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Thursday, January 23, 2025

Anthos spells out benefits of abelacimab in quest for safer blood thinners


In the race for safer anticoagulants, Anthos Therapeutics thinks it has a winner. New data published in the NEJM show that its dual-acting Factor XI/XIa inhibitor abelacimab reduced major or clinically relevant non-major bleeding by 62% compared to Xarelto (rivaroxaban) in patients with atrial fibrillation (AFib).

The company previously reported that the Phase II AZALEA-TIMI 71 trial, which was stopped early due to "overwhelming" benefit, had shown that monthly subcutaneous doses of abelacimab led to a substantial 67% lower risk on the combined primary endpoint of major or clinically relevant non-major bleeding.

"Many doctors are put in the unfortunate position of having to weigh the risk of stroke against the risk of bleeding for their patients with AFib," said principal investigator Christian Ruff in a company release Wednesday. "This study reinforces the promise of abelacimab as a potentially safer alternative to current anticoagulants."

Anthos said abelacimab also achieved a median 99% inhibition of Factor XI sustained over two years. In addition, the study showed a 67% reduction in major bleeding alone and an 89% reduction in gastrointestinal bleeding compared to daily Xarelto.

The success of abelacimab as well as a similar drug — Bristol Myers Squibb and Johnson & Johnson's oral Factor XIa inhibitor milvexian — have been a counterweight to Bayer's ill-fated asundexian. The surprise failure of Bayer's drug, another oral Factor XIa programme, in the Phase III OCEANIC-AF trial in late 2023 led it to being stopped early due to inferior efficacy versus BMS's Eliquis (apixaban).

Abelacimab's long half-life and clean bleeding profile could translate to clinical advantages versus direct oral anticoagulants (DOACs), Ruff suggested in a recent FirstWord interview.

In a physician poll, FirstWord found that 89% of cardiologists described abelacimab's clinical profile as "impressive," compared to current DOACs. Anthos estimates that 40-60% of AFib patients currently either receive insufficient doses or forgo anticoagulation altogether due to concerns about bleeding.

"Building on the overwhelmingly positive data from the AZALEA study, data on the safety of abelacimab in patients undergoing surgical procedures as well as data in patients taking antiplatelet therapy further reinforce the fundamental premise of the promise of Factor XI inhibition — the potential to prevent thrombotic events without affecting normal haemostasis," said Dan Bloomfield, chief medical officer at Anthos.

Currently, the Phase III LILAC-TIMI 76 study, which got underway in 2023, is evaluating abelacimab against placebo in AFib patients deemed unsuitable for conventional anticoagulations. That study is expected to wrap in the second half of 2026.

https://firstwordpharma.com/story/5929833

DOJ orders investigation of local compliance with Trump immigration crackdown


The Justice Department has ordered federal prosecutors to investigate state or local officials who they believe are interfering with the Trump administration’s crackdown on immigration, saying they could face criminal charges, in an apparent warning to the dozens of so-called sanctuary jurisdictions across America.

The memo, from acting Deputy Attorney General Emil Bove, signals a sharp turnabout in priorities from President Joe Biden’s Democratic administration, with the Justice Department’s civil division told to identify state and local laws and policies that “threaten to impede” the Trump administration’s immigration efforts and potentially challenge them in court.

It also tells prosecutors in no uncertain terms that they will be on the front lines of an administration-wide effort to crack down on illegal immigration and border crime and that they are expected to carry out the policy vision of President Donald Trump’s Republican White House when it comes to violent crimes, the threat of international gangs and drug trafficking.

“Indeed, it is the responsibility of the Justice Department to defend the Constitution, and accordingly, to lawfully execute the policies that the American people elected President Trump to implement,” wrote Bove, who prior to joining the administration was part of the legal team that defended Trump against two criminal cases brought by the Justice Department.

“Sanctuary” has no legal definition, but the term encompasses a range of protection for immigrants, particularly those living in the U.S. illegally. Most often, the laws put legal limits on how law enforcement in those jurisdictions can cooperate with federal immigration authorities.

Courts have repeatedly upheld most sanctuary laws, and legal experts said that while prosecutions are possible, they doubted the charges would have any traction in court.

“What would you charge these people with?” asked Robert J. McWhirter, a constitutional scholar and longtime Arizona-based immigration lawyer. “Nothing obligates local law enforcement to cooperate with federal law enforcement on any issue. Not even bank robbery.”

In Chicago, which has some of the strongest sanctuary protections nationwide, city leaders brushed off word of potential investigations. The nation’s third-largest city has been a sanctuary city for decades, limiting cooperation between police and federal immigration agents.

“If the federal government is going to investigate, that is their prerogative,” said Alderman Andre Vasqez, who is Mayor Brandon Johnson’s handpicked chair of the City Council immigration committee.

Vasquez, the son of two Guatemalan immigrants, noted a 2016 campaign rally at the University of Illinois Chicago that Trump abruptly scrapped as crowds of boisterous protesters grew. The cancellation remains a badge of honor for many young activists in the Democratic stronghold.

“There will always be that kind of relationship between Chicago, President Trump and the Republican Party,” said Vasquez. “I was born and raised in Chicago, in an immigrant family. It will take more than that to make me feel a little scared.”

Across the country, cities and towns were sending out reminders about the delicate balance of sanctuary laws, which draw distinctions between not cooperating with federal immigration officials, particularly U.S. Immigration and Customs Enforcement, and actively undermining those federal officials.

New York’s police department, for example, told employees in a memo that they are not permitted to “assist in any manner with civil immigration enforcement,” but also said they must not “take any action that will interfere with or impede civil immigration enforcement undertaken by federal authorities.”

Denver Mayor Mike Johnston said the city, where more than 40,000 migrants have arrived since early 2023, would work with ICE to arrest violent criminals. But he said the city would go to court if immigration raids targeted schools, among other places.

“We’re not going to be bullied or blackmailed out of our values,” he told The Associated Press.

Bove’s memo directs prosecutors to investigate for potential criminal charges against state and local officials who obstruct or impede federal functions. As potential avenues for prosecution, the memo cites a conspiracy offense as well as a law prohibiting the harboring of people in the country illegally.

“Federal law prohibits state and local actors from resisting, obstructing and otherwise failing to comply with lawful immigration-related commands and requests,” the memo says. “The U.S. Attorney’s Offices and litigating components of the Department of Justice shall investigate incidents involving any such misconduct for potential prosecution.”

But in Colorado, where state law bars local law enforcement from helping federal immigration agents make an arrest without a court order, the attorney general’s office said it knew of no state or local officials obstructing immigration enforcement.

“The federal government—not local law enforcement—is responsible for enforcing federal immigration laws,” the office of Phil Weiser, a Democrat, said in a statement.

The memo includes a series of directives beyond those related to sanctuary jurisdictions. It suggests there will be a spike in immigration cases under the new administration, instructing U.S. attorney’s offices across the country to inform courts of its policy “and develop processes for handling the increased number of prosecutions that will result.” Any decisions by federal prosecutors to decline to prosecute immigration violations must be disclosed to Justice Department headquarters in so-called urgent reports, which are used to update leadership on law enforcement emergencies or significant matters of national interest.

The memo also says the department will return to the principle of charging defendants with the most serious crime it can prove, a staple position of Republican-led departments meant to remove a prosecutor’s discretion to charge a lower-level offense. And it rescinds policies implemented by Biden Attorney General Merrick Garland, including one designed to end sentencing disparities that have imposed harsher penalties for different forms of cocaine.

“The most serious charges are those punishable by death where applicable, and offenses with the most significant mandatory minimum sentences,” Bove wrote.

It is common for Justice Departments to shift enforcement priorities under a new presidential administration in compliance with White House policy ambitions. The memo reflects the constant push-and-pull between Democratic and Republican administrations over how best to commit resources to what officials regard as the most urgent threat of the time.

The edict to charge the most readily provable offense, for instance, is consistent with directives from prior Republican attorneys general including John Ashcroft and Jeff Sessions, while Democratic attorneys general including Eric Holder and Garland have replaced the policy and instead encouraged prosecutorial discretion.

https://thehill.com/homenews/ap/ap-politics/ap-doj-investigations-immigration-enforcement/

Elevance Profit Plunges 50%, But Shares Jump on Dividend Hike, 2025 Growth Bet

 Elevance Health (NYSE:ELV) just dropped its Q4 earnings, and it's a mixed bag. Revenue climbed 6% to $45 billion, fueled by higher premium yields and a 19% surge in its Carelon division. But medical costs? Still a major headache. Net income took a 50% hit, landing at $418 million, as Medicaid-related expenses kept rising. The benefit expense ratio shot up to 92.4%, a clear sign that the company is still dealing with a flood of Medicaid patients catching up on postponed care.

Despite the cost surge, Elevance gave investors something to cheer about: a 5% dividend boost to $1.71 per share. CEO Gail Boudreaux doubled down on the company's strategy, emphasizing operational improvements and a push for long-term growth. The 2025 outlook? Adjusted EPS projected between $34.15 and $34.85, signaling confidence in navigating industry pressures. But the Medicaid drag is real membership dipped by 1.1 million, now sitting at 45.7 million.


https://finance.yahoo.com/news/elevance-healths-profit-plunges-50-171110293.html

Veeva cut to Sell from Buy by Goldman

 Target to $200 from $261

https://finviz.com/quote.ashx?t=VEEV&ty=c&ta=1&p=d

SELLAS Life Sciences stock falls on data

 SELLAS Life Sciences (SLS) stock falls following interim results from a Phase 3 REGAL trial for its lead asset, galinpepimut-S (GPS)

https://seekingalpha.com/news/4397943-sellas-life-sciences-stock-falls-gps-data

Option Care uppled to Buy from Hold by Jefferies

 Target to $35 from $26

https://finviz.com/quote.ashx?t=OPCH&ty=c&ta=1&p=d

ALX Oncology stock falls amid Phase 2 data update

 ALX Oncology (NASDAQ:ALXO) stock fell 16% Thursday after the company reported updated data from a Phase 2 study called ASPEN-06 for its drug candidate evorpacept.

ALX said the data showed evorpacept generated a durable clinical response and exhibited a well-tolerated safety profile in patients with previously treated HER2-positive advanced gastric cancer or gastroesophageal junction cancer, according to a statement.

The updated results are scheduled to be presented Thursday at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium in San Francisco.

https://www.msn.com/en-us/money/markets/alx-oncology-stock-falls-16-amid-phase-2-data-update/ar-AA1xJPbd?ocid=finance-verthp-feeds