Biotech · Wednesday, 23 September 2026
Telix is buying ITM for at least $1.65 billion, a month after the US regulator turned down ITM's cancer drug over how it is made
Signals on this beat
Big firms buying outside drugs High ↑
- Novartis agreed to pay a company in China up to $900 million for one early radioactive drug.
[3] - Boehringer Ingelheim signed a deal worth up to $1 billion to find cancer targets with Envisagenics, a New York company.
[22] - AbbVie signed a research deal with Iambic, a company that designs drugs with AI.
[15]
China as a source of medicines High ↑
- Almost half of the US deals to license drugs from abroad in 2025 were with Chinese companies.
[11] - More early human trials now start in China than in the US, two former FDA heads wrote.
[25]
New companies raising money Building ↑
- Iambic, Retension and TRex Bio all filed to sell shares on the US stock market in the past few days.
[12] - All five of this year's best-performing large share sales are biotech companies, one analyst said.
[12]
The FDA changing its rules Building ↑
- The FDA made a final rule that lets drug safety tests use methods other than animals where they fit.
[19] - It accepted a wearable sensor as a way to measure a nerve disease in trials.
[20] - Its former leaders pushed in February for one big trial, not two, to be enough for approval.
[26]
The weight-loss drug race High →
- Roche's weekly injection cut weight by 15.5% in 48 weeks in people with diabetes.
[16] - Viking said people kept most of their lost weight on one injection a month.
[18] - Novo's shares fell 8% after it set out its plans to 2030.
[9]
The stories
23 on this beat today.
Every story told the same way: what happened, who is involved, why it matters, how it works, the truth and the good news.
-
01
Telix is buying ITM for at least $1.65 billion, a month after the US regulator turned down ITM's cancer drug over how it is made
$1.65bn
the least Telix will pay for ITM, a German maker of radioactive cancer drugs
a month after the FDA turned down ITM's main drug
[1] [2] $100m
paid only if the FDA approves ITM-11 for one gut tumour by the end of 2027
the rejection cited a factory run by another company
[1] $900m
the most Novartis could pay BoomRay, a company in China, for one early drug
signed the day after Telix announced its deal
[3] What happened
-
Telix Pharmaceuticals, an Australian company that sells radioactive drugs for scanning cancer, is buying its rival ITM in a deal worth at least $1.65 billion.
[1] [2] [3] -
ITM Isotope Technologies Munich is a privately owned German company.
[2] -
Its medicines carry a radioactive atom straight to cancer cells.
[2] -
The radioactive metal is what kills the cancer.
[1] -
Last month the FDA, the US drug regulator, turned down ITM's lead drug, ITM-11.
[1] -
It cited how the drug is made and problems found at a factory run by another company.
[1] -
ITM plans to file again.
[1] -
ITM-11 is for neuroendocrine tumours, cancers that start in hormone-making cells, here in the gut and pancreas.
[1] -
It would compete directly with Lutathera, a drug Novartis already sells.
[3] -
Telix could pay up to $700 million more on top.
[1] -
Up to $250 million depends on approvals, and up to $450 million on how well ITM-11 sells.
[1] -
The first extra $100 million is paid only if the FDA approves ITM-11 for one gut tumour by the end of next year.
[1] -
The deal cannot close until ITM files with the FDA again, or the two companies agree a way forward.
[1] -
Telix's chief executive, Christian Behrenbruch, said a rejection is not the end of the road when the drug itself is strong.
[1] -
He pointed to Telix's own brain-scan drug Pixclara as proof.
[1] -
ITM also makes lutetium-177, the radioactive metal inside Pluvicto, Novartis's big-selling prostate cancer drug.
[1] -
Other companies make it too.
[1] -
Novartis leads this field, with two such drugs launched in 2018 and 2022.
[2] -
ITM sold $273 million of products in 2025, and Telix expects the joined company to take in $1.3 billion this year.
[1] -
On 22 September Novartis licensed an early-stage radioactive drug from BoomRay, a company in Suzhou, China, for up to $900 million.
[3] -
Analysts at the bank William Blair wrote that they were extremely bullish on the joined company.
[1]
Paid for ITM whatever happens$1.65bnPaid only if ITM-11 is approved and sells$0.70bnThe first bar is the least Telix pays. The second bar is the most it adds later, and only if a drug the FDA has already turned down gets approved. Who is involved
- Telix Pharmaceuticals an Australian company that makes radioactive drugs for scanning and treating cancer; it is buying ITM
- ITM Isotope Technologies Munich a privately owned German company; the FDA turned down its lead drug ITM-11 last month
- Novartis a Swiss drug giant that leads radioactive cancer medicines; it licensed a new one from China's BoomRay
- The FDA the US drug regulator; its approval of ITM-11 decides the first $100 million
How it unfolded
-
2018 and 2022
Novartis launches its two radioactive cancer drugs
[2] -
Last month
the FDA turns down ITM-11 over how it is made
[1] -
20 Sept
Telix and ITM announce the deal
[2] -
22 Sept
Novartis licenses a radioactive drug from BoomRay in China
[3] -
End of 2027
deadline for the first $100 million approval payment
[1]
Why it matters
The next step is ITM filing again with the FDA: the deal closing and the first $100 million both depend on the regulator accepting the fixed factory.
[1] How it works
Why a company that sells a famous drug still has to find new ones
A patent lets one company sell a drug alone until a fixed date, so every bestseller comes with a deadline to find the next one.
The twist
A company can sell the most famous drug in the world and still be short of medicines, because the patent on that drug has an end date.
The picture
- 1Today2,026
- 2Novo expects growth only in line with rivals, to here2,030
- 3US patent on semaglutide ends2,032
Novo has about six years to find new drugs that sell before copies of its bestseller are allowed in the US. Step by step
- A patent lets one company sell a new drug with no copies allowed
- The patent ends on a date everyone knows years ahead
- After that, other companies can sell copies and take most of the sales
- The company's own labs often cannot replace the drug in time
- So it buys or licenses medicines from smaller firms, in the US and in China
- That buying is a big reason investors put money into young biotech companies
The same force, elsewhere today
Where this chain is also running, in today's other stories.
-
Novo sets out its plans, and shares fall
Novo named the 2032 patent end as its biggest problem and said it will fill the gap partly by buying companies.
-
US weighs letting drug deals with China continue
Pfizer argued against limits because licensing from China is where US companies now find many new drugs to replace old ones.
-
More drug companies line up to sell shares
An analyst tied this year's rush of new listings to big drugmakers buying young companies, which is the last step of the chain.
-
Telix and Novartis
Both paid for radioactive drugs made by other companies instead of building them in their own labs.
Where you've seen this
Oil companies
a field that will run dry pushes the company to buy other companies' oil in the ground
Big tech firms
when their main product stops growing they buy young companies with the next one
Book publishers
when the copyright on a classic ends, anyone can print it, so publishers chase new authors
Football clubs
they sign young players before their star's contract or career runs out
The catch
Buying does not guarantee a replacement, because a bought drug can fail its trials like any other, and Telix has just bought one the FDA already turned down.
And the whole of it
A patent date set years ago now shapes who gets money in biotech. Scientists at a small company in Suzhou or San Diego may be funded because a big company must replace a drug. People who take semaglutide will be able to buy copies from other companies once the US patent ends in 2032.
The truth
-
What is really going on
Telix agreed to pay at least $1.65 billion for ITM, whose main drug the FDA turned down last month, and Novartis agreed to pay a company in Suzhou, China, up to $900 million for one early drug.
[1] [2] [3] -
Who gains
ITM's owners
— They get at least $1.65 billion for a company whose main drug has just been turned down, plus up to $700 million more if it is approved and sells.
[1] [2] -
Who gains
BoomRay, in Suzhou, China
— Novartis can pay it up to $900 million for a radioactive drug that has not yet been tested in people.
[3] -
Nobody knows yet
Whether ITM's factory problems can be fixed in time.
The FDA cited how ITM-11 is made and a factory run by another company, and ITM's timing for filing again depends on repairs and talks with the regulator.
[1] Telix's first $100 million is due only if the drug is approved by the end of next year.[1]
-
Telix Pharmaceuticals, an Australian company that sells radioactive drugs for scanning cancer, is buying its rival ITM in a deal worth at least $1.65 billion.
-
02
FDA advisers review a blood test for many cancers
What happened
-
A panel of outside experts that advises the FDA meets on 23 September to review Grail's Galleri.
[4] -
It is a blood test for adults aged 50 and over that looks for signs of many kinds of cancer at once.
[4] -
In Grail's two big studies, it flagged 32% to 35% of the cancers diagnosed within a year.
[4] -
Of the people it flagged, 66% to 77% turned out to have cancer.
[4] -
About one healthy person in 500 got a false alarm.
[4] -
FDA documents posted before the meeting suggest a favourable view, with one oddity, STAT reported.
[5]
32 of 100
cancers the test flagged, of every 100 diagnosed within a year in England's NHS-Galleri trial
The filled dots are the cancers Galleri caught. The empty dots are cancers it missed that were found another way within a year. Why it matters
Galleri is already sold through laboratories, and FDA approval would be expected to help it get paid for by Medicare and other insurers.
[5] Grail's own document says people should keep having their usual screening, because the test misses most cancers.
[4] The truth
-
Who gains
Grail
— FDA approval of Galleri would be expected to help it get paid by Medicare and other insurers.
[5] -
Who pays
Healthy people given a false Galleri alarm
— In Grail's PATHFINDER 2 study, 48% of people flagged who turned out not to have cancer went through a biopsy, scope or other invasive test.
[4] -
Who pays
People whose cancer Galleri misses
— The test missed about two in three cancers diagnosed within a year, which is why its maker says usual screening must continue.
[4] -
Nobody knows yet
What the FDA's advisers will say about Galleri.
The panel meets on 23 September.
[4] STAT reported that the FDA's documents suggest a favourable view but contain one oddity, and the details sit behind a paywall we could not read.[5] -
Nobody knows yet
Whether finding cancer with Galleri means fewer people die of it.
England's NHS-Galleri trial was set up to test whether three yearly blood tests cut the number of late-stage cancers.
[4] The document sent to the FDA includes only the first of those three rounds.[4]
-
A panel of outside experts that advises the FDA meets on 23 September to review Grail's Galleri.
-
03
First win in a late-stage Sjogren's trial
What happened
-
Amgen said its drug dazodalibep improved Sjogren's disease more than a dummy drug in a final-stage trial of 651 people.
[6] -
Sjogren's is a disease in which the immune system attacks the glands that make tears and saliva, and it can affect the whole body.
[6] -
There is no medicine approved in the US specifically for it.
[6] -
The trial measured overall disease activity after 48 weeks, and Amgen has not yet given the scores.
[6] -
A second final-stage trial, in people with milder disease, is still running.
[6]
Why it matters
Novartis and Sanofi have each dropped a Sjogren's drug in recent years, and Astellas stopped one in April.
[6] Patients now mostly get general anti-inflammatory drugs to ease the symptoms.
[6] The truth
-
Nobody knows yet
How much dazodalibep helped people with Sjogren's.
Amgen said the trial met its main goal but gave no scores, and says full results will come at a medical meeting.
[6]
Good news
- In a final-stage trial of 651 people with Sjogren's disease, where the immune system attacks the glands that make tears and saliva, Amgen's dazodalibep reduced disease activity more than a dummy drug. No medicine is approved in the US specifically for Sjogren's.
-
Amgen said its drug dazodalibep improved Sjogren's disease more than a dummy drug in a final-stage trial of 651 people.
-
04
US weighs letting drug deals with China continue
What happened
-
The US Treasury is drafting rules that would probably let US drugmakers keep licensing new medicines from Chinese companies, Reuters reported, citing unnamed sources.
[11] -
Deals on germs or biotechnology that could be made into weapons would be excluded.
[11] -
Licensing deals for Chinese biotech drugs were worth $115 billion last year, according to the research firm GlobalData.
[11] -
The rules come under a 2025 US law that screens investment in sensitive technology in certain countries, and a drug industry group is lobbying over them.
[5] -
They are not final, and could change if President Trump weighs in.
[11]
Why it matters
Pfizer and other big drugmakers argued that limits would cut US companies off from a fast-growing source of new medicines.
[11] Some smaller biotech companies and two Michigan members of Congress want the deals restricted, saying they help China lead in biotechnology.
[11] How it works
Pfizer argued against limits because licensing from China is where US companies now find many new drugs to replace old ones.
The idea, in story 01: Why a company that sells a famous drug still has to find new ones →The truth
-
What is really going on
Meanwhile Pfizer and other big drugmakers are pressing the US Treasury to keep allowing deals with Chinese companies, while smaller US biotechs and two members of Congress want them limited.
[11] -
Who gains
Pfizer and other big US drugmakers
— The rules being drafted would probably let them keep licensing Chinese drugs, a market worth $115 billion in deals last year.
[11] -
Who pays
Smaller US biotechs that license to big companies
— They often depend on licensing their drugs to big US companies, which in 2025 signed almost half of their deals for drugs from abroad with Chinese firms.
[11] -
Nobody knows yet
What the US Treasury's rules on China drug deals will say.
Reuters' sources said the rules are not final and could change if President Trump weighs in.
[11] A drug industry group and members of Congress are lobbying in opposite directions.[5] [11]
-
The US Treasury is drafting rules that would probably let US drugmakers keep licensing new medicines from Chinese companies, Reuters reported, citing unnamed sources.
-
05
A gene-targeted ALS drug passes its big trial
What happened
-
Ulefnersen, a drug for a rare form of ALS, slowed the disease in a final-stage trial of 89 people, its makers Otsuka and Ionis said.
[8] -
ALS destroys the nerve cells that control muscles.
[8] -
This form, caused by faults in a gene called FUS, is about 0.6% of cases and can kill younger patients within two years.
[8] -
The drug lowers the amount of the harmful FUS protein, and patients did better than on a dummy drug on function and survival after 72 weeks.
[8] -
Otsuka, a Japanese drugmaker, will take it to regulators.
[8]
Why it matters
The market is tiny: analysts at Guggenheim expect Ionis to earn only about $14 million a year from it by 2030.
[8] The drug was designed for ALS with one genetic cause, not for ALS in general.
[8] The truth
-
Nobody knows yet
How big ulefnersen's effect on ALS was.
Otsuka and Ionis said patients did better than on a dummy drug on function and survival, but the report we read did not say by how much.
[8]
Good news
- Ulefnersen, a drug built for ALS caused by faults in one gene called FUS, slowed the disease in a final-stage trial of 89 people, and its maker Otsuka is taking it to regulators.
-
Ulefnersen, a drug for a rare form of ALS, slowed the disease in a final-stage trial of 89 people, its makers Otsuka and Ionis said.
-
06
Hives drug wins two late-stage trials
What happened
-
Celldex said its antibody barzolvolimab beat a dummy injection in two final-stage trials with 1,939 people who have chronic hives with no known cause.
[7] -
The drug blocks a signal that mast cells, the immune cells behind hives and swelling, need to survive.
[7] -
In people not helped by the standard injection Xolair, 55% on the lower dose were fully clear at 12 weeks in one trial, against 9% on a dummy.
[7] -
In the other trial the figures were 42% against 15%.
[7] -
Two patients had a severe allergic reaction, and 16% left the trials, mostly by choice.
[7]
Lower dose of barzolvolimab55.3%Dummy injection9.3%People whose hives had not cleared on Xolair, fully clear after 12 weeks in one of the two trials. Why it matters
The same drug failed a trial in a different itchy skin disease in July, so this is a recovery for the company.
[7] Celldex plans to ask the FDA for approval in 2027.
[7] Good news
- Among people whose hives had not cleared on the standard injection Xolair, 55% on the lower dose of Celldex's barzolvolimab were completely clear of hives after 12 weeks, against 9% on a dummy injection.
-
Celldex said its antibody barzolvolimab beat a dummy injection in two final-stage trials with 1,939 people who have chronic hives with no known cause.
-
07
Novo sets out its plans, and shares fall
What happened
-
Novo, the Danish maker of Ozempic and Wegovy, laid out its plans to 2030 to investors on Monday, and its shares fell 8%.
[9] -
The US patent on semaglutide, the ingredient in both drugs, runs out in 2032, which its chief executive called the elephant in the room.
[9] [10] -
Novo expects its sales to grow at about the same rate as other big drugmakers until 2030.
[10] -
It aims for more than $23 billion of sales from drugs in its pipeline by 2035, allowing for some to fail, and plans to buy companies as well as invent.
[9]
Why it matters
Novo has lost ground to Eli Lilly, whose drug Zepbound beat Wegovy for weight loss in a head-to-head trial.
[10] The same day Novo said its newer drug CagriSema beat Zepbound in another trial, though against a lower dose of Lilly's drug.
[10] How it works
Novo named the 2032 patent end as its biggest problem and said it will fill the gap partly by buying companies.
The idea, in story 01: Why a company that sells a famous drug still has to find new ones →The truth
-
Who pays
Novo's shareholders
— The shares fell 8% after Novo said sales would grow only in line with rivals until 2030.
[9] [10]
-
Novo, the Danish maker of Ozempic and Wegovy, laid out its plans to 2030 to investors on Monday, and its shares fell 8%.
-
08
More drug companies line up to sell shares
What happened
-
Iambic Therapeutics, which designs cancer drugs with AI and is backed by the chipmaker Nvidia, filed to list on the US Nasdaq stock market.
[12] -
It has raised about $461.8 million from investors since 2019.
[12] -
Its most advanced drug, for tumours driven by a gene called HER2, is in a first safety trial.
[13] -
Retension Pharmaceuticals and TRex Bio filed on Friday, and ADARx began pitching its share sale to investors.
[12] -
On the same day, AbbVie signed a research deal with Iambic.
[12] [15]
Why it matters
One analyst said this year's rush of listings has been helped by big drugmakers buying up young companies.
[12] Eli Lilly has already said it may buy shares in TRex, whose drug it licensed in 2023.
[14] How it works
An analyst tied this year's rush of new listings to big drugmakers buying young companies, which is the last step of the chain.
The idea, in story 01: Why a company that sells a famous drug still has to find new ones →The truth
-
Who gains
Iambic's investors, including Nvidia
— They have put about $461.8 million into the company, which has now filed to sell shares on the Nasdaq.
[12]
-
Iambic Therapeutics, which designs cancer drugs with AI and is backed by the chipmaker Nvidia, filed to list on the US Nasdaq stock market.
-
09
Roche's weight-loss drug tested in diabetes
What happened
-
Roche said its weekly injection enicepatide cut blood sugar in a mid-stage trial in people with type 2 diabetes.
[16] -
HbA1c, a measure of average blood sugar, fell 2.65 points on the top dose after 48 weeks.
[16] -
Weight fell by 15.5%, with no sign yet of levelling off.
[16] -
Roche got the drug by buying Carmot Therapeutics for $2.7 billion, and 2% of patients stopped because of side effects.
[16]
Why it matters
Lilly's Mounjaro lowered HbA1c by up to 1.8 points in its own trial, but the trials ran for different lengths, so the numbers cannot be compared directly.
[16] Roche wants to become one of the three biggest companies in obesity drugs.
[16] The truth
-
Nobody knows yet
Whether Roche's drug is better than Lilly's.
Roche measured blood sugar eight weeks later than Lilly did, so the two trials cannot be compared directly.
[16]
-
Roche said its weekly injection enicepatide cut blood sugar in a mid-stage trial in people with type 2 diabetes.
-
10
Vertex kidney drug cuts protein in urine
What happened
-
Vertex said its pill inaxaplin cut protein leaking into the urine in a mid-stage trial for kidney disease driven by a gene called APOL1.
[17] -
In 22 people with milder leaking, it fell by 42.7% on average after 13 weeks.
[17] -
In 17 people who also had type 2 diabetes, it fell by 17.3%.
[17] -
A larger trial has finished enrolling, and early results are due next year.
[17]
Why it matters
If the larger trial is positive, Vertex could ask the FDA for a faster, conditional approval.
[17] Vertex says the group in that larger trial covers about 150,000 people in the US and Europe.
[17] The truth
-
Nobody knows yet
Whether Vertex's smaller result in people with diabetes matters.
Protein in urine fell 42.7% in one group and 17.3% in the group with type 2 diabetes.
[17] Early results from the larger trial are not due until next year.[17]
-
Vertex said its pill inaxaplin cut protein leaking into the urine in a mid-stage trial for kidney disease driven by a gene called APOL1.
-
11
Viking tests fewer weight-loss injections
What happened
-
Viking Therapeutics said people kept most of the weight they lost on its drug VK2735 when injections were spaced out.
[18] -
After 21 weeks of weekly doses, people had lost 16% to 19% of their weight.
[18] -
Moved to one injection every two weeks, they kept 90% of that loss on average; moved to monthly injections, 85%.
[18] -
Viking's shares rose sharply on the news.
[18]
Why it matters
Weight-loss drugs have to be taken for good to keep weight off, and many people stop taking them.
[18] Fewer injections could make staying on the drug easier.
[18] -
Viking Therapeutics said people kept most of the weight they lost on its drug VK2735 when injections were spaced out.
-
12
A bipolar drug calms mania within days
What happened
-
Johnson & Johnson said Caplyta reduced manic symptoms in people with bipolar I disorder after three weeks in a final-stage trial, compared with a dummy drug.
[15] -
Bipolar I is a mental illness defined by manic episodes, sudden swings in mood and behaviour.
[15] -
Some improvements showed up within three days.
[15] -
Caplyta is already approved for schizophrenia, bipolar depression and major depression, but not for mania.
[15]
Why it matters
J&J paid nearly $15 billion last year for the company that made Caplyta.
[15] A second final-stage trial in mania is still running.
[15] -
Johnson & Johnson said Caplyta reduced manic symptoms in people with bipolar I disorder after three weeks in a final-stage trial, compared with a dummy drug.
-
13
FDA rewrites its rule on animal testing
What happened
-
The FDA issued a final rule saying the safety of drugs and biological medicines can be tested with methods other than animals where appropriate.
[19] -
The rule replaces the words 'animal tests' with 'nonclinical tests' in its regulations.
[19] -
It is the second package of this kind announced this year by the US health department.
[19] - Health secretary Robert F.
-
Kennedy Jr. said it moves research toward human biology.
[19]
Why it matters
Kennedy said researchers have been kept dependent on animal testing when better tools exist.
[19] The department says it is paying to develop testing methods based on human biology.
[19] -
The FDA issued a final rule saying the safety of drugs and biological medicines can be tested with methods other than animals where appropriate.
-
14
FDA accepts a wearable sensor for trials
What happened
-
The FDA accepted a proposal to use a wearable movement sensor to measure foot drop in people with a nerve disease called CMT1A.
[20] -
Foot drop means being unable to lift the front of the foot, which disturbs walking.
[20] -
The sensor records it during a six-minute walk at clinic visits.
[20] -
It is the first such digital tool for a rare nerve disease accepted into this FDA programme.
[20]
Why it matters
CMT1A gets slowly worse over years, so trials need a way to measure small changes.
[20] The sensor is meant to track that change as a trial result.
[20] -
The FDA accepted a proposal to use a wearable movement sensor to measure foot drop in people with a nerve disease called CMT1A.
-
15
The FDA nominee faces senators
What happened
-
Heidi Overton, nominated to lead the FDA, goes before the US Senate health committee on Thursday for her confirmation hearing.
[25] -
Two former FDA commissioners, Scott Gottlieb and Mark McClellan, wrote in support of her.
[25] -
They noted that more early human trials now begin in China than in the US.
[25] -
In February, the FDA's leaders at the time argued that one large final trial, instead of two, should be the usual standard for approval.
[26]
Why it matters
The FDA has since published draft guidance on the one-trial idea, which is not yet final.
[26] How much evidence a company must gather before a drug reaches patients depends on it.
[26] -
Heidi Overton, nominated to lead the FDA, goes before the US Senate health committee on Thursday for her confirmation hearing.
-
16
A drug-coated balloon approved for blocked stents
What happened
-
The FDA approved Cordis's Selution balloon for heart arteries that narrow again inside a stent, a metal tube put in earlier to hold them open.
[21] -
The balloon coats the artery wall with sirolimus, a drug usually given to stop the body rejecting a transplanted organ.
[21] -
It leaves no new metal behind.
[21] -
About 10% of the roughly one million US artery-opening procedures a year treat this re-narrowing.
[21]
Why it matters
Doctors often have to put a second stent inside the first one when this happens.
[21] The approval rested on a study of more than 400 patients, and a 960-patient trial in small arteries has finished enrolling.
[21] Good news
- The US regulator approved a balloon that coats a re-narrowed heart artery with a drug and leaves no new metal behind, for a problem behind about one in ten US artery-opening procedures.
-
The FDA approved Cordis's Selution balloon for heart arteries that narrow again inside a stent, a metal tube put in earlier to hold them open.
-
17
Boehringer pays for AI-found cancer targets
What happened
-
Boehringer Ingelheim, a German drugmaker, signed a deal worth up to $1 billion with Envisagenics, a New York company.
[22] -
Envisagenics uses AI to screen more than 14 million ways cells edit gene messages.
[22] -
It looks for protein versions made only by tumours, which a drug could hit while sparing healthy tissue.
[22] -
Its chief executive said the money will take its own brain drug into human trials.
[22]
Why it matters
Neither company gave the split between money paid now and money paid later.
[22] Boehringer can choose targets and license them for itself alone.
[22] -
Boehringer Ingelheim, a German drugmaker, signed a deal worth up to $1 billion with Envisagenics, a New York company.
-
18
A pill plus radiation in lung cancer
What happened
-
A final-stage trial registered in China tested aumolertinib, a pill that blocks a faulty EGFR gene, with radiotherapy for lung cancer that cannot be operated on.
[24] -
It was compared with chemotherapy plus radiotherapy.
[24] -
Half the patients on the pill went 34 months before their cancer grew, against 7.4 months on chemotherapy.
[24] -
The trial stopped early with only 43 of a planned 98 patients, partly because it enrolled slowly.
[24]
Aumolertinib pill with radiation34 monthsChemotherapy with radiation7.4 monthsMedian time before the cancer grew again, in a trial of 43 patients that stopped early. Why it matters
Chemotherapy with radiation has been the standard for this stage of lung cancer.
[24] A trial this small cannot yet show a clear difference in how long people live.
[24] Good news
- In a small trial of people with lung cancer that could not be operated on, those given the pill aumolertinib with radiotherapy went a median of 34 months before the cancer grew, against 7.4 months on chemotherapy.
-
A final-stage trial registered in China tested aumolertinib, a pill that blocks a faulty EGFR gene, with radiotherapy for lung cancer that cannot be operated on.
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19
Lexeo buys a rare-disease pipeline for $8m
What happened
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Lexeo Therapeutics bought four drugs for Friedreich's ataxia from Mantle for $8 million.
[23] -
Friedreich's ataxia is an inherited disease that destroys balance and coordination and affects about one American in 50,000.
[23] -
About 80% of patients develop heart muscle disease.
[23] -
The lead drug improved a 93-point disease rating by 6 points in 11 patients in early testing.
[23]
Why it matters
Lexeo already has a gene therapy for the same disease in a late-stage trial.
[23] It has money to run until 2028.
[23] -
Lexeo Therapeutics bought four drugs for Friedreich's ataxia from Mantle for $8 million.
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20
A team of AI agents proposes a lung-cancer drug
What happened
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Scientists at Stanford University built a 'virtual biotech' of up to 37,000 AI agents that split drug-discovery work between them, reported in the journal Science.
[27] -
It studied more than 55,000 past clinical trials.
[27] -
It found that drugs aimed at proteins active in only certain cell types were nearly 50% likelier to reach the market.
[27] -
It also proposed an antibody carrying a cancer drug to a protein called CD276 in lung tumours.
[27]
Why it matters
None of its predictions has been tested in a lab, let alone a trial, other scientists pointed out.
[27] It is a test of whether AI can speed up the early, slow part of making a drug.
[27] -
Scientists at Stanford University built a 'virtual biotech' of up to 37,000 AI agents that split drug-discovery work between them, reported in the journal Science.
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21
Designing safer psychedelic-like drugs
What happened
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Researchers mapped two serotonin receptors, the docking points that psychedelic drugs act on, in the journal Nature Communications.
[28] -
One, called 2A, is behind the effects doctors want; the other, 2B, causes side effects.
[28] -
Using that map, they designed a compound that switches on 2A and blocks 2B.
[28] -
Images of the molecule in place confirmed how it works.
[28]
Why it matters
The authors say avoiding the 2B receptor is critical for safe medicines inspired by psychedelics.
[28] This was laboratory work, not a test in people.
[28] -
Researchers mapped two serotonin receptors, the docking points that psychedelic drugs act on, in the journal Nature Communications.
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22
A blood test for stomach and bowel cancer
What happened
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Researchers tested blood for 28 sugar-coated protein fragments in 550 people, half with stomach or bowel cancer and half healthy.
[29] -
A computer model using them picked out 77.3% of the cancers and wrongly flagged 18.4% of the healthy people.
[29] -
It did less well on early cancers.
[29]
Why it matters
About one healthy person in five was wrongly flagged, against about one in 500 for Galleri.
[4] [29] It compared known patients with healthy people, which is not the same as screening the general public.
[29] -
Researchers tested blood for 28 sugar-coated protein fragments in 550 people, half with stomach or bowel cancer and half healthy.
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23
FDA clears a quick COVID test
What happened
-
The FDA cleared the latest version of Aptitude's Metrix, a small molecular test for COVID.
[30] -
It was paid for partly by BARDA, the US health department's fund for emergency medical products.
[30] -
It arrives before the US ends emergency approvals for COVID tests on 26 December.
[30]
Why it matters
Tests already shipped under the emergency rules can still be used until they expire, the company said.
[30] Aptitude is also seeking clearance for a combined COVID and flu test.
[30] -
The FDA cleared the latest version of Aptitude's Metrix, a small molecular test for COVID.
Across the day
What is true of the whole day.
The truth, across the day
- Drug companies spent the week buying medicines they did not invent.
- Why it works on people A deal or a trial is announced at its best headline number, the biggest price or the word 'win', before the details that would temper it are released.
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Across the beats