Avidity Touts Functional Improvements for DMD Therapy, Clearing Way to FDA

Analysts at BMO Capital Markets expect the lack of other exon-44-skiping therapies to facilitate a “smooth” approval process for Avidity’s del-zota.

Avidity’s investigational exon-44-skipping therapy reversed disease progression and improved functional outcomes in patients with Duchenne muscular dystrophy (DMD) in two mid-stage trials after one year of treatment.

In a note to investors on Wednesday morning, BMO Capital Markets noted that delpacibart zotadirsen—also known as del-zota—demonstrated “robust” biomarkers, which then translated to “functional improvements.” The readout, the analysts added, “further derisks” a biologics license application for the asset and suggests a “clear” path to approval.

Avidity is aiming to complete a submission by the end of 2025 to seek accelerated approval for del-zota, according to a company announcement. The biotech is also preparing a confirmatory trial for the antibody-oligonucleotide conjugate (AOC), with an eye toward full global approval.

If approved, del-zota could help Avidity transition “into a commercial-stage company in ~2026,” BMO wrote on Wednesday. “We expect lack of approved Exon-44 skipping treatments to facilitate a smooth BLA submission/approval for del-zota.” The group anticipates around 1,000 addressable U.S. patients.

Wednesday’s findings come from the Phase I/II EXPLORE44 and EXPLORE44-OLE studies. The former enrolled 26 patients with DMD who are amenable to exon 44 skipping, while the latter included 16 participants from EXPLORE44 who continued on to the open-label extension study. Both trials were designed to evaluate the safety of del-zota and assess its effects on key disease biomarkers.

The experimental therapy resulted in a roughly 25% increase in the production of normal dystrophin, a protein associated with muscle dysfunction in DMD. Del-zota restored dystrophin concentrations to up to 58% of normal. Additionally, treatment with the AOC led to a rapid and more-than 80% drop in creatine kinase (CK) levels, a marker indicative of muscle damage. CK concentrations were maintained at “near normal levels” through 16 months of follow-up.

The EXPLORE44 data also showed that these biomarker improvements correlated with functional benefits, as assessed against a natural-history control. Patients on del-zota saw a 2.1-second improvement in the four-stair climb test, versus a 2.7-second decline in natural history controls. The AOC likewise resulted in better outcomes in the 10-meter walk/run, time to rise from floor and North Star Ambulatory Assessment tests.

Del-zota’s readout on Wednesday could further improve Avidity’s image to potential buyers. In August, The Financial Times reported that Novartis had approached the biotech with a buyout offer—but no such deal has yet come to fruition. The pharma has since made several big-ticket buys, including the $1.4 billion takeover of Tourmaline Bio on Tuesday and a $5.2 billion commitment last week to expand its ongoing agreement with China’s Argo Biopharma.

https://www.biospace.com/drug-development/avidity-touts-functional-improvements-for-dmd-therapy-clearing-way-to-fda

US Consumer Prices Rise More Than Expected In August From Services Not Tariffs

 Following yesterday's cooler-than-expected PPI (MoM deflation), expectations for this morning's Consumer Price Inflation were for the further acceleration.

Headline CPI rose 0.4% MoM (hotter than the 0.3% expected, lifting prices up 2.9% YoY - the highest since January...

Source: Bloomberg

CPI rose 0.4% in August, after rising 0.2% in July; over the last 12 months, the all items index increased 2.9% before seasonal adjustment.

• The index for shelter rose 0.4% in August and was the largest factor in the all items monthly increase. The food index increased 0.5% over the month as the food at home index rose 0.6% and the food away from home index increased 0.3 percent. The index for energy rose 0.7% in August as the index for gasoline increased 1.9% over the month.

• The index for all items less food and energy rose 0.3% in August, as it did in July. Indexes that increased over the month include airline fares, used cars and trucks, apparel, and new vehicles. The indexes for medical care, recreation, and communication were among the few major indexes that decreased in August.

• The all items index rose 2.9% YoY in August, after rising 2.7% in July. The all items less food and energy index rose 3.1 percent over the last 12 months. The energy index increased 0.2 percent for the 12 months ending August. The food index increased 3.2 percent over the last year.

Core Services were the big driver of the increase, not driven by tariff pressures...

Source: Bloomberg

Core CPI rose 0.3% MoM as expected, lifting prices more than 3% YoY for the first time since February...

Source: Bloomberg

Core Services also dominated the rise in core CPI...

Source: Bloomberg

More details on the core CPI print which rose 0.3% in August, same as July:

• The shelter index increased 0.4% over the month, and was the largest factor in the all items monthly increase

  • The index for owners’ equivalent rent rose 0.4 percent in August and the index for rent increased 0.3 percent.

• The lodging away from home index rose 2.3 percent over the month.

• The index for airline fares increased 5.9 percent over the month, after rising 4.0 percent in July.

• The used cars and trucks index rose 1.0 percent in August and the apparel index rose 0.5 percent.

• The index for new vehicles rose 0.3 percent over the month and the index for household furnishings and operations increased 0.2 percent.

• The recreation index and the communication index both declined 0.1 percent in August.

• The medical care index decreased 0.2 percent over the month, following a 0.7-percent increase in July.

• The index for dental services decreased 0.7 percent in August and the index for prescription drugs declined 0.2 percent.

• The physicians’ services index increased 0.3 percent over the month, while the hospital services index was unchanged.

It looks like auto costs are starting to tick up again. New vehicles rose by 0.3% while used cars and trucks rose by 1.0%. But the real sting was in motor vehicle maintenance and repairs, which jumped by 2.4%. 

When we look at some import-exposed categories:

• Household furnishings are up 0.1% on the month, the least since March, and appliances within that category are up 0.4%, the most since June. A sort of mixed reading there.

• Apparel (clothing) is up 0.5%, the largest gain since February, so, an acceleration there.

• Video and audio products are up 0.5%, which is the smallest rise since May.

At least looking at these categories, there’s no overall broad story of acceleration in inflation pressures. 

Interesting, SuperCore CPI slowed in August to 3.52% YoY...

Source: Bloomberg

Transportation Services were the biggest driver of the rise in SuperCore CPI...

Source: Bloomberg

Comparing CPI to PPI shows that there is no margin pressure on firms and could suggest price pressures being passed through to end users...

Source: Bloomberg

Together with August PPI, the CPI report suggests that the Fed’s preferred inflation gauge, the core PCE deflator (due out Sept. 26) will edge up to 3.0% for August year over year...

All of this is to say, while the overall inflation numbers are in line with what economists had expected, within the details there are pockets of price pressure. 

We highlighted auto repairs and airline tickets earlier, but take a look at fruit and vegetable costs: up 1.6% on the month. Motor fuel rose by 1.8%, while tobacco costs rose 1.0%, and food-at-home jumped 0.6% on the month, the biggest gain in almost three years. 

To be clear, the overall number won’t hold the Fed from cutting, but it’s clear there’s inflation pressure in some corners of the economy. 

...not enough to scare The Fed from its rate-cutting path.

https://www.zerohedge.com/personal-finance/us-consumer-prices-rise-more-expected-august-services-not-tariffs

France In Flames As The 'Block Everything' Protest Movement Sweeps The Country

 by Rick Moran via PJMedia.com,

France and its hapless President Emmanuel Macron are in deep trouble...

On Monday, Macron's government failed to survive a "no-confidence" vote as the country spiraled into crisis. What's most worrying for Macron is that the vote wasn't even close. Prime Minister François Bayrou was dumped overwhelmingly in a 364-194 vote. At issue: Bayrou's sensible but unpopular notion that France had to cut spending to address a growing debt crisis.

"Sensible" and "socialism" don't ordinarily go hand in hand. Thus, in office only since December, Bayrou was given an unceremonious heave-ho.

Macron turned to an old ally to replace Bayrou. He named departing defense minister Sébastien Lecornu to be the fourth prime minister of Macron's government this year.

Lecornu is the only minister to have been in every government since 2017. He has his work cut out for him. He has to pass a budget by year's end and deal with a growing protest movement that will fight tooth and nail to prevent Macron's "austerity budget" from passing.

Macron gambled and called for a "snap" election last year, hoping to increase his slim parliamentary majority. It failed miserably when the populists and the far left made significant gains. Now, the streets are full of angry Frenchmen, and the nation's stability is in question.

NBC News:

Protesters set fires as they blocked highways and gas stations across France early Wednesday as part of a new nationwide movement. Authorities deployed 80,000 police, who made hundreds of arrests and fired tear gas to disperse crowds.

The "Block Everything" movement was born online over the summer in far-right circles, but spread on social media and was co-opted by left-wing, antifascist and anarchist groups. It now includes France’s far-left parties and the country’s powerful labor unions.

Their joint day of unrest adds to the country’s political turmoil, after the collapse of centrist President Emmanuel Macron’s government earlier this week in a similar backlash over proposed budget cuts and broader anger at the political class.

The far left, the largest bloc in parliament, wants Macron's scalp. Jean-Luc Mélenchon, the longtime leader of the far-left party France Unbowed, said, “Only the departure of Macron himself can put an end to this sad comedy of contempt for Parliament, voters and political decency.”

Jordan Bardella, the president of the populist National Rally, said his party would give Lecornu the benefit of the doubt and refuse to join the far left in attempting to oust him. But Bardella wasn't enamored of Lecornu.

“Emmanuel Macron’s motto: you don’t change a losing team,” Bardella wrote on social media. “How could a loyal supporter of the President break with the policy he has been pursuing for eight years?”

In the capital Paris, groups gathered and set up barricades at several entry points to the city. Demonstrations were expected to continue throughout the day, with travel disrupted as some of the main transport unions joined the strike.

Hundreds remained gathered outside Gare du Nord, one of the city's main train stations, despite earlier attempts from police to disperse the crowds with tear gas.

“We are here, even if Macron doesn’t want us, we are here,” they chanted.

There were dramatic scenes outside a high school in eastern Paris, where police clashed with dozens of students who had blocked entry to the building.

French political observers believe it's only a matter of time before Macron will be forced to call for another snap election. This would please both the left and the right, who believe they can gain a majority in parliament. The result of another snap election will probably be the same as the last: a hung parliament and more unrest in the streets. 

https://www.zerohedge.com/geopolitical/france-flames-block-everything-protest-movement-sweeps-country

Mexico Plans 50% Tariff on Chinese Cars Before US, Canada Talks

 

Mexico plans to impose tariffs of as much as 50% on cars and other products made by China and several Asian exporters, aligning the country more closely with US protectionism as President Claudia Sheinbaum prepares for talks over North America’s free-trade deal.

Higher tariffs would apply to a list of more than 1,400 categories of products coming from countries with which Mexico has no trade agreement, Economy Minister Marcelo Ebrard said on Wednesday, describing them as part of efforts to protect Mexican industry. China, South Korea and India are among the exporters that would be hit under the proposed levies, which must be approved by Congress.

https://www.bloomberg.com/news/articles/2025-09-10/mexico-seeks-to-raise-tariffs-on-cars-made-in-asia-to-up-to-50

'In AI-simulated Fed meeting, political pressure polarises board'

 A simulated Federal Reserve meeting that used artificial intelligence agents modeled on real-life policymakers showed political pressure polarised members of the board in their rate-setting deliberations.

In the study released on August 31, academics at George Washington University simulated a Federal Open Market Committee meeting using AI agents modeled by each member based on their historical policy stances, biographies and speeches.

The AI FOMC was then made to process real-time economic data and financial news to reach a decision.

The findings showed when political pressure is applied, the AI agents became fragmented and dissent more common, according to the paper by Sophia Kazinnik and Tara Sinclair.

"This simulation shows that the Federal Reserve is only partially insulated from politics," and that "outside scrutiny can shape internal decision-making, even in an institution guided by formal rules," they said in the paper.

The simulation replicates the July 2025 FOMC meeting.

While few central banks may be ready to have AI agents set monetary policy, a growing number of them are using the technology to streamline operations.

The Fed conducted research using generative AI models to analyse minutes of the FOMC meetings. The European Central Bank uses machine learning models to forecast euro-area inflation.

The Bank of Japan uses AI to gather information and deepen economic analyses. Research it published in December used large language models (LLM) to show how key factors driving up prices may be shifting to labour costs from raw material prices.

Australia's central bank is testing a new AI tool that gives summaries on policy-related analytical questions, its governor Michele Bullock said on September 3.

"To be clear, we are not using AI to formulate or set monetary policy or any other policy," she said. "Instead, we are looking to leverage it to improve efficiency and amplify the impact of staff efforts in areas such as research and analysis."

Central banks see strategic importance in AI and are actively experimenting on data retrieval and analyses, the Bank for International Settlements said in a report in April.

"Yet, below the surface, many central banks are still in the initial adoption phase," given the need to ensure the technology is used with adequate governance and high-quality data, it said.

https://finance.yahoo.com/news/ai-simulated-fed-meeting-political-043725911.html

Israeli Companies’ Defensive Wares on Display at UK Arms Show

 

Israeli weapons makers Israel Aerospace Industries, Elbit Systems and Rafael Advanced Defense Systems displayed mostly defensive hardware at the DSEI arms show in London after the UK government banned official delegations from the country.

State-owned IAI’s booth showed models and promotional material for many of its top-line products, including its Barak and Arrow air and missile defense systems. Rafael, also government-owned, displayed Stunner missiles and the Iron Beam laser, both air defense systems. Elbit showcased mostly uncrewed aerial systems such as its Hermes 900.

https://www.bloomberg.com/news/articles/2025-09-11/israeli-companies-defensive-wares-on-display-at-uk-arms-show

Labor Department watchdog reviewing challenges to BLS data collection

 The office of the Labor Department’s inspector general said Wednesday it was initiating a review of challenges the Bureau of Labor Statistics faces in collecting and reporting US economic data following recent large downward revisions to nonfarm payrolls and cuts to inflation data collection.

Assistant Inspector General for Audit Laura Nicolos sent a letter to acting BLS commissioner William Wiatrowski informing him of the review. The announcement followed on the heels of news from the BLS on Tuesday that payrolls could have been overstated by 911,000 jobs in the 12 months through March.

“Our focus will be on the challenges and related mitigating strategies for (1) collecting PPI and CPI data, and (2) collecting and reporting, including revising, monthly employment data,” the letter said.

Sharp downgrades last month to May and June payrolls figures totaling 258,000 jobs angered U.S. President Trump, who fired BLS Commissioner Erika McEntarfer, accusing her, without evidence, of faking the employment data. Trump has nominated E.J. Antoni, chief economist at the conservative think tank Heritage Foundation to replace McEntarfer.

The BLS has suffered from years of inadequate funding under both Democratic and Republican administrations. Like all government agencies, it has been severely affected by mass firings, voluntary resignations, early retirements and hiring freezes, part of an unprecedented campaign by the White House to drastically reduce the size of government and remake it.

The BLS has suspended consumer price data collection in three cities because of resource constraints. It last month ended the calculation and publication of about 350 indexes in the producer price report.

https://nypost.com/2025/09/10/business/labor-department-watchdog-reviewing-challenges-to-bls-data-collection/