Regulatory AI Capability Lead

UEGW delegates hear of strides forward in IBD treatment. At Europe's main gastroenterology get-together this week, a series of new studies from big pharma groups promised improvements in the care of people living with ulcerative colitis (UC) and Crohn's disease, the two most common forms of inflammatory bowel disease. Here are some of the clinical highlights of the United European Gastroenterology Week (UEGW) in Barcelona, Spain, which shut its doors yesterday. Lilly eyes label expansion for Omvoh in paediatric UC. While relatively uncommon, UC that starts in childhood tends to be more extensive and severe than when it emerges in adulthood, and on-label treatment options for younger patients are fairly limited. Lilly hopes to extend the available medicines for children after reporting positive results in the phase 3 SHINE-2 study, which involved patients aged six to 17 with moderately to severely active UC and studied the safety and efficacy of induction and maintenance treatment with IL-23p19 inhibitor Omvoh (mirikizumab), currently approved for treating adults with both UC and Crohn's. More than 80% of patients responded to induction treatment with Omvoh, while half of responders were in clinical remission at one year's follow-up. The company said it plans to submit the SHINE-2 data to global regulators to support potential label expansions for Omvoh, which made $182 million in global sales in the first half of this year. Approval of a paediatric label claim could give Lilly a leg-up in the fiercely competitive UC market, making it an option for around 25,000 children in the US alone. Gilead's oral drug for UC promising in SWIFT trial. Gilead Sciences chalked up a phase 2 success for oral α4β7 integrin inhibitor emvistegrast (GS-1427) in adults with moderately to severely active UC, one of a series of planned indications for the drug. The ongoing SWIFT found that a 200 mg dose of emvistegrast achieved a clinical response in 66% of patients at week 12, compared to 37% of a matched placebo group. Clinical remission at that time point was achieved in 31% and 8% of subjects, respectively, and the drug was generally well tolerated with a low rate of treatment discontinuations. Gilead now plans to start a phase 3 trial of emvistegrast monotherapy, hoping to bring it to market as an oral alternative to Takeda's $6.4 billion-a-year blockbuster Entyvio (vedolizumab), which is dosed by intravenous infusion or self-administered subcutaneous injection. Its closest oral rival is Lilly's zotemtograst, which missed the mark in a phase 2a UC trial but remains in mid-stage development for both UC and Crohn's disease. Entyvio breaks new ground in the treatment of UC. More than a decade after its first approvals for IBD, Takeda's Entyvio continues to push the boundaries of treatment. New data from the VERDICT trial show that aggressive treatment with the IV formulation of the drug can reduce the risk of UC complications, such as hospitalisation, colectomy surgery, or the need for rescue therapy, in moderate to severe UC. The study used a "treat-to-target" approach, monitoring patients' disease and adjusting treatment on a set schedule until their disease had cleared - at a histological level - and they no longer needed corticosteroids. Compared with the standard treatment approach, there was a near-70% reduction in UC complication risk overall up to 80 weeks, while the time before developing a complication was extended by around two-thirds. Lead author Vipul Jairath of Western University in Canada said the study provides strong evidence that "implementation of a treat-to-target strategy can change the disease course" in moderate to severe UC. AbbVie makes case for dual-acting drug ABBV-466 in Crohn's. Targeting α4β7 and IL-23 are both well-established strategies in IBD, so combining the two mechanisms makes sense. At UEGW, AbbVie presented the first proof-of-concept data on ABBV-466, a doublet therapy based on IL-23 inhibitor risankizumab - the active ingredient in its big-selling Skyrizi product - with experimental α4β7 inhibitor trosunilimab. In the TARGET-CD study, patients with moderate-to-severe Crohn's and a varied history of prior treatment were randomised to either Skyrizi, trosunilimab, or ABBV-466. At week 12, the rate of endoscopic remission in the three treatment groups was 21.3%, 18.0%, and 30.2%, respectively. ABBV-466 also performed better at week 24, with a remission rate of 40.5% compared to 22.4% with Skyrizi and 20.0% with trosunilimab. Gene expression analysis showed that ABBV-466 led to intestinal tissue repair and barrier restoration by week 12, and tissue remodelling and metabolic changes by week 24, which "were generally not observed with either monotherapy," said AbbVie. IBD study shows long-term benefit of Sanofi and Teva's duvakitug. Sanofi and partner Teva revealed new data at UEGW from the phase 2b RELIEVE UCCD of duvakitug, their anti-TL1A antibody, showing that it can help to maintain long-term positive outcomes in both UC and Crohn's over 44 weeks. Induction results from the study were reported in 2024, and duvakitug is now in a phase 3 programme in both indications. In UC patients, maintenance treatment with duvakitug maintained clinical remission in up to 58% of patients, with 87% remaining in clinical response and 63% still showing endoscopic improvement. In Crohn's - recognised as more complex and harder to treat - those numbers came in at up to 55%, 87%, and 84%, respectively. Sanofi and Teva are in a race to market in the anti-TL1A class with Roche and MSD, which both have drugs in the category - respectively afimkibart and tulisokibart - in late-stage testing. Following are Spyre Therapeutics, with its phase 2-ready candidate SP002, and other companies with early-stage candidates like Earendil Labs, Xencor and Absci. 21 October, 2026

Gilead's 'highly competitive' mid-stage ulcerative colitis data 'validate' I&I push. October 20, 2026 | Gilead's emvistegrast delivered greater clinical response than placebo, setting up the asset for Phase 3 testing in ulcerative colitis as well as studies in other inflammatory diseases and bolstering the company's push beyond its HIV portfolio. Gilead Sciences' investigational drug emvistegrast delivered higher response rates versus placebo in a Phase 2 study of ulcerative colitis - findings that analysts at BMO Capital Markets say "validate" the pharma's efforts to diversify beyond HIV and into immunology and inflammation. "Gilead's asset looks highly competitive vs other a4b7 agents," BMO wrote in a note on Monday. The group pointed to Eli Lilly's zotemtegrast and Takeda's Entyvio, which similarly block the a4b7 integrin in order to suppress inflammation in the gut. In the mid-stage SWIFT trial, 238 patients with moderately to severely active ulcerative colitis were randomly assigned to receive 200 mg, 75 mg or 25 mg of oral emvistegrast daily or placebo. Results, presented Monday at the 2025 United European Gastroenterology Week in Barcelona, Spain, showed that 66% of patients on the highest dose of emvistegrast achieved clinical response, compared to 37% of patients on placebo. The treatment benefit was nominally significant, meeting the study's primary endpoint. Clinical response rates for the 75-mg and 25-mg doses of emvistegrast were 51% and 43%, respectively, according to Gilead's presentation at the conference. With these data, Gilead plans to take emvistegrast into late-stage development - a Phase 3 study set to start next year - with an eye toward future emvistegrast combination therapies, said Swati Tole, senior vice president of Clinical Development, Inflammation, in a prepared statement. Gilead is also looking to launch a Phase 2b/3 study of the asset in Crohn's disease, noted BMO, which also flagged the company's plans to test emvistegrast in combination with other assets, both internal and external, for inflammatory bowel disease. "Taken together, we view SWIFT as an incremental positive for Gilead's inflammatory strategy that establishes emvistegrast as a credible oral a4b7 option," the analysts wrote. Like BMO, analysts at Truist Securities "view the 200 mg cohort results as competitive," they told investors on Monday. However, the firm pointed out that "dose response is not perfect," particularly in terms of secondary endpoints. Rates of clinical remission, for instance, reached 31% in the highest dose group, but came out to 9% and 20% in the 75-mg and 25-mg arms, respectively. Remission in placebo was 8%. A similar pattern emerged for the other secondary endpoints - including mucosal healing, endoscopic improvement and histologic endoscopic mucosal improvement - with "75 mg underperforming 25 mg," Truist explained. Gilead chalked up the lack of a dose response effect to "potential study noise" and small treatment arm sizes, the analysts wrote after speaking with Tole and other members of the Gilead team. The pharma hasn't yet provided a mechanistic explanation for this discrepancy, Truist flagged. "Despite an uneven dose response, we see the data as encouraging clinical POC [proof of concept] for emvistegrast and another step in GILD's broader I&I ambitions," Truist noted. Indeed, Gilead's business is heavily reliant on its HIV portfolio, which in the second quarter accounted for $5.7 billion of the company's total $7.8 billion sales. Seeking to diversify, Gilead has recently struck multiple deals beyond its infectious disease comfort zone. In February, for instance, the pharma dropped $7.8 billion to swallow its CAR T collaborator Arcellx ahead of a key decision for the partners' investigational multiple myeloma therapy anitocabtagene autoleucel (anito-cel). The asset is under review with a decision expected by Dec. 23. Other pickups in Gilead's diversification drive this year include the inflammatory biotech Ouro Medicines and the antibody-drug conjugate (ADC) developer Tubulis, with which the bigger company had previously partnered and which will operate as an ADC specialist under the Gilead umbrella. Gilead last week also secured an equity stake in Vir Biotechnology, giving its vote of confidence to the biotech's T cell engager platform. The pharma put up to $1.74 billion on the line in milestones, and in return received three dual-masked T cell engagers that it plans to study for solid tumors. HIV remained Gilead's strongest franchise in the second quarter, but the pharma is building out its pipeline beyond virology, particularly focusing on inflammation and oncology. August 5, 2026

Gilead's UC pill hits trial goal, stock still slips. Gilead Sciences (NASDAQ: GILD) said on 19 October 2026 that its experimental ulcerative colitis pill met the main goal of a mid-stage trial. The Gilead ulcerative colitis trial, known as SWIFT, tested emvistegrast, an oral once-daily treatment, in adults with moderately to severely active disease. At the 200mg dose, 66% of patients achieved a clinical response at Week 12 under the modified Mayo score, against 37% on placebo, according to PharmaShots. Clinical remission was reached by 31% of patients on the drug, compared with 8% on placebo, Reuters reported. Trial data presented at European gastroenterology meeting. Gilead unveiled the late-breaking Phase 2 findings at United European Gastroenterology Week 2026. The company said its experimental once-daily pill reduced symptoms of the chronic bowel illness in more patients than placebo, meeting the trial's main goal, as Reuters reported. Emvistegrast, also known as GS-1427, is a selective oral alpha4beta7 integrin inhibitor. Gilead is positioning the pill against injectable biologics such as vedolizumab and oral rivals including Abivax's obefazimod in a crowded inflammatory bowel disease field. The drug showed a generally well-tolerated safety profile during the induction phase, Benzinga reported. Shares fall despite the positive readout. GILD shares closed at $153.555 on 19 October, down 1.42% on the day. Trading volume ran at 0.82 times the 20-day average, suggesting limited conviction behind the move. RBC Capital Markets had told clients the emvistegrast readout was unlikely to move the stock, according to MarketScreener. The muted reaction underlines that Street positioning, rather than the trial's raw numbers, set the terms of the share response. FINRA short-volume data for GILD in the fortnight before the announcement showed the daily short ratio moving between roughly 0.37 and 0.57, with no sustained build-up that would point to advance positioning against the news. Earnings swing colours the backdrop. The trial news lands against a volatile run of quarterly results. Gilead posted a net loss of $10,496m, or diluted earnings per share of -$8.45, for the second quarter of 2026, a sharp reversal from net income of $2,021m and EPS of $1.61 in the first quarter, according to the company's 10-Q filing with the SEC. Revenue for the second quarter came in at $7,803m, up from $6,960m in the first three months of the year, filings show. The swing follows a pattern of uneven quarters stretching back through 2024 and 2025. Gilead reported a net loss of $4,170m in the first quarter of 2024 before returning to profit of $1,614m in the second quarter that year, and has posted net income in every quarter since bar the latest one, according to EDGAR records. Quarterly revenue has climbed steadily over the period, from $6,686m in the first quarter of 2024 to $7,803m two years later. Two Gilead insiders, Andrew D. Dickinson and Johanna Mercier, filed Form 4 disclosures with the SEC on 16 October 2026, three days before the trial announcement, according to EDGAR records. The filings do not themselves indicate the direction or scale of any transactions tied to the disclosures. Macro backdrop stays mixed for pharma stocks. The readout also arrives as broader market conditions stay unsettled for healthcare names reliant on long-dated pipeline bets. The 10-year US Treasury yield stood at 5.1% as of 15 October 2026, down slightly from 5.19% a month earlier, according to Federal Reserve data. The 2-year yield sat at 4.77%, leaving the 10-year/2-year spread at 0.35 percentage points, little changed from 0.33 points previously. US consumer prices rose to an index level of 336.298 in September, up from 334.131 the prior month, Federal Reserve data show, while the unemployment rate ticked up to 4.2% from 4.1%. None of that macro data bears directly on Gilead's trial outcome, but it frames a backdrop in which investors have shown little appetite to reward clinical headlines that fall short of outright surprise. Gilead has not disclosed a timeline for advancing emvistegrast into late-stage testing. Investors will watch for further detail at the company's next quarterly results and for any read-across from rival oral IBD programmes now in development. This article is for information only and is not investment advice or a recommendation to buy or sell any asset. Markets move quickly; figures are correct as sourced at the time of writing. Always do your own research before making financial decisions.