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Wednesday, November 6, 2024

Novo Nordisk Affirms 25% Weight-loss Expectation for Experimental Drug CagriSema

 Novo Nordisk said the side effects in trials so far for its experimental obesity drug CagriSema were similar to its GLP-1 drugs already on the market, and reiterated its expectation the new injection will deliver 25% weight loss.

Martin Holst Lange, Novo Nordisk's head of development, made the comments to Reuters after the company released better-than-expected third-quarter results.

The Danish drugmaker is due to release data from a late-stage trial of CagriSema, a two-drug combination obesity treatment that, like its popular obesity drug Wegovy, is injected, by the end of 2024.

CagriSema targets the same gut hormone as Wegovy does, but also targets a pancreas hormone called amylin.

Novo Nordisk has previously said that CagriSema has a potential of up to 25% weight loss, compared with the 15% weight loss of Wegovy.

Lange said on Wednesday the company still expects the data from its Phase 3 trial to reflect this higher weight loss.

"No change in our confidence level," he said.

Analysts view this data as "a must-win" for Novo's obesity-driven investment case, given the hot competition among pharma companies to deliver higher weight loss than Wegovy and Zepbound, the rival obesity injection that U.S. company Eli Lilly launched last year.

Novo's share price could go up to 20% higher or lower depending on it, predict ABG Sundal Collier analysts.

Lange said that Novo needed to collect more data on the psychiatric side effects of another experimental obesity treatment, monlunabant, in a Phase 2b trial before it could progress to a Phase 3 or late-stage trial.

The company's shares fell nearly 5% in September after results from a Phase 2a trial of monlunabant, a pill, came in below market expectations. Novo acquired the drug last year as part of its $1 billion purchase of Canadian biotech firm Inversago Pharmaceuticals.

Novo had already planned to conduct a Phase 2b trial even before it got the data from the latest trial, Lange said, but the Phase 2a trial did reveal new psychiatric side effects and suggests that perhaps excessively high dose strengths were tested. The new trial will involve a lower-dose strength, he said.

Monlunabant is a cannabinoid or CB1 receptor blocker. Although it has a similar effect as the GLP-1 drugs already on the market, it has a different mechanism of action.

https://www.medscape.com/s/viewarticle/novo-nordisk-affirms-25-weight-loss-expectation-experimental-2024a1000k98

US Air Force Explores Strategic Overhaul In Pacific To Counter Rising China Challenge

 by Stephen Xia and Sean Tseng via The Epoch Times (emphasis ours),

The U.S. Air Force is considering revamping its operations in the Pacific to address increasing challenges from communist China. Rather than focusing solely on expensive fighter jets, it is shifting toward cost-effective technologies such as drones and hypersonic missiles and adopting dispersed operational tactics to maintain an advantage.

F-35A Lightning II aircraft assigned to the 4th Fighter Squadron, Hill Air Force Base, Utah, arrive at Kadena Air Base, Japan, on Nov. 20, 2023. U.S. Air Force photo by Staff Sgt. Jessi Roth

A recent report from the U.S. Air Force’s China Aerospace Studies Institute highlights the need to update equipment priorities to counter China’s military expansion. Lessons from the Russia–Ukraine war have shown that modern conflicts consume resources rapidly, making reliance on a limited number of costly weapons impractical. To prepare for prolonged engagements, developing advanced yet affordable weapons is crucial.

Long-range precision strikes and the use of drones have emerged as game-changers, allowing forces to remain effective while avoiding heavy enemy fire. Dispersed operational tactics have also proven advantageous, helping forces preserve strength and counterattack effectively. With these insights, the U.S. Air Force is preparing for potential conflicts in the Indo-Pacific, which could be more extensive and intense than the Russia–Ukraine war.

China seeks to alter the global power balance and push U.S. forces out of the Indo-Pacific using anti-access/area-denial (A2/AD) strategies. These involve the use of missiles, aircraft, and naval defenses to block access, making it costly or difficult for opponents to access contested regions.

To counter this, the Air Force think tank recommends focusing on inexpensive, easily replaceable weapons capable of penetrating defenses, such as low-cost drones and hypersonic missiles. While advanced aircraft such as the B-21 bomber and next-generation fighter jets remain important, there is increasing emphasis on survivable, high-tech weapons and expendable platforms.

Air Base Defense

A significant concern is the vulnerability of U.S. air bases in the region, particularly in Japan, which Chinese missiles, drones, and hypersonic weapons could target. The Department of Defense (DOD) noted in its 2023 China Military Power Report that the People’s Liberation Army has consistently expanded its long- and mid-range ballistic missile capacity, enabling it to target critical U.S. military installations throughout the Indo-Pacific, including key bases on Guam.

Additionally, the DOD estimates that as of May 2023, Beijing possessed more than 500 operational nuclear warheads, with numbers growing. Given China’s expanding missile capabilities, strengthening base defenses alone is insufficient. Therefore, the United States is adopting a new strategy: spreading out deployments to reduce risk.

The U.S. military is repositioning its forces across multiple locations to reduce the risk of being targeted. This strategy involves identifying, upgrading, and restoring airfields throughout the Pacific, including old World War II sites, under an initiative known as Agile Combat Employment. This includes redeveloping airfields like the one on Tinian, a small island near Guam that was a strategic location during World War II.

The airfields in Tinian are being expanded for the first time in decades. By positioning aircraft across a range of bases—including allied bases, remote islands, and civilian runways—the Air Force aims to increase flexibility and survivability.

Michael P. Winkler, the Pacific Air Force’s deputy director for air and cyberspace operations, emphasized the need to avoid putting all aircraft in one place to prevent creating a “big, juicy target” for adversaries. This strategy requires access to more airfields during crises, necessitating coordination with regional allies like Japan and the Philippines.

Operational Resiliency

Securing access agreements with regional allies is crucial, as they are in a position to offer numerous military and civilian runways, although not all meet the Air Force’s requirements. U.S. pilots are visiting potential locations like Basa Air Base in the Philippines and airfields in Tinian, Guam, Saipan, and Palau to familiarize themselves and prepare for future operations. Upgrades are underway at several sites to enhance facilities and train personnel.

While the Second Island Chain, which includes some U.S.-controlled areas, is easier to access and upgrade, the First Island Chain is strategically more important due to its proximity to China. This chain includes Japan, the Philippines, and Taiwan. Operating there requires cooperation with regional partners, whose political situations can be unpredictable. Despite these challenges, the United States currently maintains strong partnerships in the region.

Recent military exercises have tested this dispersed approach. In February, U.S. and allied aircraft operated from multiple airfields on Guam, Saipan, and Tinian. During the U.S.-led Valiant Shield exercises in June, U.S. fighter jets used Japan’s Matsushima and Hachinohe bases for the first time. Under the U.S.–Japan alliance agreement, Japanese bases can serve as evacuation sites for U.S. aircraft in emergencies.

However, spreading out forces presents challenges, particularly in logistics. In a conflict, the United States must deliver equipment, spare parts, fuel, munitions, and support personnel to scattered and potentially contested locations or pre-position supplies there. This is complex, and the strategy’s effectiveness depends on reliable support. The Air Force must balance the benefits of dispersion with logistical practicalities.

On a similar note, Stacie Pettyjohn, a senior fellow at the Center for a New American Security, a Washington-based think tank, said operating from more locations with smaller units reduces the chance of a successful large-scale attack by the Chinese regime, adding a layer of deterrence.

This strategic shift reflects a broader recognition that the nature of warfare is changing. The Air Force is adapting by embracing new technologies and tactics, prioritizing flexibility, resilience, and cost-effectiveness. By dispersing forces and investing in advanced yet affordable weapons, the Air Force aims to maintain its edge in a rapidly evolving security environment.

https://www.zerohedge.com/political/us-air-force-explores-strategic-overhaul-pacific-counter-rising-china-challenge

Guardant Health ups revenue guidance after Q3

 Revenue growth of 34% driven by strong clinical and biopharma volume and Guardant360 ASP tailwinds

Shield received favorable Medicare pricing of $920

2024 Guidance

Guardant Health now expects full year 2024 revenue to be in the range of $720 to $725 million, representing growth of 28% to 29% compared to full year 2023. This compares to the prior range of $690 to $700 million, representing growth of 22% to 24%. Guardant Health continues to expect full year 2024 non-GAAP gross margin excluding screening to be in the range of 61% to 63% and total non-GAAP operating expenses to be in the range of $720 to $730 million, representing a flat to 1% decrease compared to 2023. Guardant Health now expects free cash flow to be in the range of $(265) to $(275) million in 2024, representing an improvement of $70 million to $80 million compared to 2023.

Webcast Information

Guardant Health will host a conference call to discuss the third quarter 2024 financial results after market close on Wednesday, November 6, 2024 at 1:30 pm Pacific Time / 4:30 pm Eastern Time. A webcast of the conference call can be accessed at http://investors.guardanthealth.com. The webcast will be archived and available for replay for at least 90 days after the event.

https://www.businesswire.com/news/home/20241106173129/en/

NovaBay Pharmaceuticals Accepts Revised Offer

 NovaBay® Pharmaceuticals, Inc. (NYSE American: NBY) ("NovaBay" or the "Company") today announces that the Company has accepted a revised transaction proposal from PRN Physician Recommended Nutriceuticals, LLC ("PRN") to increase the base purchase price for the Company’s eyecare business from $9.5 million to $11.5 million. The Company has entered into an amendment (the "Amendment") to its previously announced Asset Purchase Agreement, dated September 19, 2024, with PRN (the "Original PRN APA" and, as amended, the "PRN APA"). The Company's transaction with PRN remains subject to certain closing conditions, including receiving stockholder approval.

"We are pleased to accept PRN’s revised offer for the Avenova® brand and continue our efforts to obtain stockholder approval. With the newly added value, we truly believe this deal is in the best interests of our stockholders," said Justin Hall, NovaBay CEO.

In addition to the increased base purchase price of $11.5 million, the Amendment provides for (i) the removal of debt financing contingencies and related PRN representations, while adding a new PRN representation that it has sufficient funding for the base purchase price; (ii) PRN providing the Company with a secured promissory note for up to $1.0 million to be funded by two future installments of $0.5 million each, which loan is expected to be repaid in full upon the closing of the PRN transaction as a deduction from the purchase price (the "Bridge Loan"); and (iii) PRN providing the Company with an equity funding commitment letter (collectively, the "Revised PRN Transaction Terms").


https://finance.yahoo.com/news/novabay-pharmaceuticals-accepts-revised-offer-210500782.html

Tandem Diabetes ups sales guidance after Q3

 Third Quarter 2024 Highlights

  • Worldwide GAAP sales increased 31 percent to $244.0 million compared to third quarter 2023; worldwide non-GAAP sales(1) increased 25 percent to $242.9 million compared to third quarter 2023.
  • Grew worldwide pump shipments by more than 25 percent compared to third quarter 2023.
  • Achieved year-over-year growth in new pump starts in the United States, including growth in new customers starting from multiple daily injections.
  • Demonstrated positive Adjusted EBITDA and a return to positive free cash flow.
  • Completed clinical study in support of a regulatory filing to expand the indication for Control-IQ to include people living with type 2 diabetes.

“The third quarter marked a milestone achievement for Tandem Diabetes Care as we delivered the highest quarterly sales in our Company’s history, both in the U.S. and internationally,” said John Sheridan, president and chief executive officer. “This performance, coupled with our strong operational execution, positions us well to achieve our remaining goals for 2024 and beyond, as we further our mission to improve the lives of people with diabetes.”

2024 Financial Guidance

The Company’s non-GAAP guidance for the fiscal year ending December 31, 2024 is set forth below. The most directly comparable GAAP financial measures are not accessible on a forward-looking basis due to the high degree of complexity in the accounting treatment for the Tandem Choice program. For a description of non-GAAP sales, non-GAAP gross margin, and Adjusted EBITDA margin, as well as an illustration of the reconciliation from the most directly comparable GAAP financial measures, refer to Table D “Reconciliation of GAAP versus Non-GAAP Financial Results” attached to this press release. Also see “Non-GAAP Financial Measures” below for additional information.

For the year ending December 31, 2024, the Company is increasing 2024 sales guidance and reaffirming other financial guidance as follows:

  • Non-GAAP sales are estimated to be approximately $903 million to $910 million for the full year.
    • Sales in the United States of $645 million to $650 million.
    • Sales outside the United States of approximately $258 million to $260 million.
  • Non-GAAP gross margin is estimated to be approximately 51 percent.
  • Adjusted EBITDA margin is estimated to be breakeven as a percent of sales.
  • Non-cash charges included in cost of goods sold and operating expenses are estimated to be approximately $120 million. This includes:
    • Approximately $100 million non-cash, stock-based compensation expense.
    • Approximately $20 million depreciation and amortization expense.

Conference Call

The Company will hold a conference call and simultaneous webcast today at 4:30pm Eastern Time (1:30pm Pacific Time). The link to the webcast will be available by accessing the Events & Presentations tab in the Investor Center of the Tandem Diabetes Care website at http://investor.tandemdiabetes.com, and will be archived for 30 days. To access the call by phone, please use this link (https://register.vevent.com/register/BI21747dfdc3fd4a4e98aeeeef73bf87b6) and you will be provided with dial-in details, including a personal pin.

https://www.businesswire.com/news/home/20241106987558/en/

How The Democrats And Media Finally Went Too Far

 by Frank Meile via RealClearPolitics.com,

The reelection of Donald Trump represents, if not the single greatest comeback in political history, certainly the largest middle finger ever shown to the smug, self-centered, superior-minded elitists who think the rest of us are garbage.

Of course, we didn’t need President Biden to call us “garbage” for everyday Americans to know that what we care about means nothing to the establishment. But Biden obliged anyway, and put an exclamation point to the final sorry week of Kamala Harris’ galling campaign.

You just can’t get any worse than “garbage” – or can you? Isn’t Nazi worse? After all, the Nazis killed 17 million people. If you include all the victims of fascism, you can get that number up to 20 million. But for some reason, the legacy media didn’t care when Harris and her surrogates repeatedly called Trump and his supporters Nazis or fascists.

You almost get the feeling that the left-leaning press despises Republicans as much as Biden, Harris, and the rest of the Democrats do. If you had any doubt, the totally bogus claim that Trump said he wanted to execute Liz Cheney was the last straw. He was making a perfectly valid argument that the former congresswoman would be less inclined to support wars if she had to fight in them. But apparently that was too sophisticated an attack for the news professionals who decided to lie about it. Instead, they maliciously claimed that Trump literally wanted to put Cheney in front of a firing squad.

Overall, the past three weeks have been instructive in just how little the nation’s elites in the media and politics respect average citizens, and just how much they think they can manipulate us into believing their lies.

It’s nothing new, but the latest iteration started on Oct. 13 when Kamala Harris began peddling the “enemy within” hoax, which would have voters believe that Trump had said he planned to use the military against his political opponents.

In fact, that never happened. Fox News host Maria Bartiromo interviewed Trump and said that Joe Biden doesn’t expect a peaceful Election Day. She asked Trump if he was expecting chaos that day, but she specifically asked about the impact of outside agitators, bringing up the case of an Afghan who was charged with a terror plot, and also mentioning Chinese nationals and criminals who had crossed the border illegally.

It was in this context that Trump said he wasn’t worried about outside agitators, but rather “the enemy from within,” meaning American citizens who might riot following the election, just as happened in 2016. He continued:

I think the bigger problem are the people from within. We have some very bad people. We have some sick people, radical left lunatics, and … it should be very easily handled by, if necessary, by the National Guard, or if really necessary by the military, because they can’t let that happen.

This turned into the closing argument of the Harris campaign, claiming that Trump had promised to unleash the military on his political opponents. It was yet another hoax by Democrats and the media, which is either incredibly stupid or incredibly dishonest. CNN’s headline was typical: “Trump suggests using military against ‘enemy from within’ on Election Day.”

Notice that Trump didn’t “suggest” using the military; he said that chaos could be averted “if necessary” by the National Guard or “if really necessary” by the military. He never suggested this was his plan.

The most obvious part of the lies told by CNN, Harris, and all the Democratic Party machinery was that Trump could do anything, anything at all, about Election Day violence. NOTE TO CNN: On Election Day, Joe Biden will be the president, not Donald Trump. In saying that “they can’t let that happen,” Trump was actually crediting Biden with the common sense not to let violence disrupt our most sacred democratic ritual of voting.

Yet for more than a week, Harris and her allies peddled this nonsense to convince voters that Trump is “unhinged, unstable and unchecked.”

Then, almost as though on cue, just over one week later on Oct. 22, Atlantic magazine editor Jeffrey Goldberg wrote a scandalous article that quoted anonymous sources as saying Trump had insulted the family of Vanessa Guillén, a Mexican-American soldier who was murdered in Texas. The article included a quote from Guillén’s sister praising President Trump for his kindness to the family, but Goldberg essentially pretended the quote didn’t exist. Instead he smeared Trump as a heartless exploiter.

Later in the same article, Goldberg quoted Gen. John Kelly, Trump’s disgruntled former White House chief of staff, as saying Trump had told him, “I need the kind of generals that Hitler had.”

This dubious old quote was dusted off and included in the article for only one reason – to give Kamala Harris and the Democrats and the talking heads on CNN and MSNBC more fodder for their “Trump is a fascist” narrative. Lots of White House staffers were ready to deny the Kelly story, but that didn’t matter to Goldberg. Let ’er rip.

And as further evidence of media collusion with the Harris campaign, the New York Times on the same day, Oct. 22, revealed an interview with Gen. Kelly in which he said that Trump “falls into the general definition of fascist” and “certainly prefers the dictator approach to government.”

This double whammy of remarks by Kelly gave Harris permission to expand her attack on Trump as a fascist, and it quickly became apparent that her campaign was going to replace “joy” with “fear” as the closing argument.

The media ran with this as a willing partner in the attempt to keep Trump out of the White House. And even before Trump held a historic rally at Madison Square Garden on Oct. 27, many news outlets drew bizarre comparisons to a 1939 pro-Nazi rally held by the German American Bund in an earlier iteration of the world-famous arena. Yes, that 1939 rally was an offensive anti-American gathering, but it had nothing to do with Trump’s rally in a different building 85 years later.

Moreover, the Fake News historians somehow missed the fact that in 1933, shortly after Adolf Hitler was named chancellor of Germany, the American Jewish Congress held a National Day of Protest in the same venue. The National Park Service, in its history of Madison Square Garden, writes that “After a day of fasting and prayer, more than 55,000 people flooded MSG III and the streets surrounding it for the largest rally. Jewish leaders, union presidents, politicians, and Christian clergy addressed the crowd. They denounced the Nazis and compared the persecution of European Jews to the terror of the Ku Klux Klan.”

The media somehow also missed the fact that there were Israeli flags and Orthodox Jews at Trump’s rally, along with two former Democratic presidential candidates, the richest man in America, a black congressman, and a variety of Jewish advisers. All that mattered in the long run was that rally organizers had invited an obscure insult comedian named Tony Hinchcliffe to open the show. Turned out Hinchcliffe lived up to his title and insulted a variety of people and ethnic groups, including Puerto Ricans.

“I don’t know if you guys know this, but there’s literally a floating island of garbage in the middle of the ocean right now. I think it’s called Puerto Rico,” he joked.

The media went nuts, claiming that Trump was racist because the comedian had insulted Puerto Rico. But that never made any sense.

Yes, it was an uncomfortable joke, one that seemed inappropriate in the middle of a political campaign where former President Trump has been working hard to build up his share of the Hispanic vote. But it was a joke, and though most in the audience had no idea, it wasn’t a random insult, but a topical one. 

Puerto Rico has a trash problem  thanks to a variety of causes, and it’s something a future president of the United States should help to resolve.

But the current president can’t be bothered. Instead of using the tasteless joke to bring attention to the plight of our fellow citizens in Puerto Rico, President Biden deflected attention away from the island and provocatively said “The only garbage I see floating out there is his [Trump’s] supporters.”

Which brings us full circle to the disastrous last week of the Harris campaign. As she lectured her would-be constituents during a speech on the Ellipse in D.C., preaching peace, brotherhood, and unity, her boss Joe Biden was in the White House behind her, telling a Zoom call that Trump supporters are “garbage.” You can’t make this stuff up.

The Democratic Party has been unmasked once again as the party of hypocrisy, insincerity, and smugness. Just as in 2016 when the MAGA base embraced Hillary Clinton’s description of them as “deplorables,” so too did the Trump faithful now begin to greet each other as pieces of garbage. When Trump descended from his jet in Green Bay and entered a garbage truck wearing a sanitation worker’s orange vest, he closed the deal with millions of voters who are tired of being ignored.

Don’t ever underestimate how much the establishment hates Donald Trump, but also, don’t ever underestimate how much everyday Americans hate the establishment. End of story.

*  *  *

Frank Miele, the retired editor of the Daily Inter Lake in Kalispell, Mont., is a columnist for RealClearPolitics. His book “The Media Matrix: What If Everything You Know Is Fake” is available from his Amazon author page. Visit him at HeartlandDiaryUSA.com or follow him on Facebook @HeartlandDiaryUSA and on X/Gettr @HeartlandDiary.

https://www.zerohedge.com/political/how-democrats-and-media-finally-went-too-far

QIAGEN delivers solid Q3 2024 growth ahead of outlook, ups full-year 2024 adjusted EPS outlook

 QIAGEN reported strong Q3 2024 results with net sales of $502 million, representing a 5% increase at actual rates and 6% at constant exchange rates (CER), exceeding the outlook of $495 million CER. The company achieved a 29.6% adjusted operating income margin, up 3 percentage points from Q3 2023. Free cash flow increased 73% to $364 million in the first nine months of 2024. Based on solid performance, QIAGEN reaffirmed its FY 2024 net sales outlook of at least $1.985 billion CER and increased its adjusted diluted EPS outlook to at least $2.19 CER from the previous $2.10 CER.

https://www.stocktitan.net/news/QGEN/qiagen-delivers-solid-q3-2024-growth-ahead-of-outlook-increases-full-0kwvhkeswguj.html