FDA clears Healis Therapeutics’ IND for Tyemvers®, Enabling U.S. Neuropsychiatric Trials

CAMBRIDGE, Mass., Aug. 04, 2026 (GLOBE NEWSWIRE) -- Healis Therapeutics announced that it has opened an IND with the U.S. FDA for Tyemvers®, a new botulinum toxin type A product. The milestone enables Healis to initiate its U.S. clinical trial, enter clinical-stage research and development, and advance toward participation in the therapeutic botulinum toxin market.

The Phase 1 single-ascending-dose study will evaluate Tyemvers’ safety and tolerability. Completion is expected to support Phase 2 studies in major depressive disorder, post-traumatic stress disorder, and social anxiety disorder. Healis holds exclusive rights to develop Tyemvers for major depressive disorder and additional psychiatric indications, supported by a long-term manufacturing and supply partnership.

“Healis was founded with the vision of transforming the treatment of neuropsychiatric disease,” said Eric Finzi, MD, PhD, Chief Executive Officer of Healis Therapeutics. “Opening our IND is a defining milestone for Healis. We believe Tyemvers has the potential to become an important new treatment option for neuropsychiatric illnesses. Tyemvers is unique among approved or investigational psychiatric drugs because it does not cross the blood-brain barrier, giving it the potential to have minimal side effects.”

Depression, PTSD, and social anxiety affect more than 500 million people worldwide. Approximately 8% of U.S. adults experience major depression, 4% experience PTSD, and 7% experience social anxiety disorder in a given year. Despite this burden, many patients do not respond adequately to existing treatments.

Botulinum toxin type A is an investigational treatment for depression that has shown antidepressant effects in multiple randomized controlled trials. The therapy cleaves SNAP-25, blocks acetylcholine release, and temporarily relaxes injected muscles. Reducing frown-muscle activity may diminish negative facial-feedback signals and modulate emotional-processing circuits, including the amygdala.

AbbVie, the market leader, reported $3.8 billion in 2025 Botox Therapeutic revenue, exceeding Botox Cosmetic revenue. Ipsen is a major participant. Healis is the most clinically advanced independent biotechnology company developing botulinum neurotoxin therapies for depression and other neuropsychiatric disorders.

To Healis’ knowledge, Tyemvers is the only publicly known botulinum toxin type A product in active U.S. clinical development under an open IND for a neuropsychiatric program, and only the second distinct product, after Allergan’s Botox, to enter FDA-regulated development for major depressive disorder.

This release contains forward-looking statements subject to pharmaceutical-development and regulatory risks.

Eric Finzi, MD, PhD
Info@healisthera.com

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