Aleth LifeSci Brief: 27-31 Oct 2025
Novo goes hostile on Metsera to outbid Pfizer
ALETH / LIFESCI-BRIEF / 2025-10-31 / NOVO GOES HOSTILE ON METSERA TO OUTBID PFIZERIn this edition
Tuesday: Cigna ends rebates; GHO Capital raise; Roche Gazyva kidney win; CSL delays Seqirus
Wednesday: Thermo Fisher buys Clario; UK VPAG deadline; BridgeBio double phase 3; GSK drops CD226
Monday 27 October
Novartis agreed to buy Avidity Biosciences for about $12bn, its largest bet yet on RNA medicine.
Novartis will pay $72.00 a share in cash, valuing the San Diego company at roughly $12bn in equity and about $11bn once its cash is netted off, a premium of about 46% to Avidity’s close the previous Friday. The deal brings Avidity’s antibody oligonucleotide conjugate platform and three late-stage muscular dystrophy programmes: del-desiran for myotonic dystrophy type 1, plus candidates for facioscapulohumeral and Duchenne muscular dystrophy.
Sources:
Chinese biotech has signed more than 90 licensing deals in 2025 worth a record of about $85bn, the Financial Times reported.
That would be China’s sixth consecutive annual record. Alongside licensing out single assets, Chinese companies are increasingly selling whole drugs to Western pharma, and some investors now treat the country as a source of original innovation rather than a fast follower. The pattern turned up repeatedly across the week, from Roche’s respiratory bispecific out of Qyuns to Innovent’s head-to-head win over Novo Nordisk’s semaglutide.
Sources:
China’s biotech dealmaking hits a record in 2025 - Financial Times
Intellia Therapeutics paused its two phase 3 CRISPR trials after a patient was hospitalised with a liver injury.
The company halted dosing and screening in MAGNITUDE and MAGNITUDE-2, its late-stage studies of nexiguran ziclumeran, an in vivo gene-editing treatment for transthyretin amyloidosis, after a patient dosed on 30 September developed Grade 4 liver enzyme elevations and raised bilirubin. Two days later the FDA placed both studies on clinical hold, formalising the stoppage, and Intellia’s shares fell. These are among the most advanced tests of editing genes directly inside the body.
Sources:
Intellia provides update on MAGNITUDE clinical trials - Intellia Therapeutics
US FDA places clinical hold on Intellia’s two gene-editing trials - Reuters
The FDA approved Bayer’s Lynkuet for menopausal hot flashes, opening the US market to a nonhormonal treatment.
Lynkuet (elinzanetant) is a once-daily pill that blocks the neurokinin-1 and neurokinin-3 receptors, and it now competes with Astellas’s Veozah as a hormone-free option for vasomotor symptoms. Approval rested on the phase 3 OASIS programme, which cut the frequency and severity of hot flashes over 12 weeks with 52-week safety data behind it. Britain approved elinzanetant first, over the summer, ahead of the United States, Australia, Canada and Switzerland.
Sources:
Organon’s chief executive Kevin Ali resigned after an internal investigation found the company had pushed wholesalers to over-buy its contraceptive Nexplanon.
The audit committee found that US wholesalers were paid incentives to purchase more Nexplanon than they needed at the end of several quarters, from late 2022 through the third quarter of 2025, to help Organon meet its revenue targets; the improper sales came to less than 1% of group revenue and required no restatement.
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Tuesday 28 October
The Cigna Group said it will stop taking drug rebates, a change to the plumbing of the US pricing system.
Its Evernorth health-services arm, which owns the Express Scripts pharmacy benefit manager, said it would apply manufacturers’ discounts at the pharmacy counter rather than collect them as rebates after the sale, and claimed the shift would cut the monthly cost of a brand-name prescription by an average of 30% for people who pay full price.
The move came as President Trump kept up pressure on the pharmacy benefit managers that sit between drugmakers and patients, and Cigna credited that pressure.
Sources:
GHO Capital, a London healthcare investor, closed its fourth fund at more than €2.5bn.
The fund, the firm’s largest and about a quarter bigger than its predecessor, drew money from more than 30 institutions and takes GHO’s assets under management to around €9bn. GHO said it would put the capital into pharmaceutical manufacturing, including contract drug producers, and AI-enabled healthcare businesses.
Sources:
Roche’s Gazyva met its goal in a phase 3 trial in childhood kidney disease.
In the INShore study of 85 children and young adults with frequently relapsing or steroid-dependent idiopathic nephrotic syndrome, more patients stayed in sustained remission at one year on Gazyva (obinutuzumab), a CD20 antibody, than on the standard immune-suppressant mycophenolate mofetil. Roche met its secondary goals too and reported no new safety signals, and said it would present the detailed figures at a medical meeting.
Sources:
CSL delayed the spin-off of its Seqirus flu-vaccine business, blaming a falling US vaccine market.
At its annual meeting in Melbourne, CSL said it was no longer aiming to complete the demerger in its 2026 financial year, pointing to insurance-claims data showing US flu vaccinations down about 12% this season and 14% among people over 65. The company said it still intends to separate Seqirus once conditions steady. CSL cut its full-year guidance alongside the news, and its shares fell to a multi-year low.
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Wednesday 29 October
Thermo Fisher Scientific agreed to buy Clario, a maker of clinical-trial software, for $8.875bn in cash.
Clario’s technology captures the data that trials use to measure whether a drug works, and Thermo Fisher said it has supported about 70% of FDA drug approvals over the past decade. On top of the cash, the deal adds a $125m payment in early 2027 and up to $400m in performance earn-outs; Clario is expected to bring in about $1.25bn of revenue this year. The sellers include Nordic Capital, Novo Holdings, Cinven and Astorg, and Thermo Fisher expects to close by the middle of 2026.
Sources:
Thermo Fisher Scientific to acquire Clario Holdings - Thermo Fisher Scientific
The UK government and the industry gave drug companies two more weeks to decide whether to quit the VPAG pricing scheme.
The ABPI said the deadline for firms to give notice that they will leave the Voluntary Scheme for Branded Medicines Pricing, Access and Growth moved from 31 October to 14 November, and that the required notice period was cut from two months to six weeks. Companies leaving VPAG would unpick the settlement at the centre of the UK’s dispute with the industry over what the NHS pays for branded medicines. The ABPI said the extra time was to let companies weigh their decisions amid global uncertainty.
Sources:
BridgeBio posted two phase 3 wins in three days, in muscular dystrophy and a rare calcium disorder.
In the FORTIFY study of BBP-418 in limb-girdle muscular dystrophy type 2I/R9, the biomarker glycosylated alpha-dystroglycan rose 1.8-fold from baseline (p<0.0001), serum creatine kinase fell 82% at one year, and patients gained 0.27 m/s over placebo on a 100-metre timed walk. BridgeBio said the data could support full rather than accelerated approval, which would make BBP-418 the first approved treatment for the disease.
Two days later, in the phase 3 CALIBRATE trial, 76% of patients on encaleret, an oral drug that tunes the body’s calcium-sensing receptor, reached normal blood and urine calcium at 24 weeks, against 4% on standard treatment (p<0.0001), in autosomal dominant hypocalcaemia type 1. BridgeBio plans US filings for both drugs in the first half of 2026.
Sources:
BridgeBio reports positive phase 3 FORTIFY results for BBP-418 in LGMD2I/R9 - BridgeBio Pharma
BridgeBio reports positive phase 3 CALIBRATE results for encaleret in ADH1 - BridgeBio Pharma
GSK abandoned a set of cancer immunotherapy programmes it had once framed as a new drug class.
In its third-quarter results, GSK recorded a £471m charge for scrapping belrestotug, an anti-TIGIT antibody, in the second quarter, and said it had terminated cobolimab, an anti-TIM-3 antibody, in September, returning the rights to AnaptysBio. The two sat at the centre of the group’s bet on the CD226 checkpoint axis in cancer. GSK’s immunotherapy effort now centres on its approved drug Jemperli.
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Thursday 30 October
The FDA moved to speed up cheaper copies of biologic medicines, over the industry’s objections.
The agency issued draft guidance saying biosimilar developers will no longer need to run comparative efficacy trials, which it said take 1-3 years and cost $24m on average while adding little to the analytical case. It also proposed to treat approved biosimilars as interchangeable with the original by dropping separate switching studies. The change, part of the administration’s drug-pricing effort, would expose some of the industry’s most profitable products to earlier competition.
Sources:
Roche licensed a Chinese respiratory drug from Qyuns Therapeutics in a deal worth more than $1bn.
Roche will pay $75m up front and up to $995m in milestones, plus royalties, for global rights to QX031N, a bispecific antibody targeting TSLP and IL-33 that Qyuns is developing for asthma, COPD and other respiratory diseases. Most of the value is tied to future milestones rather than cash today, and the drug is still in early development.
Sources:
Qyuns grants Roche global rights to QX031N - Qyuns Therapeutics
Novartis said its antibody ianalumab worked in two phase 3 trials in Sjögren’s disease, which has no approved disease-modifying treatment.
In the NEPTUNUS-1 and NEPTUNUS-2 studies, covering 275 and 504 patients, monthly ianalumab, which depletes B-cells by blocking the BAFF receptor, cut disease activity on the standard ESSDAI scale at 48 weeks and eased patients’ own reported burden, with benefit showing by week 16. Novartis flagged a large placebo response in both trials. It called ianalumab the first drug to reduce both disease activity and patient burden in late-stage Sjögren’s trials.
Sources:
Novartis’ ianalumab reduces disease activity and patient burden in phase 3 Sjögren’s trials - Novartis
Novo Nordisk went public with an unsolicited bid for Metsera, gatecrashing Pfizer’s agreed takeover of the obesity biotech.
Novo’s proposal values Metsera at up to $77.75 a share, about $8.5bn including milestone payments, against Pfizer’s agreed deal worth up to $7.3bn; it offers $56.50 a share in cash plus a matching dividend, with a contingent value right of up to $21.25 a share on top.
Metsera’s board judged the offer a “superior company proposal” under its Pfizer merger agreement, starting a four-business-day window for Pfizer to respond. Pfizer disputed the designation and raised antitrust concerns about a Novo takeover.
Sources:
Metsera receives unsolicited proposal from Novo Nordisk - Metsera
Novo Nordisk submits proposal to acquire Metsera - Novo Nordisk
Friday 31 October
Gilead chose which drug to pair with lenacapavir for a twice-yearly HIV treatment, and dropped the alternative.
On its third-quarter earnings call, Gilead said it had taken two experimental integrase inhibitors, GS-1219 and GS-3242, into phase 1 as partners for lenacapavir, its long-acting antiviral, and would now push ahead with GS-3242 and end work on GS-1219. The company said it will share more data on GS-3242 at a virology conference in 2026.
Sources:
Gilead Q3 2025 prepared remarks - Gilead Sciences
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