Biotech & Longevity · Friday, 23 October 2026
Moderna and Merck's made-for-each-patient melanoma vaccine cuts the risk of the cancer returning or death by 42%, and Moderna's shares fall about 25%
Full results from the final trial of intismeran show 82 in 100 patients free of melanoma after two years, against 70 in 100 on the immune drug Keytruda alone, but the gain was smaller than some investors hoped and survival data are not in yet.
82 vs 70
in every 100 patients alive and free of melanoma after two years, with and without the vaccine
measured in 1,137 patients at 157 sites around the world
42%
lower risk of the cancer returning or death when the vaccine was added
analysts had looked for 40% to 50%, and Moderna had called 35% meaningful
up to 34
mistakes from each patient's own tumour written into that patient's vaccine
older targeted drugs were chosen for a single gene mistake, an outside researcher said
nearly 25%
fall in Moderna's share price on Thursday
its shares had risen more than four-fold since the first, number-free announcement in August
The lead story — what happened
-
Moderna and Merck released the full results of their final-stage melanoma trial on Thursday, two days early, after the data leaked on social media.
[2] [3] -
Melanoma is a skin cancer, and the 1,137 patients in the trial had already had their tumour removed by surgery but were at high risk of it coming back.
[4] [1] -
Each patient got Keytruda, Merck's immune drug, for about a year, and two in three also got intismeran, a vaccine made for that one person.
[4] -
To make it, the tumour's genes are read and up to 34 of its own mistakes are written into mRNA, which teaches the immune system to hunt cells carrying them.
[2] [1] -
Adding the vaccine cut the risk of the cancer returning or death by 42% after a typical 24.6 months of follow-up.
[4] [5] -
After two years, 82 in 100 patients on the pair were alive and free of melanoma, against 70 in 100 on Keytruda alone.
[3] [1] -
The risk of the cancer spreading to distant organs, or death, fell 38%: 88.5% stayed clear of that, against 80.2%.
[3] [4] -
For the first six months, patients relapsed at about the same rate with or without the vaccine. From six months on, after the course of injections, a planned extra analysis found the risk 58% lower.
[4] -
Nobody knows yet whether patients live longer, because the trial has not run long enough to count deaths properly.
[6] [4] -
Fever hit 52% of vaccine patients and injection-site pain 51%, but serious side effects were close: 14.2% with the vaccine, 13.4% without.
[4] [3] -
Investors had expected a cut of 40% to 50%, so Moderna's shares fell nearly 25% and Merck's about 1%.
[2] -
The companies are talking to drug regulators, and the results have been accepted by the New England Journal of Medicine.
[4] [6]
Who is involved
-
Moderna
the US company behind an mRNA Covid vaccine; it makes intismeran
-
Merck
a large US drugmaker that sells Keytruda, one of the best-selling cancer drugs; it shares the vaccine
-
Georgina Long
medical director of Melanoma Institute Australia; she presents the trial at the cancer congress in Madrid on Saturday
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ESMO
the European Society for Medical Oncology, a body of cancer doctors; it released the data early after the leak
How it unfolded
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August Moderna and Merck say the trial met its main goal, with no numbers
[2] -
Thu 22 Oct screenshots of the results leak, and the full data are released early
[2] [3] -
Thu 22 Oct Moderna's shares fall nearly 25%
[2] -
Sat 24 Oct the results are presented at the cancer congress in Madrid
[1] [5] -
Later talks with drug regulators, and survival data
[4]
Where this points
The trial keeps running to count deaths, and the next test is whether the people given the vaccine also live longer; Merck and Moderna say an early look leans their way but is not settled.
Signals on this beat
The bar and the word are our reading of how hard each one is pushing, and the arrow is where it is heading.
Moderna's shares fell nearly 25% though its vaccine landed inside the 40% to 50% cut analysts had expected.
The NHS in England plans to treat 220,000 people with Mounjaro by 2028, about 6% of those eligible, and over a million pay privately.
The US drug regulator approved AstraZeneca's kidney drug Ultomiris on a fall in protein in the urine, while the trial on kidney damage runs on to 106 weeks.
Uganda says it has no Ebola, while Switzerland says the diplomat's wife now ill in Nigeria was infected there.
The rest of the day
20 more stories on this beat.
Each with its own sources. None of these is a link to the story above.
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02
US moves to limit investment in Chinese biotechs
The US Treasury, the US government's finance department, proposed rules on Thursday that add biotechnology to the industries where American investment in China can be banned.
[7] [8] They come from the COINS Act, a US law passed in December 2025.[8] Taking a stake in a Chinese biotech or forming a joint venture with one would be covered, though shares bought on a stock market and deals under $50,000 would not.[7] [8] Ordinary deals to license a single Chinese drug would not.[7] [8] Comments close on 7 December.[8] Why it matters — Pfizer and other big drugmakers had pushed to keep licensing deals open, and the draft does that.
[8] Deals with a share stake, like Pfizer's $100 million stake in China's 3SBio last year, would be banned, and China proposed its own limits on selling biotech platforms abroad last week.[7] [32] -
03
Prime editing used inside a person for the first time
Prime Medicine, a US biotech company, said this month that it has treated the first person in a trial that edits DNA directly inside the body with prime editing, the journal Nature reported.
[9] Prime editing can rewrite, add or remove short stretches of DNA, more precisely than standard CRISPR, which is often used to switch genes off.[9] The patient has Wilson disease, where a faulty gene called ATP7B stops the liver clearing copper, which then damages the liver and nerves.[9] The company expects first results next year.[9] Why it matters — The only gene-editing medicine approved in the US, Casgevy, edits a patient's cells outside the body and puts them back.
[9] Editing inside the body could be cheaper and faster, but carries different risks, a University of Wisconsin engineer told Nature.[9] -
04
US approves AstraZeneca kidney drug early
The FDA, the US drug regulator, gave accelerated approval on Wednesday to AstraZeneca's Ultomiris for adults with IgA nephropathy, a rare disease in which the immune system inflames the kidneys.
[10] In the trial, Ultomiris cut the protein leaking into urine by 43.4% against a dummy drug after 34 weeks.[10] An accelerated approval rests on an early sign like that one.[10] The trial runs to 106 weeks to show whether the drug really slows the loss of kidney function.[10] - 1Urine test read, approval given34
- 2Kidney function result due106
Weeks into the trial. The approval came at week 34, and the kidney-function result is due at week 106. Why it matters — AstraZeneca says more than 200,000 people in the US have the disease, and about half of those with high urine protein or weak kidneys risk kidney failure within 10 years.
[10] Full approval depends on the longer result.[10] -
05
AbbVie skin drug passes, by a narrow margin
AbbVie, a large US drugmaker, said on Thursday that its experimental drug lutikizumab passed a final-stage trial in hidradenitis suppurativa, a long-lasting disease that causes painful lumps and abscesses in the skin.
[11] In the 1,400-patient trial, 31.4% of people on weekly injections saw their lumps and abscesses fall by at least three-quarters after 16 weeks.[11] On a dummy injection, 23.4% did.[11] Side effects were about the same in both groups.[11] Why it matters — The result missed what investors had hoped for, and experts doubt it can compete with the treatment patients already get, STAT reported.
[11] The drug helped about 8 more people in every 100 than the dummy injection did.[11] -
06
Where Nigeria's Ebola patient caught it is still disputed
Africa CDC, the African Union's public health agency, called an emergency meeting of health ministers for 28 October, after Ebola reached a third region of Africa.
[13] [14] Switzerland's government said on Thursday that the patient in Nigeria, the Ugandan-born wife of a Swiss diplomat, was probably infected while travelling in Uganda.[12] Uganda says it has no Ebola cases.[12] The WHO and Africa CDC said they had no confirmed sign she had been to Congo, where the outbreak began in May.[12] Why it matters — The Bundibugyo strain behind this outbreak kills about half of those infected and has no approved vaccine or treatment, and about 4,700 people have died, Africa CDC counts.
[12] Kenya says it has now traced all 135 contacts of its first case.[12] -
07
US counts a third measles death, but not where
The CDC, the US national public health agency, added a third measles death this year to its count on Wednesday, but would not say in which state it happened.
[15] A spokesperson for the US health department cited privacy laws, and two law professors told the Guardian that naming a state would identify nobody.[15] US cases rose 8% in a week to 4,410, nearly double last year's total.[15] In September the CDC switched from a system that reports deaths quickly to the national health statistics office, and has not given a clear reason.[15] 3 deathsCDC count, whole US6 deathsPennsylvania alonePennsylvania has reported six measles deaths this year, five confirmed. The US agency lists three for the whole country. Why it matters — Pennsylvania alone has reported six deaths linked to measles, five of them confirmed, so the national count trails what one state says.
[15] Paul Offit, an infectious diseases doctor at the Children's Hospital of Philadelphia, said that makes risk hard to judge.[15] -
08
Roche sales rise as cheaper copies arrive
Roche, the Swiss maker of medicines and diagnostic tests, said on Thursday that its sales rose 7% to 16.1 billion Swiss francs, about $19.6 billion, in the third quarter, beating analysts' estimates.
[16] It kept its forecast for the year.[17] Its allergy and asthma drug Xolair sold 848 million francs, below estimates of over 900 million, and a cheaper US copy of it launched this month.[16] Ocrevus and Tecentriq, two more of its best sellers, face copies by 2030.[16] Why it matters — Roche is counting on giredestrant, a breast cancer pill with a US decision due by 18 December, and on obesity drugs to replace those sales.
[16] [17] An analyst at Jefferies, an investment bank, said the underlying numbers looked like a miss.[16] -
09
Rejected ataxia drug gets a second US review
The FDA has accepted a new application for Biohaven's drug Vyglxia, which it turned down last November, the company said on Thursday.
[18] The drug is for spinocerebellar ataxia, a group of rare inherited diseases where nerve damage slowly takes away balance, coordination and speech.[18] Its studies suggested the drug might slow the disease by as much as 70%.[18] The FDA found the key experiment unconvincing, partly because of how it was designed.[18] Why it matters — A panel of outside experts will meet, and a decision is due in the first three months of 2027.
[18] If approved, it would be the first medicine sold for the disease, and Biohaven's shares rose about 25%.[18] -
10
Lycia raises $318 million selling shares
Lycia Therapeutics, a California drug company co-founded by Nobel Prize winner Carolyn Bertozzi, raised nearly $318 million by selling shares to the public for the first time.
[19] It sold about 3 million more shares than it had planned, and its shares begin trading on the Nasdaq exchange on Friday.[19] Its drugs grab harmful proteins outside cells and pull them inside to be destroyed.[19] Two are in early trials, for allergies and Graves' disease, with data expected in 2027.[19] Why it matters — About two-thirds of drug company share sales this year have raised more than $250 million, BioPharma Dive counts.
[19] Its first results in patients are not due until 2027.[19] -
11
A copy of Zepbound is recalled
Apothecary Pharma, a US compounding pharmacy, has recalled 22 batches of its copy of tirzepatide, the active ingredient in Eli Lilly's weight-loss drug Zepbound.
[20] It said it could not fully guarantee the medicine's safety.[20] Compounding pharmacies mix their own versions of drugs, and many began selling cheaper copies when Zepbound and Novo Nordisk's Wegovy ran short.[20] The shortages ended, but firms kept selling copies by tailoring doses to each patient, which US law allows.[20] Why it matters — About 20% of Americans on these drugs use a copy, a Gallup survey found.
[20] Lilly and Novo have sued to stop the copies, and the recall could support their claim that copies are less safe.[20] -
12
Online clinics offer weight-loss drugs for addiction
Some US online clinics that treat addiction have begun prescribing weight-loss drugs like Ozempic, branded and copied, for alcohol and other addictions, STAT reported.
[21] The US regulator has not approved them for that, so this is off-label use: a drug prescribed for an illness it was not approved for.[21] Eli Lilly is testing a new drug, brenipatide, in alcohol addiction, and Altimmune is testing one called pemvidutide.[21] Why it matters — No new medicine for alcohol addiction has been approved in the US in two decades.
[22] The clinics are prescribing before the US regulator has approved any of these drugs for addiction.[21] [22] -
13
MPs want NHS weight-loss jabs for far more people
The Health Committee, a cross-party group of British MPs, said on Thursday that hundreds of thousands more people in England should get the weight-loss injection Mounjaro on the NHS.
[23] The NHS plans to give it to 220,000 people by 2028, about 6% of those eligible.[23] More than a million people already pay for such jabs privately.[23] Treating all 2.8 million eligible people at once would cost an estimated 15.2 billion pounds over five years.[23] 6 of 100
in every 100 eligible people in England get Mounjaro on the NHS by 2028
The committee puts the NHS plan at about 6% of eligible people. Why it matters — The committee says a two-tier system is forming, where only people who can pay get good access, and wants a crackdown on unlicensed jabs sold online.
[23] The NHS is reviewing its 12-year rollout plan.[23] -
14
Gilead pays $45 million in a Texas kickback case
Gilead Sciences, a large US drugmaker, agreed to pay $45 million to settle claims brought by the Texas attorney general.
[24] The state said Gilead paid kickbacks that swayed prescriptions paid for by Texas Medicaid, its health cover for people on low incomes.[24] A whistleblower said Gilead paid another company to hire nurses who recommended its drugs.[24] The suit also said Gilead offered doctors free support services so they would prescribe its drugs.[24] Why it matters — It is the latest drugmaker settlement with Texas over how drugs are marketed.
[24] The case grew from whistleblower suits filed nearly a decade ago against several drugmakers.[24] -
15
US regulator sets up a programme for brain drugs
The FDA launched a programme on Thursday to help develop medicines and devices for the brain and nerves, called the Neuroscience Advancement and Innovation Nexus.
[25] Its first project, the Alzheimer's Prevention Accelerator, will look at how to run trials of drugs that delay or prevent Alzheimer's disease, including which patients to enrol and which results should count.[25] The FDA says brain drugs are hard to test because diseases like Alzheimer's develop over many years.[25] Why it matters — The programme joins the FDA's centres for drugs, for biologics (medicines made from living things) and for devices and also covers psychiatric illness, addiction and pain.
[25] Acting FDA Commissioner Kyle Diamantas called Alzheimer's one of the most urgent public health challenges.[25] -
16
A free AI model designs new proteins
The Institute for Protein Design at the University of Washington and Nvidia, which makes the chips most AI runs on, released RFD4-Proteina, a free AI model that designs new proteins.
[26] It works out a protein's chain of building blocks and its shape at the same time as the molecule the protein must hold.[26] Its makers say it succeeds five to 10 times more often than earlier models, and works five to 10 times faster.[26] Why it matters — Possible uses include proteins that block a disease or detect it in a test, and any lab can build on an open model.
[26] The speed and success figures come from the developers' own benchmark tests.[26] -
17
AI agents re-read a brain study in 32 minutes
PerturbAI, which published an atlas of brain cells earlier this year, and OpenAI, the maker of ChatGPT, described a system of thousands of AI agents.
[27] They sort through large lab experiments and suggest what to test next.[27] Run on PerturbAI's atlas, the system finished in 32 minutes and recovered the study's conclusions without seeing the paper.[27] In blind comparisons, biologists preferred its reports to a single AI's 45 times out of 60.[27] Why it matters — The results are in a preprint, a paper not yet checked by other scientists.
[27] The test used one dataset, PerturbAI's own.[27] -
18
An implant burns off blood sugar in mice
Scientists at ETH Zurich, a Swiss university, built an implant the size of a USB stick that removes sugar from the blood with electricity, and tested it in mice, a study in the journal Science reports.
[28] Gold and platinum on its surface turn glucose into gluconate, which the body burns or passes out in urine.[28] In obese mice with diabetes it brought blood sugar under control within an hour and held it there for six weeks.[28] Linked to a phone and a glucose monitor, it ran by itself for two weeks.[28] Why it matters — It has been tested only in mice.
[28] An outside chemist said long-term safety, and removing enough glucose for a human body, are the next hurdles.[28] -
19
Blood proteins linked to prostate cancer years ahead
Researchers at Oxford Population Health, part of the University of Oxford, measured more than 6,000 proteins in blood taken from 982 men who later got prostate cancer and 1,573 men picked at random.
[29] The men were followed for about 16 years.[29] Twelve proteins were linked to cancers found more than 15 years after the blood was taken, and seven to aggressive cancer.[29] One, GZMK, is made by immune cells, a hint that the immune system may hold the cancer back for years.[29] Why it matters — Most links were modest, and the proteins are not ready to use as a test.
[29] Prostate cancer is the most commonly diagnosed cancer in men worldwide.[29] -
20
Overlooked immune cells attack a deadly lung cancer
Researchers at WEHI, an Australian medical research institute, found that immune cells called gamma delta T cells can find and kill small cell lung cancer, a form fewer than 7% of patients survive for five years.
[30] Patients whose tumours held more of these cells tended to live longer.[30] In mini tumours grown from patients' tissue, two approved drugs, tarlatamab and zoledronate, made the cells kill more cancer.[30] The study is in the journal Cancer Cell.[30] Why it matters — This cancer usually hides from the immune cells that most immune drugs depend on, and these cells appear able to see through that.
[30] The drug results come from lab dishes, not from patients.[30] -
21
How a deadly rodent virus grips human cells
Researchers at Albert Einstein College of Medicine, Institut Pasteur and LSU Health Shreveport mapped, almost atom by atom, how the Andes virus grabs human cells.
[31] Andes is a hantavirus, caught from rodents, that can cause a life-threatening lung illness and, unlike most hantaviruses, can pass between people.[31] Its spike holds a human protein called PCDH1 in a deep pocket formed by four copies of one viral protein.[31] Most antibodies are too bulky to reach inside.[31] Why it matters — The team says thin, long molecules might reach into the pocket and block infection, and plans to test that idea.
[31] It is lab work on the virus's structure, not yet a treatment.[31]
Why limiting a wanted medicine moves buyers to other sellers
When the health service or the regulator keeps the official way to a wanted drug narrow, buyers turn to private clinics, copies and off-label prescriptions.
The twist
When the official way to get a wanted drug is narrow, the demand does not go away. It moves to private clinics, copies and online sellers that fewer people check.
The picture
How it works
- Many people need a medicine at once
- The official route is kept narrow by cost or by rules
- Buyers turn to private clinics, copies, off-label prescriptions and online sellers
- Those routes skip some of the checks the official one makes
- So the narrower the official route, the bigger the side trade grows
The same force, elsewhere today
Where this chain is also running, in today's other stories.
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The MPs on NHS weight-loss jabs
The NHS plans Mounjaro for 6% of those eligible by 2028, and the MPs say the shortfall drove over a million to pay privately and others to unlicensed online jabs.
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The recalled copy of Zepbound
Copies spread when the branded drug ran short, and stayed on sale after the shortage, until one pharmacy could not guarantee its batches were safe.
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Online clinics and addiction
No drug of this kind is approved for addiction yet, so clinics prescribe it off-label rather than wait for the trials to finish.
Where you've seen this
Concert tickets
when a venue sells too few at the box office, resale sites fill the gap at higher prices and with more fakes
Rationed fuel
when petrol is limited at the pump, it is sold from jerry cans by the roadside
Long waiting lists
when a public hospital list grows, people who can afford it pay for the same operation privately
The catch
A side route is not always worse: some private clinics follow the same rules as the health service, and the harm comes mainly from the sellers nobody checks.
And the whole of it
A patient on a waiting list, a pharmacist mixing copies and a regulator writing the rules each see their own piece of this. The person buying a jab online sees only the price and the parcel, not the batch it came from.
What is really going on
Moderna and Merck's vaccine gave melanoma patients a real gain: after two years, 82 in 100 were alive and free of the cancer, against 70 in 100 on Keytruda alone.
Why it works on us — A cut of 42% sounds like 42 people in every 100 spared, but the difference in this trial was about 12 people in 100: 82 against 70.
Who gains
-
Merck
— Every vaccine patient in the trial also got about a year of Merck's Keytruda, and Merck's shares fell only about 1% on the day.
[4] [2] -
Pfizer and other drugmakers that license Chinese drugs
— They lobbied to keep licensing deals open, and the US Treasury's draft leaves those deals out of the ban.
[8] [7] -
Private weight-loss clinics in Britain
— The NHS plans Mounjaro for about 6% of eligible people by 2028, and more than a million people already pay privately.
[23] -
Online addiction clinics in the US
— They sell weight-loss drug prescriptions for addiction before the US regulator has approved the drugs for it.
[21] -
Biohaven's shareholders
— The shares rose about 25% on the FDA's agreement to review a drug it had rejected.
[18]
Who pays
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People who bought Moderna shares after August
— The shares fell nearly 25% on the day the full results came out.
[2] -
People in England who qualify for Mounjaro but cannot pay
— Most will not get it on the NHS by 2028, and the MPs say some turn to unlicensed jabs online.
[23] -
Americans using copied weight-loss drugs
— Apothecary Pharma recalled 22 batches of copied tirzepatide because it could not fully guarantee their safety.
[20] -
US venture investors and Chinese biotechs that need their money
— Taking a share stake in a Chinese biotech would be banned under the draft, as would deals like Pfizer's $100 million stake in 3SBio.
[7] -
Gilead
— It pays Texas $45 million to settle claims that its kickbacks swayed prescriptions paid for by the state's Medicaid programme.
[24]
What nobody knows yet
Open questions from across today’s stories — ours included.
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01
Whether people given the vaccine live longer.
The trial has not run long enough to count deaths properly. Merck and Moderna say an early look leans their way but have not shown the figures.
[4] [6] -
02
Why the vaccine did less against cancer spreading than in its earlier trial.
The risk of distant spread fell 38% in this trial, against 65% in the smaller mid-stage trial, and no source we read explains the gap.
[3] -
03
Whether the result beat or missed what was expected.
One analyst at RBC, a bank, called it the low end of expectations, while one at TD Cowen said it clears the bar doctors set.
[2] Fierce Biotech said the main result came close to the best case but spread to other organs fell less than hoped.[3] -
04
Whether the vaccine helps people whose cancer could not be removed, or other cancers.
This trial only enrolled people after surgery, and trials in lung, bladder and kidney cancer have not reported yet.
[1] [2] -
05
Where Nigeria's Ebola patient was infected.
Switzerland says Uganda, Uganda says it has no Ebola, and the WHO and Africa CDC have no confirmed sign she went to Congo. Africa CDC is checking whether she met Kenya's first case, since both left Uganda's Entebbe airport the same day.
[12] -
06
How many people have died of measles in the US this year.
The CDC lists three deaths and will not say where the third happened, while Pennsylvania alone has reported six, five of them confirmed.
[15] -
07
Whether Ultomiris slows the loss of kidney function.
It was approved on a drop in urine protein after 34 weeks, and the kidney-function result is due only at 106 weeks.
[10] -
08
What Biohaven's new analyses show.
The company resubmitted with what it calls new positive supporting analyses, and the FDA's experts have not yet met to judge them.
[18] -
09
Whether weight-loss drugs work well enough against addiction to be approved for it.
Lilly and Altimmune are still testing them in alcohol addiction, while online clinics already prescribe them for it.
[21] -
10
How the US Treasury will treat new US firms built on licensed Chinese drugs.
The draft's clause against getting around the rules could bring extra checks to deals where the Chinese seller takes shares, and comments stay open until 7 December.
[7] [8]
In a trial of 1,137 people whose melanoma had been cut out, 82 in every 100 given a vaccine built from their own tumour were alive and free of the cancer two years later. On the standard immune drug alone, 70 in 100 were.
Also true today
- A US company has edited DNA inside a living person's body with prime editing for the first time, in a patient with Wilson disease, an inherited illness that lets copper build up and damage the liver.
- The US drug regulator approved Ultomiris for IgA nephropathy, a rare kidney disease that more than 200,000 Americans live with, after it cut the protein leaking into patients' urine by 43.4%.
- Kenya says it has traced all 135 people who were in contact with its first Ebola patient.
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