Search This Blog

Friday, March 8, 2024

Arcellx Can Potentially Outperform Bristol, J&J Multiple Myeloma Cell Therapies: Morgan Stanley

 Morgan Stanley initiates Arcellx Inc 

Get Free Report
, noting a differentiated CAR-T platform for blood cancer backed by an established CAR-T partner.

ddBCMA (aka anito-cel) is Arcellx’s lead asset, incorporating its patent-protected D-domain as the extracellular binding domain. 

The domain’s differentiated design confers several advantages, including high transduction efficiency and stability, which drives a potential best-in-class profile and scalable manufacturability. 

Morgan Stanley analysts model around $5 billion in unadjusted global peak ddBCMA sales across multiple treatment lines (vs. unadjusted global peak sales of around $8 billion for Carvykti per VA consensus) with a program blended probability of success (PoS) of 60% (higher in late-line, lower in earlier-line).

Carvykti (ciltacabtagene autoleucel) is marketed in collaboration between Johnson & Johnson 

Get Free Report
 and Legend Biotech Inc 
Get Free Report
.

Morgan Stanley initiates Arcellx with an Overweight rating with a price target of $81.

If ddBCMA proves successful, it could secure approval in the United States for late-line multiple myeloma by 2026, potentially capturing up to 46% of the market. 

The promising Phase 2 data suggests that ddBCMA’s safety and efficacy profile is superior, positioning it to outperform Bristol-Myers Squibb Co 

Get Free Report
 and 2Seventy Bio Inc’s 
Get Free Report
 Abecma (idecabtagene vicleucel) and compete effectively with Carvykti. 

Collaborating with Gilead Sciences Inc 

Get Free Report
 is expected to provide Arcellx with valuable expertise in CAR-T cell manufacturing, helping avoid the manufacturing challenges that hindered Carvykti’s market reach.

In December 2023, Arcellx announced new data from its Phase 1 expansion study of CART-ddBCMA for relapsed and/or refractory multiple myeloma

The interim anito-cel Phase 1 clinical results (October 15, 2023 cutoff date) demonstrate deep and durable responses.

https://www.benzinga.com/analyst-ratings/analyst-color/24/03/37544416/arcellxs-lead-asset-can-potentially-outperform-bristol-myers-squibb-johnson-johnson

Gene Therapy Player Duchenne Data Is Impressive, RBC Upgrades REGENXBIO

 RBC Capital Markets upgraded REGENXBIO Inc 

Get Free Report
, a company focused on developing gene therapies.

Recently, REGENXBIO reported additional interim safety and efficacy data in the Phase 1/2 AFFINITY DUCHENNE trial of RGX-202 in patients with Duchenne muscular dystrophy (Duchenne) ages 4 to 11.

In new data from the first patient, aged 12.1 years, who received RGX-202 at dose level 2, RGX-202 microdystrophin expression was measured to be 75.7% compared to control at three months. 

A reduction in serum creatinine kinase (CK) levels of 77% was observed at ten weeks from baseline.

Elevated CK levels are associated with muscle injury and are uniformly elevated in Duchenne patients. 

RBC Capital remains cautious about the company’s ocular programs, though the analyst notes that the recent execution of DMD has impressed and should drive the stock higher from here.

While the data is still early, the RBC analyst highlights that the crucial question of whether retaining the CT domain can result in better outcomes is yet to be determined. 

Nevertheless, the expression data is impressive, and the upcoming PDUFA for Sarepta Therapeutics Inc 

Get Free Report
 can be a significant catalyst

RBC upgraded REGENXBIO stock to Outperform from Sector Perform, with a price target of $35, up from $20.

The analyst underwrites that 15-20% of patients are not eligible for Sarepta/Pfizer Inc 

Get Free Report
 due to neutralizing antibodies. 
The analyst notes a potential upside if REGENXBIO shows better benefits or captures a broader population. 

You Have Got To Be Kidding Me...?

by Michael Snyder via The Economic Collapse blog,

By the time you are done reading this article, you may be tempted to tear your hair out.  A substantial portion of the U.S. population is deeply struggling in our current economic environment, but instead of focusing on helping Americans that are hurting, homeless and hungry, our leaders are going to great lengths to make things better for those that have no legal right to be in this country.  Our priorities are way out of whack, and U.S. voters are fed up.  Immigration has become the hottest political issue during this campaign season, but many of our politicians still don’t seem to understand why so many of us are so frustrated with what has been going on. 

Let me give you some examples of what I am talking about.

It is being reported that more than half of all Americans over the age of 65 “are living on incomes of $30,000 or less a year”…

And, for some, the retirement crisis is already here. Just over half of Americans over the age of 65 are living on incomes of $30,000 or less a year, according to the Census Bureau’s Current Population Survey. The largest share — just under 23% — have incomes between $10,000 and $19,999.

Millions of elderly Americans are barely surviving at this point.

Meanwhile, the Biden administration has been flying hundreds of thousands of migrants that have no legal right to be here directly into the country…

It means that while record numbers of migrants were flowing over the southern border last year, the Biden White House was also directly transporting them into the country.

Use of a cell phone app has allowed for the near undetected arrival by air of 320,000 aliens with no legal rights to enter the United States.

It comes after a controversy over a 2022 transportation program in which the administration used taxpayers money to move migrants throughout the country on overnight flights.

You have got to be kidding me.

Let me give you another example.

Since 2020, the income needed “to comfortably afford a home in the US” has gone up by 80 percent…

According to Zillow, the income needed to comfortably afford a home in the US has leapt 80% since 2020, far exceeding what the BLS reports has been a 23% increase in median household income over the same period.

The real estate website found home buyers today need to make more than $106,000 a year, up $47,000 from 2020, a change driven largely by higher prices and borrowing costs.

“Housing costs have soared over the past four years as drastic hikes in home prices, mortgage rates and rent growth far outpaced wage gains,” said Orphe Divounguy, a senior economist at Zillow.

But instead of doing something about that, politicians in California actually want to provide interest-free home loans with no down payment required to newly arrived migrants

Assembly Bill 1840 would change existing law to allow illegal immigrants to be eligible for the California Dream for All Fund, which provides interest-free loans for a down payment on a home for first-time buyers.

The bill was introduced by California Assemblyman Joaquin Arambula, a Democrat, who last month told GV Wire, a Fresno-based news outlet, that he “wanted to ensure that qualified first-time homebuyers include undocumented applicants.”

You have got to be kidding me.

Don’t stop reading now, because there is more.

On Thursday, we learned that the number of layoffs in the U.S. last month was the highest total that we have seen during February since 2009

The pace of job cuts by U.S. employers accelerated in February, a sign the labor market is starting to deteriorate in the face of ongoing inflation and high interest rates.

That is according to a new report published Thursday by Challenger, Gray & Christmas, which found that companies planned 84,638 job cuts in February, a 3% increase from the previous month and a 9% jump from the same time last year.

It marked the highest layoff total for the month of February in data going back to 2009.

That is terrible news.

But instead of finding jobs for American workers, New York Governor Kathy Hochul wants to “prioritize” hiring newly arrived migrants for state jobs…

New York Governor Kathy Hochul is pushing a plan to prioritize hiring illegal aliens for state jobs by eliminating certain requirements like the civil service exam and high school diploma.

The aim is to expedite the process for illegal immigrants to secure state jobs once they have work permits.

You have got to be kidding me.

Last but not least, let’s talk about what is going on in Washington right now.

In preparation for the State of the Union address, a “large steel fence” was being put up around the U.S. Capitol…

Ahead of President Joe Biden’s State of the Union address this evening – what concerns do the political elites on Capitol Hill have that require security crews to erect a large steel fence around the immediate perimeter of the Capitol Complex?

In several posts on X, FOX News Senior Congressional Correspondent Chad Pergram said the steel, grated 12-foot fence around the Capitol Complex was erected on Wednesday night on the orders of the Secret Service.

Apparently our leaders in Washington have no problem with being protected by walls.

Unfortunately, our southern border has been left wide open and it is being estimated that approximately 10 million migrants have come pouring into this nation since Joe Biden entered the White House…

The number of illegal immigrants in the country has roughly doubled under President Biden. The United States had some 10.2 million illegal immigrants in 2020, and another 10 million have entered during Biden’s presidency. If the 20 million illegal immigrants were all in one state, it would be tied with New York for the fourth most populated state.

And here’s even worse news. If Biden wins a second term in office and there is no serious reform of U.S. immigration and asylum laws — both of which are very real possibilities — we can expect a continuing increase in the rate of immigrants crossing the border illegally.

You have got to be kidding me.

We already have tens of millions of people that are deeply suffering in this country.

To allow millions more to come marching in doesn’t make any sense at all.

We can’t even afford to take care of the people that we already have.  We are completely broke, and we have been adding another trillion dollars to the national debt about every 100 days.

We are literally committing national suicide, but most of our politicians don’t seem alarmed by this at all.

https://www.zerohedge.com/political/you-have-got-be-kidding-me

Texas GOP Voters Demand End to Unconstitutional National Guard Deployments

 In the latest indication that rank-and-file Republicans are ready to move on from an era of senseless and unconstitutional militarism, a whopping 84% of Texas GOP voters on Tuesday backed a resolution demanding that the Lone Star State reject any deployment of National Guard troops to a combat zone without a congressional declaration of war.    

The proposition, one of 13 non-binding questions put to Republican voters in Tuesday's primary election, said, "The Texas Legislature should prohibit the deployment of the Texas National Guard to a foreign conflict unless Congress first formally declares war."

The proposition's presence on the Texas ballot is a testament to the growing momentum of the nationwide "Defend the Guard" movement, which is led by Bring Our Troops Home, a group of Global War on Terror veterans and like-minded civilians seeking an end to "endless wars."

"To paraphrase that great frontiersman, Davy Crockett, the military-industrial complex can go to hell, and I'll go to Texas,said Dan McKnight, founder and chairman of Bring Our Troops Home and a veteran of an 18-month deployment to Afghanistan.  

With the help of allies like the libertarian 10th Amendment Center, Bring Our Troops Home is pushing state legislators to advance model legislation that would prevent governors from releasing National Guard soldiers into active federal duty in combat zones without proper congressional authorization.   

"'Defend the Guard' legislation does not nullify federal law. It only obligates the federal government to follow what is already federal law — Congress’ duty to declare war — as outlined in Article I, Section 8 of the U.S. Constitution." -- Defend The Guard

While no state has yet enacted such a law, the concept is gaining traction. Last week, the Idaho Senate passed the Defend the Guard Act in a lopsided 27-8 vote. The measure now advances to the Idaho House of Representatives for consideration.

"This is the third legislative body to pass Defend the Guard this year, following New Hampshire and Arizona," wrote Bring Our Troops Home on the social media platform previously called Twitter. Our bill sponsor, [Ben Adams], a U.S. Marine who served two tours in Afghanistan, was present at our organization’s founding in 2019. It’s taken four years of labor to reach this point." 

The Texas proposition's overwhelming victory and the Idaho Senate's passage of a Defend the Guard bill come weeks after three members of the Georgia National Guard were killed in a drone strike on their base in Jordan. According to a US Air Force airman the facility is a base for American drones used to conduct reconnaissance and targeting operations in Syria and Iraq

Aside from the steep toll that unconstitutional deployments take on service-members and their families, they also deprive states of National Guard resources during crises at home. As noted in a Defend the Guard deep-dive at Stark Realities:

"When Hurricane Katrina devastated New Orleans and the Gulf Coast of Louisiana and Mississippi in 2005, thousands of the states’ National Guard soldiers were deployed to Iraq. Mississippi’s 223rd Engineer Battalion returned to repair hurricane damage—but was ordered to leave its equipment in Iraq for use by other units.

In 2020, as Oregon endured some of its worst wildfires ever, half the state’s National Guard helicopters were in Afghanistan, including all its CH-47 Chinooks—dual-rotor choppers capable of carrying 26,000-pound payloads and ideal for use in firefighting. The Oregon Guard did what it could with Blackhawk helicopters that have one tenth the lifting power."

The Defend the Guard movement is led by conservative and libertarian vets. “Every one of us raised our hands and swore an oath to the Constitution…and when it says Congress shall be the only body to declare war, we take that to heart," said McKnight.  "And when Congress doesn’t do it, we understand bad things can happen: long, endless foreign misadventures."

https://www.zerohedge.com/political/texas-gop-voters-demand-end-unconstitutional-national-guard-deployments

Goldman: Angry Shouting Aside, Here's What Biden Is Running On

 Last night, Joe Biden gave an extremely dark, threatening, angry State of the Union address - in which he insisted that the American economy is doing better than ever, blamed inflation on 'corporate greed,' and warned that Donald Trump poses an existential threat to the republic.

But in between the angry rhetoric, he also laid out his 2024 election platform - for which additional details will be released on March 11, when the White House sends its proposed budget to Congress.

To that end, Goldman Sachs' Alec Phillips and Tim Krupa have summarized the key points:

Taxes

While railing against billionaires (nothing new there), Biden repeated the claim that anyone making under $400,000 per year won't see an increase in their taxes.  He also proposed a 21% corporate minimum tax, up from 15% on book income outlined in the Inflation Reduction Act (IRA), as well as raising the corporate tax rate from 21% to 28% (which would promptly be passed along to consumers in the form of more inflation). Goldman notes that "Congress is unlikely to consider any of these proposals this year, they would only come into play in a second Biden term, if Democrats also won House and Senate majorities."

Biden also called on Congress to restore the pandemic-era child tax credit.

Immigration

Instead of simply passing a slew of border security Executive Orders like the Trump ones he shredded on day one, Biden repeated the lie that Congress 'needs to act' before he can (translation: send money to Ukraine or the US border will continue to be a sieve).

As immigration comes into even greater focus heading into the election, we continue to expect the Administration to tighten policy (e.g., immigration has surged 20pp the last 7 months to first place with 28% in Gallup’s “most important problem” survey). As such, we estimate the foreign-born contribution to monthly labor force growth will moderate from 110k/month in 2023 to around 70-90k/month in 2024. -GS

Ukraine

Biden, with House Speaker Mike Johnson doing his best impression of a bobble-head, urged Congress to pass additional assistance for Ukraine based entirely on the premise that Russia 'won't stop' there (and would what, trigger article 5 and WW3 no matter what?), despite the fact that Putin explicitly told Tucker Carlson he has no further ambitions, and in fact seeks a settlement.

As Goldman estimates, "While there is still a clear chance that such a deal could come together, for now there is no clear path forward for Ukraine aid in Congress."

China

Biden, forgetting about all the aggressive tariffs, suggested that Trump had been soft on China, and that he will stand up "against China's unfair economic practices" and "for peace and stability across the Taiwan Strait."

Healthcare

Lastly, Biden proposed to expand drug price negotiations to 50 additional drugs each year (an increase from 20 outlined in the IRA), which Goldman said would likely require bipartisan support "even if Democrats controlled Congress and the White House," as such policies would likely be ineligible for the budget "reconciliation" process which has been used in previous years to pass the IRA and other major fiscal party when Congressional margins are just too thin.

So there you have it. With no actual accomplishments to speak of, Biden can only attack Trump, lie, and make empty promises.

https://www.zerohedge.com/political/angry-shouting-aside-heres-what-biden-running