CVN-424

Plus, news from Vistagen, Enterprise Therapeutics, Cerevance and Memento Medicines. 😴 Alkermes’ narcolepsy drug succeeds in Phase 3 study: The company’s drug Lumryz, approved in 2023 for narcolepsy, hit its primary endpoint in another sleep disorder called idiopathic hypersomnia. Alkermes plans to file for a label expansion with the FDA by the end of the year, but won’t be able to sell the drug until March 2028 due to a settlement agreement between Jazz Pharmaceuticals and Lumryz’s developer, Avadel Pharmaceuticals. Alkermes acquired Avadel last year after a bidding war with Lundbeck. — Max Gelman 🤝 Boehringer does an antibody deal: For up to €407.5 million ($478.4 million), the family-owned pharma giant will develop a chronic inflammatory and autoimmune disease treatment from Immunitas Therapeutics. The unnamed antibody “is designed to target pathogenic cells localized at the sites of inflammation,” Boehringer said. Waltham, MA-based Immunitas has an anti-CD161 drug in early clinical testing for cancer. It last disclosed a $58 million Series B in 2021. — Kyle LaHucik 👃 Vistagen reports signs of efficacy in anxiety study: Vistagen said patients who took its nasal spray for social anxiety disorder saw “clinically relevant improvement” in the open-label extension portion of a Phase 3 trial. The drug, called fasedienol, failed the placebo-controlled portion of the trial designed to measure its effect on anxiety symptoms in a simulated single-dose public speaking challenge. In the open-label extension portion, patients could take the drug up to six times per day for up to 12 months. Vistagen said early data from the first four months showed the drug was well-tolerated, with patients experiencing improvements in social anxiety on clinician-administered and patient-reported scales. — Nicole DeFeudis 🫁 Enterprise Therapeutics touts Phase 2 cystic fibrosis data: The private, UK-based biotech said its program ETD001 improved lung function by a statistically significant margin after four weeks compared to placebo. Enterprise is developing ETD001 for cystic fibrosis patients who don’t respond to CFTR modulators. Enterprise will test ETD001, an inhaled drug, in a longer duration Phase 2b study, and measure its effect on top of CFTR modulators. — Max Gelman 💸 Cerevance gets $20M: The Boston-based biotech closed a $20 million Series C to keep its engine humming into 2027, which means the company should get through a Phase 3 data readout in Parkinson’s disease. The global study of solengepras ( CVN424 ) is now fully enrolled with 341 patients and is slated to have data at the end of the third quarter. Existing backers such as GV, SV Health’s Dementia Discovery Fund and Gates Frontier returned for the new financing round. — Kyle LaHucik 🇰🇷 NewCo from Korea: A new US company called Memento Medicines has signed an up-to $1.08 billion deal with South Korean biotechs Curacle and MabTics. The deal revolves around MT-103, a potential treatment for wet age-related macular degeneration that aims to inhibit both VEGF and Ang-2. Those are the targets of Roche’s Vabysmo. Other experimental ophthalmology drugs go after these mechanisms, including NovaBridge Biosciences’ VIS-101 and Ollin Biosciences’ OLN324 . — Kyle LaHucik

Phase 3 ARISE trial of solengepras, a potential first-in-class non-dopaminergic therapy, is fully enrolled and topline data is expected at the end of Q3 2026 Pivotal study targets daily OFF periods, a debilitating unmet need affecting millions of people living with Parkinson’s disease worldwide Oversubscribed $20 million Series C financing provides funding through topline readout and extends cash runway into mid-2027 Financing supported by strong participation of existing investors, reinforcing strong alignment and continued conviction in Cerevance’s strategy BOSTON, May 12, 2026 (GLOBE NEWSWIRE) -- Cerevance, a clinical-stage biopharmaceutical company advancing targeted therapies for neurodegenerative diseases and obesity, today announced completion of patient enrollment in the pivotal Phase 3 ARISE trial evaluating solengepras in Parkinson’s disease and the closing of a $20 million Series C financing round. The ARISE trial enrolled 341 patients across the United States, Europe, United Kingdom, and Australia, and is assessing solengepras as an adjunctive therapy to levodopa and other standard-of-care Parkinson’s medications in patients who experience motor fluctuations, including daily OFF periods. The Series C was funded by Cerevance's existing investors, with participation from Double Point Ventures, Gates Frontier, Google Ventures, Lightstone Ventures, MQB Partners, SV Health Investors’ Dementia Discovery Fund, and UPMC, underscoring their continued commitment to the program. Proceeds are expected to fund the company's operations into mid-2027, supporting completion of the ARISE trial and continued advancement of Cerevance's pipeline. Solengepras is a potential first-in-class, once-daily oral therapy that works through a fundamentally different mechanism than existing Parkinson’s treatments. By targeting the GPR6 receptor rather than the dopamine system, solengepras is designed to reduce OFF periods, the hours each day when symptoms recur despite medication. This approach has the potential to markedly reduce the incidence and severity of side effects typically associated with dopaminergic therapies. "This is a critical moment for Cerevance," said Craig Thompson, chief executive officer of Cerevance. "In our Phase 2 trial, solengepras demonstrated reduced OFF time and a favorable tolerability profile. With ARISE fully enrolled and our oversubscribed Series C secured with strong support from our existing investors, we are funded through topline data and poised to deliver what could be the first non-dopaminergic therapy to reach patients in decades. We expect to report results later this year, and are well positioned from both a clinical and financial standpoint as we approach this important inflection point." "More than 10 million people worldwide live with Parkinson’s disease, and motor fluctuations remain one of the most persistent and disruptive challenges in disease management, with current therapies leaving a substantial gap in care," said Stuart H. Isaacson, MD, director of the Parkinson’s Disease and Movement Disorders Center of Boca Raton and principal investigator of the ARISE trial. "The ARISE trial is designed to rigorously evaluate solengepras' impact on OFF time in patients receiving standard-of-care therapy, and we look forward to seeing the data later this year." About Parkinson’s Disease Parkinson’s disease is a progressive neurodegenerative disorder characterized by both motor symptoms—such as tremor, rigidity, and bradykinesia/akinesia—as well as non-motor symptoms such as mood changes, apathy, and cognitive deficits. Parkinson’s disease is the fastest growing neurological disorder globally, affecting more than 10 million people worldwide and approximately 1 million people in the United States. The current standard of care relies primarily on dopaminergic therapies such as levodopa, which tend to lose effectiveness over time and are associated with side effects—including motor fluctuations and dyskinesias—that create increasingly difficult risk-benefit tradeoffs for patients. About Solengepras (CVN424) Solengepras is designed to provide a potentially novel approach to treating Parkinson’s disease. Unlike dopaminergic therapies, which act primarily by replenishing, enhancing, or mimicking dopamine, solengepras selectively targets the indirect pathway by inhibiting the GPR6 receptor. This mechanism aims to restore both motor and non-motor function without directly altering dopamine levels or signaling, potentially improving the balance between the direct and indirect basal ganglia pathways and reducing the risk of side effects such as dyskinesias and motor fluctuations that are commonly associated with dopaminergic therapies. Solengepras is being evaluated as a once-daily, oral adjunctive therapy to levodopa and other anti-Parkinsonian medications in the Phase 3 ARISE trial. About the Pivotal Phase 3 ARISE Trial The multicenter, randomized, double-blind, placebo-controlled Phase 3 ARISE trial is evaluating the efficacy and safety of solengepras as an adjunctive therapy to levodopa and other background Parkinson’s disease medications. The trial enrolled 341 patients with Parkinson’s disease age 30 and older with motor fluctuations who have an average of three or more hours of total OFF time per day. Study participants were randomized to solengepras 75 mg or 150 mg or placebo once daily for 12 weeks. The primary endpoint is the change from baseline to week 12 in average daily OFF time for solengepras 150 mg versus placebo. Secondary objectives include assessing safety and tolerability and further characterizing the effect of solengepras on other motor symptoms (e.g., ON time), non-motor symptoms (e.g., daytime sleepiness), cognitive function, and several quality-of-life measures (e.g., Movement Disorder Society-UPDRS, PD Questionnaire 39, Clinical Global Impression scale, Patient Global Impression scale). ARISE was conducted globally at sites in the United States, Europe, and Australia. About Cerevance Cerevance is focused on advancing cell type-specific therapies for the treatment of neurodegenerative diseases and obesity. Our proprietary platform, N uclear E nriched T ranscript S ort seq uencing (NETSseq), enables identification of potential drug targets from human brain samples expressed in specific cell types, including those at very low levels or within rare cell populations, and whose expression may change as a disease progresses. Our most advanced investigational treatment, solengepras, is currently in Phase 3 development and has the potential to be a first-in-class, oral non-dopaminergic therapy for both motor and non-motor symptoms of Parkinson's disease. Our second investigational treatment, CVN293, is a highly selective investigational oral inhibitor targeting THIK1 (KCNK13), a two-pore potassium channel family member. CVN293 represents a potentially novel intervention point for neurodegenerative disorders and obesity. For more information, please visit and follow us on LinkedIn and X . Contacts Cerevance: Johnna Simoes, ir@cerevance.com Media: April Dovorany, Real Chemistry, media@cerevance.com