Madrid hosts the oncology calendar, but the checkable European news is narrower than the headlines
The ESMO Congress runs 23–27 October 2026 in Madrid.1 Moderna and Merck plan to present detailed intismeran results there on 24 October and to engage with regulators about potential filings.2 The topic framing we were given also mentions CHMP opinions on RASONQUE and Libtayo and an FDA decision on Tecentriq. Our verified dossier holds no source documents for those three. We do not describe them, because a shorter piece we can stand behind is worth more than a longer one we cannot. Readers should also know how much weight the sources can bear. The press-release feed behind most of the documents below held up in 53% of 6,520 checked claims, so each press-release claim here is the company's own account.
The EU regulatory record we can verify
On 24 July 2026 the European Medicines Agency's human-medicines committee (CHMP) adopted a positive opinion recommending marketing authorisation of Gilead's Trodelvy, combined with Keytruda, in PD-(L)1-positive first-line metastatic triple-negative breast cancer.3 Gilead said a second first-line approval would establish Trodelvy as a backbone therapy across PD-L1 status in the European Union.3 A CHMP opinion is a recommendation, not the final authorisation. The clinician quoted in the release spoke conditionally too. Evandro de Azambuja said: “People with metastatic triple-negative breast cancer need effective treatment options as early as possible in the course of their disease, particularly when their tumors express PD-L1. This positive opinion is welcome news for our patients and the entire clinical community.”3
Two other items give a European commercial and clinical picture. Novocure received a CE Mark for Optune Pax in locally advanced pancreatic cancer, and Germany is the first EU market to launch. More than 280 patients were active on Optune Pax as of 30 June 2026.4 The company reported second-quarter net revenues of $184 million, up 16% year on year, with 18% growth in global active patients.4 Frank Leonard said: “This was our strongest quarter to date, with record net revenues and active patients on therapy.”4
On the clinical side, the final MINT study analysis covered 109 patients with mycosis fungoides and Sézary syndrome at 18 German centres, treated with mogamulizumab (Poteligeo) in routine care. Median time to next treatment, the primary endpoint, was 14.9 months. The best overall response rate was 62.4% and median progression-free survival was 20.2 months.5 This is real-world evidence from clinical practice, not a randomised trial.
Below the large caps: a Nordic delisting and an unfunded niche
The capital picture is uneven below the big names. On 22 October 2026 the board of Spago resolved to apply to delist its shares from Nasdaq First North Growth Market, to improve conditions for financing the next phase of Tumorad development. The move is subject to an extraordinary general meeting.6 That meeting is planned for 19 November 2026. The delisting application is intended no earlier than 25 January 2027, and the last day of trading is expected in February 2027.6 For a European small-cap holder the practical point is the timetable. The shares are expected to stop trading on that market within roughly three months.
Akari Therapeutics, dual-based in Tampa and London, is pitching a different kind of bet. Its stated position is that patients who have stopped responding to antibody-drug conjugates (ADCs) are a significant, growing unmet need. It says its novel payload gives it an exclusive route to them, one that current and most future ADCs cannot reach.7 That is the company's own claim. The same release says its AKTX-101 programme is planned to enter Phase 1 clinical development in mid-2027.7 Nothing in our dossier tests the claim independently.
Ivonescimab: positive survival data, but whose trial is it?
The positive result belongs to Akeso. Its Phase III HARMONi-GI1 trial showed positive overall survival for ivonescimab plus chemotherapy versus durvalumab plus chemotherapy in first-line advanced biliary tract cancer. It was selected as a Late-Breaking Abstract for the ESMO Presidential Symposium.8 The dossier gives no survival figures, so we cannot say how large the benefit was. The comparator, durvalumab, is developed by AstraZeneca.9 Summit Therapeutics separately announced ivonescimab data across 10 ESMO 2026 presentations spanning many tumour types, including biliary tract, thymic carcinoma, renal cell, endometrial, esophageal, gastric/GEJ, pancreatic, glioblastoma and head and neck squamous cancers.10
Summit's filings show what that breadth costs. Every figure below is verified against its SEC filings.11
- Revenue was zero in both FY2023 and FY2024.11
- The net loss was $614.9 million in FY2023, $221.3 million in FY2024 and $1,079.6 million in FY2025. The FY2025 loss is nearly five times the year before.11 Loss per share was $0.99, $0.31 and $1.44 over the same three years.11
- Operating cash outflow was $76.8 million, $142.1 million and $322.9 million in FY2023, FY2024 and FY2025.11
- Capital expenditure was $128,000, $139,000 and $657,000 over the same years.11
The net loss and the cash outflow are different measures. The FY2025 net loss ($1.08 billion) is more than three times the cash that left the business ($322.9 million), and FY2023 shows the same gap. The dossier does not explain it, so we do not either. Readers should not treat the headline loss as the amount of money Summit is spending.
Cash held by the company has been volatile. It was $71.4 million at the end of FY2023, $104.9 million at FY2024 and $225.3 million at FY2025.11 It was $106.5 million at Q1 2026 and $419.4 million at Q2 2026, against $297.9 million at Q2 2025.11 The dossier does not say what drove the Q1-to-Q2 2026 jump. Our own arithmetic, not a forecast: $419.4 million is a little over one year at FY2025's operating outflow rate. The dossier contains no index weighting for Summit, so we cannot say whether a typical index fund holds it.
The large-cap backdrop: AstraZeneca's launch and its AI pitch
On 22 October AstraZeneca announced US availability of ZEGFROVY (sunvozertinib) for adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease progressed on or after platinum-based chemotherapy. It describes it as the only approved oral, single-agent targeted therapy for these patients.12 That description is AstraZeneca's. Mohit Manrao said: “As a leader in treating EGFR-mutated lung cancer, the US launch of ZEGFROVY marks an important step forward in our commitment to this patient community.”12 AstraZeneca sits in the FTSE 100, so anyone holding a tracker of that index owns some of it. The dossier gives no weighting.9 It lists Eli Lilly, Pfizer and Novo Nordisk as competitors.9
AstraZeneca is also pitching an AI-and-robotics “lab of the future”. Puja Sapra describes it this way: “Where a self-driving car uses sensors and models to navigate its environment, this system uses AI to make predictions, robotic systems to execute experiments, and instruments to generate data.”13 She names data as the differentiator: “Data is our differentiator.”13 She also concedes the hard part: “One of the hardest problems in de novo design is predicting whether a computationally generated molecule will be safe in the human body.”13 On oversight she says: “With more autonomous systems, human oversight remains at the heart of this approach—ensuring explainable and ethical AI for the benefit of patients.”13 Treat this as a company vision, not a result. The source article is from MIT Technology Review, and only 6% of 16 claims checked from that source held up. It also carries no verified date in our dossier. We also have no figure in the dossier for what the programme has produced.
What to watch
- The detailed intismeran results at ESMO on 24 October, and any regulator filings Moderna and Merck announce.2
- The extraordinary general meeting on Spago's delisting on 19 November, and the application date no earlier than 25 January 2027.6
- Whether the European Commission follows the CHMP's Trodelvy opinion. The dossier does not yet contain that decision.3
- Summit's next filing: whether cash stays above Q2 2026's $419.4 million as ten ESMO presentations' worth of development continues.11
