ALETH / LIFESCI-BRIEF / 2026-11-06 / CVS BREAKS UP ITS HEALTHCARE EMPIREThe Aleth Briefs link to the sources behind the stories and show how the week unfolded.
The week in five lines:
CVS Health planned a split into two listed companies.
Novartis disclosed nine tumour reports after Zolgensma treatment.
Boehringer Ingelheim agreed a cancer deal with Sino worth up to $7.4bn.
Servier’s sevasemten failed its pivotal Becker muscular dystrophy trial.
Inovio won FDA accelerated approval for DNA medicine Voceryq to treat RRP.
Browse by day:
Weekend catch-up: Agios · Inovio
Monday: Fresenius-WuXi · UK pensions · Bright Minds · uniQure · Karyopharm
Tuesday: Lonza · Theramex · BioNTech · Servier · Waters · Signatera · Ultragenyx
Wednesday: Novo · Nxera-AbbVie · Boehringer-Sino · CVS
Thursday: Egetis · T-Therapeutics · Alethio · Zolgensma · Rybrevant · Palantir
Weekend catch-up
The FDA pushed back its decision on Agios’s mitapivat in sickle cell disease by three months, to 1 February 2027.
The agency asked on 9 October whether the drug, sold as Aqvesme in thalassaemia, needs a risk evaluation and mitigation strategy (REMS). It then classed Agios’s answer as a major amendment to the application. Agios says it is ready to launch and still in labelling talks.
Agios announces new PDUFA goal date for mitapivat sickle cell disease sNDA · Agios
Inovio won FDA accelerated approval for Voceryq, the first FDA-approved DNA medicine.
Voceryq is approved to reduce surgery in adults with recurrent respiratory papillomatosis (RRP). In the RRP-001 study, 7 of 26 patients (27%) needed no surgery to remove papillomas in the 12 months after treatment. Inovio announced the approval of Voceryq, previously INO-3107, on Friday 30 October. Continued approval may depend on a confirmatory study.
Inovio announces FDA accelerated approval of Voceryq for RRP · Inovio
Monday 2 November
Fresenius signed an exclusive deal giving it access to up to 37 biosimilar candidates from WuXi Biologics over the next decade.
Fresenius calls it the largest development agreement yet announced in biosimilars. It would take Fresenius’s portfolio from 29 molecules to up to 66, aimed at >€370bn of originator sales at list prices. Fresenius pays WuXi Biologics a fee per selected candidate and keeps global commercial rights. Fresenius expects initial development to focus on copies of Polivy (polatuzumab vedotin) and Tepezza (teprotumumab).
Fresenius and WuXi Biologics enter biosimilars agreement · Deutsche Börse
Scottish Widows’ growth fund began putting UK workplace pension savings into venture-stage UK companies, through a portfolio run by IP Group.
Aberdeen Investments, which manages the growth sub-fund, appointed IP Group. The first investments are expected to include Oxford Quantum Circuits, Quantum Motion, battery maker Nyobolt and Genomics, which applies AI and large genetic datasets to preventative healthcare and drug discovery. Seventeen workplace pension providers pledged in the May 2025 Mansion House Accord to put at least 10% of their default funds into private markets by 2030, at least half of it in the UK.
IP Group to manage UK venture portfolio for Scottish Widows · IP Group
Mansion House Accord · Pensions UK
The FDA put a partial clinical hold on Bright Minds’ planned phase 2 trial of BMB-101 in severe childhood epilepsies, and its shares lost 52%.
The agency cited toxicity in mice and too little pharmacokinetic and juvenile toxicity data to support enrolling children. Bright Minds says the hold covers only that US trial, and that it believes the mouse findings were incidental.
Bright Minds update on planned BMB-101 study · Bright Minds Biosciences
Partial hold of Bright Minds’ DEE drug sends shares plummeting · BioWorld
The FDA accepted uniQure’s Huntington’s disease gene therapy for priority review, with a decision date of 1 May 2027.
The agency tentatively plans an advisory committee meeting on ifezuntirgene inilparvovec (AMT-130), filed under the accelerated approval pathway. uniQure says it would be the first disease-modifying treatment for Huntington’s, and expects screening for its confirmatory trial to start by the end of the year.
uniQure announces FDA acceptance and priority review of BLA · uniQure
Karyopharm Therapeutics filed for Chapter 11 protection under a plan to merge with Ayrmid, the parent of Gamida Cell.
Ayrmid will be the lead bidder in a court-supervised sale that is open to rival bids. Karyopharm, which sells the myeloma drug Xpovio (selinexor), has a $55m financing commitment and expects the deal to close in Q1 2027. Its shares are expected to be delisted from Nasdaq.
Karyopharm announces planned merger with Ayrmid · Karyopharm
Tuesday 3 November
Lonza agreed to buy Merck KGaA’s five US contract manufacturing sites, more than doubling its US footprint.
About 1,100 employees transfer, taking Lonza to nine US contract development and manufacturing (CDMO) sites and >6,000 US staff. Lonza put the price in the low- to mid-hundreds of millions of Swiss francs, to be paid in cash. The deal is expected to close in mid-2027.
Lonza to acquire US CDMO network from Merck KGaA · Deutsche Börse
Cinven agreed to buy London-based women’s health company Theramex from Carlyle and PAI Partners.
Cinven did not disclose the price. The Financial Times, citing sources, put it at about €2.6bn, almost double the €1.4bn the sellers paid in 2022. Theramex sells treatments for menopause, fertility, contraception and osteoporosis in >80 countries.
Cinven to acquire Theramex · Cinven
Cinven acquires Theramex for €2.6bn · Private Equity Wire
BioNTech is ending a phase 2 trial of its personalised mRNA cancer immunotherapy in colorectal cancer, as Q3 revenue fell to €1.29bn from €1.52bn.
The trial tested autogene cevumeran, partnered with Genentech, after surgery in ctDNA-positive stage II-III colorectal cancer. Its pancreatic cancer trial continues. In October, BioNTech reported that off-the-shelf BNT113 plus Keytruda (pembrolizumab) missed significance on progression-free survival in the AHEAD-MERIT trial, which continues to its overall survival endpoint. Revenue fell because demand for Covid vaccines dropped.
BioNTech announces Q3 2026 results and corporate update · SEC EDGAR
Sevasemten failed its late-stage trial in Becker muscular dystrophy.
The 18-month placebo-controlled GRAND CANYON study showed no significant benefit on the North Star Ambulatory Assessment, and the secondary endpoints also missed. Servier said the result does not match the phase 2 CANYON study and is analysing the data. In June, Servier agreed to buy Edgewise’s muscular dystrophy business, including sevasemten, for $1.55bn upfront and up to $1.1bn in milestones.
Servier announces topline results for sevasemten in Becker · Servier
Servier to acquire Edgewise Therapeutics’ muscular dystrophy business · Servier
Waters bought MOBILion Systems, adding its high-resolution ion mobility technology to Waters’ mass spectrometers to move into proteomics.
Waters announced the deal with Q3 results. Revenue was $1.767bn, and Waters raised every part of its 2026 guidance, including a $43m rise in revenue guidance at the midpoint.
Waters acquires MOBILion Systems · Waters
Waters Corporation reports third quarter 2026 financial results · SEC EDGAR
Medicare extended coverage of Natera’s Signatera molecular residual disease (MRD) test to hepatocellular carcinoma, the most common liver cancer.
Coverage includes repeat testing to watch for recurrence after surgery in early-stage disease. In a 125-patient study, Signatera’s sensitivity was 83%, against 42% for the standard blood marker alpha-fetoprotein.
Medicare expands Signatera coverage in hepatocellular carcinoma · Natera
Ultragenyx will cut about 20% of its staff and has ended UX701, its gene therapy for Wilson disease, after it missed study goals.
The cuts leave about 1,000 employees and should halve 2027 R&D spending against 2025. Ultragenyx reaffirmed its 2026 revenue guidance and its target of profitability in 2027.
Ultragenyx reports Q3 results, announces expense reductions · SEC EDGAR
Wednesday 4 November
Novo raised its 2026 outlook to adjusted sales growth of -2% to +2% at constant currency, after Q3 sales rose 4%.
The Wegovy (semaglutide) pill brought in DKK5.4bn in Q3. Novo is preparing a US launch of CagriSema in early 2027, subject to approval. Endpoints News reported outgoing chief financial officer Karsten Munk Knudsen as saying CagriSema will not launch in Europe for “a couple of years”. Luigi La Corte will replace him.
Novo raises full-year outlook on continued GLP-1 momentum · SEC EDGAR
Novo’s CFO Karsten Munk Knudsen to leave company · Euronext
CagriSema won’t launch in Europe for ‘a couple of years’ · Endpoints News
AbbVie licensed Nxera Pharma’s gut-targeted EP4 agonist for inflammatory bowel disease (IBD), for $100m upfront and up to $1.37bn in milestones.
Nxera’s UK subsidiary signed the deal, and Nxera will also receive tiered royalties. NXE0033744 has completed phase 1, where it showed a gut-selective profile.
Nxera Pharma enters global license agreement with AbbVie · BioSpace
Boehringer Ingelheim took options on six preclinical cancer programmes from Sino Biopharmaceutical.
Sino Biopharmaceutical gets $358m upfront/near-term and is eligible for up to $7bn in milestones, plus royalties. The antibody-drug conjugates and T-cell engagers come mainly from LaNova Medicines. Sino runs early development and Boehringer takes rights outside mainland China, Hong Kong and Macau for four programmes, and worldwide for two.
Boehringer Ingelheim and SBP Group enter cancer partnership · BioSpace
CVS Health plans to split into two listed companies, separating its pharmacies from Aetna and Caremark.
The healthcare solutions company keeps Aetna, the pharmacy benefit manager (PBM) Caremark, CVS Specialty, Oak Street Health and Signify Health under the CVS Health name. CVS Pharmacy takes about 9,000 stores, the mail pharmacy and MinuteClinic. The split unwinds the combination CVS built by merging with Caremark in 2007 and buying insurer Aetna for about $70bn in 2018. CVS intends the separation to be tax-free and expects to complete it in H1 2028.
CVS Health announces intent to create two distinct leaders · SEC EDGAR
CVS Health completes acquisition of Aetna · SEC EDGAR
Thursday 5 November
ANI Pharmaceuticals made a recommended cash offer for Swedish rare disease drugmaker Egetis Therapeutics, valuing it at about SEK5.3bn.
ANI offers SEK11.25 a share, a 12.6% premium to Egetis’s last close, and Egetis’s board unanimously backs the bid. Egetis sells Emcitate (tiratricol), approved in the EU and, on 28 September, by the FDA. On 4 November Egetis agreed to sell the priority review voucher that came with the US approval.
ANI announces a recommended cash offer to Egetis shareholders · Cision
Cambridge, UK-based T-Therapeutics raised a $133m series B to take two TCR-CD3 bispecifics in cancer and autoimmune disease to clinical proof of concept.
Advent Life Sciences and the British Business Bank co-led the round. New investors include Johnson & Johnson’s JJDC, Samsara BioCapital, M-Ventures and Eli Lilly.
T-Therapeutics announces oversubscribed $133m series B · T-Therapeutics
Oxford University spinout Alethio Therapeutics raised a $90m series A to take its antibody ATX-011 into trials in essential thrombocythaemia.
Sofinnova Partners and RA Capital co-led the round with founding investor Oxford Science Enterprises. ATX-011 targets G6b, a protein on platelets and megakaryocytes. BioPharma Dive reported that it should enter the clinic in H1 2028.
Alethio raises $90m in oversubscribed series A · Alethio Therapeutics
Alethio raises $90M to target rare blood cancers · BioPharma Dive
Siemens Healthineers began carving out its diagnostics business as Olyrian Diagnostics, and will rename itself Healthineers.
The transition should be complete by mid-2028. Olyrian stays part of the group until then.
Siemens Healthineers to rebrand diagnostics as Olyrian · Siemens Healthineers
Novartis said it has received nine reports of tumours in patients treated with its gene therapy Zolgensma.
In a statement shared by patient group SMA Europe, Novartis said two cases showed the gene therapy’s viral vector DNA integrated into the patient’s DNA, a risk already in the prescribing information. Both patients were treated and remain under monitoring. Novartis said >6,000 patients have received Zolgensma (onasemnogene abeparvovec), which was approved in 2019.
Information regarding recent Zolgensma safety concerns · SMA Europe
The FDA granted accelerated approval to J&J’s Rybrevant Faspro in head and neck cancer that has progressed after platinum and PD-(L)1 therapy.
Rybrevant Faspro is the subcutaneous version of Rybrevant (amivantamab), which targets EGFR and MET. In the phase 1b/2 OrigAMI-4 trial, the confirmed response rate was 42%. The label excludes HPV-associated oropharyngeal cancer, and continued approval may depend on the phase 3 OrigAMI-5 trial in first-line disease.
Rybrevant Faspro approved in head and neck cancer · Johnson & Johnson
The UK government is preparing to extend Palantir’s £330m contract to run the NHS federated data platform, the Financial Times reported.
The FT said Health Secretary Yvette Cooper will not trigger the first break clause, in February 2027, because doing so risks lengthening waiting lists. It said ministers will use a review to design a fresh procurement for the platform’s long-term future.
UK prepares to extend Palantir’s NHS contract · Financial Times
Labour set to extend Palantir NHS contract · Yahoo News
Aleth · Open Access Research