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Tuesday, September 2, 2025

Vertex forges $2B-plus alliance with Enlaza to create new autoimmune drugs

 Vertex Pharmaceuticals is offering Enlaza Therapeutics more than $2 billion in biobucks through a multi-target drug discovery deal aiming to create new T-cell engagers and small-format drug conjugates.

Initially, Vertex is paying the California biotech $45 million, which includes an upfront payment and equity investment, according to a Sept. 2 release. In exchange, Vertex will work with Enlaza’s tech platform, dubbed War-Lock, which is designed to use synthetic biology in efforts to build potentially first-in-class covalent biologics.

The freshly linked pair is chasing new drugs to treat undisclosed autoimmune diseases and also to improve conditioning regimens for sickle cell disease and beta thalassemia. More gentle conditioning would benefit Vertex, which sells Casgevy, a CRISPR/Cas9 gene-edited therapy approved in both sickle cell disease and beta thalassemia.

Enlaza is expected to head up all research activities through development candidate nomination, according to the terms of the four-year pact. Vertex will then take the reins for all future R&D, manufacturing and commercialization of successful product candidates, according to the release.

Boston-based Vertex will bankroll all R&D efforts related to the pact. The biopharma is also offering Enlaza more than $2 billion in future milestone payments, plus royalties.

For Enlaza, the partnership represents a move into the autoimmune space. The company said it had several preclinical cancer candidates in 2024, when the biotech raised $100 million in series A money.

The biotech touts itself as the “first covalent biologics platform company,” with big-name backers such as J.P. Morgan Asset Management’s Private Capital life sciences group, Frazier Life Sciences, Amgen, Regeneron and Alexandria Venture Investments joining in on last year’s fundraise.

Enlaza’s War-Lock platform is designed to create “highly specific warheads” that covalently bind to drug targets, according to the biotech.  

For Vertex, the deal announcement shortly follows the termination of company efforts to follow up on its non-opioid pain reliever, Journavx (suzetrigine). The biopharma axed its investigational sodium channel inhibitor after the asset failed to outpace placebo at improving pain scores in a phase 2 trial.

The company also laid off 125 staffers this summer, a move tied to the cancelled development of Vertex’s VX-264, a “cells plus device” therapy prospect for type 1 diabetes. The approach involved creating insulin-producing cells and surgically implanting them into patients.

The biopharma abandoned VX-264 after the cell-device combo failed to improve a diabetes biomarker in a phase 1/2 trial. The discontinuation triggered an impairment charge of $379 million, according to a May earnings report.

The company is still continuing development for another islet cell therapy, which successfully reduced dangerously low blood sugar levels in a phase 1/2 test.

https://www.fiercebiotech.com/biotech/vertex-forges-2b-alliance-enlaza-create-new-autoimmune-drugs-improve-conditioning-methods

Cigna’s Evernorth invests $3.5B in ex-Walgreens specialty pharmacy

 

  • Cigna’s health services division Evernorth has invested $3.5 billion in Shields Health Solutions as the company continues to build out its lucrative specialty pharmacy business.

  • Shields, which helps hospitals and other providers create and manage their own specialty pharmacies, is one of five standalone businesses created from pharmacy behemoth Walgreens, which was acquired and chopped up by private equity firm Sycamore Partners last week.

  • Evernorth’s investment in the form of preferred stock does not give Evernorth a controlling stake in Shields and is not expected to materially impact Cigna’s earnings guidance for 2025. The deal does give the company the option to invest more in Shields in the future.


Specialty drugs are expensive prescription medicines for complex and chronic conditions that are only dispensed through specialized pharmacies like Shields. Less than 5% of the U.S. population takes specialty drugs, according to industry estimates, but the prescriptions account for more than 50% of total U.S. pharmacy spend.

Margins on specialty drugs can be equivalent to or lower than those of non-specialty medicines. But since their list price is significantly higher, specialty drugs can result in profits of hundreds or even thousands of dollars per prescription.

As such, specialty pharmacy is a major driver of revenue and profit for pharmacy benefit managers like Cigna’s Express Scripts — a business housed under its Evernorth division — and for their parent companies. On a recent earnings call, Cigna executives attributed higher-than-expected Evernorth earnings in part to strong momentum in its specialty and care services platform.

Similarly, Shields was one of Walgreens’ most lucrative business lines before the beleaguered retailer sold to Sycamore in a $10 billion deal that closed last week.

Shields brought in slightly below $700 million in revenue over the last twelve months, up from $212 million in 2021, according to estimates from J.P. Morgan analyst Lisa Gill. Moreover, the specialty pharmacy also boasts strong profit margins, with adjusted operating income estimated at more than $200 million for the 2024 fiscal year.

The numbers are fueled by rising demand for specialty drugs. Employers say the trend is a major driver of spiking healthcare costs as conditions like cancer become more prevalent, driving higher prescribing of complicated and expensive medications to treat them.

https://finance.yahoo.com/news/cigna-evernorth-invests-3-5b-084916317.html

US Pulls TSMC’s Waiver for China Shipments of Chip Supplies

 


The US has revoked Taiwan Semiconductor Manufacturing Co.’s authorization to freely ship essential gear to its main Chinese chipmaking base, potentially curtailing its production capabilities at that older-generation facility.

American officials recently informed TSMC of their decision to end the Taiwanese chipmaker’s so-called validated end user, or VEU, status for its Nanjing site. The action mirrors steps the US took to revoke VEU designations for China facilities owned by Samsung Electronics Co. and SK Hynix Inc. The waivers are set to expire in about four months.

https://www.bloomberg.com/news/articles/2025-09-02/us-pulls-tsmc-s-waiver-for-china-shipments-of-chip-supplies

Trump will announce Space Command is moving from Colorado to Alabama

 President Donald Trump’s administration will announce on Tuesday that U.S. Space Command will be located in Alabama, reversing a Biden-era decision to keep it at its temporary headquarters in Colorado, according to two people familiar with the announcement.

Trump is expected to speak Tuesday afternoon, and he will give the new location, according to the people, who spoke on the condition of anonymity to confirm the plans ahead of the official announcement. A Pentagon website set up to livestream the remarks describes the event as a “U.S. Space Command HQ Announcement.”

“The president will be making an exciting announcement related to the Department of Defense,” White House press secretary Karoline Leavitt said.

Space Command’s functions include conducting operations like enabling satellite-based navigation and troop communication and providing warning of missile launches.

In this photo released by the U.S. Air Force, Capt. Ryan Vickers stands for a photo to display his new service tapes after taking his oath of office to transfer from the U.S. Air Force to the U.S. Space Force at Al-Udeid Air Base, Qatar, Sept. 1, 2020. (Staff Sgt. Kayla White/U.S. Air Force via AP, File)

Alabama and Colorado have long battled to claim Space Command because it has significant implications for the local economy. The site also has been a political prize, with elected officials from both Alabama and Colorado asserting their state is the better location.

Huntsville, Alabama, nicknamed Rocket City, has long been home to the Army’s Redstone Arsenal and NASA’s Marshall Space Flight Center. The Army’s Space and Missile Defense Command is also located in Huntsville, which drew its nickname because of its role in building the first rockets for the U.S. space program.

The announcement caps a four-year back-and-forth on the location of Space Command.

The Air Force in 2021 identified Army Redstone Arsenal in Huntsville as the preferred location for the new U.S. Space Command. The city was picked after site visits to six states that compared factors such as infrastructure capacity, community support and costs to the Defense Department.

President Donald Trump steps off Air Force One after arriving at Huntsville International airport, Sept. 22, 2017, in Huntsville, Ala. President Donald Trump's administration says U.S. Space Command will be based in Alabama, reversing a Biden-era decision to keep it in Colorado. The announcement was made Wednesday. (AP Photo/Evan Vucci, File)

Then-President Joe Biden in 2023 announced Space Command would be permanently located in Colorado Springs, Colorado, which had been serving as its temporary headquarters. Biden’s Democratic administration said that keeping the command in Colorado Springs would avoid a disruption in readiness.

A review by the Defense Department inspector general was inconclusive and could not determine why Colorado was chosen over Alabama. Trump, a Republican who enjoys deep support in Alabama, had long been expected to move Space Command back to Alabama.

https://apnews.com/article/space-command-trump-alabama-colorado-96589ce26df5ddaf59e2fc856084a8ca

STAAR Surgical largest holder to oppose Alcon bid (STAA)

 STAAR Surgical (STAA) stock in focus as its biggest shareholder Broadwood Partners intends to vote against Alcon's $1.5B buyout 

https://seekingalpha.com/news/4491272-staar-surgical-largest-holder-oppose-alcon-bid

Solventum ups guidance after asset sale

 

  • Accelerates Solventum's business transformation to deliver long-term shareholder value
  • Net proceeds will be used primarily to pay down debt

 Solventum (NYSE: SOLV) today announced it has completed the sale of its Purification & Filtration business ("P&F") to Thermo Fisher Scientific Inc. (NYSE: TMO) ("Thermo Fisher") for $4.0 billion in cash before customary adjustments. 

"Completing the transaction is an important milestone in Solventum's three-phased transformation plan and positions us well to advance our capital allocation strategy as we reduce leverage and strengthen our balance sheet with enhanced flexibility to invest in organic and inorganic growth opportunities," said Bryan Hanson, chief executive officer of Solventum. "Looking ahead, we remain focused on strategic execution, ensuring we deliver even greater value to our customers, team members and investors."

As previously announced, Solventum will use the net proceeds from the sale of $3.4 billion primarily to pay down outstanding debt.

Updated Full-Year 2025 Guidance
Solventum is updating its full year 2025 guidance to reflect the partial year accretion of the accelerated P&F divestiture.

  • Organic sales growth in the range +2.0% to +3.0% (+2.5% to +3.5% excluding ~50 bps of SKU exit impact); no change
  • Increased adjusted EPS range to $5.88 to $6.03 from prior range of $5.80 to $5.95
  • Free cash flow in the range of $450 million to $550 million; no change

Updated additional financial considerations

  • Expect net interest expense of $400 million, from prior estimate of $450 million
  • Expect operating margin to be toward the high-end 20% to 21% range for full year 2025

Solventum's updated full year 2025 guidance reflects the expected reduction of net interest expense, which will more than offset the financial impact of the divestiture of the P&F business and is subject to the timely completion of the recently announced tender offers.

Following the transaction close, Solventum will provide transitional services and perform certain manufacturing and distribution activities on behalf of Thermo Fisher.

https://www.prnewswire.com/news-releases/solventum-completes-sale-of-its-purification--filtration-business-to-thermo-fisher-scientific-inc-302543458.html

The Secret Sauce of High Reliability and Success

 

I hope you had a good Labor Day weekend. Now, it’s back to work. Time to buckle down for the last part of the year, right?

Along these lines, I recently visited a defense plant. It occupies an important place in the scheme of America’s national security, and I had to sign a nondisclosure agreement (NDA) just to drive up to the front gate and park in the parking lot, let alone go inside and have a tour. There’s an investment angle here, but it’ll take time to unfold.

For now, though, I want to discuss a few takeaway thoughts, even though I can’t give away any details of this particular visit.

High Reliability Organization

First, ask yourself… Would you board an airliner if you thought that there was a chance you’d crash? Umm… no, I don’t think so.

Let’s consider some pertinent numbers with respect to airline travel. According to the Federal Aviation Administration, in 2024 the U.S. air system logged over 16.4 million flights. That’s almost 45,000 flights per day. And the average daily passenger load was about 2.34 million flyers.

Think about that, about what makes it all work. It’s a lot of skilled people, functional airplanes, airports, itineraries, flight tracking, baggage handling, fuel, tires, food concession courts, trash hauling, floor cleaning and much more.

Meanwhile, we’re truly blessed and fortunate not to hear much about airline accidents, let alone a major crash. Yes, bad things happen every now and then, but they’re rare and that’s the point when you consider such massive numbers.

Or let’s look at the numbers for another challenging procedure, heart surgery. According to the American Heart Association, the U.S. medical system performs about 1.1 million cardiac procedures every year, or just over 3,000 per day.

The vast majority of procedures are successful in prolonging life, and those that fail are usually due to morbidity factors that were present before the patient rolled into the operating room. Overall, in this field we see very few raw screwups or mistakes; again, yes they sometimes occur but are rare.

And once more, think about what it takes to accomplish so much successful heart surgery. The U.S. medical system is filled with skilled people, functioning hospitals, all manner of astonishing equipment, medical supplies and much more.

Sure, you might not like it when the doctor says that you need heart surgery, whether it’s planned ahead of time, or perhaps after a sudden trip to the emergency room in an ambulance; but you’re grateful that there’s a medical system to deliver the goods and keep you going. And yes, the U.S. spends a lot of money on the medical side, but at least it’s there.

I could offer other examples besides the airline system or heart surgery, but my focus here is on the idea of “high reliability” organizations.

Some Thing Just Cannot Fail

That is, some things require an environment where everyone, from top managers to people on the figurative (or literal) factory floor, must be totally preoccupied with avoiding failure, or even the possibility of failure due to the smallest imperfection. Think about pilots and mechanics who pre-flight an airplane. Or the operating room staff who count every item of equipment that moves toward a patient and then recount everything on the way out.

This takes a certain kind of personality because it always boils down to dedicated people who make these difficult things work. But there’s an institutional angle as well. That is, every high reliability organization must have a culture that emphasizes what’s at stake in the end product. No detail is too small, and simplification is not necessarily a virtue. While cutting corners or what’s called “quality fade” over time is entirely unacceptable.

In high reliability endeavors, everything must work down to the tightest specification. To use a Navy analogy, there can be no leaks on a submarine, right? This demands a work environment of super-high standards, rigorous training, constant attention to detail, continuous learning, and deference to technical expertise if not to the laws of math, physics and chemistry.

Over the years, I’ve visited many different sites that are high reliability facilities. Consider, say, an oil refinery where the air contains combustible hydrocarbons, and pipelines are filled with high pressure gases and steam. It would be relatively easy for someone to screw up, cause an explosion and everybody dies; so at every level the process strives to screen out those unsafe people.

And I’ve been aboard deepwater drill-ships, holding position within a meter or two of a spot on the ocean, in surging seas, and with a massive derrick dangling a mile or more of risers and drill pipe above a hole in the ocean floor that may go down to two miles below seabed. Indeed, I was the last “civilian,” one might say, to visit a drilling project in the Gulf of (then) Mexico before the BP Macondo well blowout in 2010. Macondo definitely illustrated how bad things can get.

Or consider the defense plant that I recently visited. The company builds devices and systems that require high tolerances for use in entirely intolerant environments; think deep underwater, if not outer space. And with the distinct possibility of somebody else trying to destroy you with their own systems and electronics.

Inside the equipment that the company builds, electronic products work at the speed of light; well, at the speed of electrons in copper. And at the kinetic end of things, think in terms of missiles that fly at supersonic speeds, nearly hypersonic; and more if they’re in earth orbit.

Building and fielding things like this requires a certain kind of approach to doing everything not just “right,” but totally perfect down to the last step of execution. And let’s use a missile as an example. Begin with all the energy contained within such a device: the fuel, batteries, explosives, fast-moving parts and more.

And consider how most missiles are not assembled for rapid use but are instead put together with the intent to store them. The nickname for these articles is “wooden rounds,” meaning that they will sit in a land-based warehouse, or in a ship’s weapon magazine, for many weeks or months. But when it’s time to shoot? These things must ignite, move, accelerate, steer, maneuver, perform and function flawlessly, and in an environment of high speed, energy transients, shock, high vibration and more.

Companies that make high reliability products, or deliver such services, tend to exhibit a crisp, no-nonsense approach to getting things done. The best companies show off their technical style even in the quarterly earnings reports. That is, when you look at the numbers a company reports to Wall Street you see clean, polished facts.

Allow me to mix a military metaphor here: with the financial statements as with the missiles, there’s nothing sticking out to corrupt the laminar flow. There’s nothing in the slipstream, disrupting boundary layers and creating turbulence.

Distilled to an essence, you want to see a company or organization that’s all about designing and delivering high-performance, high-reliability products. And that’s a tough business, where it’s hard to meet the specs all day, every day. Then again, that’s the challenge.

Wrap-Up

Okay, enough musing… And again, it’s the day after Labor Day weekend. Time to get back to work. Shake off the summer cobwebs, buckle down and get rolling into the rest of the year.

We have challenges ahead, and everywhere. Stay healthy and look after yourself and your family. Work hard at your job or at least play the game right and make some money. Deal with the world as it is, not as you wish it might be. Stay ahead of events, and if you have to hit the “sell” button, make sure you do it too soon versus too late.

Byron King is a Senior Geologist at Rickards' Gold Speculator. He is a Harvard-trained geologist who has traveled to every U.S. state and territory and six of the seven continents. He has been interviewed by dozens of major print and broadcast media outlets including The Financial TimesThe GuardianThe Washington PostMSN MoneyMarketWatchFox Business News, and PBS Newshour.

https://dailyreckoning.com/the-secret-sauce-of-high-reliability-and-success/