ALETH / LIFESCI-BRIEF / 2026-10-09 / HALOZYME DERAILS KEYTRUDA EUROPEAN ROLLOUTThe Aleth Briefs link to the sources behind the stories and show how the week unfolded.
The week in five lines:
Halozyme blocked Keytruda SC in eight European countries.
Nobel Prize awarded to optogenetics pioneers Deisseroth, Hegemann and Nagel.
Biohub and partners committed $1.8bn for AI biology data.
Lilly won first-line approval for Jaypirca in CLL.
AbbVie and Genmab reported positive phase 3 Epkinly data in first-line DLBCL.
Browse by day:
Weekend catch-up: UK dementia · Jaypirca · Novo · CSL-Alentis
Monday: Shionogi · Epkinly · Vaxcyte · Nobel · AZ
Tuesday: Option Care · Recordati · Forbion · ArriVent · Caribou
Wednesday: Keytruda SC · Biohub · WHO · Cerevance
Thursday: argenx · Viatris-Pacira · Isomorphic valuation · MSK
Friday: TRexBio IPO
Weekend catch-up
UK Research and Innovation (UKRI) launched an £80m challenge to speed up dementia diagnosis in the NHS.
Nine technologies will be tested in NHS services, among them faster MRI scans, a remote cognitive assessment and a panel of blood biomarkers. Only those that prove they work get further money. The target is for 92% of people to be diagnosed within 18 weeks of referral, against about 60% today.
£80m challenge for faster, better dementia diagnosis launched · UKRI
The FDA approved Lilly’s Jaypirca as a first-line treatment for chronic lymphocytic leukaemia (CLL).
Jaypirca (pirtobrutinib), a non-covalent BTK inhibitor, is now cleared for previously untreated CLL or small lymphocytic lymphoma without a known 17p deletion. In the phase 3 BRUIN CLL-313 trial against chemoimmunotherapy, the hazard ratio for progression-free survival (PFS) was 0.20. Median PFS was not reached, against 33.5 months.
FDA approves pirtobrutinib for previously untreated CLL or SLL · FDA
The FDA extended its review of Novo Nordisk’s haemophilia A drug denecimig because of problems at a manufacturing site.
The agency has found no deficiencies in the clinical efficacy or safety data and has set no new timeline, Novo said. A decision had been expected in Q3 2026. Novo now aims to launch the bispecific antibody in the US in H1 2027.
Update on the denecimig Biologics License Application in the US · Novo Nordisk
CSL agreed to pay Alentis Therapeutics $355m upfront to co-develop the kidney and liver drug lixudebart.
Lixudebart is an antibody against claudin-1. The companies agreed to split profits 55:45 in CSL’s favour, with up to $1.2bn for Alentis in commercial milestones. CSL will fund the phase 2 and planned phase 3 trials in ANCA-associated vasculitis with rapidly progressive glomerulonephritis, plus phase 2 trials in two other rare diseases.
CSL & Alentis announce partnership to develop & commercialise lixudebart · CSL
Monday 5 October
Shionogi agreed to buy IntraBio for $2bn upfront, gaining the approved rare-disease drug Aqneursa.
Aqneursa (levacetylleucine) has been approved in the US since 2024 for Niemann-Pick disease type C, and the FDA cleared it for ataxia-telangiectasia on 18 September. The deal follows Shionogi’s purchase of global rights to Radicava (edaravone) in April.
Shionogi continues rare disease expansion with acquisition of IntraBio · Shionogi
AbbVie and Genmab’s Epkinly improved on R-CHOP in first-line lymphoma.
In the phase 3 EPCORE DLBCL-2 trial in newly diagnosed diffuse large B-cell lymphoma (DLBCL), adding fixed-duration Epkinly (epcoritamab) to R-CHOP chemotherapy cut the risk of progression or death by 51% (HR 0.49). The figure held in both the primary population, with IPI scores of 3 to 5, and the wider 2-to-5 group. The partners call it the first phase 3 win on PFS for a bispecific antibody combination in first-line DLBCL. They will now discuss next steps with regulators.
Epcoritamab with R-CHOP improves PFS in newly diagnosed DLBCL · AbbVie
Vaxcyte’s 31-valent pneumococcal vaccine met all its primary endpoints in a phase 3 trial in adults.
In OPUS-1, with 4,047 adults, VAX-31 matched Prevnar 20 (PCV20) on all 20 shared serotypes and Capvaxive (PCV21) on 17 of 19, under a stricter non-inferiority bar than past trials. Serotypes 3 and 12F missed that bar against Capvaxive but cleared the historical one. Vaxcyte plans a Biologics License Application (BLA) in H1 2028, following further phase 3 studies.
Vaxcyte reports positive topline data from OPUS-1 phase 3 trial of VAX-31 · Vaxcyte
VAX-31 OPUS-1 pivotal phase 3 adult trial: topline results · SEC EDGAR
The Nobel Prize in Physiology or Medicine went to Karl Deisseroth, Peter Hegemann and Georg Nagel for developing optogenetics.
Hegemann and Nagel discovered channelrhodopsin, a light-sensitive ion channel in single-celled algae that opens when illuminated, generating an electrical signal. In 2005, Deisseroth showed that introducing the gene into mammalian neurons allowed their activity to be controlled with pulses of light.
Optogenetics has transformed neuroscience by allowing researchers to activate or silence specific populations of neurons and establish causal links between neural circuits, behaviour and memory. Beyond widespread research use, the technology is being developed clinically to restore partial sight in people with retinal degeneration.
Nobel Prize in Physiology or Medicine 2026 · NobelPrize.org
AstraZeneca opened an R&D centre in Kendall Square, Cambridge Massachusetts.
With AstraZeneca’s nearby genomic medicine site, the centre will house nearly 2,000 researchers. It is part of >$1bn AstraZeneca is investing in Massachusetts, which will expand its workforce there by >50%, within its $50bn US investment programme.
AstraZeneca opens new global strategic R&D centre in Kendall Square · AstraZeneca
Tuesday 6 October
CD&R and McKesson agreed to buy Option Care Health for an enterprise value of $5.8bn.
The buyers will pay $32.05 a share for the US home and alternate-site infusion provider, a 37% premium to Monday’s close. CD&R will hold about 51%, and McKesson will invest about $1.4bn for the other 49%. The agreement sets out a framework for McKesson to buy CD&R’s stake later. Closing is expected in H1 2027.
CD&R and McKesson sign agreement to acquire Option Care Health · SEC EDGAR
CVC and Groupe Bruxelles Lambert raised their offer for Recordati to €53 a share.
Their bid vehicle, Respighi BidCo, raised the price from €51.29, called it its “best and final offer“ and extended acceptances to 23 October. CVC already holds about 46.8% of the Italian drugmaker and wants to delist it. Activist Palliser Capital and Recordati’s four independent directors had opposed the original price.
Increase in the offer consideration to €53.00 per share · Respighi BidCo
CVC and GBL raise their bid for Recordati to 53 euros per share · Il Sole 24 Ore
Forbion raised €2.3bn across two funds, the largest fundraise in its history and one of the largest life sciences VC fundraisings globally in the past five years.
The Dutch firm’s new growth and venture funds can back about 30 companies, and its assets under management rise to about €7.5bn. Eli Lilly invested alongside MN, PGGM, KfW Capital and the Kauffman Foundation.
Forbion raises €2.3 billion across two new funds · Forbion
ArriVent’s firmonertinib failed its phase 3 trial in first-line lung cancer with EGFR exon 20 insertions.
FURVENT missed its primary endpoint of PFS by blinded independent review. At the 240 mg dose, median PFS was 11.0 months against 9.5 months with chemotherapy (HR 0.75, p=0.0654). ArriVent reported benefits on secondary measures, including investigator-assessed PFS and response rate, and is reviewing the full data before deciding the drug’s future. ArriVent shares fell 47% on the news, reflecting the setback to its lead development programme.
ArriVent announces program update from the phase 3 FURVENT trial · ArriVent
Caribou Biosciences decided to stop developing its allogeneic CAR-T therapies and to explore strategic alternatives.
Caribou plans to discontinue vispa-cel in lymphoma and CB-011 in myeloma and to substantially reduce its workforce, incurring $15-$19m of restructuring costs. Caribou shares fell by about 60% as investors assessed the implications of abandoning its development pipeline. The decision highlights the financing challenges facing allogeneic CAR-T, which promises lower manufacturing costs and faster treatment than patient-derived (autologous) therapies but faces questions over immune rejection, durability and commercial competitiveness.
Caribou Biosciences Form 8-K on restructuring & strategic alternatives · SEC EDGAR
Wednesday 7 October
Halozyme won a Dutch injunction blocking Keytruda SC in eight European countries.
The Hague court found that Merck’s subcutaneous (SC) Keytruda infringes Halozyme’s MDASE patent EP622. The dispute centres on the hyaluronidase technology licensed from South Korea’s Alteogen, which enables SC delivery of pembrolizumab. Halozyme had previously granted BMS exclusive rights to its ENHANZE technology for PD-1 therapies, underpinning the rival SC Opdivo Qvantig, approved in 2024.
Keytruda SC is approved in the US, but the Dutch ruling and an earlier German injunction restrict its European rollout. Merck disputes the patent’s validity and is also facing US litigation. Intravenous Keytruda is unaffected.
Halozyme wins injunction on Keytruda SC in multiple European markets · Halozyme
Halozyme stymies SC Keytruda launch as Merck vows to fight · Fierce Pharma
Biohub and its partners committed $1.8bn to build AI-ready bio data.
Biohub, the DOE and NIH expanded the Virtual Biology Initiative, launched in April with $500m from Biohub. DOE will invest >$500m over five years in biological measurement, modelling and computing, while NIH will contribute datasets developed with >$500m of prior federal investment. Google DeepMind, Isomorphic Labs and Meta are investing $300m. The initiative aims to generate large-scale, standardised experimental data to train predictive models of living cells, potentially allowing researchers to simulate biological interventions before testing in the lab.
AI-ready biological data: $1.8 billion global commitment · Biohub
The WHO issued its first global guidelines on childhood obesity, allowing medicines for some adolescents but not children under 10.
The guidelines recommend against medicines, bariatric surgery and weight-loss devices for children under 10. Adolescents aged 10-19 may receive medicines only after a supervised lifestyle programme has failed. Bariatric surgery may be considered for severe adolescent obesity. In 2024, 170m people aged 5-19 lived with obesity.
WHO issues first global guidelines on child and adolescent obesity · WHO
Cerevance’s once-daily pill solengepras met the primary endpoint of a phase 3 trial in Parkinson’s disease.
In ARISE, solengepras was added to existing Parkinson’s treatments in 341 patients experiencing motor fluctuations. The 150 mg dose reduced daily OFF time by 0.61 hours more than placebo at week 12 (p=0.0350) and increased ON time without troublesome dyskinesia by 0.60 hours. The drug inhibits GPR6 rather than targeting dopamine receptors. Cerevance plans FDA discussions on a potential filing.
Positive phase 3 ARISE results for once-daily oral solengepras · Cerevance
Thursday 8 October
argenx stopped its phase 3 UNITY trial of Vyvgart Hytrulo in Sjögren’s disease.
An independent data monitoring committee concluded that the trial was unlikely to meet its primary endpoint. argenx shares fell 12% on the news, reflecting the loss of a potentially significant expansion opportunity for Vyvgart.
argenx provides update on phase 3 UNITY study in Sjögren’s disease · argenx
Viatris agreed to buy Pacira BioSciences at a $1.65bn equity value, adding two non-opioid pain products.
Viatris will pay $36.50 a share in cash for the maker of Exparel (bupivacaine liposome), for post-surgical pain, and Zilretta (extended-release triamcinolone acetonide), for osteoarthritis knee pain. Pacira had about $746m of revenue in the year to June. The deal should close by the end of 2026.
Viatris agrees to acquire Pacira BioSciences · Viatris
Isomorphic Labs is in early talks to raise money at a valuation of $40bn to $50bn, Bloomberg reported.
The Alphabet-backed AI drug discovery company raised $2.1bn in May at an undisclosed valuation. The proposed valuation compares with a market capitalisation of about $2bn for Recursion Pharmaceuticals. Isomorphic has yet to advance its first drug into clinical trials.
Isomorphic Labs in funding talks for at least $40 billion value · Bloomberg
Isomorphic Labs reportedly raising at up to $50B valuation · SiliconANGLE
Memorial Sloan Kettering researchers found that restricting germline testing by age could miss most inherited cancer risk variants.
Testing 39,184 patients with solid tumours identified pathogenic germline variants in 16.3%. Restricting testing to patients under 50 would have missed 4,601 carriers, or 72% of those identified. The researchers, publishing in Cancer Discovery, argue for offering germline testing to all cancer patients regardless of age, with implications for treatment and screening of relatives.
Current age-based genetic testing in patients with cancer may miss majority of inherited gene variants · AACR
Friday 9 October
TRexBio priced its IPO at $14 a share for expected proceeds of about $117m.
The company, which works on tissue regulatory T-cell biology, sold 8.3m shares. Trading on Nasdaq under TRXB was due to start on 9 October.
TRexBio announces pricing of initial public offering · TRexBio
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