FDA approves Zepbound for weight loss; Wegovy Is Shown to Reduce Risk of Heart Attacks and Strokes; Trevor Milton's ridiculous argument for probation instead of prison; The Sleep Habit That's More Important Than Getting Eight Hours

1) Yesterday, I sent a 10-item e-mail to the personal e-mail list I created in June to follow the miraculous new weight-loss drugs. Here are the first two items...

There have been all sorts of important developments confirming the miraculous nature of the new weight-loss drugs...

Importantly, Eli Lilly's (LLY) Mounjaro, which had only been approved by the U.S. Food and Drug Administration ("FDA") for diabetes, was approved for weight loss (under the name Zepbound). This should greatly expand insurance coverage.

Here's the New York Times with more details: F.D.A. Approves New Obesity Drug That Will Compete With Wegovy. Excerpt:

The Food and Drug Administration on Wednesday approved an obesity drug from the company Eli Lilly that will be a direct competitor to the wildly popular Wegovy.

The drug is called tirzepatide and will be sold under the name Zepbound. It joins a class of new medications that are transforming obesity, a condition that affects 100 million American adults and is linked to a spectrum of diseases including diabetes, heart disease, sleep apnea, liver disease, kidney disease and joint pain.

Patients who used tirzepatide lost an average of 18% of their body weight, according to the F.D.A., when it was taken at its highest dose in a drug trial. That's compared with Wegovy, manufactured by Novo Nordisk, which produced an average 15% weight loss.

The F.D.A. approved Zepbound for people with obesity and for those who are overweight and have at least one obesity-related condition.

Tirzepatide is already approved for diabetes under the brand name Mounjaro where it competes with Novo Nordisk's diabetes drug semaglutide, known better as Ozempic. But until now, Wegovy – also semaglutide but with a higher maximum dose than Ozempic – was the only approved drug that could safely elicit substantial weight loss in people with obesity alone.

And here's more from the NYT on this newly approved drug: What to Know About Zepbound, the New Weight Loss Drug, answering these questions:

• Who qualifies for Zepbound?
• How does tirzepatide work for weight loss?
• If I'm already taking Ozempic or Wegovy, should I switch?
• Will insurance cover it and what is it likely to cost out of pocket?
• What are the side effects?

Equally important, another study showed major health benefits to patients on these drugs (which isn't surprising given the horrific effects of obesity). The NYT has the story: Wegovy Is Shown to Reduce Risk of Heart Attacks and Strokes in Some Patients. Excerpt:

A pivotal new study suggests that the weight loss drug Wegovy cut the risk of heart attack, stroke, or death from cardiovascular issues by 20% among overweight or obese people with heart disease – a striking benefit that could change the standard of care for these patients.

"We've just identified a new best practice," said Dr. Clyde Yancy, chief of the division of cardiology at Northwestern Medicine, who was not involved with the study. But the research also raises questions about exactly how the drug helps the heart – through weight loss itself, or other mechanisms – and whether it can be as effective in a real-world setting, with a more diverse group of patients than those included in the trial.

Still, the results of the study, presented Saturday in a standing-room only session at an American Heart Association meeting in Philadelphia, are a turning point for the sought-after new class of obesity and diabetes drugs that also includes Ozempic and the newly approved Zepbound.

Drug companies see potential for the medicines that extends far beyond obesity. Proving that the drugs not only treat diabetes and help patients lose weight, but also can lower the risk of other serious diseases linked with obesity, could further drive demand – and pressure insurance companies to cover them at a broader scale.

The research is "one of the most anticipated trials in the last 10 years," said Dr. Yuan Lu, an assistant professor of cardiovascular medicine at the Yale School of Medicine who was not involved in the study. Outside of statins, she said, no medication has so dramatically reduced cardiovascular risk among people with heart disease. "The uptake of this drug is going to be skyrocketing in the next couple of years," she said.

To read the entire e-mail – and the prior ones – I sent to my personal e-mail list about the weight-loss drugs, you can click here. If you wish to join the list, simply send a blank e-mail to: weightlossdrugs-subscribe@mailer.kasecapital.com.

2) Trevor Milton, the founder of electric-car promotion Nikola (NKLA), was found guilty on a count of securities fraud and two counts of wire fraud 13 months ago. In an appeal for probation rather than prison time, his lawyers argued that:

Trevor Milton sees the world differently than most other people. Where others see darkness, Trevor sees light. Where others see despair, Trevor sees hope. Where others see impossibility, Trevor sees possibility. Where others see problems, Trevor sees solutions.

Activist short seller Nate Anderson of Hindenburg Research posted this on X, formerly Twitter:

You cannot make this stuff up! Milton is a lifelong fraudster and hopefully the judge will give him a stiff sentence...

I've been warning my readers about Nikola going back more than three years to September 11, 2020, when I wrote the following:

One of the best-known activist short sellers is Nate Anderson of Hindenburg Research. I've met him and can attest that he does great work and has an excellent track record.

Yesterday, he published a lengthy and damning report on electric-truck maker Nikola (NKLA), Nikola: How to Parlay An Ocean of Lies Into a Partnership With the Largest Auto OEM in America.

I concluded that "Nikola is toast."

The stock closed that day at $32.13 per share.

I later added it to my Short Squeeze Bubble Basket on January 27, 2021 at $28.58 per share and my Dirty Dozen on January 4, 2022 at $10.32 per share.

Nikola closed yesterday at $1.07 per share – and it's still a stock to avoid, as it's likely a zero.

3) I've written many times about the importance of getting lots of good sleep, so I read a recent Wall Street Journal article with interest...

As the WSJ reports, it seems that consistency is important: The Sleep Habit That's More Important Than Getting Eight Hours. Excerpt:

There is hope for those of us who live (and sleep) in the real world: Getting less than eight hours of shut-eye a night doesn't mean you're doomed to an early grave.

A recent study looking at sleep and longevity found that sleep "regularity" – going to bed and waking up at consistent times with few mid-slumber interruptions – matters more than how long you sleep. Sleeping six hours every night on a consistent schedule was associated with a lower risk of early death than sleeping eight hours with very irregular habits.

The study adds to a growing understanding of the links between sleep and longevity. Research in recent years has shown not only how important sleep is for health and lifespan, but also that the duration of sleep isn't the only thing that matters.

"We've been missing maybe half of the story," says Matt Walker, a neuroscientist and director of the Center for Human Sleep Science at the University of California, Berkeley, who wasn't involved with the recent study. "Not just how much you sleep but the regularity with which you sleep has now come onto the map and exploded as perhaps the more important thing."

More than a third of Americans don't get the seven to nine hours of sleep recommended by sleep and medical organizations on a regular basis, according to Centers for Disease Control and Prevention data. Roughly 20% report rarely or never waking up feeling well rested, according to a recent U.S. News & World Report survey.

New science

The study, published in the journal Sleep, found that sleep regularity reduced the risk of premature death from any cause by 20% to 48% compared with those with the most irregular sleep. Irregular sleep habits included inconsistent sleep and wake times, interrupted sleep, and napping.

Sleep duration was still important: People who got long, consistent sleep had the lowest mortality risk, says Angus Burns, a research fellow at Harvard Medical School who co-wrote the study. But shorter, regular sleep was generally associated with lower mortality than longer, inconsistent sleep.

That is welcome news for people whose work and family demands make it difficult to get the recommended seven to nine hours a night, Burns says.

Best regards,

Whitney

P.S. I welcome your feedback – send me an e-mail by clicking here.