Biotech & Longevity · Wednesday, 21 October 2026

01 Briefing what happened

US regulator approves Hibsago, a hepatitis B drug after which about one in five trial patients kept the virus away for six months with no medicine

The FDA approved GSK's Hibsago, the first antisense drug approved in the US for long-term hepatitis B, after 19% of treated patients still had the virus under control 24 weeks after stopping every medicine.

19%

of treated patients still had the virus under control 24 weeks after stopping every medicine

none of the people given a dummy injection did [1]

250 million+

people in the world living with long-term hepatitis B

today's pills give a lasting functional cure to only 1% to 4% of them [2]

24 weeks

the longest course of Hibsago injections

the usual pills continue for at least 24 weeks after the last injection [1]

$2.7bn+

GSK's expected yearly sales of the drug at its peak, more than 2 billion pounds

GSK did not answer when asked what it will charge in the US [2]

The lead story — what happened

The FDA, the US medicines regulator, approved Hibsago on Tuesday 20 October, an injection made by GSK, the British drugmaker, for long-term hepatitis B. [1][2]
Hepatitis B is a virus that infects the liver. Over years it can scar the liver, which doctors call cirrhosis, and raise the risk of liver cancer. [1]
More than 250 million people live with it worldwide, about 1.7 million of them in the US. [2][3]
Today's hepatitis B pills suppress the virus but rarely get rid of it, so many people take them for life. [2]
With those pills, only 1% to 4% of patients reach what doctors call a 'functional cure'. [2] That means no virus and no HBsAg in the blood for at least 24 weeks after all treatment stops. [3]
Hibsago is the first antisense drug the FDA has approved for hepatitis B: a short strand of genetic material that sticks to the virus's instructions. [1][2]
That blocks the virus from making copies of itself and its surface protein, HBsAg, which shows up in the blood. [1]
Patients get the injection under the skin for up to 24 weeks, beside their usual pills, then keep the pills for at least 24 more weeks. [1]
In two trials, 24% of people on Hibsago met the rules to stop all hepatitis B medicine. None on a dummy injection did. [1]
Twenty-four weeks after stopping everything, 19% still had the virus under control and no HBsAg in their blood. [1]
Across the trials that was 233 of 1,220 people on the drug and none of 614 on placebo. Among people who started with less HBsAg, 26% reached it. [3]
It is only for adults without cirrhosis whose virus is already kept low by pills and whose HBsAg is at or below a set level, measured with an approved test. [1]
The drug carries a boxed warning, the FDA's strongest kind, for serious liver reactions and for low platelet counts, which can cause dangerous bleeding. [1]
Ionis Pharmaceuticals, a US company, invented the drug and licensed it to GSK in 2019. Ionis gets 10% to 12% of sales as royalties. [3]

Met the rules to stop all medicine24%

Virus still controlled 24 weeks later19%

On a dummy injection0%

Out of every 100 people given Hibsago in the two trials. Fewer passed the 24-week check than were allowed to stop their medicine.

Who is involved

GSK

a British drugmaker; it won the approval and will sell Hibsago
Ionis Pharmaceuticals

a US company that makes genetic drugs; it invented bepirovirsen and earns royalties on it
The FDA

the US medicines regulator; it approved Hibsago with its strongest safety warning
Roche

a Swiss maker of drugs and medical tests; its blood test was approved to pick who qualifies

How it unfolded

2019 GSK licenses bepirovirsen from Ionis [3]
Earlier Japan approves the drug [2]
20 Oct The FDA approves Hibsago and a blood test to choose patients [1]
Next Reviews in China and Europe; GSK expects key decisions in the coming months [2][3]

Where this points

The next tests are the US price, which GSK has not given, and the reviews in China and Europe. [2] GSK expects key decisions in several countries in the coming months. [3]

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.

Ebola crossing borders High↑

Nigeria confirmed its first Ebola case of this outbreak, in a woman who reached Abuja from Uganda. [4] Kenya now has nine cases, and the US has told its citizens to reconsider travel there. [8] The Africa CDC says no Ebola outbreak has ever reached so many places. [5]

Drug prices running high High→

ICER, a US group that judges drug prices, says two in three of the new drugs it reviewed from 2022 to 2025 launched far above what their health benefit is worth. [10] GSK has not said what Hibsago will cost in the US. [2] The FDA approved a first copy of a menopause patch to make that treatment cheaper to get. [19]

US health rules being rewritten Building↑

The US health secretary wants a regulated market for peptides that the FDA has never approved. [11] The FDA set new rules for the apps drug companies give patients. [21] A US science agency has not opened a grant round that was due on 15 October. [25]

Money chasing early drugs Building↑

Lycia Therapeutics is selling shares that would value it at up to $938 million, for a drug in an early trial. [17] One analyst says more success in bipolar mania could add over $1 billion to the best-year sales of Rapport's new pill. [13] Pfizer stopped a trial and called it a business decision. [24]

The rest of the day

17 more stories on this beat.

Each with its own sources. None of these is a link to the story above.

02
Ebola reaches Nigeria

Nigeria confirmed its first Ebola case of this outbreak on Tuesday, in a woman in Abuja, its capital, who had arrived from Uganda. [4] She fell ill on 7 October and spent several days in a private hospital before Ebola was found. [5][4] Health Minister Muhammad Ali Pate said 44 of her contacts have been identified. [4] Uganda, declared free of Ebola in August, says she only passed through after a business trip to eastern Congo. [4][5] The outbreak began in Congo in May and has killed more than 4,600 people. [6]

Why it matters — Nigeria is Africa's most populous country, and the head of the Africa CDC, the continent's public health agency, called this the most widely spread Ebola outbreak on record. [4][5] In 2014 Nigeria stopped an Ebola outbreak after 20 cases. [7]
03
Kenya's Ebola cases reach nine

Kenya has now confirmed nine Ebola cases, all linked to its first patient, a man who travelled from Congo and died two weeks ago. [8] They are four of his relatives, three health workers and a hospital cleaner. [8] On Tuesday Patrick Amoth, Kenya's health director-general, said the eight patients were improving. [8] Ebola can take up to 21 days to show, and 134 of 135 listed contacts are in quarantine. [8] Kenya's doctors' union says border posts are short of staff and hospitals need more protective gear. [8]

Why it matters — On Monday the US told its citizens to reconsider travel to Kenya, and a Kenyan court has halted a quarantine centre the US built at a Kenyan air base. [8][9] Jennifer Nuzzo, a pandemic researcher at Brown University in the US, says US aid cuts leave countries less prepared for outbreaks. [9]
04
Most new drugs launch above their worth

ICER, a US non-profit that judges whether drug prices match the health they buy, reported on Tuesday on 26 drugs approved from 2022 to 2025. [10] Two in three launched far above its limit for good value. [10] After inflation, the median net launch price rose from $190,000 in 2022 to $257,000 in 2025, partly because of one-time gene and cell therapies. [10] ICER said two drugs, Insmed's Brinsupri for a lung disease and Merck's Winrevair for high blood pressure in the lungs, would need discounts of about 90%. [10]

2022190 k
2025257 k
The median net launch price of the new drugs ICER reviewed, after inflation, in thousands of US dollars.

Why it matters — ICER said four in ten prescriptions for these drugs were turned down, and people on Medicare, the US scheme for older people, fared worse. [10] Drugmakers call its method flawed, though the UK's NICE uses a similar one. [10]
05
US health chief wants a peptide market

Robert F. Kennedy Jr., the US health secretary, said on Tuesday the Trump administration wants a regulated market for peptides. [11] Peptides are short chains of the building blocks of proteins, promoted on social media for pain, muscle growth and beauty with little evidence from human studies. [11] The ones under review are not approved by the FDA as safe or effective. [11] Last Thursday the FDA sent the US president's office a plan that could let pharmacies mix some more easily, with no details published. [12] 'Americans are going to be buying these anyway,' Kennedy said. [11]

Why it matters — In July the FDA's outside advisers backed loosening the rules on six of seven peptides, against the advice of FDA staff. [11] Hims & Hers, a US online health company, has said it plans to sell peptides if the rules allow. [12]
06
An epilepsy pill passes a bipolar test

Rapport Therapeutics, a Boston drug company, said its pill RAP-219 beat a dummy pill in about 250 adults with bipolar mania, the high phase of bipolar disorder. [13] After three weeks, scores on a 60-point symptom scale fell by 15.4 points on the drug and 12.3 on placebo. [13] The 3.1-point gap only just counted as more than chance. [13] Last month Rapport's chief executive had called a 4-point gap the level that matters to patients. [14] Rapport plans two final-stage trials from late 2027. [13]

RAP-21915.4 points
Dummy pill12.3 points
How far symptom scores fell after three weeks, on a 60-point scale. The gap between the bars is the drug's effect.

Why it matters — The pill was built for epilepsy and calms a protein found mostly in the brain areas where seizures start. [13] Side effects were mild to moderate, and analysts at Raymond James said the bipolar drugs that work best are the ones patients stay on. [13]
07
US cancer patients go to China for drugs

KFF Health News, a US health news service, reported on Tuesday that Americans are travelling to China for cancer medicines and trials they cannot get at home. [26] One New York woman, whose lung cancer had spread to her brain, takes sunvozertinib, a pill made by Shanghai's Dizal Pharmaceutical, which her son brings back from Shanghai. [26] The FDA licensed it in July 2025, but it was still not on sale in the US in mid-October. [26] Her son knows of at least 30 Americans who have gone for it. [26]

Why it matters — China ran as many as 46% of the new drugs tested worldwide in 2025, the report says. [26] Two US lawmakers want the US Treasury to clear every US drug deal with a Chinese firm, and AstraZeneca plans to sell sunvozertinib in the US by early 2027. [26]
08
An AI-designed virus given to a patient

Radical Numerics, an AI start-up, said on Tuesday it had treated a patient with a virus designed by AI, the first time this has been done, it says. [15] The virus is a phage, a kind of virus that kills bacteria, and it was given for a deadly bacterial infection. [15] The company says the FDA authorised the trial. [15] It gave no details about the patient or the doctors, citing confidentiality, and its report has not been checked by outside scientists. [15]

Why it matters — Phages can sometimes clear infections that antibiotics no longer can. [15] Until the patient's outcome is published, nobody outside the company can tell whether the AI-designed virus worked.
09
CagriSema results for women

Novo Nordisk, the Danish maker of Wegovy, said women on its newer weekly injection, CagriSema, lost 25% of their weight on average after 68 weeks. [16] Women on placebo lost 3%. [16] The figure covers 2,309 women in a final-stage trial of more than 3,400 adults. [16] Across everyone, the drug's average loss was 22.7%, below the 25% Novo had aimed for. [16] Novo said analyses done after a trial ends only raise ideas that need more study. [16]

Why it matters — Novo is counting on CagriSema to win back ground lost to Eli Lilly, and Wegovy's patents run out after 2030. [16] A US decision on approving CagriSema is expected by the end of this year. [16]
10
Lycia sets its share price range

Lycia Therapeutics, a California drug company founded by Nobel Prize winner Carolyn Bertozzi, set a price range on Tuesday for its first sale of shares. [17] It plans to sell 14.7 million shares at $16 to $18 each, valuing it at up to $938 million. [17] Its lead drug, LCA-0061, is built to remove IgE, the antibody behind allergic reactions; Lycia says today's drug Xolair only blocks it. [18] LCA-0061 is in an early trial for food allergy. [17]

Why it matters — Lycia expects about $80 million of the money to take LCA-0061 through a mid-stage trial. [18] Health companies have carried this autumn's US share sales, and City Therapeutics and Iambic listed last week. [17]
11
First copy of a weekly menopause patch

The FDA approved on Monday the first generic copy of Climara Pro, a skin patch changed once a week to treat menopause symptoms. [19] It holds two hormones, an oestrogen and a progestogen. [19] It is only for women who still have a womb, because the second hormone lowers a risk to the womb's lining from oestrogen alone. [19] It also helps prevent bone thinning after menopause. [19] New CDC figures show 15.6% of US women aged 40 to 60 with menopause symptoms take a prescription medicine for them. [20]

Why it matters — The FDA said the copy is meant to make the treatment cheaper and easier to get. [19] By the CDC's count, about one in six women with symptoms gets prescription treatment. [20]
12
FDA sets rules for drug companies' apps

The FDA published final guidance on Tuesday for apps that drug companies offer with prescription medicines. [21] An app tied to a device, such as one paired with an asthma inhaler, should generally be described on the drug's official label. [21] A standalone app, such as a dose reminder, goes on the label only if the company shows it is needed for safe use or brings a real health benefit. [21] Most of what such apps show patients will be treated as advertising. [21]

Why it matters — The guidance says what companies must send the FDA when their apps tell patients things, a question left open for years. [21] An FDA official said these apps are moving from dose reminders to tools that adapt to each patient. [21]
13
A breast cancer pill's survival gap

A trial in China has reported long-term survival results for entinostat, a breast cancer pill, in a journal from the Nature group. [22] The 354 patients had advanced hormone-sensitive breast cancer that kept growing on hormone therapy. [22] Those given entinostat with the hormone pill exemestane lived a median 38.6 months, against 29.2 months on exemestane and a dummy pill. [22] But the gap was not statistically significant, so it may be chance. [22]

Why it matters — The same trial had already shown the cancer stayed in check longer, 6.3 months against 3.7, and China's regulator approved the drug. [22] Severe side effects hit 65.5% of the patients taking it. [22]
14
Why radiation can scar healthy lungs

Scientists at City of Hope, a US cancer centre, have found in mice one way radiation for lung cancer harms healthy lung. [23] Radiation raised a signalling protein, interferon-beta, which turned protective immune cells into ones that cause inflammation. [23] Blocking that signal during radiation cut inflammation and scarring in the mice. [23] Human immune cells showed similar changes in the lab. [23] The study was published in Nature Communications. [23]

Why it matters — More than 70% of people with lung cancer get radiation at some point, and up to 20% are left with lasting breathing trouble. [23] This is a mouse study, and most things that work in mice never work in people.
15
Pfizer stops a blood disorder trial

Pfizer has ended a mid-stage trial of PF-06835375, an antibody for immune thrombocytopenia, or ITP. [24] ITP is an illness in which the body's own immune system leaves too few platelets, the blood cells that help it clot. [24] The 61-patient trial began in 2022. [24] Pfizer called the ending 'a business decision' not based on safety, and would not say whether all work on the drug has stopped. [24]

Why it matters — The drug is still listed on Pfizer's website for ITP and for lupus. [24] A trial stopped this way may never show whether the drug worked for the people who took part.
16
A US grant for lab machines stalls

The US National Science Foundation, which funds basic research, has not opened applications for its Major Research Instrumentation grants, due to open on 15 October. [25] The grants pay up to $4 million for costly shared machines, such as microscopes, lasers and computer clusters. [25] In 2025 the agency suspended the same round, so this is the second year it has stalled. [25] A spokesperson said the agency is updating the programme but gave no date. [25]

Why it matters — One scientist said it is often the only option for researchers without money from the NIH, the US medical research funder. [25] A single proposal takes 30 to 40 hours to write, and universities run their own contests before applying. [25]
17
Gene therapy frees a UAE patient from transfusions

A 43-year-old man in Abu Dhabi no longer needs regular blood transfusions after gene therapy, the UAE's state news agency reported on Tuesday. [28] He has thalassaemia, an inherited blood disorder in which the body lacks haemoglobin, the protein that carries oxygen in the blood. [28] He had needed transfusions every three to four weeks. [28] Doctors collected his own stem cells, changed their genes and put them back. [28]

Why it matters — A haematologist at Yas Clinic said gene therapy helps patients who have no matching bone marrow donor. [28] It is one patient, and he remains under medical watch, so how long the benefit lasts is not yet known. [28]
18
UAE bans vets from using an antibiotic

The UAE will ban vets from using ciprofloxacin, an antibiotic, from 1 November, its drug regulator, the Emirates Drug Establishment, said. [29] Ciprofloxacin belongs to a group of antibiotics classed as critically important for treating serious human infections such as sepsis and pneumonia. [29] Vets give it to dogs and cats for skin and bladder infections. [29] Nine products are affected, and sellers must withdraw their stocks before the ban starts. [29]

Why it matters — The regulator said using the drug in animals can help bacteria learn to resist it, weakening it for people. [29] Drug resistance contributed to more than 4.7 million deaths worldwide in 2021, by the WHO's estimate. [29]

02 Lesson why it matters

Why the proof that a virus is beaten comes only after the medicine stops

While medicine keeps a virus quiet, nobody can tell if the body could manage alone, so the test is to stop every drug and wait.

The twist

As long as a patient takes the pills, nobody can see whether their own body would keep the virus in check. The only way to find out is to stop the pills and wait.

The picture

24%Allowed to stop all medicine

19%Still clear 24 weeks later

Of the people given Hibsago, 24% were allowed to stop all medicine. Twenty-four weeks later, 19% still had no virus in their blood, so fewer passed the wait than started it.

How it works

Hepatitis B pills stop the virus copying, but some of it stays inside liver cells
While the pills work, nobody can see if the body could keep the virus in check alone
Hibsago cuts the virus's surface protein in the blood, so the immune system may take over
The only test is to stop every medicine and keep checking the blood
After 24 weeks with no virus found, it counts: 19% of patients got there

The same force, elsewhere today

Where this chain is also running, in today's other stories.

Ebola reaches Nigeria

Uganda was declared free of Ebola in August only after its last patient left hospital and a waiting period passed with no new case: the same wait after the last sign.
Kenya's Ebola cases reach nine

Kenya keeps 134 contacts in quarantine because Ebola can take up to 21 days to show, so a contact counts as clear only after that wait passes with no illness.

Where you've seen this

A broken arm

only taking the cast off shows whether the bone has knitted strong enough to carry weight

Learning to ride a bike

nobody knows if a child can balance until the stabilisers come off

Breathing machines

doctors turn the machine's help down and watch whether the patient breathes alone

The catch

Twenty-four weeks is the wait the trials chose, not a lifetime, and whether the virus stays away for years after that has not yet been shown.

And the whole of it

A person on daily hepatitis B pills, the doctor who prescribes them and the company that sells them all see a virus kept quiet. None of them can see what would happen without the pills, and the same wait decides when Kenya and Nigeria can say Ebola has gone.

03 Truth what's really going on

What is really going on

The US approved GSK's Hibsago after it let 19% of treated patients in two trials stop all hepatitis B medicine and stay clear for 24 weeks, and GSK has not said what it will charge. [1][2] On the same day ICER, a US group that rates drug prices, reported that two in three new drugs it reviewed from 2022 to 2025 launched far above what their health benefit is worth. [10]

Why it works on us — A 'first of its kind' approval sounds like the end of the story, but for a patient the price, the insurer's answer and the blood test that decides who qualifies all come after it.

Who gains

Ionis Pharmaceuticals — It earns royalties of 10% to 12% on every sale of Hibsago, plus payments when the drug is approved in more places. [3]
GSK — It expects more than 2 billion pounds a year at peak, and the drug is central to its plan to grow sales as patents on its biggest HIV medicines run out. [2]
Lycia's backers, such as Versant Ventures and RTW Investments — A share sale at up to $938 million gives them a public price for a company whose lead drug is in its first trial. [17][18]
Sellers of peptide injections, including Hims & Hers — A regulated market would let pharmacies and online clinics sell products the FDA has never approved, and Hims & Hers says it plans to. [11][12]
Novo Nordisk — It can now point to a 25% weight loss in women, against 22.7% across the whole trial, ahead of a US decision due this year. [16]

Who pays

People with hepatitis B and liver scarring, or high HBsAg levels — The approval covers only adults without cirrhosis whose HBsAg is at or below 3,000 on an approved test. [1]
Patients prescribed the new drugs ICER reviewed — Four in ten of their prescriptions were turned down, and people on Medicare fared worse. [10]
Health workers in Kenya — Three health workers and a hospital cleaner are among Kenya's nine Ebola cases, and their union says hospitals still need more protective gear. [8]
People buying unapproved peptides — They are using products sold with little evidence from human studies on safety or benefit. [11]
US university scientists who need costly machines — They spend 30 to 40 hours on a proposal with no date for when the grant round will open. [25]

What nobody knows yet

Open questions from across today’s stories — ours included.

01

What Hibsago will cost in the US.

GSK did not answer Reuters when asked about US pricing and when the drug will be available. [2]
02

How many people with hepatitis B reach a functional cure on today's pills.

Reuters puts it at 1% to 4% of patients; Ionis, which invented Hibsago, says under 1% after a year of treatment. Neither says how its figure was counted. [2][3]
03

How long the virus stays away after Hibsago.

The trials checked people 24 weeks after they stopped all treatment, and no longer result has been published. [1][3]
04

Where the woman in Nigeria caught Ebola.

Uganda says she only passed through after a trip to eastern Congo, and that where she was infected is still being investigated. [5] She spent several days in a private hospital in Abuja before the diagnosis. [4]
05

Whether Nigeria has found everyone she met.

The health minister said 44 contacts had been identified and tracing was still going on. [4]
06

Whether RAP-219's effect is big enough to matter.

Rapport's chief executive cited 4 to 7 points for existing drugs, one analyst cited 2 to 6, and the pill managed 3.1. [14][13]
07

Whether the AI-designed virus worked.

Radical Numerics gave no details of the patient or the doctors, and its report has not been reviewed by outside scientists. [15]
08

What the FDA's peptide plan allows.

The filing sent to the US president's office for review carries no details of the policy. [12]
09

Why Pfizer stopped its ITP trial.

Pfizer called it a business decision and would not say whether all work on the drug has stopped. [24]

04 Hope carry this

In two trials of Hibsago, 19% of people with long-term hepatitis B still had no sign of the virus 24 weeks after stopping every medicine. Among those given a dummy injection, none did.

Also true today

All eight people being treated for Ebola in Kenya were improving on Tuesday, and 134 of the 135 people listed as contacts of the first patient are in quarantine.
The FDA approved the first generic copy of Climara Pro, a once-a-week skin patch for menopause symptoms.
Rapport's new pill eased the symptoms of about 250 adults with bipolar mania more than a dummy pill did, and its side effects were mild to moderate.