Life science news 31 August 2026: three US approvals, two UK device safety alerts and two licensing deals.
Revolution Medicines won approval for a broad RAS-targeted pancreatic cancer drug. AstraZeneca and Ionis presented the full data behind a closely watched heart therapy trial miss. The MHRA issued alerts covering hip replacements and nasogastric feeding tubes.
Revolution Medicines has won US Food and Drug Administration approval for Rasonque (daraxonrasib). The oral RAS(ON) inhibitor is cleared for adults with metastatic pancreatic adenocarcinoma. Patients must have received at least one prior systemic therapy. It is also approved for those who are not candidates for multiagent systemic therapy. The FDA granted approval on 26 August 2026. Revolution Medicines submitted the application on 22 July and used a priority review voucher.
Approval was supported by the Phase 3 RASolute 302 trial in 500 patients. Median overall survival reached 13.2 months against 6.7 months for chemotherapy. The hazard ratio was 0.40, a 60 per cent reduction in the risk of death. Chief executive and chair Mark Goldsmith called it “a monumental step forward for patients with pancreatic cancer.” The comment came in the company’s approval announcement. Revolution Medicines describes Rasonque as the first broad RAS-targeted medicine in the disease. Pancreatic cancer survival remains among the poorest of any common cancer. Revolution Medicines has set the US list price at $39,800 for a 30-day supply. That sits above the $25,000 to $30,000 range some analysts had expected.
AstraZeneca and Ionis Pharmaceuticals presented full results from the Phase 3 CARDIO-TTRansform trial on 28 August 2026. The data were shown at the European Society of Cardiology Congress in Munich. They confirmed that Wainua (eplontersen) missed its primary endpoint in transthyretin-mediated amyloid cardiomyopathy. The trial enrolled 1,432 patients across 130 centres in 20 countries.
The primary endpoint combined cardiovascular mortality and recurrent cardiovascular events through Week 140. There were 381 events among 210 patients on eplontersen. Placebo produced 392 events among 231 patients. The rate ratio was 0.89, short of statistical significance. A prespecified subgroup showed a nominally significant benefit in patients not taking a stabiliser drug. No additional benefit appeared among the 57 per cent already on stabiliser therapy. The ESC release concluded that an unmet need remains for new ATTR-CM treatments. The result follows a topline miss reported in July. Rivals including Alnylam and BridgeBio are watching the read-across to their own programmes.
The Medicines and Healthcare products Regulatory Agency issued a device safety alert on 26 August 2026. It warns of increased wear and corrosion risk in certain cobalt-chrome modular neck hip replacements. Affected systems come from Aesculap, LimaCorporate, Smith and Nephew, Stryker and Symbios. All were withdrawn from the UK market before 2019 and none remain commercially available.
Implant numbers range from 12 for Smith and Nephew’s SMF system to 597 for Symbios’ SPS modular device. Revision rates due to metal-related effects varied between products. The MHRA said all identified patients should be invited for a virtual or face-to-face clinical review. Blood metal testing and cross-sectional imaging are recommended where symptoms or findings suggest an adverse reaction. Symptomatic patients should then be followed up annually. Asymptomatic patients should move onto a patient-initiated follow-up pathway. The agency stressed that most patients have well-functioning hips. A small number may need revision surgery.
Takeda secured FDA approval on 28 August 2026 for Mimrylo (rusfertide). The drug treats erythrocytosis in adults with polycythaemia vera. Mimrylo is the first hepcidin mimetic approved for the condition, according to the FDA. Protagonist Therapeutics discovered rusfertide and led its development through Phase 3.
In the Phase 3 VERIFY trial, 293 patients received Mimrylo or placebo alongside standard care. Clinical response during weeks 20 to 32 reached 76.9 per cent against 32.9 per cent on placebo. The drug held haematocrit below 45 per cent, cut phlebotomy burden and improved fatigue scores. The most common adverse reactions were injection site reactions at 56 per cent and anaemia at 16 per cent. The label advises full blood count monitoring every two to four weeks after initiation and during dose changes. Tanya Wroblewski of the FDA welcomed the approval. She said the new option has the potential to meaningfully reduce patient burden.
In further life science news 31 August 2026, the week brought a third US approval. It also brought another UK device alert and two significant licensing deals.
Priovant Therapeutics and parent company Roivant Sciences announced FDA approval for Lisraya (brepocitinib) on 27 August 2026. The once-daily 30mg pill is approved for adults with dermatomyositis. Priovant describes the TYK2/JAK1 inhibitor as the first targeted therapy approved for the disease.
Approval rests on the Phase 3 VALOR trial, which Priovant calls the largest study conducted in dermatomyositis. Some 55 per cent of patients achieved moderate or better improvement on minimal or no steroid use. The placebo figure was 30 per cent. Among patients on higher baseline steroid doses, 45 per cent stopped corticosteroids entirely against 29 per cent on placebo. Benefits on the primary myositis improvement score appeared by week four and held through 52 weeks. Lisraya carries a boxed warning covering serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis. Priovant chief executive Ben Zimmer said the approval marks “a historic moment for the dermatomyositis community.”
The MHRA issued a further device alert on 24 August 2026 covering NGPod pH testing devices. The handheld device and sensor aid confirmation of nasogastric feeding tube placement. Users have been told to quarantine remaining stock and dispose of all devices. The manufacturer, NGPod Global, ceased UK trading on 20 July 2026 and can no longer support the product.
The MHRA assessed two adverse incident reports received in January 2026. In both, the device gave a green result suggesting correct gastric placement. The tube was in fact located in the lung. One incident had a fatal outcome. The MHRA said multiple factors are thought to have contributed to that death. It added that it could not rule out a contributing role for the NGPod result. Clinicians should switch to alternative CE-marked pH testing methods for gastric aspirate. Incidents should be reported through the Yellow Card scheme, or IRIC in Scotland.
Genentech, part of the Roche Group, agreed on 24 August 2026 to license Hanmi Pharmaceutical’s HM17321. The obesity candidate is covered worldwide except in South Korea. The deal is worth up to $2.3 billion. That includes a $190 million upfront payment plus development, regulatory and commercial milestones and tiered royalties.
HM17321 is a UCN2 analogue with a non-incretin mechanism. In preclinical studies it promoted weight loss while preserving lean body mass. Hanmi positions that profile as a differentiator from existing GLP-1 therapies. The candidate entered Phase 1 testing after FDA clearance in November 2025. That study is assessing safety, tolerability and pharmacokinetics in healthy volunteers and people with obesity. The deal adds to a wave of obesity pipeline dealmaking this year.
Biohaven and SK Biopharmaceuticals entered a global licensing agreement on 26 August 2026. It covers Biohaven’s Kv7 ion channel platform and its lead candidate opakalim. Opakalim is in Phase 2/3 development for focal epilepsy. Upfront and milestone payments related to the platform total up to $795 million.
SK Biopharmaceuticals will pay $350 million at closing and a further $50 million in 2027. Up to $150 million in development and regulatory milestones may follow. Biohaven is also eligible for tiered royalties in the mid-teens to low twenties on US sales. Royalties elsewhere run in the mid-single digits. SK Biopharmaceuticals assumes future Kv7 programme costs totalling $245 million. Those include up to $185 million payable to Knopp Biosciences on US and EU approval. A further $60 million covers milestones on future Kv7 pipeline programmes. Biohaven continues to run the RISE3 trial, with topline results expected in the second half of 2026. The agreement is subject to antitrust clearance and customary closing conditions.
That’s your life science news digest for 31 August 2026, back next Monday with the latest from pharma, biotech and healthcare at www.lifesciencedaily.news. Catch up on the 24 August news roundup.
