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Monday, June 23, 2025

Amgen down after weight loss trial results

 Amgen Inc (NASDAQ:AMGN) stock fell 6% following the release of full results from its Phase 2 study of MariTide, its obesity treatment candidate, despite the drug showing promising efficacy data.

The peptide-antibody conjugate demonstrated up to 20% average weight loss in people with obesity without Type 2 diabetes compared to 2.6% in the placebo group. For those with obesity and Type 2 diabetes, MariTide produced up to 17% average weight loss versus 1.4% for placebo. Notably, weight loss had not plateaued by the 52-week mark, suggesting potential for further reduction.

The treatment, administered subcutaneously on a monthly or less frequent basis, also showed a robust reduction in hemoglobin A1c of up to 2.2% in participants with obesity and Type 2 diabetes. Additional improvements were observed across cardiometabolic measures including waist circumference, blood pressure, and select lipid parameters.

No new safety signals were identified in the study. The most frequently reported adverse events were gastrointestinal-related and primarily mild to moderate. Discontinuation rates due to gastrointestinal events were lower in dose escalation arms (up to 7.8%) compared to non-dose escalation arms.

The company has already initiated its Phase 3 MARITIME program, which will evaluate MariTide in participants with obesity or overweight with and without Type 2 diabetes over 72 weeks. Amgen also plans to begin Phase 3 studies for atherosclerotic cardiovascular disease, heart failure, and obstructive sleep apnea in 2025.

Despite the positive efficacy data, investors appeared to react negatively to the news, potentially due to competitive concerns in the increasingly crowded obesity drug market.

https://www.investing.com/news/stock-market-news/amgen-stock-falls-after-obesity-drug-maritide-shows-20-weight-loss-93CH-4106570

GeneDx stock soars after AAP recommends genome testing as first-tier test

 GeneDx Holdings Corp (NASDAQ:WGS) stock surged 18.5% after the American Academy of Pediatrics (AAP) issued updated guidance recommending exome and genome sequencing as first-tier tests for children with global developmental delay or intellectual disability.

The new guidelines represent a significant shift in pediatric medicine, positioning general pediatricians to initiate genetic testing earlier in the diagnostic process. This change could substantially benefit GeneDx, a leader in genomic testing, as the company is well-positioned to support the implementation of these new recommendations.

The AAP’s updated guidance cites superior diagnostic yield and higher cost-effectiveness when genome sequencing is pursued earlier rather than as a last resort. This marks a departure from the organization’s 2014 recommendations, which had suggested narrower testing methods now considered outdated given advancements in genomic technology.

"This is a milestone in pediatric medicine that validates what many healthcare professionals have recognized - that earlier access to comprehensive genetic testing leads to faster diagnoses and better outcomes for children," said Katherine Stueland, President and CEO of GeneDx. The company aims to reduce the average five-year "diagnostic odyssey" that many families currently endure.

GeneDx has sequenced more than 800,000 exomes and genomes and built one of the largest rare disease datasets. The company delivers standard results in as little as three weeks, with insurance coverage for testing expanding across commercial payors and Medicaid programs.

The company recently launched a brand campaign called "Diagnosis is Power" to educate clinicians and parents about the benefits of earlier genetic testing, aligning with the new AAP recommendations that could significantly expand the market for GeneDx’s testing services.

https://www.investing.com/news/stock-market-news/genedx-stock-soars-after-aap-recommends-genome-testing-as-firsttier-test-93CH-4106610

'NYC Mayor's Race Upended As Business-Unfriendly Former Rapper Socialist Tops Cuomo'

 A major poll before primary day in New York City shows Queens Assemblyman Zohran Mamdani pulling ahead of former Gov. Andrew Cuomo in the race to become the city's next mayor. 

According to Emerson College / Pix11 / The Hill, Mamdani - a socialist and former rapper who went by "Mr. Cardamom," has a 52% edge over Cuomo's 48% among early voters and likely voters. 

The survey allowed voters to rank up to five candidates in order of preference. The ranked-choice voting simulation over eight rounds ends with Mamdani at 52% and Cuomo at 48%. 

Over five months, Mamdani’s support has surged from 1% to 32%, while Cuomo finishes near where he began,” said Spencer Kimball, executive director of Emerson College Polling. “In the ranked-choice simulation, Mamdani gains 18 points compared to Cuomo’s 12, putting him ahead in the final round for the first time in an Emerson poll.”

Meanwhile Polymarket has then neck and neck...

As journalist Collin Rugg notes, Mamdani "is accused of voicing his love for leaders of a nonprofit convicted of funneling $12 million to Hamas."

"This is him saying he loves, that is his own words, he loves the Holy Land Five, who are convicted, funders of Hamas. It’s disgusting and despicable," said Cuomo - reacting to one of Mamdani's songs.

Billionaires to Bail?

As The Free Press noted last week, New York business owners plan to flee both the city and the state if Mamdani wins...

"We may consider closing our supermarkets and selling the business," said 76-year-old billionaire John Catsimatidis of Gristedes Supermarkets, adding "We have other businesses. Thank God, we have other businesses."

He also suggested that his real estate conglomerate - Red Apple Group, may move to New Jersey too.

"There’s the possibility we’d move our corporate offices to New Jersey. Why not?" he said. "Then you’d have four years of peace."

As The Free Press notes further;

Their fear isn’t just higher taxes or stricter regulations—it’s that a democratic socialist with a history of railing against Wall Street could bring an adversarial ethos into City Hall, targeting the very class that powers the city’s economy.

Bill Ackman, a billionaire hedge-fund manager, predicted that if Mamdani enters Gracie Mansion the exodus that began during Covid would spike again.

“This would absolutely be a tipping point for a lot of companies and individuals,” he said, adding that most of his peers would flee to the same place: Florida, where he said the wealthy are “welcomed as opposed to viewed as the enemy.”

He explained that business is a “confidence game,” and under a Mayor Mamdani, “You’re going to have a massive loss of confidence in doing business in New York.

https://www.zerohedge.com/political/nyc-mayors-race-upended-business-unfriendly-former-rapper-socialist-tops-cuomo

Evercore ISI downgrades Compass Pathways stock on durability concerns

  Evercore ISI downgraded Compass Pathways (NASDAQ:CMPS) stock rating to In Line from Outperform on Monday, while reducing its price target to $6.00 from $11.00. The stock, currently trading at $2.43, has shown significant volatility with a beta of 2.25. 

The research firm cited concerns about the durability of the company's treatment effects as a key reason for the downgrade. Evercore ISI noted that while recent data suggests Compass may have an approvable drug, the relatively unclear durability in Phase 2b trials and weaker effect at six weeks remain significant questions for commercial success. Despite these concerns,

Evercore ISI also pointed out that the effect size of Compass Pathways' treatment is lower compared to Spravato's monotherapy study, creating additional competitive challenges. The firm characterized the company's second Phase 3 trial as a "show me" story for investors amid what it described as an increasingly competitive landscape.

The downgrade comes despite Evercore's acknowledgment that Compass has "already taken some of the downside off the table with previous heavily dilutive financings." These earlier financial moves have provided some cushion against market reactions to clinical development challenges.

https://www.investing.com/news/analyst-ratings/evercore-isi-downgrades-compass-pathways-stock-on-durability-concerns-93CH-4106113

"America's Hive-Mind Is Aflame With Histrionic Hypotheticals Over Iran..."

 by James Howard Kunstler,

Boom

"In eight days, the United States and Israel eliminated Iran’s nuclear capabilities with minimal civilian casualties. One of the greatest military achievements ever." 

- Bill Ackman

Of course, you must expect a whole lot of deranged thinking after the USA’s Saturday night “Mother of All Bombs” (MOAB) attack on Iran’s three nuke sites — because derangement drives the spirit of our time in Western Civ. France, Germany, the UK, Sweden still can’t wrap their brains around the jihad they have fecklessly invited inside their countries — and they prosecute anyone who suggests as much.

Over here, the Oregon state legislature brought in drag-queens to entertain members in the chamber . . .California taxpayers subsidize the riots in LA . . . a federal judge orders Kilmar Abrego Garcia released from custody . . . AOC endorses a Muslim lunatic for mayor in New York. . . .

So it goes.

For all that, often the simplest explanation is the correct one. Of the MOAB attack on Iran, Secretary of State Rubio said, “They had all the pieces in place to have a nuclear weapon. . . now, not so much.” Mr. Rubio’s Sunday chat with Maria Bartiromo is well worth a listen for clarity. He also succinctly stated, “They [Iran] are the sole source of instability in the entire Middle East, and the world has been paying a price for this for forty-something years.”

Yet, the American hive-mind is aflame with histrionic hypotheticals over Iran, driven by the same prevailing anxiety that infects the illegal alien issue, lawfare, sexual insanity, our role in the Ukraine fiasco. The leitmotif lately is the popular idea that Israel controls the US like a puppeteer and that the Jews are out to rule the world. Yes, the shrill charge of “Zionism” boils down to that.

There is, necessarily, uncertainty about the result of our MOAB strikes. We will not be sending troops in to inspect Fordo, Natanz, and Isfahan. Iran had time, while jerking-around American diplomats, to move its stockpile of 60-percent enriched uranium (if that’s what it was). But they no longer have the facilities to do anything with it, or the top scientists to run the program, and if they attempt to restart all of that, the US will have the option to take them out again. So, you can stop the handwringing over that.

Another popular rumor in circulation is that the MOAB mission was a charade, just a show that Mr. Trump put on to satisfy his ego. That assumes everybody in the chain-of-command was duped, a low-percentage supposition. How is it unclear that the president is not messing around? The main message is “No nukes for Iran.” There was, apparently, some part of that simple proposition the mullahs did not understand. Perhaps the Iranian people understand that the mullahs are not fit to govern their country. It looks like we’ll find out soon enough.

Meanwhile propaganda-central keeps trying to steer the hive-mind back onto RussiaRussiaRussia, and onto Mr. Putin especially. CBS’s 60 Minutes re-worked an old segment last night on Putin opposition leader Alexei Navalny, who died in prison last year at 47 under curious circumstances. I doubt we know the whole story, and CBS surely did not try to present it. But the main purpose was to call Mr. Putin names — thief, murderer, tyrant — and the reason for that was also clear and simple: to derail Mr. Trump’s efforts to normalize relations with Russia.

That effort is a cornerstone of Mr. Trump’s campaign to re-arrange trade relations in such a way that our country can become productive again, employing its citizens in a purposeful way. It happens to imply an end to the Ukraine war, which the Obama State Department and the CIA set the groundwork for in 2014. Ending this war is not in the interest of a certain Beltway blob that thrives on creaming-off the weapons industry.

Their schemes require Russia to remain an enemy of the US, a wholly engineered idiocy that media outfits like CBS promote.

Viewed through a wider lens, the MOAB mission was also intended as a message to China. It is a simple and straightforward message: Expect that Mr. Trump means what he says when he says it. He is not messing around. China has been messing around with us to a stunning degree, especially during the past four years of the phantom president “Joe Biden.” China has infiltrated every critical corner of American life: our government, our universities, our medical research, our computer tech sector, our finances, Hollywood, our news media, our critical infrastructure, you name it.

China has been waging war on us in every way except troops and kinetics. Mr. Trump seeks to end all these operations, without coming to blows. That is, he is trying to find a path to what used to be quaintly called peaceful coexistence. If there’s a reason that the political Left in America can’t get behind that simple idea, it might be because the CCP is too deeply mixed up in Democratic Party politics. Their intentions intersect: to bring chaos to America.

Earlier today (Monday), Iran sent another salvo of missiles into Israel at civilian targets, and Israel answered with its own salvo aimed at Iran’s government offices in Teheran. Many expect some sort of retaliation by Iran against the US, either at our bases around the Middle East and Mediterranean, or here in the homeland.

[ZH: and sure enough they did fire missiles at US bases in Iraq and Qatar - with no injuries. Theater, much?]

You can’t doubt that Iran managed to sneak in many hundreds of capable saboteurs during the “Joe Biden” open border fiesta.

Why wouldn’t they seize the opportunity? (Or China, too.)

There’s also the usual talk about Iran shutting down the Straits of Hormuz, through which roughly 20-percent of the world’s oil supply passes — and much of that (up to 45-percent) goes directly to China, which does not have enough of its own oil to function. So, blocking Hormuz would mainly harm Iran’s fellow BRICs nations in Asia while it would deprive Iran of the oil revenue that represents most of its national income. In other words, a really stupid play.

Otherwise, the Trump government looks to exit its role in the Iran-Israeli war. The chief aim has been accomplished. No nukes. Iran’s usual henchmen, Hamas, Hezbollah, and the Houthis, are standing down for the moment, probably perceiving that Iran can no longer support, supply, or protect them. Israel is managing to do what it did in two earlier wars (despite doomish predications): prevail against its enemy. And rather quickly, too. Wouldn’t it amazing if the Middle East happened to become a little peaceful for a while?

https://www.zerohedge.com/geopolitical/americas-hive-mind-aflame-histrionic-hypotheticals-over-iran

Amgen Expands MariTide Development Plans After Weight-Loss Trial

 Amgen's weight-loss drug MariTide had a successful Phase 2 trial so the company is expanding development plans to study its use for heart disease and sleep apnea.

The drug demonstrated 20% average weight loss among people with obesity without Type 2 diabetes, and 17% among people with both obesity and Type 2 diabetes. Weight loss hadn't plateaued by 52 weeks, indicating patients could potentially lose more weight, Amgen said Monday.

MariTide also showed sustained reduction in hemoglobin A1c.

The trial results are informing a third phase of trials, which will last 72 weeks and will evaluate the safety, efficacy and tolerability of MariTide for overweight and obese patients with and without Type 2 diabetes.

Amgen also expects to start a Phase 3 study for atherosclerotic cardiovascular disease and heart failure, as well as a Phase 3 study for obstructive sleep apnea in 2025.

https://www.morningstar.com/news/dow-jones/202506236489/amgen-expands-maritide-development-plans-after-successful-weight-loss-trial

Kennedy, Oz Secure Industry Pledge to Fix Broken Prior Authorization System

 U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. and Centers for Medicare & Medicaid Services (CMS) Administrator Dr. Mehmet Oz today met with industry leaders to discuss their pledge

, links to an external website, opens in a new tab to streamline and improve the prior authorization processes for Medicare Advantage, Medicaid Managed Care, Health Insurance Marketplace® and commercial plans covering nearly eight out of 10 Americans.

In a roundtable discussion hosted by HHS, health insurers pledged six key reforms aimed at cutting red tape, accelerating care decisions, and enhancing transparency for patients and providers. Their commitments reinforce the role of CMS in monitoring outcomes and promoting accountability. Companies represented at the roundtable included Aetna, Inc., AHIP, Blue Cross Blue Shield Association, CareFirst BlueCross BlueShield, Centene Corporation, The Cigna Group, Elevance Health, GuideWell, Highmark Health, Humana, Inc., Kaiser Permanente, and UnitedHealthcare.

“Thank you to the insurance companies for making these commitments today. Americans shouldn’t have to negotiate with their insurer to get the care they need,” said Secretary Kennedy. “Pitting patients and their doctors against massive companies was not good for anyone. We are actively working with industry to make it easier to get prior authorization for common services such as diagnostic imaging, physical therapy, and outpatient surgery.”

“These commitments represent a step in the right direction toward restoring trust, easing burdens on providers, and helping patients receive timely, evidence-based care,” said Administrator Oz. “We applaud these voluntary actions by the private sector, which is how these types of issues should be solved. CMS will be evaluating progress and driving accountability toward our shared goals, as we continue to champion solutions that put patients first.”

Participating health insurers have pledged to:

  • Standardize electronic prior authorization submissions using Fast Healthcare Interoperability Resources (FHIR®)-based application programming interfaces.
  • Reduce the volume of medical services subject to prior authorization by January 1, 2026.
  • Honor existing authorizations during insurance transitions to ensure continuity of care.
  • Enhance transparency and communication around authorization decisions and appeals.
  • Expand real-time responses to minimize delays in care with real-time approvals for most requests by 2027.
  • Ensure medical professionals review all clinical denials.

Praise from members of Congress regarding today’s developments:

“It was an honor to attend this discussion with Secretary Kennedy and CMS Administrator Dr. Oz,” U.S. Senator Roger Marshall, M.D. (R-KS) said. “This is an important topic that has continued to be an issue for far too long. I applaud the leadership of Secretary Kennedy and President Trump for bringing us all to the table to find solutions for our patients and providers.”

“Thank you to President Trump, Secretary Kennedy, and Administrator Oz for working to improve the prior authorization process for American patients,” Congressman Greg Murphy, M.D. (R-NC) and co-chair of the House GOP Doctors Caucus, said. “As a physician for over 30 years, I witnessed the ridiculous and ever-increasing obstructions caused by insurance companies to delay or deny care to patients. These bureaucratic hurdles end up hurting patients and those who care for them. Practices have had to hire many more staff just simply to fight with insurance companies. I have made reform a top priority of mine since coming to Congress. I am grateful for the collaborative effort by stakeholders to make commitments to streamline approvals and look forward to them delivering on this pledge.”

These private sector reforms complement ongoing regulatory efforts by CMS to improve prior authorization interoperability within Medicare Advantage, Medicaid Managed Care, Health Insurance Marketplace®.

CMS encourages continued innovation and collaboration but reserves the right to pursue additional regulatory actions if necessary.

https://www.hhs.gov/press-room/kennedy-oz-cms-secure-healthcare-industry-pledge-to-fix-prior-authorization-system.html