Investors
Announcements, reports, presentations and shareholder information for Solvonis Therapeutics plc, a clinical-stage psychedelics company developing therapeutics for addiction, PTSD and depression.
Latest announcements
All RNS announcementsHalf-year report 2026 (unaudited), published 30 September 2026.
Read the announcementThe Solvonis story in one document
Why now, the strategy, the pipeline, the AUD franchise, the de novo engine, a summary, the catalyst roadmap and the team, with supporting data and references in the appendix.
Information is given as at 16 October 2026 unless stated otherwise. Announcements made through a Regulatory Information Service (RNS) prevail over the presentation.
Late-stage clinical assets, scientifically de-risked, with near-term milestones
Late-stage clinical assets
SVN-001 is in Phase 3 in severe alcohol use disorder (AUD), recruiting in the UK, with Portuguese sites being assessed. SVN-002, an esketamine oral thin film (OTF), has an FDA-agreed 505(b)(2) route to a U.S. Phase 2b.
Scientifically de-risked
Built on ketamine and esketamine, with established pharmacology and an approved precedent in SPRAVATO®. The published SVN-001 Phase 2a/b met one of its two co-primary endpoints. The FDA confirmed that no additional clinical data are needed before the SVN-002 Phase 2b.
Near-term milestones
SVN-015: further studies funded and conducted by the U.S. National Institute on Drug Abuse (NIDA). SVN-002: Investigational New Drug (IND) submission for the U.S. Phase 2b, planned for 2027.
SVN-001, SVN-002, SVN-015 and SVN-114 are investigational; their safety and efficacy have not been established. FDA feedback is not an approval or a guarantee of any outcome. Timings are indicative and subject to the availability of capital, regulatory feedback and trial progress. Sources: Grabski et al., Am J Psychiatry 2022;179(2):152–162; Solvonis RNS, 21 January 2025 and 13 October 2026; Company information. Epidemiological estimates, not treated or addressable patients; thresholds differ by region, so the two figures are not additive. Sources: Company estimates (July 2026); SAMHSA, 2024 NSDUH.
Investor enquiries and updates
Email info@solvonis.com, or join the mailing list for pipeline updates and events.