RCS - Solvonis Therapeutic - US CNS Executive Order

Solvonis TherapeuticsAnnouncement

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RNS Number : 1122B  Solvonis Therapeutics PLC  20 April 2026

 

20 April 2026

 

Solvonis Therapeutics plc

("Solvonis" or the "Company")

 

Welcomes President Trump's Executive Order as a positive signal for
rapid-acting CNS therapies in the United States

 

Solvonis Therapeutics plc (LSE: SVNS), an emerging biopharmaceutical company
developing novel small-molecule therapeutics for high-burden central nervous
system ("CNS") disorders, views the Executive Order signed by President Donald
Trump on 18 April 2026, "Accelerating Medical Treatments for Serious Mental
Illness," as a major and highly encouraging signal for the growing regulatory,
commercial and strategic importance of the sector in which the Company
operates, particularly in the strategically important U.S. market. The
Executive Order states that it is U.S. policy to accelerate innovative
research models and appropriate drug approvals to increase access to
psychedelic drugs for serious mental illness, and includes measures relating
to review prioritisation, Right to Try access pathways, federal-state
collaboration funding, data sharing and rescheduling review following
successful Phase 3 trials.

In Solvonis' view, the Executive Order is a powerful indication that
rapid-acting CNS and psychedelic-adjacent therapies are moving more firmly
into the strategic, regulatory and policy mainstream in the world's most
important pharmaceutical and capital-markets arena for this category. The
Company believes this development is significant not only because of the
specific measures announced, but because it reflects a broader shift in U.S.
policy attention toward accelerating innovation in serious mental illness and
addiction. The Order itself refers to major depressive disorder and substance
abuse disorder among the conditions for which innovative methods are needed
beyond existing prescription medications.

While the Executive Order does not relate directly to any specific Solvonis
programme, the Company believes it is highly relevant to the therapeutic areas
in which it operates, including addiction, PTSD and broader psychiatry.
Solvonis' pipeline spans addiction and psychiatry, including SVN-001 in severe
alcohol use disorder, SVN-002 in moderate-to-severe alcohol use disorder in
the United States, SVN-015 in stimulant addiction with optionality in
depression, and SVN-114 in PTSD.

In particular, Solvonis believes the improving U.S. backdrop is relevant to
SVN-002, its U.S.-focused programme being advanced through a 505(b)(2)
strategy designed to bridge to an established U.S. esketamine framework. The
Company also believes the increasing U.S. focus on innovative treatments for
addiction and serious mental illness is supportive of the broader long-term
positioning of programmes such as SVN-015, its stimulant addiction programme,
which was accepted into the U.S. National Institute on Drug Abuse's ("NIDA")
Addiction Treatment Discovery Program ("ATDP"). Under the programme, NIDA,
part of the U.S. National Institutes of Health ("NIH"), will fund and conduct
early preclinical evaluation of SVN-015, including initial in vitro predictive
safety studies, with potential progression into efficacy studies in validated
preclinical models of methamphetamine and cocaine addiction if results are
supportive.

Solvonis also believes the Executive Order reinforces a wider strategic
reality: the United States remains the most attractive long-term commercial,
regulatory and capital-markets environment globally for innovative CNS
therapeutics. As policy support, regulatory engagement and investor attention
continue to evolve, the Company believes the opportunity set for
well-positioned businesses in this space may expand materially.

Anthony Tennyson, CEO of Solvonis Therapeutics plc, commented: "We welcome the
White House Executive Order as a major positive signal for the broader sector
and as further evidence that rapid-acting CNS and psychedelic-adjacent
therapies are gaining real momentum in the United States.

While this is not a programme-specific announcement for Solvonis, it is highly
relevant in strategic terms. It reinforces our view that the broader backdrop
is improving, particularly in the United States, and highlights the increasing
importance of companies able to build differentiated positions across
addiction, PTSD and psychiatry.

With SVN-001, SVN-002, SVN-015 and our broader pipeline, we believe Solvonis
is building a highly differentiated portfolio with meaningful optionality in
an area of increasing regulatory, commercial and policy importance. As the
sector continues to mature, we believe businesses with credible programmes,
clear execution pathways and strong U.S. relevance are likely to be well
placed, and we believe Solvonis is one of them."

The Company will continue to monitor U.S. policy, regulatory and market
developments in this area and assess their relevance to its pipeline,
strategic positioning and long-term capital-markets plans.

 

Enquiries:

 

 Solvonis Therapeutics plc                                       Via Walbrook
 Anthony Tennyson, CEO & Executive Director

 Singer Capital Markets (Broker)                                 +44 (0) 20 7496 3000
 Phil Davies

 Walbrook PR (PR/IR advisers)  Tel: +44 (0)20 7933 8780 or solvonistherapeutics@walbrookpr.com
                               (mailto:solvonistherapeutics@walbrookpr.com)
 Anna Dunphy                                                     Mob: +44 (0)7876 741 001
 Lianne Applegarth                                               Mob: +44 (0)7584 391 303
 Rachel Broad                                                    Mob: +44 (0)7747 515 393

About Solvonis Therapeutics plc

Solvonis Therapeutics plc (LSE: SVNS) is an emerging biopharmaceutical company
developing small-molecule therapeutics for high-burden central nervous system
(CNS) disorders. Headquartered in London and listed on the main market of the
London Stock Exchange, Solvonis is advancing a differentiated pipeline of
repurposed and discovery-stage compounds across addiction and psychiatry.

 

The Company's lead programmes target Alcohol Use Disorder (AUD) and
Post-Traumatic Stress Disorder (PTSD), with additional development and
discovery work supporting expansion into further addiction and psychiatric
indications, including stimulant use disorder and depressive disorders.

 

Its lead asset, SVN-001, is currently in Phase 3 for severe AUD in the UK,
while SVN-002 is preparing for a Phase 2b trial in the United States targeting
moderate-to-severe AUD. The Company's PTSD discovery programme has identified
SVN-114 as a lead compound, emerging from a proprietary compound series
designed to modulate key brain signalling systems associated with emotional
processing and social behaviour.

 

In parallel, Solvonis is advancing proprietary CNS discovery programmes
supported by a dedicated compound library to identify new small-molecule
modulators of key neurotransmitter systems. This platform enables efficient
early-stage innovation and supports the Company's integrated approach to
developing therapies across addiction and psychiatry.

 

With a capital-efficient development model and a focus on partnering
opportunities, Solvonis aims to deliver sustained value through innovation in
CNS therapeutics.

 

solvonis.com (https://solvonis.com) | LinkedIn
(https://www.linkedin.com/company/solvonis) | X (Twitter)
(https://x.com/Solvonis)

 

 

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