Revolution Medicines’ Rasonque receives FDA approval as what the FDA calls the first in class targeted therapy for metastatic pancreatic cancer, Priovant’s Lisraya is cleared as the first oral therapy indicated for dermatomyositis in adults, Johnson & Johnson’s IMAAVY becomes the first treatment approved specifically for warm autoimmune haemolytic anaemia, AstraZeneca and Amgen’s Tezspire meets both co-primary endpoints in the Phase 3 CROSSING trial in eosinophilic oesophagitis, Summit and Akeso’s ivonescimab meets its primary endpoint in the Phase 3 HARMONi-GI1 trial in first-line biliary tract cancer, and ViiV Healthcare’s Tivicay PD is approved for infants from birth: the most significant clinical trial results 28 August 2026 has to offer from across the pipeline.
This was a week made by regulators rather than by trial sponsors, with four approvals arriving in the space of four days alongside two late-stage readouts, and not a single missed endpoint among them. The standout is a once-daily tablet for a cancer that has defeated targeted drug development for decades, cleared more than six months ahead of its user fee goal date on a survival result that almost doubled median life expectancy in previously treated disease. Around it sat three further regulatory firsts, in conditions where patients have depended on broad immunosuppression, on adult medicines used off-label, or on nothing designed for them at all. Both readouts were positive, and both were reported without a single effect size attached. Here, Life Science Daily News brings you the most significant clinical trial results 28 August 2026.
Clinical Trial Results 28 August 2026: Rasonque Approved as First in Class Targeted Therapy in Metastatic Pancreatic Cancer
Revolution Medicines announced on 26 August 2026 that the US Food and Drug Administration had approved Rasonque (daraxonrasib) for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. Rasonque is a once-daily oral tablet inhibiting the RAS GTPase family, and the FDA described it as the first in class targeted therapy approved for metastatic pancreatic cancer. The label requires no companion diagnostic and covers patients with or without an identified RAS mutation. The agency granted approval more than six months before its user fee goal date, under the Commissioner’s National Priority Voucher pilot programme.
The approval rests on RASolute 302 (NCT06625320), a randomised, open-label trial in which 500 patients with previously treated metastatic pancreatic adenocarcinoma were randomised 1:1 to daraxonrasib or physician’s choice of chemotherapy. The primary endpoints were progression-free survival and overall survival in patients with a RAS G12 mutation, with the same measures in the overall population as key secondary endpoints. In the intention-to-treat population, Rasonque reduced the risk of death by 60 per cent, with a hazard ratio of 0.40 (95% CI 0.30 to 0.53, p<0.0001), and median overall survival of 13.2 months against 6.7 months. Median progression-free survival was 7.2 months against 3.6 months, with a hazard ratio of 0.49 (95% CI 0.38 to 0.64, p<0.0001). The trial met all primary and key secondary endpoints in both the RAS G12 mutant and overall populations, and results were presented at the 2026 American Society of Clinical Oncology Annual Meeting with simultaneous publication in the New England Journal of Medicine. Adverse reactions occurring in at least 20 per cent of patients included rash, diarrhoea, stomatitis, nausea, fatigue, vomiting, abdominal pain, oedema, decreased appetite and haemorrhage. Tolerability is not a footnote here: dermatologic toxicity occurred in 86 per cent of patients, 10 per cent of them Grade 3, and gastrointestinal perforation in 0.9 per cent of patients, with one fatal event. The drug is available to US patients immediately. Revolution Medicines has set a wholesale acquisition cost of $39,800 for a 30-day supply, and told investors it expects insurer discounts of roughly 20 to 30 per cent.
FDA Approves Priovant’s Lisraya as First Oral Treatment Indicated for Dermatomyositis
Priovant Therapeutics announced on 27 August 2026 that the FDA had approved Lisraya (brepocitinib) 30 mg, a once-daily oral first-in-class TYK2/JAK1 inhibitor, for dermatomyositis in adults. The regulator described it as the first oral drug indicated for the condition, while Priovant calls it the first and only targeted therapy approved for it. Both claims are worth reading precisely, because an intravenous immunoglobulin, Octagam 10%, has carried an FDA-approved adult dermatomyositis indication since July 2021. The advance lies in oral administration and a targeted mechanism, not in being the first approved option. Dermatomyositis causes progressive muscle weakness and painful, itchy skin lesions, and has long been managed with chronic high-dose corticosteroids and non-specific immunomodulators.
Approval follows the Phase 3 VALOR trial (NCT05437263), which enrolled 241 adults across 90 sites randomised 1:1:1 to brepocitinib 30 mg, 15 mg or placebo over 52 weeks, with the myositis Total Improvement Score as the primary endpoint; only the 30 mg dose was approved. By the end of the study, 55 per cent of Lisraya patients had achieved both moderate or better improvement on that score and minimal or no steroid use, against 30 per cent on placebo. Among those on 7.5 mg per day or more of prednisone-equivalent corticosteroid at baseline, 62 per cent tapered to 2.5 mg or less against 38 per cent, and 45 per cent stopped corticosteroids entirely against 29 per cent. The 30 mg dose produced a 15.3 point greater improvement in mean Total Improvement Score at week 52 than placebo (p<0.001), a figure published in the New England Journal of Medicine in March 2026 rather than restated in either approval announcement. Lisraya carries a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis. Skin-specific secondary endpoints were published in JAMA Dermatology this month.
Johnson & Johnson’s IMAAVY Approved as First Treatment for Warm Autoimmune Haemolytic Anaemia
Johnson & Johnson announced on 24 August 2026 that the FDA had approved IMAAVY (nipocalimab-aahu) for warm autoimmune haemolytic anaemia in adults and paediatric patients aged 12 and over currently or previously treated with corticosteroids; the agency listed the action the following day. The company describes it as the first therapy proven safe and effective specifically for the condition, in which pathogenic immunoglobulin G autoantibodies tag red blood cells for destruction, causing severe anaemia and profound fatigue. Nipocalimab is a selective FcRn blocker that reduces circulating IgG while preserving B-cell function, first approved in April 2025 for generalised myasthenia gravis. Treatment has until now meant corticosteroids and immunosuppressants acting broadly rather than on the driving autoantibodies.
The approval rests on the Phase 2/3 ENERGY study (NCT04119050), which randomised 115 adults roughly evenly across two nipocalimab dose schedules and placebo over 24 weeks. The primary endpoint was durable haemoglobin response: a concentration of at least 10 g/dL plus a rise from baseline of at least 2 g/dL sustained for at least 28 days without rescue therapy. Approximately three times as many patients on the approved 30 mg/kg dose achieved it compared with placebo, 23.7 per cent against 7.7 per cent, a statistically significant difference. Full ENERGY results were presented at the European Hematology Association congress in June 2026. Two further figures require care: a mean haemoglobin increase of 1 g/dL at week 1 and a 3.51-point FACIT-Fatigue advantage at week 24 (95% CI 0.64 to 6.39) are both described by the company as descriptive under the pre-specified statistical analysis plan rather than inferentially significant. The label also extends to patients aged 12 and over while ENERGY enrolled adults only. The most common adverse reactions were peripheral oedema, diarrhoea and fever.
AstraZeneca and Amgen’s Tezspire Meets Both Co-Primary Endpoints in Phase 3 CROSSING Trial
AstraZeneca announced on 27 August 2026 positive high-level results from the Phase 3 CROSSING trial, in which Tezspire (tezepelumab) delivered statistically significant and clinically meaningful improvements across both co-primary endpoints and all key secondary endpoints at week 24 in eosinophilic oesophagitis, sustained through week 52 in both doses tested. The co-primary endpoints were histologic remission and the frequency and severity of dysphagia against placebo, and safety was generally consistent with the drug’s approved indications. This is the third epithelial-driven inflammatory disease in which the first-in-class anti-TSLP antibody has shown efficacy, after severe asthma and chronic rhinosinusitis with nasal polyps, though it is not the first biologic to succeed here, dupilumab having been approved in eosinophilic oesophagitis since 2022.
CROSSING (NCT05583227) randomised 368 patients aged 12 to 80 in equal proportions to a low dose of Tezspire, a high dose or placebo, given subcutaneously every four weeks, with patients remaining on maintenance therapy throughout. Histologic remission was a peak oesophageal eosinophil count of six or fewer per high-power field, and dysphagia was measured as mean change from baseline on the patient-reported Dysphagia Symptom Questionnaire. No effect sizes were disclosed, so the magnitude of benefit cannot be assessed until the data are presented. Eosinophilic oesophagitis affects more than 470,000 people in the United States, and nearly half do not achieve adequate control on first-line therapy. Full results will go to regulators and to an upcoming medical meeting.
Summit and Akeso’s Ivonescimab Meets Primary Endpoint in Phase 3 HARMONi-GI1 Biliary Tract Cancer Trial
Summit Therapeutics announced on 25 August 2026 that its partner Akeso had reported positive topline results from HARMONi-GI1 (AK112-309), which compared ivonescimab plus chemotherapy against durvalumab plus chemotherapy as first-line treatment for advanced biliary tract cancer. At a pre-specified interim analysis assessed by an independent data monitoring committee, the ivonescimab regimen achieved statistically significant and clinically meaningful superiority on the primary endpoint of overall survival, and met its key secondary endpoints of progression-free survival and objective response rate. Summit describes it as the first known Phase 3 study in advanced biliary tract cancer to show overall survival superiority against an anti-PD-(L)1 plus chemotherapy regimen, and the first positive ivonescimab readout outside non-small cell lung cancer to show a survival benefit. Durvalumab plus chemotherapy is the guideline-preferred first-line immunotherapy option here.
The trial (NCT06591520) enrolled 682 patients, but no efficacy figures of any kind were released; detailed data are due at an international conference and in a peer-reviewed journal. The two partners also describe the same study differently, which matters for how the result should be read. Akeso’s release calls the trial multicentre without stating where it was conducted, while Summit’s same-day announcement opens by describing it as a single-region, multi-centre Phase 3 study conducted in China and sponsored by Akeso, with all relevant data exclusively generated, managed and analysed by Akeso. Ivonescimab, a bispecific antibody combining PD-1 blockade with VEGF neutralisation, has been approved in China since May 2024 but remains investigational across Summit’s licensed territories, including the United States and Europe.
FDA Approves ViiV Healthcare’s Tivicay PD for Infants with HIV from Birth
ViiV Healthcare announced on 26 August 2026 that the FDA had approved Tivicay PD (dolutegravir), a dispersible tablet for oral suspension, for use with other antiretroviral agents in paediatric patients weighing at least 2 kg who are treatment-naive, or treatment-experienced but naive to integrase strand transfer inhibitors. The decision, taken on the 25 August user fee date following Priority Review, extends use to term babies from birth. The medicine had previously been available only from four weeks of age and at a minimum weight of 3 kg, and it is the drop in that weight threshold to 2 kg that opens the neonatal window. ViiV describes it as the first second-generation integrase inhibitor approved for this group.
The evidence base deserves to be described accurately. The approval is supported by the National Institutes of Health funded IMPAACT 2023 study (NCT05406583), a Phase 1 trial in which 48 term newborns weighing at least 2 kg received dolutegravir from birth for up to six weeks alongside standard of care antiretrovirals and were followed to 16 weeks of age, together with pharmacokinetic modelling incorporating additional paediatric data. It is a pharmacokinetic and safety package rather than a randomised efficacy trial: dolutegravir reached therapeutic concentrations in term neonates comparable to exposures associated with efficacy in adults, with safety consistent with that established in older children and adults. The rationale for acting on it is stark: ViiV cites data showing around half of untreated infants with HIV die by the age of two, and newborns have historically had the fewest age-appropriate options of any group. United States paediatric HIV guidance had already moved ahead of the regulator. The Department of Health and Human Services panel updated its recommendations at the end of June 2026 to make dolutegravir, combined with zidovudine plus either lamivudine or emtricitabine, the preferred initial regimen for full term infants from birth to under 30 days weighing at least 2 kg, noting at the time that the dosing strategy was not then FDA approved.
Looking Ahead
This week’s clinical trial results 28 August 2026 close out a month in which regulators, rather than the trial pipeline, produced most of the news. The pancreatic cancer approval is the one that will be remembered, for the survival figures behind it and for a review completed more than six months early. The three remaining approvals are smaller commercially but arguably no less consequential for those affected, giving a first oral option in a disfiguring autoimmune disease, a first targeted therapy in a blood disorder previously managed with blunt immunosuppression, and a licensed medicine for newborns who have had almost nothing designed for them. The two readouts are harder to weigh, because neither sponsor released an efficacy figure of any kind, and in one case one partner did not say where the study was run. A met endpoint is the beginning of an assessment, not the end of one. Life Science Daily News will continue to bring you accurate, timely coverage of the clinical trial results 28 August 2026 that matter most across the global life sciences pipeline. Catch up on last week’s clinical trials roundup.
