Reunion's Fast-Track Psychedelic Aims to Transform Mental Healthcare

MORRISTOWN, NJ – January 12, 2026 – Reunion Neuroscience has received a significant green light from the U.S. Food and Drug Administration (FDA) for its lead psychedelic-inspired drug, RE104, establishing a clear and potentially accelerated path to market for treating postpartum depression (PPD). The biopharmaceutical company announced today that following a productive End-of-Phase 2 meeting, the FDA has agreed that a single, successful Phase 3 trial could be sufficient to support the drug's registration.

This pivotal development, coupled with program expansions into anxiety and the advancement of a novel non-psychedelic compound, positions Reunion at the forefront of a movement seeking to revolutionize how mental health conditions are treated. The company is poised to initiate the crucial Phase 3 trial for PPD later this year, marking a major step toward delivering what it hopes will be a best-in-class therapy for a debilitating condition that affects millions of new mothers.

A Landmark Moment for Postpartum Depression Treatment

The FDA's alignment on the registrational path for RE104 is a testament to the strength of the data from Reunion's Phase 2 RECONNECT trial. The study successfully met its primary endpoint, demonstrating a clinically meaningful reduction in depression scores with a favorable safety profile. This positive outcome is now being leveraged to streamline the final stage of clinical development.

“Last year, we reported positive topline data from our Phase 2 RECONNECT trial in PPD, demonstrating that a single dose of RE104 can safely deliver clinically meaningful improvements in depression and anxiety scores,” said Greg Mayes, President and Chief Executive Officer of Reunion Neuroscience. “These results unlock a blockbuster opportunity in PPD, where we believe we are advancing a best-in-class therapy poised to disrupt a significant and still underserved market.”

The requirement of only a single additional pivotal trial is a significant departure from the traditional two-trial standard and reflects a growing regulatory openness to more efficient pathways for drugs addressing high unmet needs. Postpartum depression is the most common complication of childbirth, affecting up to 1 in 8 women in the U.S. The market for effective treatments is substantial, with some analysts projecting the global PPD market to reach over $2.3 billion by 2034. Current treatments can be slow to act or carry significant logistical burdens, creating a clear opening for a rapid, single-dose therapy.

Further enhancing its patient-centric approach, Reunion confirmed that after reviewing the company’s lactation study, the FDA supports the enrollment of actively breastfeeding women in the upcoming Phase 3 trial. Critically, these participants can expect to resume breastfeeding on the same day as their treatment, a groundbreaking allowance that addresses a major barrier to care for new mothers who are often forced to choose between their mental health treatment and breastfeeding their infants.

The Science Behind a Shorter Trip

At the heart of Reunion's strategy is the unique profile of RE104, a proprietary prodrug of 4-OH-DiPT. Unlike first-generation psychedelics such as psilocybin or LSD, which can induce psychoactive experiences lasting six to eight hours or more, RE104 is designed to deliver a much shorter acute experience of approximately three to four hours. This is a key differentiator with profound clinical and logistical implications.

A shorter duration significantly reduces the time a patient must be monitored in a clinical setting, lessening the strain on healthcare resources and potentially making the therapy more scalable and accessible. Phase 1 data confirmed this profile, showing that a single subcutaneous injection of RE104 led to a rapid onset of effects and a manageable duration, all while producing a psychedelic state comparable in intensity and quality to that of psilocybin. The drug was found to be generally safe and well-tolerated.

Like other classic psychedelics, RE104 acts as an agonist on the serotonin 5HT2A receptor. This mechanism is widely believed to be responsible for both the acute psychoactive effects and the rapid, durable antidepressant effects by promoting neuroplasticity—the brain's ability to form new neural connections and rewire itself. By packaging this mechanism into a shorter-acting formulation, Reunion aims to retain the therapeutic benefit while improving the treatment experience for both patients and providers.

Expanding the Frontier to Anxiety and Life's Stressors

Bolstered by the positive results in PPD, Reunion is executing a broader strategy to leverage RE104 across a range of mood and anxiety disorders. The company announced it will initiate its Phase 2 RECLAIM trial in the first quarter of 2026 to evaluate RE104 for Generalized Anxiety Disorder (GAD), a chronic condition affecting millions of adults for which there has been little pharmaceutical innovation in decades. The GAD space is becoming a key battleground for psychedelic-inspired therapies, with competitors like MindMed also advancing their own candidates, signaling a significant market opportunity.

Simultaneously, the company is continuing to enroll patients in its Phase 2 REKINDLE trial, which is studying RE104 for Adjustment Disorder (AjD). This condition, often triggered by a stressful life event like a cancer diagnosis, currently has no specifically approved FDA pharmacotherapy, representing another area of high unmet need. Initial data from the REKINDLE trial is anticipated in the first quarter of 2027.

Mr. Mayes noted the strategic importance of this expansion, stating, “Beyond advancing our PPD program, the RECONNECT data are critical in de-risking our planned indication expansion strategy across other mental health disorders characterized by depression and anxiety.”

The Next Wave: Neuroplasticity Without the Hallucinations

Looking further into the future of psychiatric medicine, Reunion also highlighted progress on RE245, a novel, non-psychedelic compound. Described as a serotonergic neuroplastogen, RE245 is designed to stimulate 5HT2A-mediated neuroplasticity to achieve therapeutic benefits without inducing the hallucinations characteristic of classic psychedelics.

This approach represents a potential paradigm shift. A drug that could promote brain health and emotional resilience without a psychoactive experience could overcome many of the logistical, regulatory, and social barriers associated with psychedelic-assisted therapy. Such a treatment could potentially be prescribed more broadly and taken by patients at home, dramatically expanding access. Reunion plans to file an Investigational New Drug (IND) application for RE245 in 2026 and aims to begin Phase 1 trials in 2027, signaling a long-term vision that extends beyond its current pipeline.

This multi-pronged strategy—combining a fast-tracked psychedelic for acute care, indication expansions, and a next-generation non-psychedelic—is backed by significant financial confidence. The company successfully raised $133 million in a Series A funding round, with the investment notably increasing after the positive Phase 2 data for RE104 was released. This capital infusion is fueling the ambitious clinical programs and underscores investor belief in Reunion’s potential to redefine mental healthcare. With a clear regulatory runway for its lead candidate and a visionary pipeline, Reunion Neuroscience is not just developing a drug; it is helping to build a new toolkit for mental wellness.