In this edition
Monday: Metsera war; UK rare-disease rules; FDA drug chief out; uniQure Huntington’s; Roche lupus
Tuesday: Kimberly-Clark buys Kenvue; AstraZeneca NY listing; Sarepta Duchenne miss
Wednesday: Novo Nordisk outlook cut; UK biotech letter; Biohaven ataxia rejection
Thursday: US envoy’s UK warning; AstraZeneca Q3; J&J Caplyta; BillionToOne IPO
Friday: Trump obesity prices; Intellia trial death; UK Lords warning
Story of the week
Pfizer sued to keep Novo Nordisk away from Metsera, opening a fortnight of open bidding that ran the price for the obesity biotech to $10bn.
On 3 November Pfizer filed federal antitrust claims against Metsera, its controlling stockholders and Novo Nordisk in the US District Court in Delaware, and asked the Delaware Court of Chancery for a temporary restraining order to stop Metsera walking away from their agreed deal. Pfizer had already secured early clearance from the Federal Trade Commission for its own purchase on 31 October, before the antitrust waiting period was due to expire.
The next day Metsera declared Novo’s amended offer superior: a cash dividend of $62.20 a share plus a contingent value right worth up to $24.00, up to $86.20 in all and about $10bn, against Pfizer’s $60.00 in cash and up to $10.00 more. On 5 November the Chancery court refused Pfizer’s restraining order, and an FTC official wrote to lawyers for Novo and Metsera that Novo’s two-step structure “may violate the procedural provisions” of US merger law.
Pfizer came back on 7 November with a matching $65.60 in cash and up to $20.65 in contingent payments, up to $86.25 a share. Metsera’s board reaffirmed the Pfizer deal, judging Novo’s offer to carry unacceptably high legal and regulatory risk, and set the shareholder vote for 13 November.
Sources:
Pfizer receives early clearance from the FTC for Metsera acquisition - Pfizer
Metsera declares Novo Nordisk amended proposal “superior” - Metsera
FTC tells Novo its Metsera offer may violate US merger law in current form - Fierce Biotech
Pfizer and Metsera enter into merger agreement amendment; Metsera’s board reaffirms support - Metsera
Monday 3 November
The MHRA set out a new framework to speed treatments for rare diseases.
On 2 November the agency published plans for a Rare Disease Therapies Framework aimed at the 3.5 million people in the UK who live with a rare disease, fewer than one in twenty of whom have an approved treatment. Its centrepiece is an Investigational Marketing Authorisation that would fold clinical-trial approval and a progressive route to full marketing authorisation into a single authorisation, alongside adaptive trial designs and real-world evidence. A draft is due for consultation in the first half of 2026.
Sources:
George Tidmarsh resigned as head of the FDA’s drug centre, then said he would fight to get the job back.
Tidmarsh, who had run the Center for Drug Evaluation and Research (CDER) since July, was put on administrative leave on 1 November and resigned the next day, after Commissioner Marty Makary told him of a complaint from the healthcare investor Kevin Tang. Tang chairs Aurinia Pharmaceuticals, which sued Tidmarsh over a deleted LinkedIn post attacking one of its drugs and accused him of a personal vendetta. A day after resigning Tidmarsh told Endpoints News he would contest his exit.
Sources:
FDA’s George Tidmarsh resigns amid Kevin Tang complaint - STAT
A day after resigning, Tidmarsh now says he’ll fight exit from FDA - Endpoints News
The FDA pulled back from an earlier position on uniQure’s Huntington’s gene therapy, and the shares halved.
At a pre-submission meeting the agency told uniQure it no longer agreed that data from its one-time therapy AMT-130, measured against an external natural-history control, could serve as the primary basis for an accelerated-approval filing. That reversed guidance the FDA had given in November 2024. Chief executive Matt Kapusta called the news unexpected and said the timing of any application was now uncertain, with Huntington’s patients still without a disease-modifying treatment.
Sources:
Roche’s Gazyva met the main goal of a phase 3 trial in the broader form of lupus.
The ALLEGORY study showed more patients given Gazyva, an anti-CD20 antibody, on top of standard therapy reached a four-point improvement on a standard lupus activity score at one year than those on standard therapy alone, and all its secondary goals were met too, with no new safety signals. The result extends the drug beyond its blood-cancer use and its earlier win in lupus nephritis into systemic lupus erythematosus (SLE).
Sources:
Tuesday 4 November
Kimberly-Clark agreed to buy Kenvue in a cash-and-stock deal with an enterprise value of about $48.7bn.
The offer gives Kenvue holders $3.50 in cash and 0.14625 of a Kimberly-Clark share for each share, about $21.01, and would join the Kleenex brand with Tylenol, Listerine and Aveeno. The combined group has about $32bn in annual revenue and will target $2.1bn in savings, with K-C shareholders owning about 54% and completion expected in H2 2026. Kenvue has been under pressure from President Trump’s claim linking Tylenol to autism and from litigation over Johnson’s Baby Powder.
Sources:
AstraZeneca shareholders voted almost unanimously to add a New York listing.
At a general meeting on 3 November, 99.4% backed new articles of association that harmonise the company’s listing across London, Stockholm and New York. The UK and Swedish listings are unaffected and stay in the FTSE 100, the headquarters remains in the UK, and New York trading is expected to begin on 2 February 2026.
Sources:
Result of General Meeting held on 3 November 2025 - AstraZeneca
Sarepta’s long confirmatory trial of two Duchenne drugs missed its main goal, and the company said it would seek full approval anyway.
The ESSENCE study of the exon-skipping drugs casimersen and golodirsen, both cleared years ago under accelerated approval, did not beat placebo on a walking-speed measure at 96 weeks. Sarepta said it would file to convert both to traditional approval using the trial’s randomised data and real-world evidence, and that its labelling talks over its gene therapy Elevidys were near conclusion.
Sources:
Sarepta Therapeutics announces third-quarter 2025 financial results and business update - Sarepta Therapeutics
Wednesday 5 November
Novo Nordisk cut its 2025 outlook to the bottom of its range and confirmed a pullback in early research.
In its nine-month report the company lowered expected full-year sales growth to 8 to 11% and operating-profit growth to 4 to 7% at constant exchange rates, citing slower growth for its GLP-1 medicines in diabetes and obesity. It said it would stop starting new trials for a string of early programmes in cancer, liver disease, gout and its stem-cell platform, part of a restructuring that carries a charge of about 9bn Danish crowns and roughly 9,000 job cuts.
Sources:
More than 200 biotech chief executives asked the chancellor to spare innovative companies in the Budget.
The letter, coordinated by the BioIndustry Association (BIA) urged Rachel Reeves not to raise taxes or business rates on innovative companies and their research sites, and to speed already-committed public funding and strengthen tax reliefs. It landed three weeks before the 26 November Budget, against the backdrop of a funding drought for the UK sector.
Sources:
BIA update, 3 November 2025: over 200 CEOs write to the Chancellor ahead of the Budget - BioIndustry Association
The FDA rejected Biohaven’s treatment for a rare inherited movement disorder.
The agency issued a complete response letter for troriluzole in spinocerebellar ataxia, citing the limits of the real-world evidence Biohaven had used despite a positive prespecified study. Biohaven said it would request a meeting with the FDA and cut its direct research spending by about 60%, reprioritising to three lead programmes.
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Thursday 6 November
The US ambassador to Britain warned that American drugmakers will shut UK sites unless prices rise soon.
Speaking at a business lunch in London, Warren Stephens said pharmaceutical companies “will not only cancel future investments, they will shut down their facilities in the UK” if changes are not made quickly. His remarks came during UK-US talks under which Britain would pay more for some medicines in return for lower tariffs on its pharmaceutical exports.
Sources:
AstraZeneca beat expectations with its largest quarterly revenue yet.
Third-quarter revenue rose 10% at constant exchange rates to $15.19bn, ahead of forecasts, carried by cancer, heart and kidney medicines. Nine-month revenue reached $43.24bn, the company reaffirmed its full-year guidance, and it said it remained on track for its target of $80bn in annual revenue by 2030.
Sources:
AstraZeneca nine-month and Q3 2025 results - AstraZeneca
The FDA approved Johnson & Johnson’s Caplyta as an add-on treatment for depression.
The clearance lets the drug be used alongside antidepressants for major depressive disorder in adults, its fourth approved use and the first won since J&J bought Intra-Cellular Therapies for $14.6bn. The company has pointed the drug toward $5bn in eventual sales.
Sources:
FDA approval of Caplyta (lumateperone) for adults with major depressive disorder - Johnson & Johnson
The molecular-diagnostics company BillionToOne raised about $273m and its shares jumped on the first day.
The upsized offering priced 4,551,100 shares at $60, above the marketed range, and the stock began trading on Nasdaq the next day under the ticker BLLN, closing about 82% higher at $108.94.
Sources:
Friday 7 November
President Trump announced deals with Eli Lilly and Novo Nordisk to cut the price of their weight-loss drugs and bring them into Medicare and Medicaid.
Under the agreements, the companies will sell their injections to Medicare at $245 a month, with a $50 patient co-pay, and Medicare and Medicaid will cover the drugs for obesity for the first time. The TrumpRx website will sell direct to cash-paying patients from January at about $350 a month, and future weight-loss pills would start at $150. The terms reset US pricing for the whole obesity category.
FDA named Lilly and Novo among the companies to receive its new national priority vouchers, which compress a drug review to a matter of months. Boehringer Ingelheim, Johnson & Johnson, GSK and Vertex took the other four.
Sources:
Fact sheet: President Trump announces major developments in bringing most-favored-nation pricing to American patients - The White House
A patient in an Intellia gene-editing trial died, the first death in the company’s in-vivo CRISPR programme.
Intellia said that a patient given its one-time therapy nex-z for transthyretin amyloidosis, in the phase 3 MAGNITUDE study, developed severe liver injury and died on 5 November. Both of the drug’s phase 3 studies remain under FDA clinical holds imposed on 29 October, after the company had paused dosing two days earlier, and Intellia said it was working to understand the liver events and design a way to reduce the risk.
Sources:
Intellia Therapeutics provides update on MAGNITUDE clinical trials - Intellia Therapeutics
A House of Lords committee told the government the UK’s failure to grow its science companies has reached crisis point.
In a report titled “Bleeding to death”, published on 5 November, the Science and Technology Committee said promising firms start up in Britain and then sell or scale abroad, citing recent sales of Oxford Ionics and OrganOx. It called for a new National Council for Science, Technology and Growth chaired by the prime minister or chancellor, reform of visa rules for global talent, and faster action to channel pension money into UK companies.
Sources:
Bleeding to death: the science and technology growth emergency (HL Paper 192) - House of Lords Science and Technology Committee