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ALETH / LIFESCI-BRIEF / 2026-10-16 / STRYKER CHALLENGES INTUITIVE WITH $400M CMR DEAL

Stryker challenges Intuitive with $400m CMR deal

Also this week: BMS reports two positive phase 3 readouts, EMA backs Rasonque in pancreatic cancer, OMass raises $310m and FDA proposes rare disease regulatory overhaul.

The Aleth Briefs link to the sources behind the stories and show how the week unfolded.

The week in five lines:

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Weekend catch-up

Natera’s multi-cancer early detection blood test received FDA Breakthrough Device designation.

The assay analyses circulating cell-free DNA to screen for multiple cancers, extending Natera’s oncology ambitions beyond its established Signatera molecular residual disease (MRD) monitoring business. The FDA considered data across 12 cancer types, including sensitivity, specificity and the ability to identify a cancer’s tissue of origin. Natera did not disclose performance figures. The designation provides an expedited development and review pathway, but does not constitute regulatory approval.

Principles agreed for the UK’s next branded medicines pricing scheme include a seven-year term, newly published minutes show.

The Department of Health and Social Care (DHSC) released minutes of a July review of the voluntary scheme for branded medicines pricing, access and growth (VPAG) with the Association of the British Pharmaceutical Industry (ABPI). Principles agreed for the successor scheme cover growth, innovation, uptake, competition and investment links. Government will work with companies on strategically important medicines, including flexible commercial and risk-sharing models.

The FDA approved Asahi Kasei’s Hovilpri (pritelivir) for mucocutaneous herpes simplex lesions refractory to standard antivirals in immunocompromised adults.

The oral tablet is approved where lesions are refractory, with or without documented resistance, to acyclovir, valacyclovir or famciclovir. Asahi Kasei says it is the first US herpes simplex treatment with a new mechanism in nearly 30 years and plans to launch it by the end of 2026.

AstraZeneca’s efzimfotase alfa missed statistical significance in a phase 3 trial in hypophosphatasia.

In HICKORY, presented on Sunday at the American Society for Bone and Mineral Research meeting, patients aged 12 and over who had never taken Strensiq (asfotase alfa) walked 17.05 metres further than on placebo in six minutes at week 25 (p=0.1675). AstraZeneca said the lack of statistical significance was largely due to better-than-expected results in the adult-onset placebo group.

Monday 12 October

BMS reported two positive phase 3 readouts, one in idiopathic pulmonary fibrosis and one for an alpha-emitting radiopharmaceutical.

RYZ101, acquired through the $4.1bn 2024 purchase of RayzeBio, improved progression-free survival against standard treatment at the ACTION-1 interim analysis. Patients had gastroenteropancreatic neuroendocrine tumours that progressed after lutetium-177 therapy. BMS says these are the first phase 3 results for an alpha-emitting radiopharmaceutical in any indication and will discuss a filing with the FDA.

In ALOFT-IPF, the 60 mg twice-daily dose of admilparant, an oral LPA1 antagonist, slowed the loss of lung capacity against placebo at week 52. The 120 mg dose also slowed the decline but missed significance. BMS plans regulatory submissions.

Stryker agreed to invest ~$400m in CMR Surgical, with an option to buy the whole company.

The deal marks Stryker’s entry into soft-tissue surgical robotics, challenging Intuitive Surgical’s dominant da Vinci platform. Stryker will take preferred equity in the Cambridge, UK, company and become exclusive US sales agent for its Versius robots, extending its existing Mako orthopaedic robotics business. CMR’s modular Versius system has been used to treat more than 45,000 patients worldwide, although its US clearance is currently limited to gallbladder surgery. CMR retains development and sales outside the US. The transaction remains subject to regulatory approval.

Steris agreed to buy Xodus Medical, a Pennsylvania maker of specialty surgical products, for $2.1bn in cash.

Xodus makes operating-room consumables, including its Pink Pad patient-positioning systems. Steris expects 2026 revenue of $245m and adjusted EBIT of $135m. The deal includes an estimated $300m of tax benefits, reducing the effective purchase price to $1.8bn, with up to $150m more payable if Xodus meets performance targets in 2028. Steris will fund the acquisition with debt and expects to close by end 2026.

Tuesday 13 October

Rona Therapeutics licensed its ALK7-targeting RNAi obesity drug to Roche for up to $100m in upfront and near-term milestone payments.

Rona can earn up to $1.06bn more in milestones, plus royalties. ALK7 sits mainly in fat tissue, and Rona says blocking it could cut visceral fat while preserving lean mass. The drug uses Rona’s platform for delivering RNAi beyond the liver.

BioNTech’s mRNA cancer immunotherapy BNT113 did not significantly improve progression-free survival in a phase 2/3 head and neck cancer trial.

AHEAD-MERIT tested BNT113 with Keytruda (pembrolizumab) as first-line treatment for unresectable recurrent or metastatic, PD-L1-positive, HPV16-positive head and neck cancer. On its monitoring committee’s advice the trial continues to overall survival, its second primary endpoint. A gain there would still make the trial positive. The setback follows BioNTech’s decision in August to discontinue a phase 2 trial of its personalised mRNA cancer vaccine BNT122 in colorectal cancer, contrasting with Moderna and Merck’s positive phase 3 melanoma results that month.

Liquidia and United Therapeutics settled all six lawsuits between them, with Liquidia paying a net $381m and giving up Yutrepia’s PH-ILD indication.

Liquidia can continue selling inhaled treprostinil Yutrepia for pulmonary arterial hypertension. It has submitted an FDA supplement to remove pulmonary hypertension associated with interstitial lung disease from the label and will no longer promote the drug for PH-ILD.

Biotech start-ups are turning to reverse mergers to fast-track their stock market listings, the Financial Times reported.

The FT counted 23 reverse-merger announcements in 2026, up almost sixfold from four in 2025, matching the number of traditional biotech IPOs. The transactions exploit a pool of listed biotechs left with depleted pipelines following clinical failures, often retaining cash and a stock market listing. Specialist life sciences investors are increasingly backing these mergers with substantial new financing, turning what was once considered a backdoor listing into an alternative route to the public markets.

Wednesday 14 October

The FDA launched an initiative to rebuild its regulation of rare disease drugs.

The Rare Disease Framework Initiative, set out in a white paper, aims for rules fitted to each disease, its patients and the evidence a small population can realistically produce. Only about 5% of rare conditions have an FDA-approved treatment, the agency said. It promises clearer, more consistent decisions and risk-based manufacturing reviews. A public meeting on 28 October opens consultation, which could lead to new guidance, revised regulations and organisational changes.

Vir Biotechnology agreed a collaboration with Gilead to discover three dual-masked T-cell engager candidates for solid tumours.

Vir gets $90m upfront, made up of $65m in cash and a $25m equity investment at a 30% premium. Up to $45m in near-term milestones and $1.74bn later can follow. Vir designs the candidates. Gilead develops and sells them.

Verastem’s KRAS G12D inhibitor VS-7375 produced a 41% confirmed response rate in second-line or later pancreatic cancer at its selected 900 mg daily dose.

In the phase 1/2 TARGET-D 101 trial, 9 of 22 patients had confirmed objective responses, including one complete response. Another patient had an unconfirmed complete response. In second line specifically, 4 of 8 responded. Verastem plans to open a first-line phase 3 trial in metastatic pancreatic cancer by the end of 2026. It later priced a $250m stock and pre-funded warrant offering to fund clinical development and other corporate purposes.

Galderma agreed to buy ZO Skin Health in an all-cash transaction valuing the business at $1.5bn on an enterprise value basis.

ZO’s physician-dispensed skincare business generated ~$330m in net sales in the 12 months to June and sells through more than 16,500 physician, medical-spa and online accounts in over 40 countries. Closing is expected in Q4 2026/early 2027.

GSK told a Belgian works council it could cut up to 1,217 jobs.

The proposed cuts cover 482 office and 735 managerial posts across R&D, production and international support functions in Wallonia.

Senior dementia specialists asked Yvette Cooper for help getting Leqembi (lecanemab) and Kisunla (donanemab) onto the NHS, The Times reported.

The letter said both Alzheimer’s drugs are “genuine advances” that could substantially improve memory clinics’ capacity to help people with Alzheimer’s. The drugs treat the underlying cause of Alzheimer’s by clearing toxic amyloid protein from the brain. Trial data suggests that lecanemab slows memory decline by up to 27% over 18 months.

AI drug developer Iambic Therapeutics priced its $150m Nasdaq IPO at $16.

It offered 9,375,000 shares, with trading beginning on 15 October. Iambic says its AI platform took lead candidate IAM1363 to the clinic in about two years.

Thursday 15 October

OMass Therapeutics raised $310m to take OMS1620 through phase 2 in adrenal disorders.

Bain Capital Life Sciences, Forbion and Novo Holdings co-led the Series C in the University of Oxford spin-out, taking its total funding to about $475m. The money will advance OMS1620 through phase 2 in congenital adrenal hyperplasia and ACTH-dependent Cushing’s syndrome, and support initial clinical data from OMass’s SLC15A4 programme. Syncona, its listed Series A investor, committed $10.1m.

OrbiMed raised $3bn across two new funds, more than $1bn of it for Asia.

OrbiMed Private Investments X raised more than $1.9bn for US and European venture deals. OrbiMed Asia Partners VI raised more than $1bn for growth and venture investment across Asia.

AstraZeneca signed an AI-enabled drug discovery deal with insitro in liver disease and cardiomyopathies.

The AI company receives $40m upfront and up to about $1.46bn in milestones, plus single-digit royalties. The work covers metabolic dysfunction-associated steatohepatitis (MASH) and heart muscle disease.

The EMA’s human medicines committee backed Rasonque for metastatic pancreatic cancer, following US approval in August.

The Committee for Medicinal Products for Human Use (CHMP) recommended EU approval of Revolution Medicines’ Rasonque (daraxonrasib), an oral RAS inhibitor, for adults whose disease has progressed after at least one treatment. In a 500-patient phase 3 trial, median survival was 12.4 months against 6.7 months on chemotherapy, and median progression-free survival was 7.2 months against 3.6 months. A phased review cut the assessment to fewer than 150 active review days. The European Commission now takes the final decision.

Labcorp agreed to pay $722m in cash for selected assets of OPKO Health’s BioReference Health business, including the 4Kscore prostate cancer test.

Labcorp expects the acquired businesses to generate ~$250m in revenue in the first year after closing. Up to $150m more depends on 4Kscore sales over up to ten years. The assets include clinical, women’s health, urology and corrections testing, more than 80 patient service centres and 4Kscore. The deal needs US antitrust clearance.

The FDA approved Roche’s Enspryng for adults with thyroid eye disease.

Roche says Enspryng (satralizumab) is the first at-home subcutaneous treatment for the condition. The approval is based on two phase 3 SatraGO trials. SatraGO-2 met its primary endpoint, with a proptosis response in 52.9% of Enspryng patients against 23.4% on placebo among patients with active thyroid eye disease. SatraGO-1 missed its primary endpoint. Enspryng is given every four weeks during maintenance.

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