Solvonis Therapeutics PLC (LSE:SVNS) has described 2025 as a “transformative year” after reshaping the business and pushing its drug pipeline forward, setting up what it says will be a catalyst-rich period in 2026.
The London-listed biotech is working on new treatments for addiction and psychiatric conditions, areas where existing medicines are limited and demand is high.
As the year closes, the company says it now has programmes ranging from late-stage clinical trials to early discovery work, some backed by US government funding.
Solvonis’s most advanced project, SVN-001, is being tested in a phase III trial for severe alcohol use disorder. This is the final stage of clinical testing before a drug can be considered for approval.
The study is running through the NHS in partnership with the University of Exeter and is partly funded by public bodies, including the National Institute for Health and Care Research.
Recruitment is still under way and headline results are not expected until late 2027 or early 2028. Alongside the trial, the company says it is holding licensing and commercial discussions in the UK, Europe and further afield.
A second alcohol-use programme, SVN-002, is aimed at the much larger US market and uses an oral form of esketamine, a drug already approved for other conditions.
Solvonis plans to follow a regulatory shortcut that allows developers to rely in part on existing safety data, potentially saving both time and money.
Work during the final quarter of 2025 focused on so-called pharmacokinetic studies — tests that show how a drug behaves in the body. Initial data are due early in 2026. If successful, the company hopes to move straight into a mid-stage trial with the US regulator’s blessing.
In December, Solvonis secured a boost for SVN-015, a compound aimed at stimulant addiction, including methamphetamine and cocaine.
The project has been accepted into a US National Institute on Drug Abuse programme, under which the institute will pay for and run early safety and pharmacology tests.
That matters because there are currently no approved medicines for these addictions. Early results are expected in the first quarter of 2026, with the possibility of further publicly funded studies if the data are supportive.
The company is also advancing a programme for post-traumatic stress disorder, known as SVN-SDN-14. Several compounds are being tested to see which has the best balance of brain activity and safety, with a lead candidate expected to be chosen early next year.
Chief executive Anthony Tennyson said the past year had fundamentally changed the group following the acquisition of Awakn Life Sciences in May.
“2025 has been a transformative year for Solvonis,” he said. “The completion of the acquisition of Awakn Life Sciences in May materially reshaped the Company, establishing a differentiated CNS platform spanning late-stage clinical development, earlier-stage discovery, and multiple regulatory pathways.”
Looking ahead, he added: “As we look ahead to 2026, the Company is entering a period with multiple clearly defined catalysts across regulatory, preclinical, and discovery activities.”
For now, Solvonis says its priority is disciplined execution — pushing each programme forward without overstretching its finances, while keeping options open for partnerships as data emerge over the coming year.