Nouscom Announces €120 Million Series D Funding and Upcoming Presentation of Long-Term Lynch Syndrome Clinical Data at ESMO; Viatris Announces FDA Approval of RYZUMVI for Presbyopia; Lilly’s Omvoh Meets Clinical Remission Endpoint in Children with Ulcerative Colitis; Estuary Biotherapeutics Debuts with $103 Million in Funding to Tackle Kidney Disease; Roche’s Enspryng Receives FDA Approval as a First-in-Class IL-6R Inhibitor for Thyroid Eye Disease

Nouscom Secures Major Series D Funding and Prepares to Share Long-Term Clinical Findings in Lynch Syndrome Carriers at ESMO

Nouscom has announced the completion of an oversubscribed €120 million ($135 million) Series D financing round. The investment was co-led by M Ventures and Revelation Partners, with participation from new investors Angelini Industries, through Angelini Investments; the European Investment Bank, through Aurea, its co-investment facility with Angelini Ventures; and Neva SGR, part of the Intesa Sanpaolo Group. Existing international life sciences investors also participated, including 5AM Ventures, Andera Partners, Angelini Ventures, Bpifrance through its InnoBio2 fund, CDP Venture Capital through its Large Ventures Fund, EQT Life Sciences, Indaco Venture Partners, Panakes Partners, Versant Ventures, and XGEN Ventures. The strong investor demand underscores confidence in Nouscom’s development pipeline and its recently reported clinical findings.

The proceeds will support the development of NOUS-209, an investigational, off-the-shelf neoantigen-based cancer immunotherapy, through a single global clinical trial designed to support registration for cancer interception in individuals carrying Lynch syndrome (LS). The investigational therapy has received Fast Track designation from the U.S. Food and Drug Administration (FDA).

The financing announcement coincides with the planned presentation of long-term cancer interception data from a Phase 1b/2 trial evaluating NOUS-209 in LS carriers at the European Society for Medical Oncology (ESMO) Congress, scheduled to take place in Madrid, Spain, from October 23–27, 2026. The findings will be presented by the study’s principal investigator, Eduardo Vilar-Sanchez, M.D., Ph.D., chair ad interim of Clinical Cancer Prevention at The University of Texas MD Anderson Cancer Center.

According to the abstract published by ESMO, all evaluable participants treated with NOUS-209 remained free of advanced adenomas and colorectal cancer, based on colonoscopy findings, at the one- and two-year assessments (n=43 and n=17, respectively). These results provide an encouraging indication of sustained clinical activity and are consistent with a potential treatment effect compared with the expected incidence of these conditions among LS carriers. The findings were further supported by broad, potent, and durable T-cell responses against neoantigens induced by NOUS-209, which were enhanced following annual re-treatment.

Viatris’ RYZUMVI Gains U.S. FDA Approval for Presbyopia

The US Food and Drug Administration (FDA) has approved Viatris’ Ryzumvi (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia in adults. Ryzumvi is already marketed in the US as the only authorised treatment for pharmacologically induced mydriasis, a condition characterised by pupil dilation caused by certain medications.

Under a global licensing agreement with Opus Genetics, Viatris holds exclusive US commercialisation rights for phentolamine ophthalmic solution 0.75%. Following the expanded approval, the company is evaluating opportunities to partner with another organisation to support the nationwide commercialisation of the solution for presbyopia.

Presbyopia is an age-related condition characterised by a gradual decline in the eye’s ability to focus on nearby objects. It typically develops in the early to mid-40s and affects nearly all adults over the course of their lives. If left uncorrected, the condition can contribute substantially to vision-related disability. Common symptoms include blurred near vision and eye strain, which can interfere with routine activities and reduce productivity.

According to the medication’s safety instructions, contact lens wearers should remove their lenses before administering Ryzumvi and wait at least 10 minutes after dosing before reinserting them. In clinical trials evaluating Ryzumvi for presbyopia, the most frequently reported ocular adverse reactions, occurring in more than 5% of participants, were conjunctival hyperaemia (21%) and instillation-site irritation (16%).

In addition to its newly approved indication, Ryzumvi is indicated for the treatment of pharmacologically induced mydriasis caused by adrenergic agonists, such as phenylephrine, or parasympatholytic agents, including tropicamide, in adults and paediatric patients aged three years and older. For this indication, the most common adverse reactions reported in more than 5% of patients were instillation-site discomfort, including burning, pain and stinging (16%); conjunctival hyperaemia (12%); and dysgeusia, or altered taste perception (6%). Most of these reactions were mild, transient and resolved without intervention. Viatris is headquartered in the US and operates global centres in Hyderabad, India; Pittsburgh, US; and Shanghai, China.

Lilly’s Omvoh Achieves Clinical Remission Primary Endpoint in Phase 3 Pediatric Ulcerative Colitis Trial

Eli Lilly and Company announced positive one-year results from the Phase 3 SHINE-2 study evaluating Omvoh (mirikizumab-mrkz) in children and adolescents aged 6 to 17 years with moderately to severely active ulcerative colitis (UC). The late-breaking findings included clinical, symptomatic and endoscopic outcomes. In the single-arm, open-label trial, 81% of patients achieved a clinical response following Omvoh induction treatment at Week 12. Among these responders, 50% achieved clinical remission at Week 52, meeting the study’s primary endpoint. Omvoh is the first interleukin-23 p19 (IL-23p19) inhibitor to report one-year Phase 3 results in pediatric UC. The findings were presented in a late-breaking oral presentation at United European Gastroenterology (UEG) Week 2026.

Omvoh is currently approved for adults with moderately to severely active UC, while its safety and efficacy in pediatric patients remain under clinical evaluation. Lilly intends to submit the SHINE-2 findings to regulatory authorities worldwide to support a potential expansion of the drug’s indication. If approved for pediatric use, Omvoh would become the first IL-23p19 inhibitor indicated for children and adolescents with UC.

“Children and adolescents living with ulcerative colitis often struggle with persistent bowel urgency, abdominal pain and unpredictable symptoms that can prevent them from enjoying a normal childhood, particularly when their disease returns after previous treatments,” said Mark Genovese, M.D., senior vice president of Lilly Immunology Development. “Omvoh is already approved for adults with ulcerative colitis and is the first IL-23p19 inhibitor to report one-year Phase 3 results in pediatric patients with the disease. We look forward to engaging with regulatory authorities to explore the possibility of making Omvoh available to affected children and adolescents, who continue to experience a considerable disease burden and significant unmet treatment needs.”

More than 26,000 children and adolescents in the United States are affected by UC. Although pediatric-onset UC is relatively uncommon, it often involves more extensive and severe disease than cases that develop during adulthood. Up to 50% of children receiving corticosteroid treatment become dependent on these medications, while as many as one-third may require surgery within one year.

The SHINE-2 trial assessed Omvoh in a pediatric population characterized by substantial disease burden and considerable unmet medical need. Notably, 54% of enrolled patients had previously experienced treatment failure with biologic therapies, and half had severe disease activity at study entry, as measured by the Pediatric Ulcerative Colitis Activity Index.

“For children with ulcerative colitis, spending years dependent on corticosteroids or living with the prospect of surgery can significantly affect growth, development and quality of life,” said Marla C. Dubinsky, M.D., professor of pediatrics and medicine at the Icahn School of Medicine at Mount Sinai and chief of pediatric gastroenterology and nutrition at Mount Sinai Kravis Children’s Hospital. “Against this backdrop, the finding that half of the pediatric patients who responded to Omvoh achieved corticosteroid-free clinical remission without surgery at one year is particularly encouraging. This is especially noteworthy given that many participants had previously experienced treatment failure with advanced therapies.”

Estuary Biotherapeutics Emerges with $103 Million to Advance Gene Therapies for Kidney Disorders

Estuary Biotherapeutics, Inc., a biotechnology company focused on developing genetic medicines for patients with serious kidney diseases, has announced its launch with $103 million in total committed financing. The funding includes a $93 million Series A round led by RA Capital Management, with participation from Deep Track Capital, Biogen New Ventures, UPMC Enterprises, Pivotal bioVenture Partners, the National Kidney Foundation Innovation Fund, and a family office affiliated with an individual living with autosomal dominant polycystic kidney disease (ADPKD). 4BIO Capital and GV, which jointly led the company’s $10 million seed round, also participated in the Series A financing.

The proceeds will fund the advancement of Estuary’s two lead programs, EST-201 and EST-101, toward clinical proof of concept, while supporting further development of its kidney-targeting platform. The programs are designed to address the most common genetic subtypes of ADPKD, an inherited, chronic and progressive condition marked by the formation of cysts in both kidneys. As these cysts grow, they progressively replace healthy kidney tissue, potentially leading to organ failure and the need for dialysis or transplantation.

“ADPKD is one of the world’s most common genetic diseases, yet patients are still awaiting a therapy that can transform the course of their disease,” said Wayne Sackett, co-founder and CEO of Estuary. He noted that the company combines landmark discoveries in disease biology made by its scientific co-founders with a dedicated team working to overcome a major obstacle in kidney gene therapy: effective delivery. By pioneering targeted local administration and an efficient global development strategy, Estuary aims to accelerate the advancement of its therapies into clinical development.

“Estuary’s programs have the potential to transform the care of patients with ADPKD,” said Emily Minkow, managing director at RA Capital Management. She highlighted the company’s differentiated strategy, which combines an established gene therapy modality with localized, kidney-directed delivery designed to reach the nephron directly. Citing compelling scientific evidence suggesting the potential to reverse disease, Minkow expressed confidence that the approach could significantly expand treatment possibilities for patients and reaffirmed RA Capital’s support as the company progresses toward clinical development.

Roche Secures FDA Approval for Enspryng as an At-Home Treatment Option for Thyroid Eye Disease

Roche announced that the U.S. Food and Drug Administration (FDA) has approved Enspryng® (satralizumab) for treating adults with thyroid eye disease (TED). The approval introduces the first and only at-home subcutaneous treatment option for patients with the condition. Following training from a healthcare professional, Enspryng can be administered by patients themselves or by a caregiver.

“Today’s FDA approval of Enspryng provides an important new option for people with thyroid eye disease, who have long faced limited treatment choices,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. He added that, as the first subcutaneous treatment for TED, Enspryng offers a favourable safety and efficacy profile, with the added convenience of potential at-home administration.

“Treating thyroid eye disease requires balancing efficacy, safety, and the practical realities of long-term treatment,” said César A. Briceño, MD, Clinical Trial Investigator and Associate Professor of Ophthalmology at the Scheie Eye Institute, University of Pennsylvania. Drawing on his experience as a clinical trial investigator, he highlighted the potential of targeted therapies such as Enspryng. He noted that an effective subcutaneous treatment could offer greater flexibility for patients and physicians while reducing the logistical challenges associated with infusion-based therapies, thereby broadening available treatment options for people living with TED.

Data from the pivotal Phase III SatraGO clinical programme, comprising the SatraGO-1 and SatraGO-2 studies, demonstrated clinically meaningful improvements in patients with TED. Although SatraGO-1 did not meet its predefined primary efficacy endpoint at Week 24, SatraGO-2 showed significant and clinically meaningful improvements in proptosis response and diplopia reduction among patients with active TED. Proptosis response was achieved by 52.9% of patients receiving Enspryng, compared with 23.4% in the placebo group. For diplopia reduction, the corresponding rates were 60.7% and 25.8%, respectively. Consistent findings were also observed in the overall SatraGO-2 population, which included patients with both active and chronic TED.

No new safety signals were identified across the SatraGO studies, and Enspryng’s safety profile remained consistent with its established profile in neuromyelitis optica spectrum disorder (NMOSD). Full study results were presented at the American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) Fall Scientific Symposium in October 2025.

“Thyroid eye disease not only affects a person’s eyes through bulging and vision problems, but it also takes a profound emotional toll on confidence, identity, relationships and daily life,” said Christine Gustafson, Chief Executive Officer of the TED Community Organization. She noted that treatment options for the community have historically been limited and described Enspryng’s approval as a critical milestone, offering patients a convenient, targeted treatment alternative.

The FDA approval for TED, granted following a priority review designation, represents Enspryng’s second approved indication, following its 2020 approval for NMOSD. The development programme continues to advance, with the FDA recently accepting an application for priority review in myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). Enspryng is also being investigated in other neurological autoimmune and inflammatory conditions that may benefit from the inhibition of interleukin-6 (IL-6)-mediated signalling.