Solvonis Therapeutics (formerly Awakn)

Solvonis Therapeutics plc announces Positive Preclinical Results in PTSD Programme Today we announced positive preclinical results from our SVN-SDN-14 programme, identifying three high-performing candidates to advance into in vivo studies. The SVN-SDN-14 series is a novel class of serotonin (SERT), dopamine (DAT) and noradrenaline (NET) modulators designed to enhance pro-social behaviour and improve therapeutic outcomes for people living with Post-Traumatic Stress Disorder (PTSD) — a condition we estimates affects over 20 million people across the UK, US, and major EU markets. From in-vitro screening, three of six synthesised candidates showed robust, balanced modulation profiles across all three neurotransmitter systems — exactly the mechanistic attributes we are targeting to deliver a new class of medicine for trauma-related mental health conditions. Why it matters: Having three strong candidates at this stage — rather than a single clear lead — gives us greater flexibility, a stronger dataset, and increases the probability of selecting a best-in-class PTSD treatment with strong commercial potential. What’s next: The shortlisted candidates now move to in vivo preclinical studies, with results to guide the selection of a single lead candidate. 🔗 https://lnkd.in/e-xb_irn #PTSD #DrugDiscovery #Neuropsychiatry #MentalHealth #Neuroscience #Biotech #AIinBiotech #LifeSciences #ClinicalDevelopment

PTSD isn’t just psychological — it’s neurological. Trauma alters brain systems — including serotonin, dopamine, and noradrenaline pathways — disrupting emotional stability, cognitive function, and the ability to manage stress. Effective new treatments must target these systems directly. #PTSD #Neurobiology #CNSBiotech #Solvonis

Solvonis Therapeutics plc (LSE: SVNS) is focused on developing medicines for chronic, high-prevalence diseases where effective treatment options remain limited. According to the World Health Organization, an estimated 3.9% of the global population — over 300 million people — will experience #PTSD in their lifetime. First-line treatments like #SSRIs show limited efficacy, and trauma-informed therapy remains inconsistently available. At Solvonis Therapeutics plc, we believe people living with #PTSD deserve more — and we’re working to deliver it. #PTSD #MentalHealth #InnovationInBiotech #UnmetNeed #Solvonis #Neuropharma

Solvonis Therapeutics plc (LSE: SVNS): Positioned for value as neuropsychiatry market resets. The neuropsychiatry sector has shifted gears. In the past month, ATAI, COMPASS Pathways, and MindMed — high-profile Nasdaq CNS names — have gained 35–75%, reflecting rising investor conviction across three fronts: 🔹 Commercial proof: J&J’s Spravato® posted $320M in Q2 sales, now on a $1.3B run rate, with peak sales guidance of $3–3.5B. Esketamine is no longer theoretical — it’s commercial. 🔹 Regulatory momentum: RFK Jr.’s push for FDA reform is signaling broader support for modern CNS pathways. 🔹 Market rotation: Investors are moving from concept to execution — backing clinically active, capital-efficient platforms. Solvonis Therapeutics plc (LSE: SVNS) is built to align with these dynamics. We’re advancing a focused pipeline in addiction and mental health, including: -SVN‑001: Phase 3, Severe AUD (UK/EU) -SVN‑002: IND-ready, Moderate-to-Severe AUD (US) -SVN‑SDN‑014: Preclinical, PTSD -Plus an AI-driven CNS discovery programme With dual clinical tracks, regulatory clarity, and a high-need focus, Solvonis Therapeutics plc is structurally aligned with where the market is going — not where it’s been. 📈 Listed on the LSE Main Market (LSE: SVNS) 🧠 Led by a CNS-experienced team ⚙️ Executing with discipline and purpose “Investors want credibility, clarity, and clinical focus. We're building Solvonis with those principles at the core.” #Biotech #Neuropsychiatry #CNS #MentalHealth #AUD #PTSD #Spravato #505b2 #FDA #DrugDevelopment #Solvonis #SVNS #CapitalMarkets

Solvonis Therapeutics plc's SVN‑002: Advancing a differentiated esketamine treatment for Moderate to Severe Alcohol Use Disorder (AUD). Solvonis Therapeutics plc (LSE: SVNS) has initiated the next phase of development for SVN‑002, our sublingual esketamine oral thin film for moderate-to-severe AUD, as we prepare for a planned Phase 2b clinical trial in the US. SVN‑002 is planned to progress via the FDA’s 505(b)(2) pathway, using J&J's Spravato as a reference product — a drug that has become a key CNS franchise for J&J, approved specifically for Treatment-Resistant Depression (TRD). -Spravato Q2 2025 sales: $320M, tracking a $1.3B annual run rate -J&J now guides to $3B–$3.5B in peak sales, more than 50% above Street consensus But here’s the bigger picture: -Moderate-to-severe AUD affects ~20 million adults in the US -TRD affects ~4–6 million adults, or just 20–30% of those with depression Despite this, TRD has attracted significantly more investment and innovation than AUD. SVN‑002 is designed to change that, with: - A differentiated sublingual thin film formulation - A capital-efficient 505(b)(2) regulatory strategy - Psychosocial integration for meaningful clinical outcomes - A large, under-treated population with high public health impact “We believe this programme has the potential to reshape care for one of the most neglected public health challenges in mental health.” — Prof. David Nutt, Chief Scientific Officer #Biotech #AUD #SVN002 #Spravato #505b2 #Esketamine #Neuropsychiatry #AddictionMedicine #MentalHealth #ClinicalDevelopment #Solvonis #SVNS

Solvonis Therapeutics plc is advancing SVN‑002 under the FDA’s 505(b)(2) pathway, with Spravato® — J&J’s intranasal esketamine — as the proposed reference product. SVN‑002 is being developed specifically for moderate-to-severe Alcohol Use Disorder, with a differentiated formulation designed for delivery in addiction treatment clinics. Spravato® is one of J&J’s 26 blockbuster drugs, generating over $1B in annual sales — providing a potentially strong foundation for Solvonis’ regulatory and clinical strategy. #SVN002 #AUD #505b2 #Spravato #AddictionTreatment #Solvonis #SVNS

Alcohol Use Disorder Is the Public Health Crisis We Keep Ignoring. 29.5 million Americans meet the diagnostic criteria for Alcohol Use Disorder. Fewer than 5% receive treatment. The system isn’t reaching those who need it most. SVN‑002 is Solvonis Therapeutics plc's neuroscience-led response for the U.S. market: ✔ Novel sublingual esketamine-based therapeutic ✔ Delivered in real-world addiction clinics ✔ Pursuing FDA 505(b)(2) path, with Spravato® as reference — subject to scientific bridging It’s time for a treatment that fits the scale of the crisis — and the system we already have. #AUD #SVN002 #505b2 #AddictionTreatment #Solvonis #PublicHealth

Solvonis Therapeutics plc Congratulates Chair Dennis Purcell on $1.9B IGI–AbbVie Deal Congratulations to our Chair, Dennis Purcell, on the announcement of a landmark $1.9 billion global licensing deal between IGI (Ichnos Glenmark Innovation) and AbbVie. Under the terms of the agreement, AbbVie has secured exclusive rights to ISB 2001, a first-in-class CD38×BCMA×CD3 trispecific antibody, across North America, Europe, Japan, and Greater China. Deal highlights: 💰 $700 million upfront payment 📈 Up to $1.225 billion in development, regulatory, and commercial milestones 📊 Tiered, double-digit royalties on future net sales Dennis Purcell serves as a Non-Executive Director at IGI and brings unmatched experience in scaling breakthrough science across global markets. This deal is further testament to the calibre of strategic leadership Dennis brings to the sector — and to Solvonis Therapeutics plc. We're proud to have him lead our Board as we advance our differentiated pipeline of repurposed and novel compounds targeting high-burden neuropsychiatric conditions with significant unmet need. #Solvonis #SVNS #DennisPurcell #AbbVie #IGI #BiotechLeadership #AddictionTreatmentInnovation #MentalHealthTreatmentInnovation #CNS https://lnkd.in/eH-Km6ki

Solvonis Therapeutics plc Chair Dennis Purcell joins biotech luminaries at Lucid Capital Markets LLC exclusive event We’re proud to share that our Chairman, Dennis Purcell, will appear alongside Dr. Jeremy M. Levin and Stelios Papadopoulos in an exclusive Lucid Capital Markets LLC event hosted by Elemer Piros, one of the sector’s most respected #biotech analysts. 📅 Thursday, July 17th at 2:00pm ET 🧬 Hosted by Lucid Capital Markets This panel brings together three of the most influential figures in global biopharma — leaders who have shaped the trajectory of our industry over the last three decades. Dennis’ inclusion reflects his unmatched credibility, having led Aisling Capital, deployed over $15B in ~200 biotech investments, and supported the growth of some of the sector’s most successful companies. We’re honoured to have his strategic guidance as Chair of Solvonis Therapeutics plc as we advance our mission to build a differentiated CNS drug development pipeline. #Solvonis #SVNS #DennisPurcell #LucidCapitalMarkets #BiotechLeadership #AIinBiotech #MentalHealthInnovation #AddictionTreatmentInnovation #CNS

29.5M Americans meet the diagnostic criteria for #AlcoholUseDisorder | Only 5% Treated | Time for a New Paradigm. In 2022, 29.5M people in the U.S. met criteria for #AlcoholUseDisorder (AUD). Yet only 1 in 20 received any treatment (Substance Abuse and Mental Health Services Administration (SAMHSA), 2022). #SVN‑002 is Solvonis Therapeutics plc’s acute, neuroscience-based response — being designed for real-world clinical deployment for the #US market. #AUD #505b2 #PublicHealth #Solvonis #AddictionTreatmentInnovation