FT : EU warned new medical trial rules will slow approval of vital treatments

EU warned new medical trial rules will slow approval of vital treatments
Pharma groups and patients say guidance prioritising mass trials threaten development of drugs for rare diseases

New EU rules threaten to cut the number of new treatments for the rarest diseases because of stricter curbs on medical trials, warn pharmaceutical companies, researchers and patient groups.

Almost 40 groups, including Cancer Patients Europe, the European Association of Urology and World Federation of Hemophilia, have called on Brussels to revise the rules — which give less weight to so-called single-arm trials, where one group of patients do not receive the treatment — before they come into force in January.

They said guidelines issued by EU regulators would make it much harder to get approval for drugs for rare diseases, which only have a handful of patients, by prioritising expensive mass trials. One example is Wiskott-Aldrich syndrome, which causes recurrent infections, bleeding, eczema and an increased risk of developing autoimmune diseases and cancer.

The Alliance for Regenerative Medicine, an advocacy organisation for the cell and gene therapy sector, said randomised control trials, which often require a group of patients to receive a dummy therapy, were too expensive and unethical, as giving an ineffective placebo to a person with such a severe illness would cause unnecessary suffering.

“In rare diseases, single-arm trials are often necessary for ethical, practical and scientific reasons,” said Paolo Morgese, ARM’s Europe vice-president of public affairs.

“The joint clinical assessment guidelines largely ignore this reality and miss a huge opportunity to build a modern EU system. Without changes, the current approach will undermine the EU’s goal to get transformative therapies to patients faster and could prevent access in many EU member states.”

The guidelines were introduced as interest grows in innovative but expensive new cell and gene therapies that treat cancer and rare diseases. According to data provider IQVIA, 76 cell and gene therapies had been launched globally by the end of 2023, double the number a decade earlier.

ARM analysis found that about 80 per cent of approved and available advanced therapies in the EU use single-arm studies that dispense with the control group. By contrast, randomised control trials are considered the most rigorous method of clinical research and involve comparing new treatments with the current standard of care, or a placebo where no standard treatment exists. Researchers often conduct “blind” trials where participants do not know which drug they are receiving.

In an effort to beat the new rules, Fondazione Telethon, an Italian charity, said it was trying to secure authorisation for its experimental treatment for Wiskott-Aldrich syndrome before January.

Stefano Benvenuti, head of public affairs, told the Financial Times that it could not conduct randomised control trials since the condition only affects four in 1mn men. Women who carry the faulty gene are unaffected. A bone-marrow transplant can cure the condition. 

Telethon’s Milan facility is the only location licensed to host the experimental treatment. Benvenuti said he was worried that even if Italy approved it, other countries would not send patients because the guidelines risk “an inconclusive evaluation” for single-arm trials.

Regulators hope the rules, adopted by the European Commission in May, will allow countries to authorise medicines more quickly as countries work together on joint clinical assessments.

“This will help them to decide about its use in the national health system . . . and thus take more effective, timely decisions when bringing medicines to the market,” the commission said at the time.

The new EU guidelines do not rule out single-arm trials and each member state will makes its own decisions based on JCA reports.  

This Regulation on Health Technology Assessment applies to cancer and advanced therapeutics from January 12, and all medicines from 2030. 

Benvenuti said the rules were positive but their implementation guidelines were too restrictive. “The way the guidelines are written right now it is scary,” he said. “In continental Europe we love regulation so much [but] they didn’t consider the peculiarity of some of these advanced therapies.”

He added that many pharma companies had abandoned treatments for rare diseases because it is hard to get a return on investment with so few patients. In 2016 Telethon developed the first treatment for “bubble boy disease”, the autoimmune disease that requires sufferers to live in a sterile environment. 

Its Strimvelis gene therapy, which costs €600,000, has treated 45 patients with adenosine deaminase severe combined immunodeficiency in more than 20 countries.

FT : Russian navy trained to target sites inside Europe with nuclear-capable mis

Russian navy trained to target sites inside Europe with nuclear-capable missiles
Secret presentation for officers reveals plans for overwhelming strikes in early stages of potential war against Nato

Russia has trained its navy to target sites deep inside Europe with nuclear-capable missiles in a potential conflict with Nato, according to secret files seen by the Financial Times.

Maps of targets as far-flung as the west coast of France and Barrow-in-Furness in the UK are detailed in a presentation for officers that predates the full-scale invasion of Ukraine.

The FT has previously reported from the same cache of 29 secret Russian military files that Moscow had rehearsed using tactical nuclear weapons in the early stages of a conflict with a major world power.

The latest revelations show how Russia envisioned a conflict with the west reaching well beyond its immediate Nato frontier, planning for a series of overwhelming strikes across western Europe. The documents were shown to the FT by western sources.

The files, drawn up between 2008 and 2014, include a target list for missiles that can carry either conventional warheads or tactical nuclear weapons. Russian officers highlight the advantages of using nuclear strikes at an early stage.

The presentation also indicates that Russia has retained the capability to carry nuclear weapons on surface ships, a capacity that experts said carries significant extra risks of escalation or accidents.

The document notes the navy’s “high manoeuvrability” allows it to conduct “sudden and pre-emptive blows” and “massive missile strikes . . . from various directions”. It adds that nuclear weapons are “as a rule” designated for use “in combination with other means of destruction” to achieve Russia’s goals. 

Analysts who reviewed the documents said they were consistent with how Nato assessed the threat of long-range missile strikes by the Russian navy and the speed with which Russia would probably resort to nuclear use.

The maps, which were made for presentational purposes rather than operational use, illustrate a sample of 32 Nato targets in Europe for Russia’s naval fleets.


But William Alberque, a former Nato official now at the Stimson Center, said the sample was a small portion of “hundreds, if not thousands, of targets mapped across Europe . . . including military and critical infrastructure targets”.

Russia’s capacity to strike across Europe means that targets all over the continent would be at risk as soon as its army engaged with Nato forces in frontline countries such as the Baltic states and Poland, said analysts and former officials. 

“Their concept of war is total war,” said Jeffrey Lewis, a professor at the Middlebury Institute of International Studies at Monterey who studies arms control.

“They see these things [tactical nuclear warheads] as potentially war-winning weapons,” he added. “They’re going to want to use them, and they’re going to want to use them pretty quickly.”

Tactical nuclear weapons, which can be delivered by land or sea-launched missiles or from aircraft, have a shorter range and are less destructive than the larger “strategic” weapons designed to target the US.

However, they can still release significantly more energy than those dropped on Nagasaki and Hiroshima in 1945.

Russian President Vladimir Putin has repeatedly turned to threats against Ukraine’s European allies to stave off western military support for Kyiv. “They need to remember they are small, densely populated states,” he said in May.

The presentation also references the option of a so-called demonstration strike — detonating a nuclear weapon in a remote area “in a period of immediate threat of aggression” before an actual conflict to scare western countries. Russia has never acknowledged such strikes are in its doctrine.

Such a strike, the files say, would show “the availability and readiness for use of precision non-strategic nuclear weapons” and the “intention to use nuclear weapons”.

Alberque, a former director of Nato’s Arms Control, Disarmament and WMD Non-Proliferation Centre, said: “They want the fear of Russian nuclear weapon use to be the magic key that unlocks western acquiescence.”

The files said that Russia’s top priority in a conflict with Nato was “weakening the enemy’s military and economic potential”. Analysts said this meant Russia would strike civilian sites and critical infrastructure, as it has done in Ukraine.

Fabian Hoffmann, a doctoral research fellow at the University of Oslo who studies nuclear policy, said that the combination of nuclear and conventional strikes set out in the presentation make up “one package to basically signal to the adversary that right now things are really heating up. And it would be wise for you to start talking to us on how we can settle this.”

According to Nato’s calculations, countries in the alliance have less than 5 per cent of the air defence capacities required to protect the alliance’s eastern flank against a full-scale attack from Russia.

Putin said in June that Europe would be “more or less defenceless” against Russian missile strikes.

Dara Massicot, a senior fellow at the Carnegie Endowment for International Peace, said Russian strategists partly viewed nuclear weapons as central to the early stages of any conflict with Nato because of their military’s inferior conventional resources. “They just don’t have enough missiles,” she said.

The leaked documents also indicate that Russia has retained the capability to carry tactical nuclear weapons on surface ships despite a 1991 agreement between the Soviet Union and the US to remove them.

Among Russia’s carriers of tactical nuclear weapons, it lists “anti-submarine missiles with nuclear warheads placed on surface ships and submarines” and “ship and shore-based anti-aircraft guided missiles with nuclear warheads to defeat enemy air defence groups”.

The admission was stunning given the inherent dangers of carrying nuclear weapons at sea even in peacetime, said Alberque.

Unlike a strategic ballistic missile submarine designed to fire nuclear payloads from deep in the ocean, a surface fleet vessel with nuclear warheads onboard would be at much greater risk from storm damage or an enemy hit.

Recent exercises ordered by Putin to rehearse the use of tactical nuclear weapons indicate the leaked papers are still consistent with current Russian military doctrine.

In June, Russia’s armed forces practised loading Soviet-era P-270 anti-ship cruise missiles on to a Tarantul-class corvette in Kaliningrad, where Nato officials say it stores an undeclared stockpile of tactical nuclear warheads. 

Footage of the drills showed the troops of Russia’s 12th GUMO, custodians of nuclear warheads within the Russian military, practise moving the missile in the container they would use to move a fully nuclear-armed missile, accompanied by the appropriate guard force and procedures for handling a nuclear warhead.

FT : Patrick Drahi’s fire-sale heats up

Patrick Drahi’s fire-sale heats up

Media giant goes into fire-sale mode
Patrick Drahi’s French media conglomerate Altice is on the defensive, as it stares down $60bn of debt and attempts to fend off angry creditors.

On Monday, Altice unveiled its latest bid for cash: it intends to sell its 24.5 per cent stake in UK telecommunications company BT Group to Indian billionaire Sunil Bharti Mittal.

Over the past decade, Altice sprang from relative obscurity into a global media giant, supercharged by cheap debt during an era of rock-bottom interest rates.

But now, stubbornly high rates and a criminal probe into one of the company’s founders are weighing on it. As a result, Drahi is facing pressure to sell assets to reduce the colossal debt pile he amassed during the cheap money era.

The BT stake is the latest in a number of recent attempts to raise cash. In March, Altice sold a news channel and a radio station to shipping magnate Rodolphe Saadé. And last week, Drahi partnered with Abu Dhabi-based sovereign wealth fund ADQ to give a $1bn capital injection to auction house Sotheby’s.

Despite the recent rally in BT shares (including an 8.4 per cent jump on Monday), the investment in the former UK telecoms monopoly had resulted in losses for Altice, according to a person familiar with the matter.

Altice first took a stake in BT in 2021, acquiring a 12 per cent holding that it later increased to 24.5 per cent. Altice borrowed heavily from banks to build the stake, which has dropped about £1bn in value since it was disclosed, according to FT calculations.

Sotheby’s has also proved a sore spot. Its parent company had $3.5bn in long-term debt as of the end of last year, made up of loans stemming from Drahi’s 2019 buyout and mortgages he took out against its trophy properties.

Earlier this summer, S&P Global Ratings cut the auction house’s credit rating to B minus from B, citing “pressured profitability and continued ebitda decline”.

Yet spectators are still waiting for an opening salvo between Drahi’s empire and its biggest creditors. Bondholders for the company’s French telecoms business banded together earlier this year after management warned they could expect writedowns on their debt.

DD’s still waiting for that fight to break out into the open.

FT : Can Sweden deliver its much hyped green energy boom?

Can Sweden deliver its much hyped green energy boom?
Abundant electricity in the north was supposed to power a new wave of industrialisation. But projects are struggling to scale up

Harald Mix has what he describes as a “big hairy goal”: to set up enough green companies to reduce global emissions by 1 per cent himself. And the Stockholm-based private equity executive has found the perfect place to do it: northern Sweden.

Blessed with copious green energy from its extensive network of hydropower, the far north of the Scandinavian country has experienced nothing short of a green rush. Thousands of people have flocked to this often snow-covered region that straddles the Arctic Circle to work for companies using the surplus power, such as battery maker Northvolt and H2 Green Steel, set up by Mix and business partner Carl-Erik Lagercrantz. “It is a Klondike situation, where the gold is green electricity,” says one executive working there.

For Mix, cutting emissions in sectors such as steel, cement, transport and residential heating requires “re-industrialisation” on a massive scale, bringing together some of the world’s biggest investors and companies with entrepreneurs, green technology, government subsidies and large amounts of renewable energy.

“The only way that we are going to save the planet is by actually proving this represents the single biggest investment opportunity of the century. It’s really about investment: hundreds of billions and trillions of capital that needs to be mobilised,” he adds.

The reality has been far from easy. Northvolt and H2GS have raised extraordinary amounts of capital — €15bn and almost €6.5bn respectively, from investors such as Volkswagen, Siemens, Goldman Sachs, Temasek, BlackRock and an Ikea foundation — making them some of the best-funded private companies in Europe. But both are facing serious challenges over their main projects and question marks about future expansion. 

Northvolt has struggled to ramp up production in its first, northern Swedish gigafactory, losing a $2bn contract with carmaker BMW — its first customer and one of its shareholders — causing the lossmaking battery maker to launch a strategic review about its growth ambitions and financing needs.

H2GS’s first plant, which will use hydrogen gas as an alternative to coking coal to reduce iron ore, is under construction in the north. But its ability to scale up production is threatened by problems in accessing enough power amid a growing dispute with several Swedish state-backed companies with their own green steel project, Hybrit.

Critics argue that the green industry plans are too risky for this country of 10.5mn people, and the local and national governments backing them. “The very size of these projects relative to the Swedish economy means you jeopardise the national economic system,” says Magnus Henrekson, professor of economics at the Research Institute of Industrial Economics in Stockholm. “In the US or China, even if they fail, it’s manageable. In Sweden, if you put in so many resources, so many political investments and it still fails, it will harm the entire economy for decades.”

Christer Gardell, co-founder of Europe’s largest activist investor Cevian Capital and who helped fund Henrekson’s research, adds that such large-scale projects are extremely difficult to pull off. “There was so much hallelujah [about northern Sweden] in the early days. But there was no real analysis of these big investments that were heavily supported by taxpayer money, and the risk involved,” he says.

The stakes are high, for both Sweden and Europe. As businesses and governments across the continent pour money into clean energy to try to meet emission targets, Asian companies have stolen a march in industries such as batteries and electric vehicles, while US President Joe Biden’s Inflation Reduction Act has seen a surge of green investment. Northern Sweden has been much touted as Europe’s answer, with the entire European Commission visiting an iron ore mine — and large deposit of rare earths needed in the green transition — in Kiruna last year, which also included a briefing from Northvolt’s chief executive.


“The Nordics have the potential to be the Silicon Valley of sustainability,” says Magnus Tyreman, managing partner for consultant McKinsey in Europe.

With vast amounts of money invested in various factories across the region, one word is on the lips of those involved in northern Sweden. Now, says Mix, “it’s really about execution”.

Sweden’s natural advantage is its electricity surplus. The drive to lower global greenhouse gas emissions is forcing countries to decarbonise both power generation and their industry. In Sweden, the first part is already done. Northern Sweden last year generated 76 terawatt hours of electricity from its hydropower and wind farms, but only consumed 33TWh. That surplus of 43TWh is equivalent to or more than the annual electricity consumption of countries such as Hungary, Denmark or Ireland.

Due to poor transmission links to the south, Sweden’s surplus electricity is largely trapped in the north of the country, attracting interest from a range of companies keen to exploit it.

Social media group Meta was the first big business to react, opening its first data centre outside the US in Luleå, a port and steel city in northern Sweden, in 2013. “This was an important thing to happen because it gave a new picture of northern Sweden. It showed the clean air, the clean water,” says Lorents Burman, mayor of Skellefteå, a town south of Luleå.

Skellefteå Kraft, the municipality-owned power company, saw the chance to exploit its own power surplus, beating offers from about 40 Nordic cities in 2017 to attract Northvolt to build its first gigafactory. Joachim Nordin, chief executive of Skellefteå Kraft, says it was important to attract a company that would create a lot of jobs, unlike data centres. Northvolt expects to employ 3,000 workers when its factory is completed; Meta says its Luleå data centre supports about 300.

Northern Sweden’s energy boom is leading to a dramatic reversal in the region’s fortunes. The population in most northern towns has declined steadily in the past decades as young people in particular moved to the warmer, lighter and more prosperous south.

“The picture of our region from the rest of Sweden is: a place you want to leave. But this has always been an area where we have a lot of natural resources,” says Carina Sammeli, the mayor of Luleå. “Now we are at the start of a green industrial revolution. We need to be fast, because it’s about being the first on the market.”

Hybrit’s test facility for green steel is based in Luleå while Spanish fertiliser Grupo Fertiberia, as part of the Power2Earth consortium, is planning to build a plant there and H2GS’s first factory will be close by in Boden.

Lotta Finstorp, governor of Norrbotten, Sweden’s northernmost and largest county, says the region has given a lot of raw materials and people to the south over the decades. But now she is inundated by requests from ambassadors wanting to learn more about the north.

The sudden boom is bringing headaches, however. Housing is a big problem. Such is the surge in foreign workers moving to Skellefteå that house prices have shot up, while some people had to live temporarily in shipping containers. Upgrading infrastructure such as roads and rail is time-consuming in bureaucratic Sweden, as is securing permission for new factories. “It’s permits, permits, permits. We have to go faster,” says Ebba Busch, Sweden’s minister for energy, business and industry.

There is also the issue of what climate activists such as Greta Thunberg call “green colonialism” — using the cloak of green projects such as wind farms to usurp the rights of the Sami, the indigenous people in the north. Thunberg and others have protested against a number of mining projects and wind farms, both in Sweden and Norway. Busch concedes that “it’s a difficult balancing act” between combating climate change and protecting nature.

And there are even questions about northern Sweden’s trump card: its electricity surplus. The amount of electricity needed by some projects would eventually eat up the entire surplus. LKAB, the state-owned iron ore mining company, estimates it will need 70TWh of power by 2050 to reach zero carbon emissions. That is equivalent to 43 per cent of total Swedish electricity production last year. Hybrit and H2GS estimate they would each require about 15TWh for full production.

“The surplus will be gone and gone again with these efforts. So the big question is: where is the power going to come from?” asks Cevian’s Gardell.

Energy executives say it will have to come from wind farms, onshore and offshore, noting that there is still time to build them, as long as Sweden and its bureaucracy acts fast. “I’m not especially worried,” says Nordin of Skellefteå Kraft. But he concedes that there is heavy local opposition to windmills. As Sammeli says: “Everybody wants renewable energy, just not right here.”

However, it is the performance of the supposed crown jewels of the green transition in northern Sweden — Northvolt and H2GS — that is drawing the most attention. Mix argues he is doing nothing less than setting up an entirely new asset class, and that “we are early on in that process”.

Peter Carlsson, Northvolt co-founder and chief executive, adds: “It is a very critical time for Europe, the next couple of years. The way we and others are executing, and to some extent being supported by the EU, is going to determine the long-term outcome of what the [battery] industry looks like globally.”

Mix says “industrial scale-ups” fall between the cracks of existing asset classes such as start-ups, infrastructure projects and private equity. The companies are young, but need massive amounts of capital. Their financing — involving offtake agreements where customers such as carmakers and steelmakers agree to buy their future products — is like infrastructure, but is backing a relatively risky start-up, not a well-regulated single project.

“Northvolt is the first real example of how you can create a new business model, how you can create long-term partnerships between suppliers and customers, defining what a green premium should be,” Mix adds.

The battery industry is dominated by Asian companies such as China’s CATL, Japan’s Panasonic, and Korea’s LG and Samsung. But Northvolt was the first homegrown European battery manufacturer to produce a cell from its own gigafactory, in late 2021. The problem has been in scaling up.

Northvolt’s Skellefteå plant now has 16GWh of capacity but is currently producing well under 1GWh of batteries. The company declines to give the exact figures, but Carlsson says it should reach 1GWh if it manages to increase its production four- to fivefold over what it produced in the second quarter. In 2025, it should manage “a handful” of GWh. When announced in 2017, it said the full factory would be completed in 2023 and produce 32GWh.

It has obviously been more challenging than everybody would have liked. But building and scaling an operation like this is not always going to be a straight line

Truckmaker Scania expressed frustration last year at the slow pace of deliveries. Meanwhile, Northvolt blames the Covid-19 pandemic for much of its own delays, as well as a production shutdown following the death of a worker last year. Its net loss deepened to $1.2bn last year compared with $285mn in 2022, but it still has more than $50bn of orders.

Northvolt will report on its strategic review to the board in September, which is likely to include reassessing plans to open new gigafactories in Sweden, Germany and Canada. The aim is to ensure “the core engine of Skellefteå is getting up and running before we take the next steps”, says Carlsson.

All this is taking place against the backdrop of lower-than-expected demand for electric vehicles, which many in the sector believe will cause a clear-out among battery start-ups and even established players. “It is an open question if Northvolt succeed. And if they don’t, then the whole business model fails with them,” says one well-connected technology investor in Stockholm.

H2GS has also faced delays, and is now forecasting it will produce its first steel in two years’ time at Boden, versus its initial forecast from 2021 of this year. It is planning other plants in Canada, Portugal and Brazil for its green steel, which it claims cuts emissions by up to 95 per cent compared with traditional production. But a second phase of production at Boden is uncertain after Vattenfall, a state-owned utility, moved it behind another state-owned company, steelmaker SSAB, in the queue for electricity.

H2GS executives have reacted furiously, as they have to their difficulties in getting iron ore from the local miner, LKAB. LKAB insists there is not enough capacity on the local railway to ship iron ore to H2GS, and Vattenfall says SSAB’s plans are more mature. But for H2GS it is no coincidence that LKAB, SSAB and Vattenfall are the three companies involved in its rival — Swedish green steel venture Hybrit.

Mix is undaunted by the problems of two of the main assets for Vargas, his holding company together with Lagercrantz. Vargas has just launched Syre, a joint venture with retailer H&M to produce fossil-free polyester. Last year, it helped start up Aira, a heat pumpmaker and seller.

In the future, “we would see the logic” on aluminium while “cement is interesting”, Mix says. “It’s a question about bandwidth and the importance of focus. We need to make sure we don’t drop the ball.”

His goal to reduce global emissions by 1 per cent may seem unachievable now. But Mix says taking 5 per cent market share in sectors that could disrupt the transport, steel, textile and heating industries could get him there in the decades ahead. In any case, he argues his biggest impact would be “to demonstrate it’s possible to make great returns — to attract others to invest in this”.

One of the common refrains throughout Sweden is: what would happen if the country’s push does not succeed and Europe loses its leadership on green industrialisation? In Stockholm, Busch, the deputy prime minister, warns that, were this to happen, the dependence the EU had on Russian gas would be “a summer breeze” in comparison to how dependent the bloc could become on China.

“The EU’s route to the green transition very much goes through China. We are saying that it could go through the EU itself,” she says.

In northern Sweden, they are aware of the urgency. Sammeli, Luleå’s mayor, is confident her country can lead the green revolution: “Right now, we are the first mover on this. It will be done somewhere. Maybe it is in Sweden.”

>>> US After Hours Summary: PACS +9.5% and RUM +4.2% jump on earnings; SYRS -70.

After Hours Summary: PACS +9.5% and RUM +4.2% jump on earnings; SYRS -70.3% plummets on clinical trial update

After Hours Gainers:

Companies trading higher in after hours in reaction to earnings/guidance: PACS +9.5%, RUM +4.2% (also partnering with Miami Dolphins), KYTX +2.9%, WULF +2.2%

Companies trading higher in after hours in reaction to news: KYTX +2.9% (receives U.S. FDA RMAT designation for KYV-101), STXS +2.2% (submits 510(k) in the U.S.), RXO +0.8% (private placement), ENVA +0.5% (new $300 mln repurchase program), CPA +0.4% (July metrics), DD +0.2% (files mixed shelf), BA +0.2% (awarded U.S. Navy contract), ROG +0.1% (CFO resigns), LXU +0.1% (Chairman retiring, appoints CEO as new Chairman), SLF +0.1% (to renew NCIB to repurchase 15 mln shares)

After Hours Losers:

Companies trading lower in after hours in reaction to earnings/guidance: CATX -1.9%, DHT -1.2%

Companies trading lower in after hours in reaction to news: SYRS -70.3% (provides update on SELECT-AML-1 Phase 2 Clinical Trial), WES -2.3% (secondary public offering), TNDM -2.2% (provides update on recall of t:connect Mobile App), AB -1.1% (prelim AUM), ANNX -0.7% (stock offering), AMSC -0.6% (files mixed shelf and stock offering), OXY -0.5% (stock offering), VRTS -0.4% (prelim AUM), AHR -0.2% (files mixed shelf and stock offering), ARMN -0.2% (drill results from Segovia Operations), IVZ -0.1% (prelim AUM), LDOS -0.1% (adds Curtiss-Wright (CW) to LAPN), DCI -0.1% (completes acquisition of minority stake in Medica S.p.A.), MEOH -0.1% (idling its manufacturing operations in New Zealand)

>>> US Ckose Dow -0.36% S&P +0.00% Nasdaq +0.21% Russell -0.91%

Closing Stock Market Summary
The stock market had a somewhat lackluster session after last week's volatile price action.

The S&P 500 closed less than one point above its prior closing level while the Dow Jones Industrial Average (-0.4%) and Nasdaq Composite (+0.2%) closed slightly lower and slightly higher than Friday's settlement.

The muted action was due to hesitation in front of market-moving economic releases. The Producer Price Index (Tuesday), the Consumer Price Index (Wednesday), Retail Sales (Thursday), and Housing Starts (Friday) are among the influential reports.

Only three of the S&P 500 sectors settled higher while the real estate (-0.6%) and communication services (-0.6%) sectors logged the biggest declines. The information technology sector led the pack, rising 0.9%, followed by energy (+0.5%) and utilities (+0.2%).
The info tech sector was boosted by gains in Apple (AAPL 217.53, +1.54, +0.7%),
Microsoft (MSFT 406.81, +0.79, +0.2%), NVIDIA (NVDA 109.02, +4.27, +4.1%), and Broadcom (AVGO 148.62, +0.36, +0.2%).

The energy sector reacted to a jump in oil prices ($79.91/bbl, +3.13, +4.1%) on geopolitical angst after the recent death of Hamas political leader Ismail Haniyeh stirred concerns about a retaliation from Iran (and/or its proxies) against Israel.

Separately, the New York Fed's Survey of Consumer Expectations showed that median one- and five-year-ahead inflation expectations were unchanged in July at 3.0% and 2.8%, respectively, while median three-year-ahead inflation expectations declined by 0.6 percentage point to 2.3%. This was the lowest level since the survey's started in June 2013.

The 10-yr note yield settled three basis points lower at 3.91% and the 2-yr note yield fell three basis points to 4.02%.
  • S&P 500: +12.1% YTD
  • Nasdaq Composite:+11.8% YTD
  • S&P Midcap 400: +4.8% YTD
  • Dow Jones Industrial Average: +4.4% YTD
  • Russell 2000: +1.7% YTD

Reviewing today's economic data:
  • The Treasury Budget for July showed a deficit of $243.7 billion compared to a deficit of $220.8 billion in the same period a year ago. The July deficit resulted from outlays ($574.1 billion) exceeding receipts ($330.4 billion). The Treasury Budget data is not seasonally adjusted so the July deficit cannot be compared to the June deficit, which was revised higher to $70.9 billion (from -$66.0 billion).
    • The key takeaway from the report is that the U.S. government continues to run large budget deficits, driven in part by net interest costs that are outweighing defense spending.

Tuesday's economic lineup features:
  • 6:00 ET: July NFIB Small Business Optimism (prior 91.5)
  • 8:30 ET: July PPI (consensus 0.1%; prior 0.2%) and Core PPI (consensus 0.2%; prior 0.4%)

>>> Insider Trading: notable purchases -- CEO adds to ZI; notable sales -- Tria

Insider Trading: notable purchases -- CEO adds to ZI; notable sales -- Trian Fund active in WEN
Buyers:
  • ACA President and Chief Executive Officer bought 12,125 shares at $80.32 - $82.75 worth approx. $995K.
  • AGCO Director bought 1,415 shares at $88.26 - $88.31 worth about $125K.
  • APLE Executive Chairman bought 5,000 shares at $14.045 worth about $70K.
  • APPN 10% owner Abdiel Capital bought 275,000 shares worth approx. $7.6 mln.
  • AXR 10% owner bought 5,000 shares at $23.125 - $23.68 worth about $117K.
  • CTOS President - Sales bought 84,254 shares at $3.95 - $4.00 worth approx. $335K.
  • DIS Director bought 11,756 shares at $85.0191 - $85.09 worth approx. $1 mln.
  • GRPN Director bought 15,000 shares at $10.61 worth about $159K.
  • GT President, EMEA bought 18,292 shares at $8.20 worth about $150K.
  • LAB 10% owner Casdin Partners bought 1,069,562 shares worth approx. $1719K.
  • LGND Chief Executive Officer bought 2,500 shares at $97.3922 worth approx. $243K.
  • ML Director bought 10,000 shares at $42.62 - $47.62 worth approx. $459K.
  • ODP Director bought 3,875 shares at $25.77 worth ~$100K.
  • ONEW Directors (2) bought 61,705 shares worth approx. $1.4 mln.
  • PBF 10% owner Control Empresarial de Capitales S.A. de C.V. bought 73,000 shares worth nearly $2.7 mln.
  • PMTS Director bought 2,000 shares at $25.26 worth ~$51K.
  • PRAA Director bought 11,750 shares at $21.25 - $21.45 worth approx. $251K.
  • SHEN President / Chief Executive Officer bought 18,500 shares at $14.84 - $14.96 worth approx. $276K.
  • TALO 10% owner Control Empresarial de Capitales S.A. de C.V. bought 650,000 shares at $10.275 - $10.40 worth approx. $6.7 mln.
  • TBPH 10% owner bought 999,800 shares worth approx. $7.8 mln.
  • WLKP SVP, Olefin Material & Corp Pr bought 12,000 shares at $22.89 - $23.00 worth ~$276K.
  • XRAY Director bought 8,212 shares at $24.305 - $24.38 worth about $200K.
  • ZI Chief Executive Officer bought 1,500,000 shares at $8.17 - $8.70 worth approx. $12.7 mln.
Sellers:
  • ATGE Director sold 67,330 shares at $71.24 - $71.88 worth approx. $4.8 mln.
  • QDEL 10% owner Carlyle Group (CG) sold 184,885 shares worth approx. $7.5 mln.
  • MUSA Director sold 13,454 shares at $514.38 worth approx. $6.9 mln.
  • PEBK Director sold 8,686 shares at $28.906 worth approx. $251K.
  • PGY Chief Revenue Officer and Chief Technology Officer sold 23,263 shares combined at $15.60 - $16.25 worth about $368K.
  • PIPR General Counsel sold 1,789 shares at $256.73 worth approx. $459K.
  • SFM Director sold 20851 shares at $96.0407 - $96.2826 worth more than $2.0 mln.
  • SIRI President & Chief Content Officer sold 1,447,238 shares at $3.125 to $3.20worth approx. $4.6 mln.
  • SNCR 10% owner B. Riley Financial (RILY) sold 98,564 shares worth approx. $1.1 mln.
  • VYX Chief Executive Officer and Executive VP & CFO bought 20,000 shares combined at $11.02 - $11.51 worth approx. $226K.
  • WCN Senior VP Operations sold 1,000 shares at $180.15 worth about $180K.
  • WEN 10% owner Trian Fund sold 1,000,000 shares worth approx. $17.2 mln.

TechCrunch : Synopsys’s plans to buy Ansys for $35B falls on UK regulatory radar

Synopsys’s plans to buy Ansys for $35B falls on UK regulatory radar


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Synopsys’s plans to buy Ansys for $35B falls on UK regulatory radar
Paul Sawers
5:45 AM PDT • August 12, 2024
Comment

Close-up of sign with logo at Silicon Valley headquarters of technology company Synopsys, Mountain View, California.
Image Credits: Smith Collection/Gado/Getty Images
The U.K. antitrust regulator has confirmed that it’s carrying out an early-stage inquiry into Synopsys‘s plans to buy Ansys.

The Competition and Markets Authority (CMA) has opened an “invitation to comment,” meaning any stakeholders or interested parties can file their objections to the transaction, after which the regulator will decide whether to progress the investigation to a formal merger inquiry. The CMA hasn’t provided any deadline for comment submissions.

Chip design software maker Synopsys revealed back in January its plans to acquire Ansys, a simulation software developer that helps engineers model and analyze the physical behavior of products (e.g. chips) to evaluate their real-world performance, in a deal worth $35 billion.

The coming together of these companies would create a comprehensive chip design and simulation powerhouse, one that’s capable of creating more efficient development processes by lowering the fail-rate during the design process. However, such a merger could create a dominant player spanning all facets of the chip design process, thus stifling competitors that don’t offer such a combination.

The Federal Trade Commission (FTC) is already looking at the transaction, though has yet to confirm any further action, and reports suggest that competitors and customers of Synopsys and Ansys are pressuring the European Commission (EC) to take action.

China’s SAMR is also expected to scrutinize the deal — Synopsys has longstanding ties to China, where it has seen significant success even with Huawei sanctions in place, and Ansys too has a notable presence in China.

With the CMA now weighing in, it seems that Synopsys and Ansys — both publicly-traded companies with a combined market cap of $100 billion — might have a long way to go before this deal reaches the finish line.