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Monday, November 3, 2025

Zelensky, VDL talk energy, Ukraine's EU membership

 Ukrainian President Volodymyr Zelensky spoke with European Commission President Ursula Von der Leyen on Monday, discussing the prospect of his country's EU membership and energy support during the upcoming winter.

Zelensky stated that "there is every reason to hope for a positive outcome" regarding Ukraine's aspirations to become a member of the EU. He also thanked von der Leyen for the bloc's pledge to provide winter support to his country.

"Ursula spoke about coordination with various institutions and countries and the funds that will be allocated to help our energy sector. These could be very significant contributions, and we will work to increase them. We agreed that our teams will start working on implementing all our agreements this week, and we agreed on further contacts and steps," he concluded.

https://breakingthenews.net/Article/Zelensky-VDL-talk-energy-Ukraine's-EU-membership/65107728

'Illinois Bars ICE Arrests In State Courthouses And Safe Zones'

 by Jonathan Turley,

Illinois has now joined California and Connecticut in barring federal immigration agents from conducting “civil arrests” of illegal aliens in or around state courthouses. The sanctuary law appears largely performative since it also appears unconstitutional. It is difficult to see how a state can bar the exercise of federal jurisdiction, at least after the Civil War.

Gov. JB Pritzker has been ratcheting up the rhetoric against ICE and the Trump Administration for months, including analogies to the Nazis and claims that democracy is dying. The new law, however, crosses the constitutional Rubicon by not only limiting the operation of Immigration and Customs Enforcement (ICE) but also establishing a 1,000-foot “buffer zone” outside of buildings.

The law makes courthouses equivalent to churches, where suspects can claim sanctuary not only when they cross the threshold but also within 1000 feet, unless, of course, ICE ignores the law.

Recently, the chief judge in Cook County issued an order with the same prohibition. A few other judges in other states have issued similar orders.

The authority for the orders is highly dubious.

The federal government can cite laws mandating the arrest of certain individuals for immigration violations. See, e.g., 8 U.S.C. § 1226(c) (mandatory detention of certain aliens who are removable due to criminal convictions or terrorist activities); id. § 1231(a) ( detention and removal of aliens with final orders of removal).

The most immediate problem for Illinois is the Supremacy Clause of the United States Constitution: “This Constitution, and the Laws of the United States which shall be made in Pursuance thereof[] . . .  shall be the supreme Law of the Land[] . . . any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.” U.S. Const. art. VI, cl. 2.

The second problem is the Supreme Court, which has repeatedly rejected such state authority to dictate federal enforcement or policies. See, e.g., Harisiades v. Shaughnessy, 342 U.S. 580, 588–89 (1952) (the United States has the “exclusive[]” control over “any policy toward aliens”); see also South Carolina v. Baker, 485 U.S. 505, 523 (1988); Mayo v. United States, 319 U.S. 441, 445 (1943).

Ironically, as I have previously pointed out, these blue states will face an unusual authority cited against them: Barack Obama. It was President Obama who went to the Supreme Court to strike down state laws that interfered with federal immigration enforcement (even in assisting that enforcement). In Arizona v. United States, 567 U.S. 387, 394 (2012), he largely prevailed and the Supreme Court affirmed that “[t]he Government of the United States has broad, undoubted power over the subject of immigration and the status of aliens.”

This recognized authority goes back to the Nineteenth Century. The Court has ruled that “Congress [has] the right, as it may see fit, to expel aliens of a particular class, or to permit them to remain,” and “has undoubtedly the right . . . to take all proper means to carry out the system which it provides.” Fong Yue Ting v. United States, 149 U.S. 698, 714 (1893).

The law also creates the ability to sue federal authorities for false imprisonment under state law.

Keep in mind that the law creates a 1,000-foot circle around any state court, creating safe zones for illegal immigrants.

The provision in the Senate legislation stated:

Section 15.

Civil arrest prohibited; certain locations.

(a) A person duly and in good faith attending a State court proceeding in which the person is a party, a witness, a potential witness, or a court companion of a party, witness, or potential witness is privileged from civil arrest while going to, remaining at, and returning from the court proceeding, including:

(1) at the place of the court proceedings;

(2) within the courthouse building;

(3) on the premises of the courthouse, including parking facilities serving the courthouse;

(4) on any sidewalk, parkway, and street surrounding the courthouse and its premises; and

(5) on any public way within 1,000 feet of the courthouse including a sidewalk, parkway, or street.

Presumably, if you rent an apartment within one of those zones, you would be able to create effective immunity by simply signing a lease. As long as you stay within the specified public areas, you will be protected from civil arrest. With Illinois and other states pushing apps tracking ICE operations, a suspect could step outside onto a sidewalk or public space to claim protection from any civil arrest. It is unclear whether landlords will raise their rents in light of the new immunity amenity.

Keep in mind, if this were constitutional, the state could add to the list of sensitive places from city services to clinics. The result would be a mosaic of safety zones that would be maddening for federal authorities. Notably, blue states have attempted the same tactic to circumvent Second Amendment rights.

The legal infirmities behind these laws is irrelevant for politicians seeking to virtue signal. However, it will come at a real cost for individuals who mistakenly rely on these assurances and assume that they are protected within safe zones.

Many states during the desegregation period challenged federal authority in the fight against civil rights. They also failed.

Of course, the greatest irony is that the two figures who will be cited against this move are the two favorite sons of Illinois who became presidents: Lincoln and Obama. Both reinforced the supremacy of federal jurisdiction.

Indeed, the bill was passed just a couple days before the anniversary of Lincoln’s election as the 16th President of the United States. He then faced states that claimed that they could take the ultimate step of removing themselves from federal authority and jurisdiction.

Illinois now claims the right to dictate where federal authority can be exercised and makes federal authorities liable for violating specified state safe zones.

Good luck with that.

https://www.zerohedge.com/political/illinois-bars-ice-arrests-state-courthouses-and-safe-zones

Alvotech Shares Slide After FDA Requests Further Action on Simponi Biosimilar

 Shares of Alvotech (NASDAQ: ALVO) fell 22% on Monday after the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the company’s proposed biosimilar to Simponi.

The FDA stated that deficiencies identified during a pre-license inspection of Alvotech’s Reykjavik, Iceland, manufacturing facility in July 2025 must be addressed before the Biologics License Application (BLA) for AVT05 can receive approval. However, the agency clarified that no additional concerns were found with the application itself, and the facility remains authorized to produce and supply Alvotech’s currently marketed products.

AVT05 is Alvotech’s biosimilar candidate referencing Simponi (golimumab), a drug that generated less than $300 million in U.S. sales in the first half of 2025, according to IQVIA data. To date, the FDA has not approved any biosimilars to Simponi in the U.S.

“As previously discussed, following the inspection of our facility, Alvotech submitted a comprehensive response to the FDA detailing our Corrective and Preventive Action (CAPA) plan. While we are disappointed in receiving the CRL, we expect to resolve any outstanding issues and will continue to work with the FDA to bring this first-to-market biosimilar to patients in the U.S.,” said Robert Wessman, Chairman and CEO of Alvotech.

In light of the FDA’s decision, Alvotech revised its 2025 financial guidance downward, now expecting total revenue between $570 million and $600 million and adjusted EBITDA in the range of $130 million to $150 million.

The company attributed the lower outlook primarily to ongoing remediation investments needed to address the facility’s inspection findings, along with a temporary slowdown in production as corrective measures are implemented.

https://www.msn.com/en-us/money/markets/alvotech-shares-slide-after-fda-requests-further-action-on-simponi-biosimilar/ar-AA1PIIVh

Prelude Therapeutics (PRLD) to Present Preclinical Findings at ASH

 Prelude Therapeutics, with ticker symbol PRLD, has announced the publication of two abstracts featuring promising preclinical data from their studies on selective inhibitors targeting the JAK2V617F mutant and CALR-targeted degrader antibody conjugates, known as DACs. These findings have been selected for oral presentation during the American Society of Hematology's (ASH) 67th Annual Meeting. The event is scheduled to occur in Orlando, Florida, from December 6-9, 2025. Full details of the abstracts are available on the ASH Annual Meeting & Exposition website for 2025.

Prelude Therapeutics Inc is a clinical-stage precision oncology company focused on discovering and developing small molecule therapies optimized to target the key driver mechanisms in cancers with high unmet needs. The company's pipeline includes four candidates currently in clinical development: PRT1419, a potent, selective inhibitor of MCL1; PRT2527, a potent and selective CDK9 inhibitor; PRT3645, a next-generation CDK4/6 inhibitor; and PRT3789, a first-in-class SMARCA2/BRM protein degrader. Operating within the biotechnology industry, Prelude Therapeutics is positioned in the healthcare sector with a market capitalization of approximately $90 million.

https://www.gurufocus.com/news/3178076/prelude-therapeutics-prld-to-present-preclinical-findings-at-ash-2025

Exact Sciences (EXAS) Tops Q3 EPS by 27c, provides guidance

 Exact Sciences (NASDAQ: EXAS) reported Q3 EPS of $0.24, $0.27 better than the analyst estimate of ($0.03). Revenue for the quarter came in at $851 million versus the consensus estimate of $810.36 million.

GUIDANCE:

Exact Sciences sees FY2025 revenue of $3.22-3.235 billion, versus the consensus of $3.157 billion.

For earnings history and earnings-related data on Exact Sciences (EXAS) click here.

https://www.streetinsider.com/Earnings/Exact+Sciences+%28EXAS%29+Tops+Q3+EPS+by+27c%2C+provides+guidance/25545139.html

Sarepta completes confirmatory study for duchenne therapies, study misses primary endpoint

 Sarepta Therapeutics (NASDAQ: SRPT) reported completion of its ESSENCE confirmatory study for AMONDYS 45 and VYONDYS 53, treatments for Duchenne muscular dystrophy. The company posted third-quarter net product revenues of $370.0 million.

The ESSENCE study evaluated the efficacy and safety of the two therapies in 225 patients aged 6-13 years with Duchenne mutations amenable to exon 45 or 53 skipping. While the study did not achieve statistical significance on its primary endpoint of 4-step ascend velocity at 96 weeks, Sarepta reported positive trends favoring treatment over placebo.

The company noted the study was impacted by the COVID-19 pandemic. When excluding data from participants whose treatment period overlapped with the pandemic, the analysis showed a 30% reduction in disease progression over two years compared to placebo.

Sarepta plans to schedule a meeting with the FDA to discuss converting from accelerated to traditional approval based on the study results and real-world evidence. The company has treated over 1,800 patients worldwide with its PMO therapies.

For the third quarter, total revenues reached $399.4 million, down from $467.2 million in the prior year period. The decrease primarily reflected lower ELEVIDYS volumes following the company's decision to suspend shipments to non-ambulatory patients in the U.S. in June 2025.

The company reported a GAAP net loss of $179.9 million for the quarter, compared to net income of $33.6 million in the prior year. Non-GAAP net loss was $12.9 million versus non-GAAP net income of $69.9 million in the prior year quarter.

Sarepta completed refinancing of a portion of its 2027 convertible notes and implemented cost restructuring initiatives during the quarter. The company expects to conclude ongoing FDA discussions regarding ELEVIDYS labeling in the near term.

https://www.streetinsider.com/Corporate+News/Sarepta+completes+confirmatory+study+for+duchenne+therapies%2C+study+misses+primary+endpoint/25545129.html

Iradimed Corporation Reports Record Q3 2025 Revenue of $21.2 M, Raises Full-Year Guidance

Iradimed Corporation reported record revenue of $21.2 million for the third quarter of 2025, a 16% increase from the previous year. The company achieved a GAAP diluted earnings per share (EPS) of $0.43, reflecting an 8% rise, and a non-GAAP diluted EPS of $0.47, up 9% year-over-year. Iradimed raised its full-year revenue guidance to between $82.5 million and $83.5 million and increased its GAAP diluted EPS guidance to $1.68 to $1.72. The company declared a quarterly cash dividend of $0.17 per share, payable on November 25, 2025. Despite some transitional challenges due to moving to a new facility in Orlando, the company maintained a strong gross margin of 78% and reported a record backlog of orders, positioning itself for future growth, including the upcoming limited commercial shipments of its next-generation MRI-compatible IV infusion pump.