# U.S. FDA Grants Reunion Neuroscience’s Luvesilocin (RE104) Breakthrough Therapy Designation Status

- URL: https://theranews.net/blog/2026-02-24-us-fda-grants-reunion-neurosciences-luvesilocin-re104-breakthrough-therapy-desig-12226a/
- Published: 2026-02-24
- Type: Archive summary (AI-assisted summary of third-party reporting)
- Original outlet: hastingstribune
- Original report: https://www.hastingstribune.com/ap/business/u-s-fda-grants-reunion-neuroscience-s-luvesilocin-re104-breakthrough-therapy-designation-status/article_5b114c3c-802f-52d2-a194-d78b06cfa09e.html
- Topics: anxiety
- Publisher: TheraNews, operated by AdvancedCare USA Inc.
- Notice: Educational content, not medical, legal, billing or financial advice. Cite the original outlet, not this summary.

> Breakthrough Therapy Designation Based on Positive RECONNECT Phase 2 Clinical Data --

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![U.S. FDA Grants Reunion Neuroscience’s Luvesilocin (RE104) Breakthrough Therapy Designation Status](/uploads/news-images/u-s-fda-grants-reunion-neuroscience-s-luvesilocin-20260224110049.jpg)

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*Originally reported by hastingstribune. [Read more](https://www.hastingstribune.com/ap/business/u-s-fda-grants-reunion-neuroscience-s-luvesilocin-re104-breakthrough-therapy-designation-status/article_5b114c3c-802f-52d2-a194-d78b06cfa09e.html)*

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*Source: [https://www.hastingstribune.com/ap/business/u-s-fda-grants-reunion-neuroscience-s-luvesilocin-re104-breakthrough-therapy-designation-status/article_5b114c3c-802f-52d2-a194-d78b06cfa09e.html](https://www.hastingstribune.com/ap/business/u-s-fda-grants-reunion-neuroscience-s-luvesilocin-re104-breakthrough-therapy-designation-status/article_5b114c3c-802f-52d2-a194-d78b06cfa09e.html)*