Argenx poised to expand Vyvgart market off new phase 3 data

 Netherlands-based argenx has published positive topline results from its ADAPT SERON trial of its market-leading drug for generalised myasthenia gravis (gMG) Vyvgart (efgartigimod). Significantly, the results show the drug is effective in AChR-Ab seronegative patients, who make up about 20% of gMG patients and have historically had few to no treatment options.

gMG is a rare but debilitating autoimmune disease that can lead to muscle weakness, breathing troubles, difficulty swallowing, and impaired speech and vision. Despite being a rare disease impacting less than a million people worldwide, gMG treatment is an increasingly crowded market, with argenX recently facing new competition from much larger pharma companies including Johnson & Johnson, AstraZeneca, and UCB.

However, many of those treatments are only effective in the approximately 80% of gMG patients who have detectable antibodies against the acetylcholine receptor (AChR) in their blood. Of the 20% of patients who lack those antibodies, about half have other types of antibodies called anti-MuSK or anti-LRP4 antibodies. Some existing therapies (such as UCB's Rystiggo (rozanolixizumab)) can target anti-MuSK antibodies. The final 10% of gMG patients have no detectable antibodies against AChR, MuSK, or LRP4 and are referred to as triple seronegative. As of now, neither anti-LRP4 Ab positive patients nor triple seronegative patients have any approved treatment options.

ADAPT SERON, a double-blind, multi-centre RCT studying 119 AChR-Ab seronegative patients in China, the Middle East, North America, and Europe, met its primary endpoint, concluding that Vyvgart led to "significant and clinically meaningful improvement in MG-ADL (Myasthenia Gravis Activities of Daily Living) total score compared to placebo" and was well-tolerated and safe. Full detailed results will be shared at an upcoming conference.

“The results of the ADAPT SERON study, the largest study to date of AChR-Ab seronegative gMG, confirm that VYVGART now has the potential to be a targeted, effective, safe, and necessary treatment for patients living with gMG, regardless of autoantibody status,” Dr James F. Howard Jr., Professor of Neurology (Neuromuscular Disease) at The University of North Carolina at Chapel Hill School of Medicine and principal investigator for the trial, said in a statement. “Paired with our existing knowledge, these data demonstrate that pathogenic IgGs are underlying drivers of gMG across patient subtypes. This is a critical advancement in the management of this debilitating and unpredictable disease for patients with limited treatment options.”

argenx plans to submit a supplemental biologics license application to the FDA based on this data by the end of the year, which could see Vyvgart approved for these additional patients by 2026 or 2027. 

https://pharmaphorum.com/news/argenx-poised-expand-vyvgart-market-new-phase-3-data

Unswayed by Cerevel Failure, AbbVie Buys Gilgamesh’s Depression Drug for $1.2B

 

The deal extends AbbVie’s commitment to the psychedelics space and depression, after emraclidine’s high-profile flop in schizophrenia last November.

Not only is AbbVie jumping back into depression after a stunning failure last year, but the company is doing so with an eye-catching modality: psychedelics. After working closely with Gilgamesh Pharmaceuticals for over a year, AbbVie will buy the neuroscience biotech’s lead depression candidate for $1.2 billion.

The deal was announced Monday morning, with AbbVie splitting the cash between an upfront payment and development milestones, which were not disclosed. The transaction will only include Gilgamesh’s lead asset, bretisilocin, which was not involved in the companies’ original May 2024 licensing partnership. The drug is being developed as a fast-acting, two-hour duration treatment option for major depressive disorder (MDD).

The remaining assets in Gilagmesh’s stable—including those in the existing AbbVie collaboration—will be spun out into a new company called Gilgamesh Pharma Inc. This new entity will hold all of Gilgamesh’s employees and programs, which include an oral NMDA receptor antagonist called blixeprodil, a cardio-safe ibogaine analog and an M1/M4 agonist program.

AbbVie will still have an option to license candidates from the new Gilgamesh entity, according to the terms of the original deal.

The deal extends AbbVie’s commitment to the psychedelics space, one of the only Big Pharmas in the game. The other major player is Johnson & Johnson, which owns the esketamine-based Spravato, though the company has told BioSpace it doesn’t consider the depression drug to be a traditional psychedelic.

AbbVie was cautious with the deal, reflecting the lower-than-expected valuation for the Gilgamesh asset, BMO Capital Markets said in a note Monday morning.

“We believe the lower deal value could reflect conservatism around psychedelic valuations in light of regulatory backdrop for compounds, making today’s deal a well-balanced risk/reward acquisition for the company,” BMO’s Evan David Seigerman and colleagues wrote.

Still, the deal reflects a vote of confidence in the psychedelics space.

“Historically, large pharma has been less active exploring psychedelic compounds due to potential regulatory concerns surrounding approval, making today’s deal more significant, starting to validate that pharma could see a therapeutic outlet for some of these drugs,” BMO’s note read.

And the deal makes sense for AbbVie, the analysts added, noting its existing neuroscience portfolio that features the MDD asset Vraylar. Others in the portfolio include Ubrelvy and Qulipta, which BMO said are under-appreciated compared to AbbVie’s headline-making immunology drugs Skyrizi and Rinvoq.

Taking on Gilgamesh’s depression asset means that AbbVie is taking another shot at the condition after the failure of emraclidine. That asset was picked up at the end of 2023 in the nearly $9 billion acquisition of Cerevel Therapeutics but ultimately failed two Phase II trials last November.

Meanwhile, a rival asset called Cobenfy from Bristol Myers Squibb’s acquisition of Karuna Therapeutics made its way to the market as the first new schizophrenia treatment in 35 years. In recent months, the drug has struggled to live up to expectations, failing a Phase III test testing it as an add-on treatment to atypical antipsychotics for schizophrenia.

AbbVie will now take over development of bretisilocin, a short-acting serotonin (5-HT)2A receptor agonist and 5-HT releaser, which is being tested in a Phase II trial for moderate-to-severe MDD. In Phase IIa data revealed in May, bretisilocin beat a low-dose psychoactive comparator in reducing symptoms of depression. The drug showed a rapid onset within 24 hours, and the results were durable out to day 74 without additional treatment. BMO called the data impressive.

At the time, Gerard Sanacora, professor of Psychiatry at Yale University and the director of the Yale Depression Research Program, compared the treatment to J&J’s Spravato, which achieves rapid results in the clinic.

“The treatment fits nicely in the two-hour in-clinic framework established by esketamine, but with the potential for significantly fewer annual visits,” Sanacora said in a statement included in Gilgamesh’s May 27 release.

https://www.biospace.com/deals/unswayed-by-cerevel-failure-abbvie-buys-gilgameshs-depression-drug-for-1-2b

'Godfather Of AI' Warns Superintelligent Machines Could Replace Humanity

 by Tom Ozimek via The Epoch Times,

Geoffrey Hinton, the pioneering computer scientist called the “Godfather of AI,” has once again sounded the alarm that the very technology he helped bring to life could spell the end of humanity as we know it.

In an interview clip released Aug. 18 as part of the forthcoming film “Making God,” Hinton delivered one of his starkest warnings yet. He said that humanity risks being sidelined—and eventually replaced—by machines far smarter than ourselves.

“Most people aren’t able to comprehend the idea of things more intelligent than us,” Hinton, a Nobel prize-winner for physics and a former Google executive, said in the clip.

“They always think, well, how are we going to use this thing? They don’t think, well, how’s it going to use us?”

Hinton said he is “fairly confident” artificial intelligence will drive massive unemployment, pointing to early examples of tech giants like Microsoft replacing junior programmers with AI. But the larger danger, he said, goes far beyond the workplace.

“The risk I’ve been warning about the most … is the risk that we’ll develop an AI that’s much smarter than us, and it will just take over,” Hinton said.

“It won’t need us anymore.”

The only silver lining, he joked, is that “it won’t eat us, because it’ll be made of silicon.”

From Breakthroughs to Regrets

Hinton, 77, has spent decades pioneering deep learning, the neural network architecture that underpins today’s artificial intelligence systems. His breakthroughs in the 1980s—particularly the invention of the Boltzmann machine, which could learn to recognize patterns in data—helped open the door to image recognition and modern machine learning.

That work earned him the 2024 Nobel Prize in Physics, awarded “for foundational discoveries and inventions that enable machine learning with artificial neural networks.”

The Royal Swedish Academy of Sciences noted how Hinton’s early use of statistical physics provided the conceptual leap that made today’s AI revolution possible.

But Hinton has since emerged as one of the field’s fiercest critics, warning that its rapid development has outpaced society’s ability to keep it safe. In 2023, he resigned from his role at Google so he could speak freely about the risks without implicating the company.

In his Nobel lecture, Hinton acknowledged the potential benefits of AI—such as productivity gains and new medical treatments that could be a “wonderful advance for all humanity.” Yet he also warned that creating digital beings more intelligent than humans poses an “existential threat.”

“I wish I’d thought about safety issues too,” he said during the recent Ai4 conference in Las Vegas, reflecting on his career. He added that he now regrets solely focusing on making AI work, rather than anticipating its risks.

Teaching AI to Care

Hinton has previously estimated there is a 10 to 20 percent chance that AI could wipe out humanity. In a June episode of The Diary of a CEO podcast, he said that the engineers behind today’s AI systems don’t fully understand the technology and broadly fall into two camps: one that believes in a dystopian future where humans are displaced, and the other, dismissing such fears as science fiction.

“I think both of those positions are extreme,” Hinton said.

“I often say 10 percent to 20 percent chance [for AI] to wipe us out. But that’s just gut, based on the idea that we’re still making them and we’re pretty ingenious. And the hope is that if enough smart people do enough research with enough resources, we’ll figure out a way to build them so they’ll never want to harm us.”

At the Las Vegas conference last week, Hinton offered a novel idea for how to mitigate the danger: instead of trying to force AI systems into submission, researchers should design them with “maternal instincts” so they would want to protect humans even as they grow smarter.

“The right model is the only model we have of a more intelligent thing being controlled by a less intelligent thing, which is a mother being controlled by her baby,” Hinton said at the conference.

“They’re going to be much smarter than us,” Hinton warned, adding that “the only good outcome” is if they care about humanity the way a mother regards her child.

“If it’s not going to parent me, it’s going to replace me.”

https://www.zerohedge.com/ai/godfather-ai-warns-superintelligent-machines-could-replace-humanity

'First human case of flesh-eating screwworm confirmed in U.S., HHS says'

The U.S. Department of Health and Human Services on Sunday reported the first human case in the United States of travel-associated New World screwworm, a flesh-eating parasite.

The case, investigated by the Maryland Department of Health and the U.S. Centers for Disease Control and Prevention, was confirmed by the CDC as New World screwworm on Aug. 4, and involved a patient who had traveled to El Salvador, HHS spokesman Andrew G. Nixon said in an email to Reuters.

“The risk to public health in the United States from this introduction is very low,” he said.

The U.S. government has not confirmed any cases in animals this year.

Cattle ranchers, beef producers and livestock traders are already on high alert for potential U.S. infestations as screwworm has moved northward from Central America and southern Mexico.

The government’s confirmation of a screwworm case comes just over a week after U.S. Department of Agriculture Secretary Brooke Rollins traveled to Texas to announce plans to build a sterile fly facility there as part of efforts to combat the pest.

The USDA has estimated a screwworm outbreak could cost the economy in Texas, the biggest U.S. cattle-producing state, about $1.8 billion in livestock deaths, labor costs and medication expenses.

What are screwworms?

Screwworms are parasitic flies whose females lay eggs in wounds on any warm-blooded animal. Once the eggs hatch, hundreds of screwworm larvae use their sharp mouths to burrow through living flesh, eventually killing their host if left untreated.

The maggots’ feeding is similar to a screw being driven into wood, giving the pests their name.

Screwworms can be devastating in cattle and wildlife, and rarely infest humans, though an infestation in either an animal or a person can be fatal.

Treatment is onerous, and involves removing hundreds of larvae and thoroughly disinfecting wounds. But infestations are typically survivable if treated early enough.

The emails from the Beef Alliance executive said that due to patient privacy laws, there were no other details available about the positive human case of screwworm. The person was treated and prevention measures were implemented in the state, the email said.

A livestock economist at Texas A&M University was asked to prepare a report for Rollins on the impacts to industry of the border closure to Mexican cattle, according to the emails, a measure that has largely been in effect since November to prevent the arrival of screwworm to the United States.

The CDC was required to report the positive New World screwworm case to both Maryland health officials and the Maryland state veterinarian, one of the emails said, adding that the CDC also notified other agriculture stakeholders.

“We remain hopeful that, since awareness is currently limited to industry representatives and state veterinarians, the likelihood of a positive case being leaked is low, minimizing market impact,” the beef industry executive wrote.

A representative for the Beef Alliance did not respond to requests for comment.

Screwworms and the beef and cattle industry

Livestock traders and beef producers have been on edge about the potential for cases in cattle as prices have already hit record highs because the U.S. cattle herd is at its smallest size in seven decades.

The USDA has set traps and sent mounted officers along the border, but it has faced criticism from some cattle producers and market analysts for not acting faster to pursue increased fly production.

Rollins first announced plans for a sterile fly facility at Moore Air Force Base in Edinburg, Texas — near where a production facility to combat screwworm operated during the last major outbreak 50 years ago — in June, saying that the facility would take two to three years to come online.

A spokesperson for the USDA did not immediately respond to a request for comment.

Mexico has also taken efforts to limit the spread of the pest, which can kill livestock within weeks if not treated. The Mexican government said in July that it started to build a $51 million sterile fly production facility in the country’s south.

The sole operating plant is in Panama City and can produce a maximum of 100 million sterile screwworm flies each week. The USDA has estimated that 500 million flies would need to be released weekly to push the fly back to the Darien Gap, the stretch of rainforest between Panama and Colombia.

Screwworms have been traveling north through Mexico from Central America since 2023. They are endemic in Cuba, Haiti, the Dominican Republic and countries in South America, according to the USDA.

Mexico reported a new case about 370 miles (595 km) south of the U.S. border in Ixhuatlan de Madero, Veracruz, in July. The USDA immediately ordered the closure of livestock trade through southern ports of entry, after previously halting imports in November and May.

The U.S. typically imports over a million cattle from Mexico a year to fatten in feedlots and process into beef.

Screwworms were eradicated from the United States in the 1960s when researchers began releasing massive numbers of sterilized male screwworm flies that mate with wild female screwworms to produce infertile eggs.

https://www.dallasnews.com/news/public-health/2025/08/25/first-human-case-of-flesh-eating-screwworm-confirmed-in-us-hhs-says/

Russia 'Made Significant Concessions' On Ukraine Talks, Trump Still Has 'Lot Of Cards' To Play: Vance

 Vice President JD Vance appeared on Sunday's Meet the Press on NBC where he presented a generally positive view of Russia-Ukraine peace efforts mediated by Trump, despite the broad consensus being that talks are stalled and neither side has budged from their maximal positions.

Vance claimed the US President still has "a lot of cards left to play to apply pressure" to end the war. "I think the Russians have made significant concessions to President Trump for the first time in three and a half years of this conflict," he said.

Source: Associated Press

Some observers have pointed out, however, that it's a major concession for Moscow to even be engaged in peace dialogue at all, given that by pretty much all metrics it is dominant and winning on the battlefield. It's a concession in its own right for the winning side to even be talking at all.

"They've actually been willing to be flexible on some of their core demands. They've talked about what would be necessary to end the war. Of course, they haven't been completely there yet, or the war would be over. But we're engaging in this diplomatic process in good faith," Vance continued.

The vice president suggested that while Russia indeed has maintained the upper-hand, it has been unable to do everything it wants. "They've recognized that they're not going to be able to install a puppet regime in Kyiv. That was, of course, a major demand at the beginning," Vance described.

"And importantly, they've acknowledged that there is going to be some security guarantee to the territorial integrity of Ukraine." And yet, the Kremlin has rejected outright the idea of deploying Western peacekeeping troops to Ukraine, or the deployment of NATO air power.

That's when he said, "We, of course, have pushed for a ceasefire. But again, we don't control what Russia does. ... What we do believe though is that we continue to have a lot of cards. The president of the United States has a lot of cards left to play to apply pressure to try to bring this conflict to a close, and that's what we're going to do."

This of course includes sanctions, which Vance made clear are not off the table. Days ago Trump said he'll make a major decision in two weeks if talks don't advance at all. 

The reality remains that Putin has made clear that he won't meet with Zelensky unless it is to sign and full and final truce agreement, and not a mere temporary ceasefire.

Essentially a deal has to already be done, and only then would the two presidents meet directly, the Kremlin has said. Otherwise, it becomes a meeting just for the spectacle of having a meeting, the foreign ministry has previously explained. Clearly this scenario of a top-level bilateral meeting is still a long way off...

Zelensky has claimed this Kremlin stance is purposeful, to avoid achieving peace and press the battle forward. Zelensky asserted Friday "the Russians are trying to do anything to avoid the meeting" because "they do not want to end the war" on Ukraine.

But Russia's top diplomat Sergei Lavrov had also stated Friday "Putin is ready to meet with Zelensky, when the agenda would be ready for a summit," but underscored: "and this agenda is not ready at all."

https://www.zerohedge.com/geopolitical/russia-made-significant-concessions-ukraine-talks-trump-still-has-lot-cards-play-vance

Mail-In Ballots Need To Go: John Lott Jr.

 “I am going to lead a movement to get rid of MAIL-IN BALLOTS,” President Trump declared Monday in a Truth Social post. Later that day, he promised an executive order “to end mail-in ballots because they are corrupt. You know we are the only country in the world, I believe, I may be wrong, just about, the only country in the world that uses them because of what happened, massive fraud all over the place.”

Trump has remained consistent; even before the 2020 election, he warned: “There is a lot of dishonesty going on with mail-in voting.”

Trump doesn’t need to hedge about voting rules abroad. Poland was the one other country that considered conducting its 2020 presidential election by mail during the pandemic, but even it abandoned the attempt. Countries don’t use the kind of mass mail-in voting now used in eight states – where states automatically send ballots to all registered voters, who then mail them back. That system differs from absentee ballots, which require a request and traditionally demanded a reason, such as being out of town on Election Day.

The United States stands out not only for mail-in ballots but also for its unusually broad use of absentee ballots. Of the 47 European countries, 35 – including France, Italy, the Netherlands, Norway, and Sweden – ban absentee voting for citizens living inside the country. Ten others – including England, Ireland, Denmark, Portugal, and Spain – allow it only if voters pick up their ballots in person and present photo ID. Six of those restrict absentee ballots to the military or hospitalized voters, and they require verification from the military or hospital itself. The U.S., by contrast, lets anyone claim they will be out of town and receive a ballot by mail.

England once followed rules similar to America’s. But in 2004, officials uncovered a massive fraud in Birmingham city council races. Six winning Labour candidates had acquired about 40,000 fraudulent absentee votes, mainly from Muslim neighborhoods. England responded by ending the mailing of absentee ballots and requiring in-person pickup with photo ID.

France once had similarly loose rules. But in 1975, authorities exposed large-scale fraud on the island of Corsica, where dead people “voted” in the hundreds of thousands and widespread vote-buying flourished. France responded by banning absentee voting altogether.

Concerns over absentee ballots used to unite both Democrats and Republicans. “Absentee ballots are the largest source of potential voter fraud.” That warning doesn’t come from Trump, but from the bipartisan 2005 Commission on Federal Election Reform, led by Democratic President Jimmy Carter and Republican Secretary of State James Baker III.

Voters across the spectrum still share those worries. A Rasmussen poll at the end of last year found 59% of likely voters believe mail-in voting makes cheating easier. Majorities of black, Hispanic, and white voters agreed, along with both young and old. Only Democrats, liberals, graduate-school alumni, and those earning more than $200,000 disagreed. Earlier surveys reached similar results.

Even the New York Times once raised alarms. In 2012, the paper warned that the increased use of absentee ballots “will probably result in more uncounted votes, and it increases the potential for fraud.” But these days, that same newspaper insists voter-fraud claims for absentee ballots are “baseless” and “without evidence.”

American history reinforces these concerns. Between 1888 and 1950, widespread vote-buying led states to adopt the secret ballot. Once voters could no longer prove to buyers how they had voted, the payments stopped. As one state after another started using secret ballots, turnout immediately fell by 8% to 12%, according to my research with the late Larry Kenny at the University of Florida – evidence of just how rampant the practice had been.

The Carter-Baker commission also highlighted how absentee voting enables coercion: “Citizens who vote at home, at nursing homes, at the workplace, or in church are more susceptible to pressure, overt and subtle, or to intimidation. Vote-buying schemes are far more difficult to detect when citizens vote by mail.” The problem is that both the buyer and seller have an incentive to hide the purchase.

But recent cases confirm the risks. Earlier this year, prosecutors indicted six Texans for harvesting ballots and buying votes by collecting absentee ballots. Absentee voting lets sellers prove how they voted, and ballot harvesting lets buyers ensure the votes count – guaranteeing they get what they paid for. Just this month, investigators in Hamtramck, Michigan, opened a fraud case after surveillance video showed a city council candidate’s aide stuffing three stacks of ballots into a drop box. The candidate had won by only a few dozen votes.

Mail-in voting reopens the door to the fraud and vote-buying America worked so hard to eliminate a century ago. That’s why countries such as Norway and Mexico prohibit absentee ballots for citizens voting domestically. Americans deserve the same safeguard – a voting system they can trust.

John R. Lott Jr. is a contributor to RealClearInvestigations, focusing on voting and gun rights. His articles have appeared in publications such as the Wall Street Journal, New York Times, Los Angeles Times, New York Post, USA Today, and Chicago Tribune. Lott is an economist who has held research and/or teaching positions at the University of Chicago, Yale University, Stanford, UCLA, Wharton, and Rice.

https://www.zerohedge.com/political/mail-ballots-need-go-john-lott-jr

ModivCare Chapter 11 bankruptcy filing

  ModivCare Inc (NASDAQ:MODV) stock plunged 45% premarket Monday after the technology-enabled healthcare services company announced it had filed for Chapter 11 bankruptcy protection and received notice that its shares would be delisted from Nasdaq.

The Denver-based company, which provides supportive care solutions focused on improving health outcomes, filed for bankruptcy on August 20, 2025, triggering Nasdaq’s decision to commence delisting proceedings. Trading in ModivCare’s common stock will be suspended at the opening of business on August 28, 2025.

ModivCare stated it plans to implement a comprehensive restructuring transaction through expedited bankruptcy proceedings to "strengthen its future, reduce debt and inject capital." The company noted that the restructuring has support from a "supermajority" of its key stakeholders.

According to the company, all of its service lines are expected to continue operating normally during the bankruptcy process, with no anticipated interruption or change in access to care.

In a separate but related development, ModivCare also received notice from Nasdaq on August 20 that it was out of compliance with listing rules due to its failure to timely file its quarterly report for the period ended June 30, 2025.

https://www.investing.com/news/stock-market-news/modivcare-stock-plummets-after-chapter-11-bankruptcy-filing-93CH-4209133