Rare Diseases Secure Four FDA Firsts in August

 

Aside from the rare disease market, Novo Nordisk also scored a key regulatory win last month for its blockbuster GLP-1 drug Wegovy, which can now be used to treat patients with metabolic dysfunction-associated steatohepatitis.

August was a big month for the rare disease space, which saw four history-making approvals—though the streak was marred by one rejection. Also walking away with a win last month was Novo Nordisk, which secured a critical label expansion that, according to analysts, could help its blockbuster GLP-1 medication gain access to nearly $2 billion in added peak sales.

Read below for more.

Four Firsts for Rare Diseases

Company: Jazz Pharmaceuticals

Drug: Modeyso

Indication: Glioma

The first rare disease nod came on Aug. 6 for Jazz Pharmaceuticals’ dordaviprone, which was approved for patients aged 1 year and above with diffuse midline glioma with an H3 K27M mutation who have progressed after prior treatments. The drug, which will carry the brand name Modeyso, is the first systemic therapy for this specific type of glioma, according to the FDA’s announcement of the approval.

Modeyso was approved under the FDA’s accelerated pathway, supported by overall response (OR) data from a pair of Phase I and Phase II studies. According to Jazz’s news release announcing the approval, Modeyso achieved an OR of 22% in 50 adult and pediatric patients. Among responders, median duration was 10.3 months. To maintain Modeyso’s approval, Jazz is running a confirmatory Phase III trial that is expected to be complete in August 2026.

Company: Insmed

Drug: Brinsupri

Indication: Non-cystic fibrosis bronchiectasis

Not a week after Jazz, Insmed secured an FDA nod for brensocatib—now sold as Brinsupri—for the rare respiratory disorser non-cystic fibrosis bronchiectasis. Brinsupri, taken orally once daily, is indicated for patients aged 12 years and up. Insmed has set its price at $88,000 per year—“a little higher” than what analysts were expecting, Guggenheim Partners wrote at the time.

Brinsupri marks two firsts for the biopharma industry: Not only is it the first drug for bronchiectasis to reach the market, but it is also the first approved treatment that works by blocking DPP1, an enzyme that plays a role in activating the inflammatory response in airways.

Brinsupri is backed by data from the Phase III ASPEN trial. Data published in The New England Journal of Medicine in April showed that Brinsupri lowered the rate of pulmonary exacerbations by around 20% versus placebo. The Phase II WILLOW trial also supported Brinsupri’s approval, demonstrating a roughly 40% reduction in the risk of exacerbations relative to placebo.

Company: Precigen

Drug: Papzimeos

Indication: Recurrent respiratory papillomatosis

Then, on Aug. 14, Precigen won the FDA’s go-ahead for zopapogene imadenovec-drba, now named Papzimeos, for the treatment of recurrent respiratory papillomatosis (RRP). In its announcement of the approval, the FDA said Papzimeos is a “first-of-its-kind” non-replicating immunotherapy for this disease.

With around 1,000 new cases in the U.S. annually, RRP is a rare disease that manifests as benign tumors in the airways, leading to difficulties in swallowing and breathing. If left unchecked, RRP can lead to death. Papzimeos works by helping the body mount an immune response against cells infected by HPV 6 and HPV 11, both associated with RRP. Pivotal Phase I/II data supported Papzimeos’ approval, showing that the biologic elicited a complete response rate of more than 50% in treated patients, while over 85% needed fewer surgical interventions in the year after treatment.

Company: Ionis Pharmaceuticals

Drug: Dawnzera

Indication: Hereditary angioedema

Capping off the rare disease rally this month is Ionis Pharmaceuticals. On Aug. 22, the California biotech’s antisense oligonucleotide donidalorsen, now branded Dawnzera, became the industry’s first RNA-targeting prophylactic for hereditary angioedema (HAE). Patients 12 years and older can receive the therapy, which is given via a subcutaneous injection every four weeks.

Dawnzera targets the prekallikrein mRNA, causing its destruction. This, in turn, reduces overall levels of PKK, a protein that plays a role in swelling and pain attacks in HAE. Data from the OASIS-HAE study backed Thursday’s approval, demonstrating an 81% reduction in HAE attack rate versus placebo over 24 weeks of observation. Results were published May 2024 in the New England Journal of Medicine and additionally showed a significant improvement in patients’ quality of life.

Wegovy Win For Novo

On Aug. 15, the FDA gave the go-ahead for Novo Nordisk’s blockbuster injection Wegovy to be used in adults with metabolic dysfunction-associated steatohepatitis. The GLP-1 drug, indicated for patients with moderate to advanced liver scarring but without cirrhosis, should be used in conjunction with a reduced-calorie diet and higher physical activity.

Wegovy’s approval in MASH is a “step in the right direction” for Novo, analysts at BMO Capital Markets wrote in an Aug. 17 note to investors, adding that breaking into the MASH market “could start to help shift the momentum” for Wegovy, which in the first half of 2025 has been hit hard by the rise of compounders. BMO anticipates peak MASH sales of $1.9 billion for Wegovy.

Data from the Phase III ESSENCE trial, which supported the label expansion, showed that Wegovy improved liver fibrosis without worsening steatohepatitis in 37% of treated patients at 72 weeks, versus 22.5% in placebo comparitors. At the same time, Wegovy resolved steatohepatitis without worsening fibrosis in 62.9% of patients, as compared with 34.1% of placebo participants.

Wegovy has “clear efficacy in MASH,” the BMO analysts wrote, adding that its “clean safety profile and broad benefits across metabolic disease” could help establish the drug “as a backbone treatment for MASH.”

Wegovy joins Madrigal Pharmaceuticals’ Rezdiffra in the MASH space. Approved in March 2024, Rezdiffra made $180.1 million last year.

Three COVID-19 Vaccines Cleared, With Restrictions

The FDA on Aug. 27 approved updated COVID-19 vaccines from Pfizer, Moderna and Novavax, but with key limitations: The shots can only be used in adults 65 years and older and younger people who are at elevated risk of severe outcomes.

There are some minor differences across the three, particularly as it pertains to use in the at-risk younger population.

• Novavax’s Nuvaxovid, a protein-based shot, is authorized for individuals 12 through 64 years.
• Pfizer and BioNTech’s mRNA-based Comirnaty can be given to children as young as 5 years.
• Moderna’s mNEXSPIKE is indicated for people 12 through 64 years, while Spikevax is indicated for individuals 6 months through 64 years. Both vaccines are mRNA-based.

These approvals come after Health Secretary Robert F. Kennedy Jr. in May removed routine COVID-19 vaccination for healthy children and healthy pregnant women from CDC recommendations.

PTC Hit With Rejection in Friedreich’s Ataxia

The FDA on Aug. 19 turned down PTC Therapeutics’ vatiquinone, which the company has proposed for the treatment of Friedreich’s ataxia in children and adults.

In its complete response letter, the FDA stated that “substantial evidence of efficacy was not demonstrated” and that PTC would need an additional “adequate and well-controlled study” to support a resubmission. Matthew Klein, the company’s CEO, said in a statement at the time that PTC is planning to meet with the FDA to discuss potential next steps.

Vataquinone is a small molecule that blocks some of the cellular pathways that go awry in patients with frataxin mutations, the underlying cause of Friedreich’s ataxia. Patients with this rare neuromuscular disease suffer from loss of coordination and muscle strength, as well as difficulty speaking, swallowing and breathing. Around 25,000 patients have been diagnosed worldwide, according to PTC.

Vataquinone missed the mark in a Phase III, registration-directed trial back in 2023, failing to meet its primary endpoint of improving gait, stability and limb function after 72 weeks. PTC sought registration with the FDA based on secondary outcomes such as stability.

https://www.biospace.com/fda/rare-diseases-secure-four-fda-firsts-in-august

Lilly Ends Two Mid-Stage Trials for Second Obesity Asset

 

While Eli Lilly’s orforglipron is full speed ahead for a regulatory filing this year, the pharma is also pushing forward with one more Phase II study of naperiglipron, which uses the same scaffold as Pfizer’s failed obesity drugs danuglipron and lotiglipron.

Eli Lilly has terminated two Phase II studies of naperiglipron, an investigational oral obesity therapy, while it continues to forge ahead with a third mid-stage trial.

Both studies were discontinued for “strategic business reasons,” according to updates to their respective clinicaltrials.gov pages. A spokesperson for Lilly, who confirmed the trial terminations to Endpoints News on Friday, declined to provide additional information, noting only that results from the remaining ongoing study of naperiglipron “will inform the next steps for this program.”

One of the cut studies was originally designed to test the weight loss pill versus placebo in 150 patients with overweight or obesity and type 2 diabetes. Only one patient enrolled in the trial. Similarly, the second study was only able to onboard one patient out of its goal of 220 participants. It was designed to focus on a population of adults aged 55 to 80 years with a body mass index between 22 and 25 kg/m2.

The last remaining ongoing study for naperiglipron remains open to enrollment, with a recruitment target of 275 patients with overweight or obesity. Participants will be dosed once daily with naperiglipron or placebo. According to its clinicaltrials.gov page, the study began in November last year and has a primary completion date of April 2026.

Naperiglipron is an orally available small molecule agonist of the GLP-1 receptor. Like other drugs in this class, it works by promoting the release of insulin from the pancreas in response to blood sugar levels, and by suppressing appetite. In a June 23 note to investors, however, analysts at BMO Capital Markets noted that naperiglipron uses a similar design scaffold as Pfizer’s danuglipron and lotiglipron—both of which have been discontinued due to safety issues.

“While history for the scaffold has been challenging, we are interested to learn more why Lilly believes it can evade these past pitfalls,” BMO wrote at the time, adding that the asset could also help the pharma diversify its oral obesity portfolio.

Currently, Lilly’s oral weight-loss push is anchored by the late-stage orforglipron, which likewise works by activating the GLP-1 receptor. While many analysts consider orforglipron the de facto leader in the oral obesity space, recent readouts have cooled expectations. Last month, for instance, a readout from the Phase III ATTAIN-1 study disappointed investors, sending the pharma’s shares sliding 7% in its aftermath.

In the trial, a 36-mg dose of orforglipron cut weight by 12.4% in patients with obesity or overweight but not diabetes, falling shy of the market’s 13.4% expectation based on Novo Nordisk’s injectable semaglutide.

Last week, results from the late-stage ATTAIN-2 trial demonstrated a 10.5% weight reduction in patients with overweight or obesity and type 2 diabetes. These data, according to analysts at Truist Securities, were “in-line” with expectations, but leave “room for competition.”

https://www.biospace.com/drug-development/lilly-ends-two-mid-stage-trials-for-second-obesity-pill

Arrowhead Nabs up to $2B Novartis Commitment for siRNA Parkinson’s Program

 

Novartis is licensing ARO-SNCA, a preclinical siRNA therapy for synucleinopathies, a group of neurodegenerative disorders including Parkinson’s disease.

Arrowhead Pharmaceuticals has notched another major partnership with billion-dollar potential. Novartis has signed on to develop the RNA interference specialist’s preclinical Parkinson’s disease program for $200 million upfront.

On the back end, Arrowhead could be eligible for up to $2 billion in milestones, plus royalties on future sales, according to a Tuesday morning press release.

The deal adds to the list of heavyweight partners Arrowhead has collected, which already included Amgen, GSK and Takeda. Its biggest partnership, though, is with Sarepta Therapeutics; the November 2024 deal is worth upwards of $11 billion if all the programs are a success.

Novartis is licensing ARO-SNCA, a preclinical siRNA therapy for synucleinopathies, or neurodegenerative disorders such as Parkinson’s, that are caused by the buildup of the protein alpha-synuclein in the brain. The deal also includes other targets using Arrowhead’s Targeted RNAi Molecule, or TRiM, platform that have yet to be named, according to the release.

Arrowhead will continue with preclinical work for the programs up to a clinical trial application, when Novartis will take over.

Besides the partnered programs, Arrowhead has a wholly owned pipeline that includes lead asset plozasiran. The drug is currently awaiting a November decision from the FDA to treat familial chylomicronemia syndrome (FCS), a rare genetic metabolic disorder that prevents the body from breaking down fats.

The company is also working on two obesity assets, including ARO-ALK7, which is meant to silence the ACVR1C  gene, in turn reducing the risk of obesity-related metabolic complications. 

CEO Chris Anzalone told BioSpace last month that he aspires to build Arrowhead into a company like Vertex or Regeneron by building long-term value as an independent entity.

Novartis’ neurodegenerative pipeline is stacked with assets in multiple sclerosis, myasthenia gravis and Huntington’s disease. The program is anchored by approved therapies Mayzent and Fabhalta.

This is not Novartis’ first foray into siRNA therapies, however. The Swiss pharma has Leqvio, which is approved for lowering lipoprotein cholesterol. The drug was licensed from Alnylam, Arrowhead’s more-senior peer in the RNAi world, in January 2020.

https://www.biospace.com/business/arrowhead-nabs-up-to-2b-novartis-commitment-for-sirna-parkinsons-program

Violence Is Back As A Tool Of National Policy

 By Benjamin Picton, senior market strategist at Rabobank

Flying Blind

News broke yesterday that a jet carrying European Commission president Ursula von der Leyen had to land using paper charts after its GPS navigation systems were apparently jammed by Russia. Traveling to Plovdiv in Bulgaria, VDL’s jet apparently circled for an hour before the pilot took the decision to do things the old-fashioned way and consult the map.

Such an incident targeting a head of not-quite-a-state is shocking to say the least, but serves as a neat metaphor for relations between Russia and Europe in recent years (decades?): European liberal internationalists assume old norms apply -> Russia disagrees and demonstrates that it views violence as a legitimate tool of national policy -> Europeans left stunned.

Some will remember the images of German diplomats guffawing at the United Nations in 2018 as Donald Trump admonished Germany for placing itself at the mercy of Russia for its energy supplies. Fast-forward to 2022 and suddenly Trump’s speech wasn’t so funny, and anyone who cares to bring up a chart of German industrial production can see the fruits of the lack of imagination of Germany’s leaders. Germany’s factories are now struggling to replace lost production for civilian applications with new production for military applications. But how to do this without cheap energy?

So, yes, violence is back as a tool of national policy. Russia is unapologetic about this. So is Israel. So is the United States if you consider the decisiveness of using B-21 bombers to drop bunker busters on Iranian nuclear facilities. Hamas and the Houthis are certainly unapologetic and China has also been stepping up the frequency and scale of ‘rehearsals’ for the invasion of Taiwan while the Chinese navy and coast guard have had semi-regular clashes with the Philippines over territories that China claims as its own through the ten-dash line. Those Chinese territorial claims are not supported by the United Nations Convention on the Law of the Sea, but that is really part of the point.

Despite being permanent members of the UN Security Council, China and Russia have never really fully subscribed to the legitimacy of the post-war global architecture. Many Western leaders continue genuflect to the ‘rules-based international order’ as if it was chiselled in stone and handed down from Mount Sinai. In reality, that rules-based order has always been a US-led order, upheld by US force of arms, and has always been viewed by China and Russia as such. Russia has demonstrated that the it is quite willing to flout the ‘rules’ when its national interest demands it. This does not mean that war is inevitable, but it does mean that it is a policy option that other countries need to dissuade revisionist powers from using. As Bismarck reputedly said “do I want war? Of course not! I want victory.”

Both the United States and China are now interested in re-writing the rules of the road to suit their own interests. The US now sees the liberal economic order as a threat to its position as global hegemon while China seeks to push the US out and establish itself as an Asian hegemon. In the view of the United States, a persistently overvalued dollar and unequal trade terms has offshored production from the US into China (and elsewhere) while the US got hooked on the drug of artificially high living standards courtesy of the strong dollar and the subsidized production of consumer goods in China.

As Scott Bessent explained to Fox News last week, the United States got a major wakeup call during Covid when it became apparent that many of the things that the United States needed (pharmaceuticals, personal protective equipment etc) were not made in the USA and could not be easily imported while global shipping was snarled up and the countries who DID produce the goods and own the ships were focusing on supplying themselves. Consequently, the US now cares about controlling supply chains for strategic goods, is using state-intervention to guide production and is increasingly autarchic. This is seen as a national security priority in the context of geopolitical competition with China. Everything must be understood through this prism.

A logical corollary of the MAGA program seeking to re-orient the US economy from being characterised by consumption to being characterised more by production (as it was at the end of WWII) is that there will have to be less consuming going on. The question then becomes which segments of society are going to see their consumption power curtailed? Trump and Bessent say the people at the top have had it too good for too long and will have to pay, while the losers from 40 years of globalization (those at the bottom of the income distribution) will see their living standards safeguarded.

China, as the main power of the emerging BRICS bloc, is seeking partners in a new multilateralism aimed at replacing the US-led order with something that better suits the interests and ambitions of China and its partners. The events of the Shanghai Cooperation Organisation summit over the weekend demonstrate that Russia, Iran and Belarus are on board. India and Brazil (not an SCO member) seemingly are too, but there are problems.

Firstly, many of these countries have had territorial skirmishes in the recent past (e.g. the Sino-Soviet war in the 1960s and China-India border skirmishes more recently). Secondly, it is not immediately apparent how these powers could be incorporated into a new economic and financial architecture. The trade flows need to net and somebody needs to play the role of deficit runner if they are going to provide a replacement for the US Dollar as reserve currency. Nobody wants to do this because everybody wants to produce and export.

Additionally, the Chinese conception of world order historically posits the Chinese emperor as the intermediary between earth and heaven. That is to say, China has the ‘mandate of heaven’ that legitimises Chinese hegemony, and delegitimises the claims of anyone else to be on equal footing with China. How does India’s ambition for a multipolar Asia fit into this conception of world order? How does Iran’s conception of itself as a central Asian hegemon fit this view? How does Russia’s view of itself as a top-tier Eurasian power fit? The answer is: they don’t.

The UK Telegraph today claims ‘China unveils plan for new world order’. However, while team BRICS appears united in grievance against the US order, it is not yet clear that they are offering a coherent alternative. Xi Jinping made his pitch to the global south by encouraging them to embrace “free trade” and announcing that the Shanghai Cooperation Organisation would establish a new development bank to build influence in Eurasia by providing infrastructure loans for green industry. Establishing development banks extending loans in (presumably) Renminbi has the added benefit of de-risking the emerging bloc of the extraterritorial power of the US Dollar. Xi also said he would open up China’s BeiDou satellite system to SCO members as an alternative to the US GPS system (perhaps Ursula von der Leyen will be tempted?).

While the BRICS bloc coalesces towards a new conception of world order and seeks an economic and financial architecture to support it, Western powers seem unsure about the direction of their own political economy. Europe wants to be green but it also wants to re-arm, and the two are not compatible. Far right parties now hold polling leads in Germany, France and the UK as popular discontent at ‘the way things are going’ continues to rise.

European style anti-immigration protests recently broke out in Australia where a Canada style net inward migration rate of ~1.7% at a time where the country can’t house its own young is testing the social fabric. Recent comments by an Indian Minister suggesting that he was “in deep negotiations with my counterpart in Australia to create 1 million homes” using Indian labour trained in Australia and funding from the UAE is sure to add fuel to the fire. The supposed plan has not been corroborated by Canberra, but could be the most sensational economic chicanery since the Khemlani loans affair if it turned out to be true.

Whether fact or fiction, the plan does highlight an important point: for economies like Australia that have labor markets at ‘full-employment’, there is simply no surplus labour to do important stuff that needs doing. Labor is a factor of production subject to scarcity, and when scarcity strikes governments take on responsibility for directing the factors of production into their most useful employment. The United States is now doing this through ‘state capitalism’ and cherry-picking high value-add industries for its own economy.

This dynamic poses a question. Is Australia best served by having 55% of school leavers attend university to add to the oversupply of law graduates carrying unserviceable student loan debts? Or would it make more sense to direct the youth into trades training to address the undersupply of builders, tilers, plasterers, welders, farm workers etc etc? These are the trade-offs of economic policymaking under real constraints, but the Australian trade minister recently implied that a more active approach to organising production would not be taken when he said that Australia could be an example to the world by abolishing 500 “nuisance” tariffs.

So, the US is taking a more active role in directing economic activity, the BRICS are seeking to reshape the world order in their own image and Europe is searching for a new model of political economy that simultaneously delivers growth, security and social cohesion. Australia, meanwhile, wants to be an example to the rest of the world by evangelising an economic model that others are rejecting as failed. In this fractious new global environment leaving decisions of what gets produced, where, and by who completely in the hands of Mr Market really would be flying blind.

https://www.zerohedge.com/markets/violence-back-tool-national-policy

Paul Singer's Elliott Management Goes Activist On Pepsi

 Activist hedge fund Elliott Management has amassed a $4 billion stake in PepsiCo, as shares of the beverage and snack giant have declined by more than 24% from their peak in the summer of 2023. This comes as PepsiCo's soda and food business units have been hemorrhaging market share to competitors.

Elliott is one of the world's most aggressive activist hedge funds. Founded by the billionaire Paul Singer, it has a long track record of successfully restructuring companies.

Now, with PepsiCo in its crosshairs, according to a Wall Street Journal report citing people familiar with the situation, Singer and his team have built one of their largest-ever equity stakes, making the hedge fund one of the top five active investors, excluding index funds, in the company. 

Singer's move comes after PepsiCo's market cap has fallen to about $200 billion, down more than 24% from its 2023 peak of $270 billion.

PepsiCo share drawdown... 

The declining share price has been attributed to sliding soda sales, which have put it behind Coke, Dr Pepper, and Sprite. Besides soda, food sales have been slowing across its North America food unit since late 2022. 

Some Wall Street analysts have pitched to clients that PepsiCo should rethink its structure...

"We admit that refranchising the bottling business would take time and not be an easy undertaking," RBC Capital Markets analyst Nik Modi told clients in a note late last year. "However, we consider it a critical step for the long-term health of the beverage business."

Elliott has not revealed its plan of action regarding PepsiCo, but it has a long history of initiating turnarounds and restructurings for companies, as it did with Honeywell and Starbucks.

https://www.zerohedge.com/markets/paul-singers-elliott-management-goes-activist-pepsi

US Manufacturing Surveys Surged In August As New Orders Jumped

 After tumbling in July, expectations for August's US Manufacturing surveys were optimistic (with both ISM and S&P Global both expected to tick higher, though the former expected to remain in contraction).

• S&P Global's US Manufacturing PMI rose dramatically from 49.8 in July to 53.0 in August (down very marginally from its preliminary print of 53.3) - the strongest in over three years

• ISM's US Manufacturing PMI rose from 48.0 in July to 48.7 in August (below the 49.0 expected)

And both of these increases in 'soft' survey data come as hard data has disappointed...

Source: Bloomberg

Under the hood of the ISM data, we see prices falling significantly, nmew orders jumping, but employment remaining significantly weaker (as we suggested will happen)...

Source: Bloomberg

“Purchasing managers reported that the US manufacturing was running hot over the summer," according to Chris Williamson, Chief Business Economist at S&P Global Market Intelligence.

“The past three months have seen the strongest expansion of production since the first half of 2022, with the upturn gathering pace in August amid rising sales. Hiring also picked up again in August as factories took on more staff to meet an influx of new orders and an accumulation of uncompleted work for waiting customers."

“The manufacturing sector is therefore on course to provide a boost to the US economy in the third quarter.

But inflationary fears loom...

“The upturn is in part being fueled by inventory building, with factories reporting a further jump in warehouse holdings in August due to concerns over future price rises and potential supply constraints. These concerns are being stoked by uncertainty over the impact of tariffs, fears which were underpinned by a further jump in prices paid for inputs by factories, linked overwhelmingly by purchasing managers to these tariffs.

“Cost increases are being passed on to customers via widespread hikes to factory gate prices. The big question is the degree to which these price rises will then feed through to higher consumer price inflation in the coming months.”

So S&P Global sees prices higher and hiring improving while ISM sees prices falling and employment still badly lagging... take your pick!!

https://www.zerohedge.com/economics/us-manufacturing-surveys-surged-august-new-orders-jumped

British Comedy Writer Arrested For Three Gender-Critical Tweets; Hospitalized As A Result

 by Steve Watson via Modernity.news,

An acclaimed comedy writer in the UK was arrested and thrown in a jail cell over three tweets that were critical of gender ideology, causing him to become extremely stressed and require hospitalisation.

In a recent Substack post, Graham Linehan recounts his arrest at Heathrow Airport upon returning from the US, a development he attributes to complaints from trans activists over three tweets.

Author JK Rowling shared the news via her X account.

The ordeal began even before Linehan boarded his flight in Arizona. “When I handed over my passport at the gate, the official told me I didn’t have a seat and had to be re-ticketed,” he writes, initially dismissing it as a typical travel mishap. In hindsight, however, he believes it was a sign he’d been “flagged” by authorities, speculating that “Someone, somewhere, probably wearing unconvincing make-up and his sister/wife’s/mum’s underwear, had made a phone call.”

Upon landing at Heathrow, Linehan says he was met by “five armed police officers” who escorted him to a private area and informed him he was under arrest for the tweets. He emphasizes the absurdity of the situation, noting “In a country where paedophiles escape sentencing, where knife crime is out of control, where women are assaulted and harassed every time they gather to speak, the state had mobilised five armed officers to arrest a comedy writer for this tweet (and no, I promise you, I am not making this up.”

The tweets in question included one showing a man in women’s clothing with the caption implying a call to challenge such individuals, and a follow-up referencing a “punch in the bollocks” as a metaphorical point about height differences and self-defense, not literal violence.

Linehan’s initial reaction was one of disbelief and humor: “When I first saw the cops, I actually laughed. I couldn’t help myself. ‘Don’t tell me! You’ve been sent by trans activists,'” he writes.

At the Heathrow police station, Linehan recounts how his belongings were confiscated, including his belt, bag, and devices. He was placed in a “small green-tiled cell with a bunk, a silver toilet in the corner and a message from Crimestoppers on the ceiling next to a concave mirror that was presumably there to make you reflect on your life choices.”

During the police interview, Linehan remarks that the tone became more intense. An officer questioned him about each tweet “with the sort of earnest intensity usually reserved for discussing something serious like… oh, I dunno—crime?”

Linehan defended his posts, explaining that the ‘punch’ tweet was “a serious point made with a joke,” explaining that “Men who enter women’s spaces ARE abusers and they need to be challenged every time.”

The conversation touched on terminology when the officer used “trans people,” prompting Linehan to challenge: “I asked him what he meant by the phrase. ‘People who feel their gender is different than what was assigned at birth.’ I said ‘Assigned at birth? Our sex isn’t assigned.'” He dismissed the officer’s response as “semantics” and accused him of using “activist language,” lamenting that “The damage Stonewall has done to the UK police force will take years to mend.”

Linehan recounts that the stress of the situation took a huge physical toll on him, and when a nurse checked on him, it was discovered that his blood pressure was “over 200—stroke territory,” and he was rushed to A&E for observation.

Linehan attributes this to “The stress of being arrested for jokes,” combined with travel fatigue, and his ongoing eight-year battle against “trans activists working in tandem with police in a dedicated, persistent harassment campaign because I refuse to believe that lesbians have cocks.”

Linehan’s account paints a picture of a surreal clash between free speech, activism, and law enforcement, highlighting his frustration with a system that now prioritises ideological complaints over real crimes.

Is it a coincidence that Linehan was on the world’s most popular podcast just three weeks ago talking about how much of a police state Britain has become?

Linehan has been targeted for cancellation and much worse for years now, since making his views on the gender issue clear:

The Free Speech Union in the UK has announced that it will back Linehan, posting on X:

We do not believe Graham’s arrest or the bail conditions imposed were lawful. We will be backing him all the way in his fight against these preposterous allegations and the disproportionate response from the police.

When @Glinner landed at Heathrow, he was met by five armed police officers, and immediately arrested.

His ‘crime’? Three gender-critical tweets.

As Graham says in his Substack:

“In a country where paedophiles escape sentencing, where knife crime is out of control, where women are assaulted and harassed every time they gather to speak, the state had mobilised five armed officers to arrest a comedy writer.”

Graham’s single bail condition is that he does not go on X.

All of this comes in the wake of Prime Minister Kier Starmer repeatedly claiming that the UK is proud of free speech.

*  *  *

https://www.zerohedge.com/political/british-comedy-writer-arrested-three-gender-critical-tweets-hospitalized-result