies Mentioned

  • COMP (COMP)
  • ACOR (ACOR)
  • NVCR (NVCR)

Corporate Developments

The article discusses imminent milestones that could alter REUN's market positioning, increasing investor interest.

Reunion Neuroscience Announces Key Program Updates and Milestones for 2026

Stock Symbol: REUN

Date: January 12, 2026

Source: GlobeNewsWire

Overview of Recent Developments

MORRISTOWN, N.J. — Reunion Neuroscience Inc., a clinical-stage biopharmaceutical company focused on improving treatment options for mental health disorders, has unveiled significant updates regarding their flagship product, RE104. The company has aligned with the U.S. Food and Drug Administration (FDA) on the registrational path for RE104 in treating postpartum depression (PPD) and is progressing towards initiating a Phase 3 clinical trial in 2026.

Key Milestones and Program Updates

  • Postpartum Depression (PPD): Reunion's RE104 is set to undergo a Phase 3 trial in 2026 following a successful End-of-Phase 2 (EOP2) meeting with the FDA.
  • Adjustment Disorder (AjD): The ongoing Phase 2 REKINDLE Trial is actively enrolling participants, with initial results expected in Q1 2027.
  • Generalized Anxiety Disorder (GAD): The Phase 2 RECLAIM Trial is anticipated to begin in Q1 2026.

Product Profile of RE104

RE104 is a proprietary prodrug of 4-OH-DiPT that is administered via a single subcutaneous injection. This innovative compound is engineered to provide a shorter acute psychoactive experience compared to conventional psychedelics like psilocybin or LSD. RE104 aims to address various mood and anxiety disorders, including PPD, AjD, and GAD.

Postpartum Depression (PPD) Insights

PPD is the most prevalent complication affecting 12.5% of new mothers in the first year postpartum. Following the RECONNECT clinical trial, which successfully met its primary endpoint by demonstrating a substantial reduction in MADRS scores, Reunion anticipates that a single additional Phase 3 trial will finalize the pivotal studies needed for potential registration of RE104 for PPD. The FDA has also indicated support for enrolling breastfeeding women in this trial.

"We are entering 2026 with tremendous momentum across our business," announced Greg Mayes, President and CEO of Reunion Neuroscience. "Our positive topline data from the Phase 2 RECONNECT trial unlocks a blockbuster opportunity in PPD."

Ongoing Trials for Adjustment Disorder and Generalized Anxiety Disorder

Adjustment Disorder, characterized by significant stress responses, affects patients globally, especially those facing cancer and other severe medical conditions. RE104 is being evaluated for its effectiveness in the REKINDLE trial, with results expected by early 2027.

Generalized Anxiety Disorder (GAD) is another focus for Reunion, with the planned RECLAIM trial targeting its treatment in adult patients. This Phase 2 trial aims to address the unmet needs of GAD patients, many of whom do not achieve remission with existing therapies.

Future Projections and Additional Developments

In addition to RE104, Reunion is advancing RE245, a non-psychedelic serotonergic neuroplastogen. This compound aims to promote neuroplasticity without the adverse effects associated with hallucinogenic substances. An investigational new drug application is scheduled for filing in 2026, with a Phase 1 clinical trial to follow in 2027.

About Reunion Neuroscience, Inc.

Reunion Neuroscience is committed to pioneering treatment for underserved mental health disorders through innovative psychedelic-inspired solutions. The company is exploring the therapeutic potential of RE104 across various conditions, aiming to fill significant gaps in the current mental health landscape.

For more information about Reunion Neuroscience, visit reunionneuro.com, and follow them on LinkedIn and Bluesky.

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