공고 • Jun 22
Solvonis Therapeutics Announces Positive Bridging Data Supporting Planned U.S. 505(b)(2) Pathway Towards Phase 2b Clinical Trial of SVN-002 Solvonis Therapeutics plc announced positive pharmacokinetic (PK) data from the preclinical bridging study for its SVN-002 development programme. SVN-002 is Solvonis' proprietary esketamine oral thin-film (OTF) formulation being developed for moderate-to-severe Alcohol Use Disorder (AUD) in the United States. It is designed for supervised, clinic-administered sublingual-buccal dosing. The programme also incorporates a structured alcohol education component, intended for future remote digital access by patients. The programme is being advanced under a planned U.S. Food and Drug Administration (FDA) 505(b)(2) regulatory pathway referencing the FDA-approved intranasal esketamine product, Spravato®. The nonclinical study was designed to assess whether the intended combined sublingual-buccal administration of SVN-002 could generate systemic esketamine exposure supportive of a scientific bridge to the approved intranasal esketamine reference product. At the same nominal dose level, combined sublingual-buccal administration of SVN-002 produced rapid systemic exposure to parent esketamine. Exposure levels for parent esketamine and the key measured metabolites, noresketamine and hydroxynoresketamine, were within the range observed for the intranasal esketamine comparator arm, providing important translational support for the planned scientific bridge. At the December 2024 Type B pre-IND meeting held with the FDA by Awakn Life Sciences, prior to the asset's acquisition by Solvonis, FDA identified systemic exposure to esketamine and relevant metabolite exposure as key considerations for the initial Investigational New Drug (IND) package. Solvonis believes these newly generated data provide important translational support in relation to the FDA-identified exposure considerations and strengthen the planned initial IND package for SVN-002. Following these positive results, Solvonis will seek further FDA feedback on the scope and scale of the remaining nonclinical toxicology work required for the initial IND submission. Subject to FDA feedback and successful completion of this targeted toxicology package, Solvonis plans to submit an IND to support the initiation of a Phase 2b clinical trial of SVN-002 in patients with moderate-to-severe AUD in the United States. AUD represents a major and underserved U.S. market opportunity characterised by limited pharmacological innovation. According to the 2024 U.S. National Survey on Drug Use and Health, approximately 27,900,000 people aged 12 and older in the U.S. had Alcohol Use Disorder in the past year. Solvonis estimates that approximately 15,000,000 U.S. adults fall within the programme's target moderate-to-severe AUD population. Spravato® provides a relevant commercial reference point for supervised, clinic-administered esketamine treatment models. Johnson & Johnson reported worldwide Spravato® sales of approximately USD 1,700 million in 2025 for depression-related indications. Solvonis estimates that SVN-002's target U.S. moderate-to-severe AUD population is approximately five times larger than the estimated U.S. treatment-resistant depression comparator population of approximately 2,800,000 people. The planned 505(b)(2) pathway is central to the capital efficiency of the SVN-002 development strategy. A successful 505(b)(2) route may allow Solvonis to rely, in part, on the FDA's prior findings of safety and/or effectiveness for the approved intranasal esketamine reference product, provided a suitable scientific bridge is established. Solvonis intends to build the SVN-002 package using existing third-party preclinical data, in-licensed Phase 1 clinical data, and targeted SVN-002 bridging and toxicology studies, rather than duplicating a full conventional de novo development package. The Company believes this approach has the potential to reduce development expenditure and support a more capital-efficient route towards Phase 2b. The pharmacokinetic profile observed in this study is very encouraging. Combined sublingual-buccal administration produced rapid systemic exposure to parent esketamine and supports the core rationale for SVN-002 as a transmucosal thin-film product. These results provide important translational evidence for the planned U.S. regulatory pathway and support SVN-002's continued development as a supervised, clinic-administered treatment candidate for AUD. 공고 • May 28
Solvonis Therapeutics plc, Annual General Meeting, Jun 19, 2026 Solvonis Therapeutics plc, Annual General Meeting, Jun 19, 2026. Location: the offices of orana corporate llp, eccleston yards, 25 eccleston place, sw1w 9nf, london United Kingdom 공고 • Mar 12
Solvonis Therapeutics plc Announces Selection of SVN-114 as Lead Candidate from its Proprietary SVN-SDN-14 Discovery Programme Solvonis Therapeutics plc announced the selection of SVN-114 as the lead candidate from the Company's proprietary SVN-SDN-14 discovery programme targeting Post-Traumatic Stress Disorder ("PTSD"), a condition affecting more than 20 million people worldwide for which effective pharmacological treatment options remain limited. The selection follows compelling pharmacology results from preclinical studies conducted by Evotec SE, in which SVN-114 demonstrated balanced modulation of serotonin ("SERT"), dopamine ("DAT") and noradrenaline ("NET"), key brain chemicals involved in mood, emotion and social behaviour. Following review of the pharmacology data, the Company's Scientific Advisory Committee, led by Professor David Nutt, agreed to designate SVN-114 as the programme's lead candidate, marking an important milestone for Solvonis' proprietary CNS discovery platform. Mechanism designed to support therapeutic engagement: The SVN-SDN-14 series is a class of serotonin ("SERT"), dopamine ("DAT") and noradrenaline ("NET") modulators designed to enhance pro-social behaviour and improve therapeutic outcomes for people living with PTSD. By modulating neurochemical pathways associated with trust, empathy and social bonding, compounds in this series, including SVN-114, are intended to help patients rebuild interpersonal relationships and engage more effectively in therapy. Novel chemistry supported by international patent applications: SVN-114 originates from a proprietary chemical series discovered through Solvonis' internal research programme. Composition-of-matter patent applications have been filed internationally covering both the compound class and its pharmaceutical applications. 공고 • Oct 28
Solvonis Therapeutics plc Appoints Paul Carter as Non-Executive Director, Effective 27 October 2025 Solvonis Therapeutics plc announced the appointment of Paul Carter as Non-Executive Director, effective 27 October 2025. Paul Carter is a highly accomplished global biopharmaceutical leader with nearly three decades of senior executive experience spanning commercial, operational, and strategic leadership roles. He has built and scaled businesses across Europe, North America, and Asia, combining deep operational expertise with a proven record of driving transformational growth and delivering long-term shareholder value. Paul currently serves as Non-Executive Chair of Clinigen Group plc. He is also Chair of Memo Therapeutics AG and Chair of Kyowa Kirin International plc. In addition, Paul serves as Non-Executive Director at Immatics N.V. He previously held senior global roles including Executive Vice President and Chief Commercial Officer at Gilead Sciences Inc., where he oversaw international operations across 38 markets and delivered annual revenues exceeding USD 30 billion. His appointment strengthens the Solvonis Board as the Company continues to advance its differentiated CNS pipeline and execute its capital-efficient, licensing-first growth strategy across addiction, psychiatry, and neurology. 공고 • Oct 17
Solvonis Therapeutics plc has completed a Follow-on Equity Offering in the amount of £1.25 million. Solvonis Therapeutics plc has completed a Follow-on Equity Offering in the amount of £1.25 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 378,787,876
Price\Range: £0.0033
Transaction Features: Subsequent Direct Listing 
