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Monday, August 5, 2024

Biden backgrounder on Gene Sperling

 August 05, 2024


Gene joined my administration as the only person to have ever directed the National Economic Council under two presidents, and has helped me execute a rescue plan that has led to one of the most equitable and resilient economic recoveries ever. His work helped nearly 40 million working families get unprecedented child tax cut relief and over 8 million renters get emergency assistance to help keep their families housed. Under Gene’s leadership, the American Rescue Plan has delivered economic relief to cities and counties across the country, protected millions of union pensions, made the largest-ever federal investment in public safety, and kept thousands of small businesses afloat.

I also looked to Gene as a trusted advisor on the economy and gave him some of the toughest assignments, including serving as my liaison to the Big 3 automakers and UAW as autoworkers fought for – and secured – record contracts.

Having traveled from Delaware to D.C. every day during my Senate career, I know a thing or two about long commutes. I’m grateful to Gene’s wife Allison, his children Nina and Miles and his godchildren Derick and Samantha for allowing Gene to lend me his wisdom, his counsel, and his friendship. They should know our nation is stronger and more just because of the families that Gene has spent every day fighting for over the past three-and-a-half years.

https://www.whitehouse.gov/briefing-room/statements-releases/2024/08/05/statement-from-president-joe-biden-on-gene-sperling/

Comerica Chief Econ Memo to the Fed: The economy's growth scare is your wake-up call

 Markets are worried that the Fed could get blindsided

Rather than a half-percentage-point rate cut in September, expect quarter-percentage-point cuts at each of the next four Federal Reserve meetings.

Friday's July jobs report capped a week of disappointing economic releases that collectively put the economy on recession watch. Jobless claims are up, payrolls growth and wage growth are weakening, and the outlook for the highly cyclical manufacturing industry is deteriorating.

Markets think the U.S. Federal Reserve is behind the curve, and that perception could be as damaging as its reality.

Hurting market sentiment even more, the U.S. unemployment rate rose enough in July to trigger the Sahm Rule. This is former Fed economist Claudia Sahm's observation that historically, when the unemployment rate's three-month moving average rises above its low over the previous 12 months, the economy has already slipped into recession.

There are several reasons why mid-2024 could prove an exception to the Sahm Rule. Hurricane Beryl shut down large swathes of the Houston economy in July, affecting more than 2% of Americans - a headwind that is quickly fading. The auto industry retools in the summer months, which may be behind some of the weak manufacturing sentiment and hiring. And many members of the recent wave of new immigrants arrived in the United States without jobs and looking for work, contributing to higher unemployment.

Even so, this economic growth scare should be a wake-up call for the Fed. Their economists forecast with statistical models, but their policymakers explain how they use those forecasts with narratives - with storytelling. Their dominant story in the last few years has been higher inflation for longer: the post COVID-19 pandemic economic boom, flood of stimulus, and labor shortage have shocked the U.S. economy into a regime of sticky high inflation, which only an extended bout of pain (or at least high interest rates) can return to normal.

There is some evidence that sticky inflation has legs. The big pay increases negotiated by unions in the past year are still contributing to overall wage growth, as is the fast-food wage hike in California. Service prices that reset infrequently, such as homeowners and auto insurance, are rising much faster than normal, and shelter inflation in both the CPI and PCE indexes is still too high.

But does that evidence make the story likely? Union wage deals move the needle on overall wages in Michigan. But across the U.S., unions represent only about 6% of private-sector workers. Slowing hiring and quits in the rest of the private job market already looks to have overpowered the effect of union wage deals on average wages.

For inflation more broadly, there is growing evidence that the regime is already shifting back to a cooler status quo. Consumers got some price relief in the first half of the year from less expensive new- and used cars, household appliances, furniture and electronics. Judging from the tone of many consumer-facing businesses on the second-quarter earnings calls, discounting is set to broaden in the remainder of the year to touch more prices in grocery stores, restaurant menus and services more generally.

Separately, the growth scare demands serious consideration even if the July data exaggerate how bad it is. After the latest revisions, the economy's trend wasn't great in June, well before Beryl. The three-month moving average of payrolls growth slowed to 177,000 in the June jobs report, and July's report revised the April-to-June average down further to 168,000. That is too slow to keep up with the workers entering the labor market this year and fulfill the Fed's mandate for maximum employment.

The Fed is likely to reassure markets that it's ready for a broad range of contingencies.

Where does that leave the Fed? When the economy looks like it's at a turning point, monetary policymakers want to make clear that they are ready to respond flexibly and nimbly if the turn goes further into weakness than expected, as well as being prepared if inflation resurges. The Fed's July monetary policy statement largely articulated this stance. But the Fed didn't articulate a plan to respond to a serious, self-reinforcing downturn - which absent some new inflationary shock could easily push inflation below their target - and markets are worried that the Fed could get blindsided.

This is apparent in financial markets' response to the growth scare. Markets priced in faster and somewhat deeper rate cuts over the last week, but still to a restrictive level. After Friday's close, the fed-funds futures curve still prices the fed funds rate at around 3.5% three years from now, despite a strong majority of FOMC members saying they think the neutral rate is between 2% and 3% in the June dot plot, and despite inflation-protected bonds pricing in inflation at under 2% for the next two years. The Fed has spent the past few years bolstering their inflation-fighting credibility with tough talk - so much so that markets are worried they wouldn't return rates to neutral even if growth and inflation seriously undershoot the Fed's benign base case.

I expect Fed policymakers to adjust their storytelling in the next few weeks to reassure markets they are ready for a broad range of contingencies, including serious downside risks. I'm watching for their communications to add language like: "If the balance of risks swings far enough to the downside, the Fed could cut interest rates to levels that not only wouldn't hinder growth, but would outright support it."

That would reassure the public that the Fed is alert to the possibility of a new regime change - and by doing so, lower the risk that the growth scare turns into a prolonged downturn.

That is why it seems unlikely to me that the Fed would make an outsize half-percentage-point rate cut in September or later this year. After the weaker than expected data for July, central bankers will probably adjust their tone and then make quarter-percentage-point cuts at each of their next four meetings. That would avoid the risk that a sudden swing in interest rates that scares the public into thinking the economy is worse than it really is, or pushes the Fed's monetary stance into too easy of a posture and fuels a resurgence of inflation.

Bill Adams is chief economist at Comerica Bank.

https://www.morningstar.com/news/marketwatch/2024080599/memo-to-the-fed-the-economys-growth-scare-is-your-wake-up-call

Bayer’s Finerenone Hits Primary Endpoint in Phase III Heart Failure Trial

 

With the late-stage win, Bayer announced Monday that it plans to talk to regulators about seeking approval in an indication that is central to its $3 billion-plus peak sales forecast.

Bayer said Monday its Phase III cardiovascular outcomes trial hit the primary endpoint, positioning the company to discuss with regulators filing for approval of finerenone in heart failure.

The FDA approved finerenone in adults with chronic kidney disease associated with type 2 diabetes in 2021. Bayer, which sells the drug as Kerendia in the kidney indication, also identified the potential for the non-steroidal, selective mineralocorticoid receptor antagonist to improve outcomes in people with heart failure with mildly reduced or preserved ejection fraction.

Bayer put that idea to the test in the FINEARTS-HF study. Investigators randomized around 6,000 people with symptomatic heart failure to take finerenone or placebo once a day for up to 42 months. Monday, Bayer said finerenone significantly reduced the composite of cardiovascular death and total heart failure events compared to placebo.

The significant reduction caused the trial to hit its primary endpoint. Bayer is yet to share data from the study but is sufficiently encouraged by the results to outline plans to talk to regulatory agencies about filing for approval.

Finerenone was well tolerated in the study, according to Bayer. While the company did not share data on safety and tolerability, the positive topline finding is encouraging for a molecule with a mechanism of action that has proven problematic in the past.

Mineralocorticoid receptor antagonists such as spironolactone and eplerenone are used to treat heart failure with reduced ejection fraction. In that population, the drugs have improved outcomes in clinical trials. However, spironolactone was less impressive in a trial in heart failure with preserved ejection fraction, failing to reduce cardiovascular mortality while raising the risk of elevated potassium levels.

Bayer’s trial program, which has enrolled more than 15,000 patients, and real-world finerenone use in kidney disease patients suggest the risk of elevated potassium levels may be lower for its molecule. The combination of improved cardiovascular outcomes and acceptable tolerability underpins Bayer’s hopes of turning finerenone into a blockbuster.

The company is targeting peak sales of more than 3 billion euros ($3.3 billion). Bayer has retained the sales target even as Kerendia has made a slow start in kidney disease. Talking on an earnings call in May, Stefan Oelrich, head of Bayer’s pharmaceuticals unit, said “I think we’ve all been a little underwhelmed with the development of the renal market.”

Oelrich said the market is “definitely not progressing at a speed that we had wished for” but predicted heart failure “will ultimately ... allow us to get to peak sales.” Finerenone is one of a clutch of key growth products at Bayer. The drugmaker shared positive Phase III data on another key product, prostate cancer drug Nubeqa, in July.

https://www.biospace.com/drug-development/bayers-finerenone-hits-primary-endpoint-in-phase-iii-heart-failure-trial

BMS Backs Out of $1.5B Deal, Returns Rights to Agenus for Bispecific Antibody

 

As part of a pipeline realignment, Bristol Myers Squibb is returning the rights to Agenus for its proprietary TIGIT bispecific antibody program and terminating their 2021 license, development and commercialization agreement.

Agenus announced in an SEC filing on Friday that Bristol Myers Squibb, as part of a broader strategic pipeline realignment, is returning the rights to the biotech for its proprietary TIGIT bispecific antibody program and their 2021 licensing agreement.

The filing said that BMS will return to Agenus the rights to AGEN1777, a bispecific antibody which binds TIGIT and CD96 on T cells. In 2021, the companies inked an exclusive license to develop, manufacture, and eventually commercialize AGEN1777.

The biotech received a $200 million cash payment upfront and was eligible to receive up to $1.3 billion in milestone payments. To date, Agenus has received two milestone payments of $20 million and $25 million in 2021 and 2024, respectively.

The return of AGEN1777 and termination of the license agreement will be effective as of Jan. 26, 2025, with BMS giving Agenus all of the regulatory registrations, authorizations and approvals that the pharma has accrued. Agenus will not have to pay any early termination penalties and “will have the right to continue development or enter a subsequent license in the future,” according to the SEC filing.

Agenus noted in its filing that it received notice on July 30 that BMS was returning AGEN1777 “as part of a broader strategic realignment of their development pipeline which involves other licensed products.”

BMS has been implementing cost-cutting measures in its overall business, including plans to lay off over 2,000 employees by the end of the year to generate around $1.5 billion in savings through 2025.

For the future development of AGEN1777, Agenus said that the asset had no clinical data when the deal was made but “significant safety data” has been generated in early-stage trials, with plans to develop the candidate further.

“We intend to explore further development and/or relicensing of this molecule, including potential combinations with our portfolio of synergistic immuno-oncology agents,” the filing said.

However, TIGIT antibodies have been struggling clinically. In May 2024, Merck ended a late-stage trial of a TIGIT-Keytruda combo in skin cancer, while Roche stopped a Phase II/III in June as its anti-TIGIT tiragolumab was not able to significantly improve survival in patients with non-small cell lung cancer.

AGEN1777’s return to Agenus comes it disclosed last month that the FDA advised against the biotech applying for accelerated approval for its investigational immunotherapy, a combination of botensilimab and balstilimab for treating a subtype of refractory colorectal cancer, after unveiling mid-stage data.

https://www.biospace.com/deals/bms-backs-out-of-1-5b-deal-returns-rights-to-agenus-for-bispecific-antibody

Retail Traders Furious As Outages Hit Major US Brokerages Amid Black Monday Chaos

 US retail traders are panicking this AM after likely receiving push notifications on their smartphones about market turmoil in Asia and Europe, which has since spread to the US premarket. Now that the cash session is about 15 minutes underway, website monitor DownDector reports outages are emerging across several major US brokerage houses as everyone tries to log into their accounts and sell stocks. 

DownDector reports that users of Charles Schwab, Fidelity, Ameritrade, Vanguard, and E-Trade are all reporting website outages, which have been surging around the start of the US cash session. 

For more color on the global stock meltdown, read this earlier note: "Black Monday: Futures Plummet As VIX Hits 62, Japan Suffers Worst Point Drop In History."

Just panic, just panic everywhere (courtesy of Bloomberg): 

Here's what X users are saying...

Hmmm. 

*Developing...

https://www.zerohedge.com/markets/retail-traders-furious-outages-hit-major-us-brokerages-amid-black-monday-chaos

Iran Says It Must 'Punish' Israel, Begins Clearing Airspace; Biden To Hold Situation Room Meeting

 President Joe Biden will convene his national security team in the situation room on Monday afternoon as the US has warned its top Middle East ally Israel that an Iranian attack is imminent. The defense chiefs of both countries - Gallant and Austin - are also discussing a "series of scenarios and corresponding defensive, offensive capabilities." Biden also plans to speak with Jordan's King Adbullah, the White House has confirmed.

Axios has reported Sunday that the message being conveyed abroad by Secretary of State Antony Blinken is that while Washington doesn't know the exact timing of the the attacks, they could start as early as the next 24-48 hours, which would mean as soon as Monday.

Separately a Wall Street Journal was particularly alarming given it said that Iran has told Arab diplomats that "it didn’t care if the response triggered a war" when they tried to urge deescalation and calm. Foreign ministers from Lebanon and Jordan have been in Iran trying to talk officials down from initiating a major attack.

Tehran in a fresh statement has said its intent is not to escalate, but to 'punish' Israel for the Wednesday killing of Hamas political leader Ismail Haniyeh on Iranian soil, and that it won't be dissuaded. 

"Iran seeks to establish stability in the region, but this will only come with punishing the aggressor and creating deterrence against the adventurism of the Zionist regime," according to the words of Iranian Foreign Ministry spokesman Nasser Kanaani.

Kanaani further blasted the United States and international community for providing continued support and cover to Israel, saying instead all countries should back pursuing the "punishment of the aggressor."

Also, Islamic Revolutionary Guards Corps (IRGC) chief Hossein Salami has warned that Israel was "digging its own grave" and that it "will receive punishment in due time." He indicated that this was not just due to the Haniyeh killing, but a string of covert killings and sabotage actions against the Islamic Republic.

Iran on Monday reportedly began clearing out its airspace by issuing NOTAM alerts (Notice to Air Missions alert):

"Iran has issued a NOTAM, a notice alerting an aircraft of dangers en route, for the center, west, and northwest of the country, advising aircraft to change their routes."

"Israel is the cradle of terrorism and it has been created out of killing and murder," the IRCG's Salami charged. "They think they can kill the nuclear scientists of another country and impede that country’s path toward peaceful nuclear technology. They think that by killing the leader of a resistance group… in another country will give them more time to live."

A wave of major airline cancelations at both Beirut and Tel Aviv airports have meanwhile left foreigners and others seeking to exit these countries on the brink of war scrambling and in some cases stranded. But things at Ben Gurion still appear somewhat normal in terms of activity. A Sunday assessment of the situation at Ben Gurion is as follows:

For the time being, Tel Aviv’s Ben Gurion Airport is working as normal, and Israel’s airspace remains open. The Civil Aviation Authority of Israel said in a statement "The security situation allows flights to and from Israel. Some of the foreign airlines have suspended or reduced their flights to Israel, for their own internal reasons. Travelers should take into account that their return to Israel may be delayed, and should keep in touch with the airlines and update themselves about their flights."

Unverified reports say that Beirut's international airport is currently more chaotic and crowded (also as it is smaller than Tel Aviv's) after a spate of foreign and Western embassies issued alerts telling their citizens to immediately get out while there are still tickets available.

A G7 statement is pleading for peace...

As for the potential big Iran attack, this time it is expected that Hezbollah in southern Lebanon will play a bigger role this time (compared to the April 13th ballistic missile and drone strikes), with Axios writing that "Blinken stressed that the US believes Iran and Hezbollah will both retaliate."

https://www.zerohedge.com/geopolitical/iran-says-it-must-punish-israel-wont-be-dissuaded-biden-hold-situation-room-meeting

BioNTech Loss Widens on Low Demand For COVID Vax, Ups R&D Spend On New Cancer Products

 BioNTech SE (NASDAQ:BNTX) reported deeper losses in the second quarter of 2024, with an EPS loss of $(3.62) or (3.36) euros, missing the consensus of (1.89) euros and higher than (79) cents in the second quarter of 2023.

The company reported a net loss of 807.8 million euros compared to 190.4 million euros a year ago.

The COVID-19 vaccine maker reported sales of 128.7 million euros ($138.56 million), down from 167.7 million euros a year ago and missing the consensus of 157 million euros, reflecting a continued shift in demand from a pandemic to a seasonal endemic COVID-19 vaccine market.

“The year to date has been marked by significant data updates across our oncology portfolio. These readouts reinforce the potential of our platform technologies, including our individualized and off-the-shelf mRNA vaccine platforms, iNeST and FixVac. We have also advanced our strategy by initiating clinical trials evaluating novel combinations of synergistic drug candidates,” said Ugur Sahin, CEO and Co-Founder of BioNTech.

“In addition, we have started commercializing variant-adapted COVID-19 vaccines for the upcoming season while accelerating our clinical development efforts to realize the full potential of our technologies,” Sahin added.

R&D expenses increased from 373.4 million euros to 584.6 million euros, mainly influenced by progressing clinical studies for the company’s late-stage oncology pipeline candidates.

On Monday, Genmab A/S (NASDAQ:GMAB) announced that it will assume sole responsibility for developing and potentially commercializing acasunlimab as BioNTech has opted not to participate in the further development of the acasunlimab program.

The program will be subject to payment of certain milestones and a tiered single-digit royalty on net sales by Genmab to BioNTech.

Genmab plans to initiate the Phase 3 study in the second half of this year.

BioNTech informed the company that it made the decision relating to its portfolio strategy.

Guidance: BioNTech said it is still targeting 2024 revenues of 2.5 billion euros to 3.1 billion euros.

Partner Pfizer Inc. (NYSE:PFE) raised its 2024 guidance to $8.5 billion from $8 billion but reaffirmed that $5 billion would come from BioNTech’s partnered Comirnaty-COVID-19 vaccine.

Moderna Inc (NASDAQ:MRNA) lowered its 2024 sales guidance on Thursday due to weaker demand for its COVID-19 vaccines.

https://finance.yahoo.com/news/biontechs-q2-loss-widens-amid-115926589.html