The Aleth Briefs trace each story to its original source and show how the week unfolded.
The week in five lines:
Grail’s Galleri missed its NHS trial primary endpoint, shares fell >45%.
Danaher and Masimo agreed a deal at about $9.9bn enterprise value.
An FDA NEJM article suggests one pivotal trial could become the approval default.
Bayer proposed a $7.25bn Roundup class settlement.
Compass Pathways’ COMP360 met its second phase 3 primary endpoint.
Browse by day:
Weekend catch-up: Gilead-Genhouse · Disc Medicine
Monday: Roche Gazyva · Novartis on the UK
Tuesday: Danaher-Masimo · Bayer · Compass · Ocular · CSL-Lilly
Wednesday: FDA one-trial · Moderna
Thursday: Grail · AZ Calquence · Hims-Eucalyptus · Guardant-MetaSight · Element
Weekend catch-up
Gilead took global rights to a clinic-ready cancer drug GH31 from China’s Genhouse Bio for $80m upfront, in a deal worth up to $1.45bn in milestones.
GH31 is a MAT2A inhibitor, a synthetic lethality approach aimed at MTAP-deleted tumours, with clearance to enter clinical trials in both the US and China. Gilead takes worldwide development and commercialisation. The deal adds to the run of US buyers sourcing clinic-ready oncology assets from Chinese biotechs.
Global partnership with Gilead on MAT2A inhibitor GH31 · Genhouse Bio
The FDA issued a complete response letter for Disc Medicine’s bitopertin.
The FDA asked for results for the erythropoietic protoporphyria candidate from the continuing APOLLO phase 3 study. The application had carried a Commissioner’s National Priority Voucher, meant to speed favoured drugs through review. The letter resets the timeline on Disc’s lead asset without ending the programme.
Complete response letter from FDA for bitopertin · Disc Medicine
Monday 16 February
Roche’s Gazyva (obinutuzumab) delivered positive phase 3 results in primary membranous nephropathy.
The results could support the first approval in the kidney disease and further extend use of the oncology antibody into immune-mediated conditions, following its clearance in lupus nephritis last autumn.
Positive phase III results for Gazyva in primary membranous nephropathy · Roche
Novartis’s UK and Ireland head said the NHS’s reformed approach to evaluating new medicines is “slowly killing the life science sector in the UK”.
Johan Kahlstrom told The Times the changes still do not go far enough. The criticism follows 15 years of Novartis cutting back its UK footprint, which the company attributes to NICE’s cost-effectiveness rules limiting access to its medicines. Novartis has repeatedly described the UK as “uninvestable”.
Novartis’s UK chief says NHS medicines assessment is throttling the sector · The Times
Tuesday 17 February
Danaher agreed to buy Masimo for $9.9bn.
Danaher will pay $180/sh in cash, valuing Masimo at $9.9bn including debt. The deal adds pulse oximetry, sensor technology and AI-enabled patient monitoring to Danaher’s diagnostics portfolio, where Masimo will sit alongside Radiometer, Leica, Cepheid and Beckman Coulter. Danaher expects Masimo to generate >$530m EBITDA in 2027, with >$125m of cost and $50m of revenue synergies by year five. The price is around 18x 2027 EBITDA, falling to 15x including expected synergies. Closing H2 2026.
Danaher to acquire Masimo Corporation · Danaher
Bayer proposed a $7.25bn settlement of the Roundup litigation.
The Monsanto US class settlement would resolve current and future claims alleging Roundup causes cancer. The litigation has weighed on Bayer since its 2018 acquisition of Monsanto. The proposed settlement would cap a long-running legal exposure that has been difficult to quantify and reduce the risk of years of further litigation.
Roundup class settlement agreement to resolve current and future claims · Bayer
Compass Pathways’ synthetic psilocybin met its endpoint in a second phase 3 trial.
COMP360, a synthetic formulation of psilocybin, the psychoactive compound found in “magic mushrooms”, met the primary endpoint in the second of two phase 3 trials in treatment-resistant depression. Shares rose about 30%. Compass has requested an FDA meeting to discuss a rolling submission and expects to complete its NDA in Q4.
Met primary endpoint 2nd phase 3 trial of COMP360 psilocybin · Compass Pathways
Ocular Therapeutix’s AXPAXLI beat a single aflibercept dose in phase 3, but shares fell more than 25%.
SOL-1 compared one dose of the axitinib intravitreal implant with a single 2 mg dose of Eylea in wet AMD after an aflibercept loading phase, rather than with continued on-label anti-VEGF treatment. AXPAXLI met the trial’s superiority endpoint, supporting planned FDA discussions, but the comparator design tempered investor enthusiasm.
Positive results from SOL-1 phase 3 superiority trial in wet AMD · Ocular Therapeutix
Eli Lilly licensed CSL’s anti-IL-6 antibody clazakizumab for $100m upfront.
Lilly will explore the antibody in kidney disease and other immuno-inflammatory indications, with CSL eligible for additional milestones and royalties. Clazakizumab previously failed a phase 3 trial in organ transplant rejection, and the licence allows CSL to retain some of the economics without fully funding further development alone.
CSL and Lilly enter licensing agreement for clazakizumab · CSL
The UK government cleared the way for UK Biobank to receive its participants’ GP records.
A data provision notice published on 10 February, picked up this week by The Times, opens coded primary care data in England to consented cohorts such as UK Biobank. For its 500,000 participants, this could double recorded cases of common conditions including arthritis, asthma, dementia and heart failure. The data cover diagnoses, symptoms, medications, referrals and test results, with identifiers removed and consultation notes excluded. Access starts once the NHS agrees data-sharing terms.
Milestone for health research Government enables access to GP data · UK Biobank
Decades of medical insight unlocked as UK Biobank gets GP records · The Times
Wednesday 18 February
FDA moves towards one pivotal trial as its default for drug approval.
Commissioner Marty Makary and Vinay Prasad argued in a New England Journal of Medicine perspective that requiring two pivotal trials has become something of a regulatory dogma, and that one adequate well-controlled trial plus confirmatory evidence should instead be the default. FDA already allowed this, but making it the norm would materially change development planning. Formal guidance is still to come.
One pivotal trial, the new default for FDA approval ending two-trial dogma · NEJM
The FDA reversed itself and will review Moderna’s flu vaccine, a week after refusing to file the application.
After a Type A meeting with CBER, Moderna proposed a revised regulatory pathway for mRNA-1010: full approval in adults aged 50-64 and accelerated approval in ages 65 and over, with an additional post-marketing study in older adults. FDA accepted the amended BLA and set a 5 August PDUFA date, in time for the 2026–27 flu season.
FDA will initiate review of seasonal influenza vaccine submission · Moderna
Thursday 19 February
Grail’s Galleri missed its primary endpoint in the NHS-Galleri trial.
The study was the largest test so far of whether a single blood test can detect multiple cancers early enough to improve outcomes, and was central to Grail’s UK strategy. It missed its primary endpoint, sending shares down >45% after hours on Thursday.
Grail highlighted a substantial reduction in stage IV diagnoses and a four-fold increase in cancer detection, but the primary endpoint failure weakens the case for NHS adoption and raises fresh questions over the clinical value of multi-cancer early detection (MCED) screening. FDA premarket approval remains under review.
NHS-Galleri demonstrates substantial reduction in stage IV cancer diagnoses · Grail
The FDA approved AstraZeneca’s Calquence with Venclexta as the first all-oral, fixed-duration combination for first-line chronic lymphocytic leukaemia (CLL).
The clearance covers adults with untreated CLL or small lymphocytic lymphoma (SLL). It gives AZ a fixed-duration front-line regimen in a market where treatment duration has become an important point of differentiation among BTK-based therapies.
FDA approves acalabrutinib with venetoclax for CLL or SLL · FDA
Approved as first all-oral, fixed-duration combination in 1st-line CLL · AstraZeneca
Hims & Hers agreed to buy Australian digital health company Eucalyptus for $240m upfront, in a deal worth up to $1.15bn.
The acquisition expands Hims further beyond the US into Australia and Japan and increases its presence in Germany, Canada and UK. Eucalyptus also adds prescribing and fulfilment infrastructure to support Hims’ international weight-loss business.
To acquire Eucalyptus, accelerating global consumer health vision · Hims & Hers
Guardant disclosed its December acquisition of MCED startup MetaSight.
Terms were $59m upfront, with up to $90m tied to regulatory and commercial milestones. The acquisition adds a multi-cancer early detection programme to a screening portfolio currently centred on blood-based colorectal cancer testing.
Q4 and full-year 2025 results and 2026 outlook · Guardant Health
Element unveiled VITARI, a new high-throughput sequencing platform.
Element Biosciences has been pushing into territory held by Illumina and Ultima Genomics with its AVITI line, and its new high-throughput instrument takes the fight to the part of the market that drives the majority of sequencing consumables revenue.
Element introduces VITARI, redefining what sequencing makes possible · Element