After FDA rejection, Sanofi, Regeneron data could pave way for Dupixent to treat hives condition

 Eleven months after sustaining a rejection from the FDA for Dupixent to treat chronic spontaneous urticaria (CSU), Sanofi and Regeneron have presented data from a phase 3 trial that could help push the megablockbuster across the finish line in the indication.

The LIBERTY-CUPID C study met its primary and secondary endpoints in testing patients with Dupixent who were already receiving background antihistamine therapy. It is the third phase 3 trial for Dupixent in CSU, a severe inflammatory condition that causes hives and deep swelling on or under the skin.

In the trial of 151 children and adults, those who took Dupixent plus standard-of-care (SOC) antihistamines experienced an average 8.6-point reduction in itch severity (on a scale of 21) compared to a 6.1-point reduction for patients who received SOC plus placebo.

The Dupixent group also experienced a 15.9-point reduction in itch and hive severity (on a 42-point scale) versus an 11.2-point reduction for the control group. 

The measurements were taken after 24 weeks on therapy.

Additionally, 30% of Dupixent-treated patients reported a complete response compared to 18% of those on placebo.

“The positive pivotal data from this study reinforce the potential of Dupixent to offer a new treatment option for the many people suffering from chronic spontaneous urticaria who do not respond to standard-of-care antihistamines,” Sanofi’s chief medical officer Dietmar Berger, M.D., Ph.D., said in a release.

The companies will share the data with the FDA in the hopes of bringing Dupixent to CSU patients “as soon as possible," Berger added. The partners plan to file their regulatory resubmission before the end of the year. Earlier this year, Dupixent was approved for CSU in Japan.

The trial confirms results from the successful LIBERTY-CUPID A study, which tested Dupixent plus SOC antihistamines against antihistamines alone in patients with moderate-to-severe CSU.

In the LIBERTY-CUPID B trial, however, Dupixent came up short, failing to significantly reduce symptoms of people who did not have success with the lone treatment approved in for CSU—Novartis and Roche’s Xolair. While the trial was stopped for futility, the companies noted that Dupixent provided numerical improvements in the each of the main evaluation criteria, including itching.

The result helped convince the FDA to reject Sanofi and Regeneron’s application for approval and ask the companies in a complete response letter for more efficacy data.

More than 300,000 people in the U.S. suffer from CSU that is inadequately controlled by antihistamines, the companies said.

Dupixent has been on the market for seven years and has been approved in atopic dermatitis, asthma, rhinosinusitis, eosinophilic esophagitis and prurigo nodularis. Another indication may soon be coming as the FDA is reviewing Dupixent as a treatment for chronic obstructive pulmonary disease. 

If approved in CSU, Dupixent would become the first new treatment in the indication in more than a decade, according to Sanofi and Regeneron. 

In 2023, Dupixent’s sales increased by 33% to $11.6 billion. More than 1 million patients have been treated with the monoclonal antibody, the companies said.

Xolair, which was approved for CSU in 2014 and covers most of the same indications as Dupixent, generated sales of $4 billion last year.

With Xolair soon to face biosimilar competition, Novartis is working to bring a new CSU treatment to the market as it recently presented data from two successful phase 3 trials for oral BTK inhibitor remibrutinib. The company expects to submit for approval of remibrutinib next year.

https://www.fiercepharma.com/pharma/after-fda-rejection-sanofi-regeneron-show-data-could-pave-way-dupixent-treat-hives-condition

Novartis cut to Neutral from Buy by B of A

 Target to $130 from $135

https://finviz.com/quote.ashx?t=NVS&p=d

BriaCell Reports Positive Overall Survival (OS) in Metastatic Breast Cancer

 

• Median overall survival of 15.6 months in Phase 2 Bria-IMT™ study patients treated in combination with immune checkpoint inhibitor
• OS of 15.6 months compares favorably with 6.7-9.3 months reported for similar patients in the literature
• Ongoing Phase 3 study investigating Bria-IMT™ in similar metastatic breast cancer population
• No drug related discontinuations to date

https://www.globenewswire.com/news-release/2024/09/11/2944400/0/en/BriaCell-Reports-Positive-Overall-Survival-OS-in-Metastatic-Breast-Cancer.html

Q32 Bio started at Overweight by Wells Fargo

 Target $95

https://finviz.com/quote.ashx?t=QTTB&p=d

Secret Service Boss Pressuring Key Official To Retire ahead Of DHS-OIG Probe: Report

 by Ken Silva via Headline USA,

Fox News reported Tuesday that Secret Service Acting Director Ronald Rowe has asked Michael Plati, the assistant director of the agency’s office of protective operations, to retire from his position.

U.S. Secret Service Acting Director Ronald Rowe, left, and FBI Deputy Director Paul Abbate testify before a Joint Senate Committee on Homeland Security and Governmental Affairs and Senate Committee on the Judiciary hearing examining the security failures leading to the assassination attempt on Republican presidential candidate former President Donald Trump, Tuesday, July 30, 2024 in Washington. (AP Photo/Kevin Wolf)

Plati may have been the one signing off on denying Donald Trump, Robert F. Kennedy Jr., and others additional security resources. According to journalist Susan Crabtree, Plati’s department was the one that repeatedly denied requests for extra security assets to Trump.

Fox News said that Plati is expected to retire “in the coming days.” The news comes as Rowe is set to brief Congress on what the Secret Service has learned in the wake of the July 13 Trump assassination attempt.

Plati’s retirement also comes as Sen. Roger Marshall, R-Ka., seeks to widen the DHS Inspector General’s investigation into the Secret Service’s failures at the Trump rally. Marshall wants DHG IG Joseph Cuffari to identify the specific individuals responsible for making decisions in Trump’s security planning—which may include Plati.

But if Plati indeed retires, the DHS-IG won’t be able to legally compel him for an interview.

The Secret Service has yet to comment on Plati’s rumored retirement.

Meanwhile, the scandal-mired agency has turned to the Defense Department for help securing 2024 campaign events.The Pentagon announced on Aug. 29 that the U.S. Northern Command will assist the Secret Service for the presidential and vice-presidential campaigns through Inauguration Day 2025.

“As part of this effort, the Department of Defense is providing the U.S. Secret Service with additional assistance including logistics, transportation and communications, through the 2024 campaign season,” Secret Service spokesman Guglielmi said in a Defense Department press release.

The Secret Service faces a reported 650-agent deficit for the United Nations General Assembly, which is scheduled to begin today in New York City. According to Crabtree, there are concerns in the Secret Service that the Pentagon’s soldiers don’t have proper training, and that their presence will create the perception that the U.S. has turned into a militarized police state.

However, the Pentagon insisted in its press release that there’s nothing unusual about its decision.

“The Department of Defense has supported Secret Service protective activities for the sitting president and vice president since Congress passed the Presidential Protection Assistance Act of 1976,” said Anthony Guglielmi, the chief of communications for the Secret Service.

https://www.zerohedge.com/political/secret-service-boss-pressuring-key-official-retire-ahead-dhs-oig-probe-report

Core Inflation Comes In Hotter Than Expected As Shelter Costs Unexpectedly Rise

 Following last month's modest miss in CPI which sparked speculation about a 50bps cut, which was then boosted by the jobs report miss and the huge downward revision, moments ago the BLS reported that - as only a handful of Wall Street strategists warned - CPI actually came in hotter than expected at the core level, rising 0.3% MoM vs expectations of a 0.2% print, with all remaining metrics coming in line, to wit:

• CPI 0.2% MoM (or 0.187% unrounded), Exp. 0.2% - in line
• CPI Core 0.3% MoM (or 0.281% unrounded), Exp. 0.2% - hotter than expected
  
• CPI 2.5% YoY, Exp. 2.5% - in line
• CPI Core 3.2% YoY, Exp. 3.2% - in line

That was the 51st straight month of MoM increases in Core CPI, and a new record high.

Looking at the headline CPI data set, the annual CPI increase dropped to just 2.5% from 2.9%, the lowest since February 2021...

... and the core....

.... as goods deflation is stalling and may even print positive in the coming months, while core service inflation remains the biggest driver.

That said, Goods deflation continues to drag overall CPI lower, with energy also adding to the base effect for the first time since early 2024...

For context, Goods prices remained down 1.9% YoY - matching the biggest deflationary impulse since 2004. Services prices continue to rise YoY but at the slowest pace since 2022.

The 3m and 6m annualized CPI rates continue to trend lower (with Energy a particularly volatile factor)

Under the hood, used car prices fell 1.0%, moderating from last month's 2.3% drop, while airline fares jumped 3.9%, a big reversal to last month's bizarre -1.2% drop and a reversal to drops in each of the past 5 months. Car insurance costs jumped another 0.6%, after rising 1.2%; furniture prices dropped 0.3% reversing last month's 0.3% rise.

Here is a more detailed breakdown:

Food:

The food index increased 0.1 percent in August, after rising 0.2 percent in each of the previous 2 months. The index for food at home was unchanged in August. Two of the six major grocery store food group indexes increased over the month while the other four indexes declined in August.

• The index for meats, poultry, fish, and eggs rose 0.8 percent in August as the index for eggs increased 4.8 percent.
• The dairy and related products index increased 0.5 percent over the month.
• The nonalcoholic beverages index fell 0.7 percent in August, after rising 0.5 percent in July.
• The index for other food at home decreased 0.3 percent over the month, the index for fruits and vegetables declined 0.2 percent, and the index for cereals and bakery products fell 0.1 percent in August
• The food away from home index rose 0.3 percent in August, after rising 0.2 percent in July.
• The index for limited service meals rose 0.3 percent and the index for full service meals increased 0.2 percent over the month

Energy

The energy index decreased 0.8 percent in August, after being unchanged in July.

• The gasoline index fell 0.6 percent over the month.
• The electricity index decreased 0.7 percent over the month and the natural gas index fell 1.9 percent in August.

All items ex good and energy

• The shelter index increased 0.5 percent in August:
  • The index for owners’ equivalent rent rose 0.5 percent over the month and the index for rent increased 0.4 percent.
  • The lodging away from home index rose 1.8 percent in August, after rising 0.2 percent in July.
• The airline fares index rose 3.9 percent in August, after declining in each of the previous 5 months.
• The index for motor vehicle insurance increased 0.6 percent over the month.
• The indexes for education and apparel also increased in August.
• The index for used cars and trucks fell 1.0 percent in August, following a 2.3-percent decrease in July.
• The index for new vehicles was unchanged over the month.
• Over the month, the household furnishings and operations index fell 0.3 percent.
• The medical care index  fell 0.1 percent in August, after falling 0.2 percent in July.
• The communication index decreased 0.1 percent in August, as did the recreation index and the personal care index.

Visually:

Perhaps more worrying is the fact that while rent inflation has flatlined, shelter inflation posted its first increase since early 2023!

• August Shelter inflation up 0.43% MoM and up 5.23% YoY vs 5.05% in July
• August Rent Inflation up 0.39% MoM and up 4.97% YoY vs 5.09% in July

And the first monthly increase since March 2023 highlighted:

Last, but not least, and perhaps most ominous of all, is that while inflation refuses to be "killed" even as the Fed is about to start cutting rates, Supercore CPI rose 0.33% MoM, the biggest monthly increase since April, driven by continued acceleration in transportation services, which jumped the most in 5 months.

Finally, money supply growth is reaccelerating...

Which begs the question: how long until the Fed's next easing cycle unleashes the Arthur Burns fed:

Putting it all together:

• Underlying inflation unexpectedly picked up, as core CPI increased 0.3% from July, the most in four months, and 3.2% from a year ago
• Only five of the 65 forecasts in Bloomberg’s survey called for a 0.3% increase in the core CPI. Almost everyone else was at 0.2%, and four had it at 0.1%. The five were right.
• Shelter prices, the largest category within services, climbed 0.5%, the most since the start of the year and the second month of acceleration, defying widespread expectations for a downshift. Owners’ equivalent rent — a subset of shelter and the biggest individual component of the CPI — rose at a similar pace.
• Airfares rose a hefty 3.9% in August after falling for the previous five months while costs for energy and used vehicles fell
• Risk assets pumped and dumped and bond yields rose. S&P 500 futures dropped steeply immediately after the report came out, before paring losses. The yield on 10-year Treasuries advanced two basis points to 3.66%. The dollar wavered.

And while one can stick a fork in the market's hopes for a 50bps rate cut (odds slumped from 30% to 20%... and from 50% last Friday)...

... the question remains: will the Fed really cut rates as shelter inflation inflects higher for the first time since 2023?

https://www.zerohedge.com/economics/core-inflation-comes-hotter-expected-collapsing-odds-50bps-rate-cut

Warren Buffett's Dumping Of Bank Of America Slows

 94-year-old Warren Buffett's Berkshire Hathaway has been on a multi-month selling spree of Bank of America shares, raising many questions about the motivation behind abruptly dumping billions of dollars worth of BofA stock. Berkshire's latest filing indicates that the selling pressure is finally easing as share price slides.

On Tuesday, Buffett's Berkshire reported a $229 million stock sale over three trading sessions. The average price was around $39.30 per share, among the lowest reported since he began abruptly selling the position in mid-July. 

Bloomberg noted:

"The fresh disposals marked a significant slowdown from the eight prior rounds, in which his conglomerate generated an average of about $870 million each time, based on filings that typically spanned three days of trading.

"Altogether, Berkshire has generated nearly $7.2 billion since Buffett began shrinking the stake almost two months ago. The conglomerate still holds just over 11% of the bank's stock, worth about $33.7 billion based on Tuesday's closing price of $39.28." 

After dumping more than $7 billion in stock, Berkshire is still the largest shareholder with 11% of the bank's stock, or about 858 million shares. The position is back to 2018 levels. 

Late last week, we offered some ideas on why Buffett might be selling. It would make a lot of sense for the billionaire's traders to reduce the BofA stake below the 10% threshold, eliminating the need for continuous reporting. 

https://www.zerohedge.com/markets/warren-buffetts-dumping-bank-america-slows