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First NASH liver disease drug is here, more coming

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3D Illustration of a human liver organ.

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Good morning! Millions of Americans with a common and potentially life-threatening form of liver disease will soon have access to the first-ever treatment for the condition. 

In a landmark decision on Thursday, the Food and Drug Administration approved Madrigal Pharmaceuticals‘ drug “Rezdiffra,” to be used along with diet and exercise. The company expects the medicine to be available next month with a hefty price tag of $47,400 per year before insurance and other rebates. 

So, why is this approval so important? 

First of all, people suffering from the disease badly need a treatment. Rezdiffra is specifically approved to treat patients with nonalcoholic steatohepatitis, or NASH, who also have moderate-to-advanced liver scarring.

Some specialists have started calling the condition metabolic dysfunction-associated steatohepatitis, or MASH, to avoid potentially stigmatizing language.

MASH is a serious form of liver disease characterized by excess fat buildup and inflammation. It can lead to liver scarring and in more severe cases, liver failure or cancer. The condition is often associated with other health problems, such as high blood pressure, Type 2 diabetes and obesity.

Roughly 6 million to 8 million people in the U.S. have MASH with moderate-to-advanced liver scarring, according to an estimate cited by the FDA. 

The agency’s approval is also a big deal because it means Madrigal has succeeded in an area where several other drugmakers have failed – or are still trying to crack. 

That gives Madrigal an edge in a market that could be huge: The MASH industry could be worth nearly $26 billion by 2032 across the U.S., France, Germany, Italy, Spain, the U.K. and Japan, according to an estimate from data analytics firm GlobalData. 

Madrigal’s drug is setting the bar for efficacy and safety for MASH treatment, while also opening the door for medicines still in development. 

There’s one important detail in the approval that could bode well for the entire MASH space: The FDA isn’t requiring patients to get a liver biopsy to determine their eligibility for Madrigal’s drug. 

That refers to a procedure in which a doctor removes a small piece of liver tissue from a patient so they can examine it under a microscope for signs of damage or disease. 

“The absence of liver biopsy requirement in Rezdiffra’s label should buoy biotech stocks” of companies developing MASH treatments and “potentially accelerate and broaden patient access,” William Blair analyst Andy Hsieh wrote in a note Friday.

In this photo illustration, the Madrigal Pharmaceuticals logo is displayed on a smartphone screen. 

Rafael Henrique | SOPA Images | Lightrocket | Getty Images

There are a handful of biotech companies with promising experimental MASH treatments: 

But the question for all of those companies is how much a blockbuster class of drugs called GLP-1s will dominate the MASH market. 

GLP-1s work by mimicking a hormone produced in the gut to suppress a person’s appetite and regulate blood sugar. 

They include Novo Nordisk‘s weight loss drug Wegovy and diabetes treatment Ozempic. Eli Lilly‘s respective weight loss and diabetes injections Zepbound and Mounjaro are also part of the class, but target an additional hormone called GIP. 

  • Novo Nordisk is studying semaglutide, also known as Wegovy and Ozempic, in a late-stage trial for treating MASH. 
  • Eli Lilly released positive mid-stage data on tirzepatide, also known as Zepbound and Mounjaro, in treating MASH, and expects to present full data from that trial later this year. 
  • Zealand Pharma and Boehringer Ingelheim released positive mid-stage data on an experimental drug called survodutide in MASH patients. The companies are also studying the treatment in late-stage trials as a treatment for obesity. The treatment activates GLP-1 and another hormone called glucagon. 
  • Merck is studying a drug called efinopegdutide in mid-stage trials. The treatment activates GLP-1 and another hormone called glucagon. 

Mizuho healthcare equity strategist Jared Holz wrote in an email to investors Friday that GLP-1 uptake is one factor that will be “key regarding the broader NASH thesis.” 

He said that’s because “there is no doubt in our minds that the use of the weight-loss therapies will greatly reduce liver fat and would expect many doctors (at least primary care) to opt for GLPs first, before referring patients to specialists.”

Wegovy, Ozempic, Zepbound and Mounjaro are already pricey at around $1,000 per month, or around $13,000 annually, before insurance and other rebates. But that’s still far less than the nearly $50,000 annual price tag of Madrigal’s drug. 

We’ll likely have a better idea of what the MASH drug landscape will look like over the next year – and how big a threat GLP-1s will be – so stay tuned for our coverage!

Feel free to send any tips, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com.

Latest in health-care technology

Takeaways from the HIMSS conference 

Attendees at HIMSS in Orlando, Florida 2024.

Courtesy of HIMSS

Perhaps unsurprisingly, generative artificial intelligence dominated my conversations at the HIMSS conference in Orlando, Florida last week. 

As I raced across the exhibition floor to meet with executives from companies like Microsoft, Google, Epic Systems, GE HealthCare, Salesforce and more, the topic was quite literally hard to avoid. I walked by a random sample of around 40 vendors at the conference, for instance, and about 75% of them had the word “AI” displayed prominently on their booths. 

AI’s popularity at HIMSS was expected. As I mentioned in last week’s newsletter, it stole the show at last year’s conference, too. But this year, the conversation around the role of AI in health care had matured. Instead of discussing long-term, far-reaching applications of the technology, most of my conversations were about how it is being tested and used in practice. 

The most popular use case by far was ambient clinical documentation, which came up over and over again. Ambient clinical documentation tools allow doctors to consensually record their visits with patients, and those conversations are automatically transformed into clinical notes and summaries using AI. 

Companies like Microsoft’s Nuance Communications, Abridge and Suki have developed these capabilities, which they argue will help reduce doctors’ administrative workloads and prioritize meaningful connections with patients. 

Administrative tasks are a major problem for doctors across the U.S. health-care system, as they are one of the primary drivers of burnout, according to a survey published by Athenahealth in February. As a result, health systems have a lot of interest in tools like ambient clinical documentation that could help reduce this clerical burden. 

Organizations like Stanford Health Care and California-based UCI Health announced at HIMSS that they are rolling out ambient clinical documentation tools across their entire enterprises. Since automating documentation does not directly impact patients’ diagnoses or care, I expect we’ll see lots of similar announcements across the country this year. It’s an easier, less risky way for health systems to deploy generative AI at scale. 

Many of the companies I spoke with are dipping their toes into more patient-facing and diagnostic AI applications, but I think it will be a while before we see doctors and nurses widely using the technology to support their treatment decisions. 

Feel free to send any tips, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.

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United Airlines (UAL) 1Q 2024 earnings

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A United Airlines Boeing 737 Max 9 aircraft lands at San Francisco International Airport.

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United Airlines on Tuesday cut its aircraft-delivery expectations for the year as it grapples with delays from Boeing, the latest airline to face growth challenges because of the plane-maker’s safety crisis.

United expects to receive just 61 new narrow-body planes this year, down from 101 it said it had expected at the beginning of the year and contracts for as many as 183 planes in 2024.

“We’ve adjusted our fleet plan to better reflect the reality of what the manufacturers are able to deliver,” CEO Scott Kirby said in an earnings release. “And, we’ll use those planes to capitalize on an opportunity that only United has: profitably grow our mid-continent hubs and expand our highly profitable international network from our best in the industry coastal hubs.”

United said it plans to lease 35 Airbus A321neos in 2026 and 2027, turning to Boeing’s rival for new planes as the U.S. manufacturer faces caps on its production and increased federal scrutiny. In January, United said it was taking Boeing’s not-yet-certified Max 10 out of its fleet plan. The airline said it has converted some Max 10 planes for Max 9s.

It lowered its annual capital expenditure estimate to $6.5 billion from about $9 billion.

United is also facing a Federal Aviation Administration safety review, which has prevented some of its planned growth. A spokeswoman told CNBC earlier this month that the carrier will have to postpone its planned service from Newark, New Jersey, to Faro, Portugal, and service between Tokyo and Cebu, Philippines.

United earlier this month postponed its investor day, which was scheduled for May, “because our entire team is focused on cooperating with the FAA to review our safety protocols and it would simply send the wrong message to our team to have an exciting investor day focused primarily on financial results.”

The airline said it would have reported a profit for the quarter if not for a $200 million hit from the temporary grounding of the Boeing 737 Max 9 in January.

The FAA temporarily grounded those jets after a door plug blew out minutes into an Alaska Airlines flight, sparking a new safety crisis for Boeing and slowing deliveries of its planes to customers including United, Southwest and others.

The airline posted a net loss of $124 million, or a loss of 38 cents a share, in the first quarter compared with a $194 million loss, or 59 cents, a year earlier. Revenue rose nearly 10% in the first quarter compared with the year-earlier period to $12.54 billion, with capacity up more than 9% on the year.

Here’s what United reported in the first quarter compared with what Wall Street expected, based on average estimates compiled by LSEG:

  • Loss per share: 15 cents adjusted vs. a loss of 57 cents expected
  • Revenue: $12.54 billion vs. $12.45 billion expected

The airline expects to post earnings of between $3.75 and $4.25 in the second quarter, ahead of analysts’ estimates of about $3.76 a share. Airlines make the bulk of their profits in the second and third quarters, during peak travel season.

The carrier also reiterated its full-year earnings forecast of between $9 and $11 a share.

United’s shares were up more than 4% in after-hours trading on Tuesday.

United executives will hold a call with analysts at 10:30 a.m. ET on Wednesday.

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Ex-Post Office boss regrets ‘missed opportunity’ to halt Horizon scandal

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“On reflection, and I have reflected on this very hard, when I finished being the Horizon programme director [in early 2000] it would have been very beneficial if I had notified both the lawyers and the [investigations team] that Horizon was a new system coming in, and that they should be very cautious about evidence coming out of that system,” he said.

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Sri Lanka’s economic crisis and debt restructuring efforts By Reuters

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COLOMBO (Reuters) – Sri Lanka’s government rejected a proposal from its international bondholders on Tuesday on restructuring the more than $12 billion the country owes to them.

It means a near two-year spell in default will drag on for Sri Lanka and that the country’s next tranche of vital IMF support money could potentially get delayed.

Below is a timeline of the key events in the crisis and the efforts to resolve it:

2021-2022: Sri Lanka’s economy crumbles after years of overspending leaves its foreign exchange reserves critically low and the government unable to pay for essentials, such as fuel and medicine.

The country’s bonds suffer from multiple downgrades by credit rating agencies warning of the increasing risk of default. At the start of 2022 it manages to make a $500 million bond payment but it leaves its foreign exchange reserves precariously low.

MAY, 2022 – Sri Lanka is declared in default after it fails to make a smaller $78 million bond coupon payment.

JULY, 2022 – Public anger drives protesters to storm then-President Gotabaya Rajapaksa’s office and residence. Rajapaksa flees to the Maldives, before moving on to Singapore.

Current President Ranil Wickremesinghe is voted into power by Sri Lankan lawmakers.

MARCH, 2023 – The International Monetary Fund approves a near $3 billion bailout for Sri Lanka after talks with Wickremesinghe’s government and assurances about its plans to repair the country’s finances.

OCTOBER, 2023

Sri Lanka announces an agreement with China’s EXIM (export/import) Bank to delay payments on about $4.2 billion worth of loans the Chinese lender it has extended to the country.

NOVEMBER, 2023

Other creditor nations including India, Japan and France agree to restructure about $5.9 billion in debt.

MARCH, 2024

A group of Sri Lankan officials arrives in London to meet with a number of investment funds that hold its more than $12 billion worth of government bonds. Talks advance to the key “restricted” phase where proposals are discussed privately and those involved agree not to buy or sell any of the debt on the open market.

© Reuters. FILE PHOTO: A general view of the main business district as rain clouds gather above in Colombo, Sri Lanka, November 17, 2020. REUTERS/Dinuka Liyanawatte/File Photo

APRIL, 2024

The government rejects a proposal tabled by the bondholders. The main stumbling blocks are that some the “baseline” assumptions used differ to those of the IMF and that the plan did not include a contingency option for the government in case the economy fails to recover as expected.



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