Pentagon Refuses To Rule Out Strikes On Moscow In Exchange On Ukraine Incursion

 The Pentagon on Thursday was asked by a reporter during the daily briefing whether Ukraine forces' use of American weapons in its ongoing Kursk incursion is "consistent" with US policy of what Ukraine can and cannot do with US weapons. It has become clear that Ukrainian troops are currently using American weapons to attack Russian territory, troops, civilians, and infrastructure.

Spokeswoman Sabrina Singh answered without hesitation that "yes it is consistent with our policy" and explained that Washington has supported the need for "crossfire" from Ukraine back across the border onto Russian positions from which it is being attacked, even if that is on Russian territory. She framed what is happening in Russia's Kursk oblast—an offensive which has entered day four—as 'defensive' in nature.

Singh still tried to point out that it remains US policy for Ukraine to avoid striking deep into Russian territory using American arms; however, when pressed about the scenario of a direct attack on Moscow, she simply said: "I’m not going to put a specific range on it" and thus refused to rule it out. But she did caveat that "we still don't support long-range attacks into Russia." Singh additionally explained, "I'm not gonna draw a circular map for you here of where they can and cannot strike." The Kremlin is likely to remain unconvinced when hearing this clear escalation in rhetoric from the Pentagon where attacking the Russian capital is discussed, even if theoretically. Watch the full exchange related to the Kursk offensive below:

Needless to say we have entered incredibly dangerous times in this major proxy war when the Pentagon's daily press briefing is openly talking about strikes on Moscow.

The Ukrainian cross-border offensive, which may have involved up to 1,000 men, began early Tuesday morning and was led by fast moving armored vehicles, which were able to penetrate up to 10km into Ukraine. Moscow says that it has observed US-supplied equipment being utilized in the attack on Russian soil.

A prior Russian Defense Ministry (MoD) statement said, "Video monitoring data shows that Lancet loitering munitions destroyed a US-made Bradley infantry fighting vehicle, a Kazak armored vehicle, a Ukrainian armored personnel carrier and an infantry fighting vehicle in their firing positions." Newsweek also confirmed based on video evidence.

The MoD further said that dozens of armored vehicles breached the border and were operating inside Russia amid a major response to push out the invaders which has included airpower.

As of Friday, the fighting in Kursk is in its fourth day, which is unprecedented for a Ukrainian military incursion inside Russia. Ukraine has simultaneously stepped up its cross-border drone attacks, reportedly hitting an important military airfield in the Lepetsk region, impacting a facility where glide-bombs are stored. According to the latest:

• Ukrainian drones struck a key military airfield in Russia's Lipetsk region, as Kyiv continues its largest offensive on Russian soil since the start of the war.
• Ukrainian forces targeted the airfield in Lipetsk — roughly 300 kilometers (186 miles) from the border with Ukraine — on Thursday night, hitting warehouses and a number of unspecified objects in the vicinity of the airport, Ukraine's General Staff of Command said in a Google-translated Telegram post.
• Earlier in the week, the Ukrainian offensive led to the evacuation of thousands of people and a state of emergency being announced in Kursk.

The timing of this high-risk assault is interesting, happening at a time where Ukraine has been on a slow and steady retreat in the Donbass. Ukraine needed something 'big' to both distract Russia's military command from front line operations and as a blow to Moscow's morale. 

And now Kiev is pressing the Biden White House to let it use ATACMS long-range missiles to strike deeper into Russia.

"This will give them the leverage they need for negotiations with Russia — this is what it’s all about," Mikhail Podoliak, a senior advisor to President Zelensky, told The Washington Post.

On Thursday, Zelensky himself had said Russia needs to "feel" the consequences of its invasion and war. "Russia brought the war to our land and should feel what it has done," he said.

It is now looking like Ukraine will actually seek to maintain hold over parts of Kursk Oblast, and its officials have dubiously claimed to have captured approximately 100 square kilometers of territory. Ukraine also says it has taken hundreds of Russian soldiers as prisoners.

According to The Washington post as well as Ukrainian media sources:

The Ukrainian leadership has approached the US for permission to use ATACMS to target Russian territory after the Armed Forces of Ukraine (AFU) conducted an incursion into Russia’s Kursk Oblast. This could allow Kyiv to hold the territory they have pushed into, according to The Washington Post, citing an anonymous advisor to President Volodymyr Zelensky.

The long-range missiles are planned to be used to strike Russian military airfields from which Russian aircraft conduct bombing raids on Ukrainian positions. According to the source, such a political decision would help the AFU maintain control over parts of the Kursk Oblast.

US Army Tactical Missile System (ATACMS), AFP

Based on the above-mentioned words of the Pentagon press secretary where she noticeably did not verbalize limits on striking Moscow, this potential greenlight from Washington to use ATACMS on Russian territory is looking more likely by the day.

President Putin will see this as the US much more directly entering the war, and has previously set firm red lines on such a scenario.

https://www.zerohedge.com/geopolitical/pentagon-refuses-rule-out-strikes-moscow-shocking-exchange-ukraines-incursion-kursk

Minnesota Supreme Court Rejects Challenge To Voting Rights For Felons On Probation

 by Katabella Roberts via The Epoch Times (emphasis ours),

The Minnesota Supreme Court unanimously upheld a 2023 state law returning voting rights to Minnesotans with felony convictions immediately after their release from prison.

In its Aug. 7 ruling, the state’s highest court did not comment on the merits of the law but rejected a challenge from the nonpartisan organization Minnesota Voters Alliance (MVA), alongside four citizen plaintiffs.

The court agreed with a previous lower court decision that found the group and individuals lacked legal standing to challenge the measure and had failed to prove that the Legislature overstepped its authority when it voted to extend voting rights to individuals who are out of jail but still on probation for a felony.

The legislation, House File 28 or the “Restore the Vote” bill, was signed into law by Minnesota Gov. Tim Walz—whom Vice President Kamala Harris announced this week as her running mate—in March last year.

It returned the right to vote for convicted felons who have completed their term of incarceration, including those who remain on parole or probation, and required the Department of Corrections or judiciary system officials to inform the convicted felons in writing that they were able to vote upon their release.

The measure maintained that incarcerated individuals would not be able to vote.

At the time Walz signed the bill into law, he said it would likely apply to more than 55,000 convicted felons in the state who have completed their prison terms, thus allowing them to vote immediately.

The measure marked the largest expansion of voting rights in Minnesota in a half-century, as previously convicted felons had to wait until the completion of their probation period to be able to vote again.

While the bill was set to go into effect on July 1, 2023, it was quickly challenged by the MVA, who argued in a lawsuit filed in Anoka County District Court that the law violates the state Constitution.

The group pointed to Article VII, Section 1 of the Minnesota Constitution, which requires that a felon may be “entitled or permitted to vote at any election in this state” only after they have been “restored to civil rights.”

They argued the law was unconstitutional because it returns a felon’s right to vote before their civil rights are returned, or before the felon has been “relieved of all limitations and burdens, such as parole and restitution, placed on them by the court-imposed sentence.”

‘Constitutional Questions Unanswered’

However, lower court Anoka County Judge Thomas Lehmann overruled the MVA’s challenge, citing a lack of standing by the taxpayer as a valid standing “requires a challenge to an illegal expenditure or waste of tax money.”

The lower court determined that the taxpayers “failed to satisfy this requirement” because they “did not challenge a specific disbursement of public funds” but instead, used the Legislature’s appropriations as a “mere jumping-off point” to “challenge something that has nothing to do with money: namely, the eligibility of some citizens to vote.”

MVA then appealed to Minnesota’s Supreme Court, which agreed with the lower court and concluded that the taxpayers lacked standing.

“We instead hold that when standing would not otherwise exist to challenge a substantive law, a taxpayer cannot manufacture standing by pointing to expenditures that are incidental to implementing the law,” the court wrote.

The ruling from the state’s Supreme Court comes as early voting for next week’s primary election is already underway. Early voting for the Nov. 5 general election will start on Sept. 20.

In a response to the Minnesota Supreme Court’s ruling, the MVA said it was “disappointed that this decision makes it more difficult for Minnesotans to hold their government accountable and leaves the important constitutional questions in this case unanswered.”

“We are deeply frustrated that the Minnesota Supreme Court chose to limit our clients’ rights as taxpayers to challenge their government’s unlawful actions in the courts,” said Doug Seaton, president of UMLC, the organization that challenged the law on behalf of the MVA. “This decision sidesteps the necessary constitutional scrutiny and leaves Minnesotans without a clear resolution on the legality of significant changes to our voting laws.”

The MVA vowed to “continue to seek resolution to government or legislative actions that negatively impact Minnesota’s election system.”

Chase Smith and The Associated Press contributed to this report.

https://www.zerohedge.com/political/minnesota-supreme-court-rejects-challenge-voting-rights-felons-probation

AN2 To Stop Phase 3 Study Of Lung Infection Candidate

 AN2 Therapeutics, Inc. (NASDAQ:ANTX) released topline results from the Phase 2 part of the EBO-301 Phase 2/3 study of epetraborole on top of an optimized background regimen (OBR) in treatment-refractory mycobacterium avium complex (MAC) lung disease.

The Phase 2 part of the study met its primary objective of demonstrating the potential validation of a novel patient-reported outcome (PRO) tool and a higher PRO-based clinical response rate in the epetraborole + OBR arm (39.5%) vs. placebo + OBR (25.0%; treatment difference 13.9%, p=0.19).

However, sputum culture conversion at Month 6, a key secondary endpoint, was similar between treatment arms (13.2% in epetraborole + OBR vs. 10.0% placebo + OBR; treatment difference 3.4%, p=0.64).

In February, the company voluntarily paused new patient enrollment in the Phase 3 part of the study due to potentially lower-than-expected efficacy observed in blinded aggregate data.

Based on today’s topline data, the company will terminate the Phase 2 (80 patients) and Phase 3 parts of the EBO-301 trial (97 patients enrolled before pause).

Oral epetraborole 500 mg daily was generally well-tolerated and the study was not terminated due to safety concerns.

“In the coming months, we will further evaluate the results from the EBO-301 study and make informed decisions regarding the potential future development of epetraborole for NTM lung disease in other patient populations,” said Eric Easom, Co-founder, Chairman, President, and CEO.

“We plan to embark on a strategic restructuring and expect to extend our cash runway through 2027, focusing our cash resources on advancing our pipeline through multiple milestones,” said Easom.

In an SEC filing, AN2 Therapeutics announced that it will reduce its workforce by 50% following the discontinuation of the EBO-301 study.

The company expects to incur approximately $2-$3 million charges.

https://finance.yahoo.com/news/lung-disease-focused-an2-therapeutics-161553808.html

Doximity upped to Buy from Hold by Needham

 Target $38

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

FDS up on a hangover update

 FSD Pharma (NASDAQ:HUGE) stock is taking off on Friday after the biopharmaceutical company provided investors with an update on its investment in Celly Nutrition.

FSD Pharma notes that Celly Nutrition is closing in on the launch of its “unbuzzd” product. This is a drink that is capable of speeding up the metabolism to ensure faster recovery from alcohol consumption.

Here’s a quick description from Celly Nutrition of unbuzzd and how it works:

“Today’s recovery drinks focus on alleviating the discomfort known as the “hangover.” However, unbuzzd™ aims to reshape this paradigm. unbuzzd helps your body process alcohol faster, restore mental alertness, and improve cognition so you can drink responsibly and drink refreshingly. unbuzzd appeals to a broad target audience of alcohol consumers who want to have a good time, be in control, and still feel great the next day.”

HUGE Stock: When Will Unbuzzd Launch?

Unbizzed will first launch as packs available on Amazon (NASDAQ:AMZN) later this month. The company intends to introduce read-to-drink versions of unbuzzd to its product lineup later this year.

It’s also worth noting that FSD Pharma launched a round of financing to support the release of unbuzzd. That includes 6,833,332 shares of HUGE stock sold for $203,469. It also has the option for additional share sales to raise additional money.

https://investorplace.com/2024/08/fsd-pharma-is-up-216-today-what-is-going-on-with-huge-stock/

Fed Judge Tosses C of C Challenge to IRA’s Drug Price Negotiation Program

 

In the latest setback for the pharma industry and its allies, the United States District Court for the Southern District of Ohio dismissed a U.S. Chamber of Commerce lawsuit on the grounds of improper venue.

A federal court on Thursday dismissed the U.S. Chamber of Commerce’s lawsuit against the Inflation Reduction Act’s Drug Price Negotiation Program, handing the pharma industry and its supporters another loss in their legal challenge to the Biden administration.

Judge Michael Newman, of the United States District Court for the Southern District of Ohio, wrote in his opinion that the Chamber of Commerce—alongside its co-plaintiffs, the respective Chambers in Ohio, Dayton Area and Michigan—“do not have standing to sue in their own right.” Newman dismissed the case on the grounds of improper venue.

Over the past year, the pharma industry has filed several lawsuits seeking to block the Inflation Reduction Act’s Medicare Drug Price Negotiation Program. The allegations are broadly similar—that the program violates their constitutional rights, represents an unlawful taking of their products and breaches due process—but the cases have been filed in many different courts.

Legal experts have described this as a divide-and-conquer strategy by the drugmakers and their allied trade groups, which are looking to secure conflicting verdicts and opinions in lower courts with the goal of attracting the attention of the U.S. Supreme Court to weigh in and resolve the matter.

However, Newman appears to have seen through this tactic and refused to play into it. In his Thursday opinion, he called out the pharma industry which has “attempted to manipulate the system and manufacture standing to obtain a favorable venue.”

If his court had found that the plaintiffs had standing in this case, “it would open the door for any individual or company to bypass venue rules by becoming a member of any association remotely related to a challenged law or regulation,” Newman wrote. “The Court will not adopt a loose interpretation of the standing requirement for the purpose of forum shopping.”

Newman is not alone in his skepticism of pharma’s campaign against the Inflation Reduction Act, with several other courts have handed the industry back-to-back defeats. New Jersey District Court Judge Zahid Quraishi ruled late last month that Novo Nordisk’s participation in the drug negotiations was voluntary—a direct rejection of the company’s argument that the government was essentially forcing it to participate in the program.

Quraishi made a similar ruling in April 2024 when he handed Johnson & Johnson and Bristol Myers Squibb similar defeats in their respective lawsuits. The government is “not taking drugs from Plaintiffs,” Quraishi wrote at the time, adding that “selling to Medicare may be less profitable than it was before the institution of the Program, but that does not make [the] decision to participate any less voluntary.”

AstraZeneca, which filed its lawsuit in Delaware, also lost its case in March 2024 with Judge Colm Connolly insisting that the pharma had “no legitimate claim of entitlement to sell its drugs to the Government at any other price other than what the Government is willing to pay.”

https://www.biospace.com/policy/federal-judge-tosses-chamber-of-commerce-challenge-to-iras-drug-price-negotiation-program

Biohaven Q2

 

• Cash, cash equivalents, marketable securities and restricted cash totaled approximately $440 million on June 30, 2024
• Biohaven's Molecular Degrader of Extracellular Proteins (MoDE™) platform advancing multiple new targets and reported positive interim data from its lead investigational drug in an ongoing Phase 1 study of BHV-1300:
  • The Company reported dose-dependent and rapid IgG reductions in its ongoing Phase 1 trial with its lead investigational degrader BHV-1300
  • No serious adverse events (SAEs) reported with BHV-1300 to date; most adverse events (AEs) were mild, deemed unrelated to study drug and resolved spontaneously
  • Phase 1 study also completed an assessment of an optimized subcutaneous (SC) formulation of BHV-1300 that demonstrated approximately a 44% higher than expected exposure compared to the dose-equivalent intravenous formulation previously studied; this new human data further confirms feasibility of convenient self-administered SC auto-injector and the SC formulation was not associated with injection site reactions
  • Degrader platform expected to deliver 3 INDs for new MoDE programs before year-end in addition to continued data from SAD/MAD with BHV-1300
  • Biohaven's beta-1 adrenergic receptor (β1AR) autoantibody targeting MoDE, BHV-1600, granted INTERACT meeting with FDA in 2H 2024 regarding development program for dilated cardiomyopathy
• Advancing novel ion channel program targeting Kv7 activation and TRPM3 antagonism across multiple neurological, pain and neuropsychiatric disease indications:
  • 5 Phase 2/3 trials with BHV-7000 underway in epilepsy and mood disorders
  • Released positive Phase 1 data with TRPM3 antagonist BHV-2100 showing drug concentrations above EC90 target and well-tolerated profile across all doses in SAD/MAD study; advancing Phase 2 study in acute migraine and proof-of-concept (POC) study in pain in 2H 2024
• Taldefgrobep alfa, a myostatin-inhibitor, progressing on track with Phase 3 topline data in spinal muscular atrophy (SMA) and Phase 2 trial initiation in obesity expected in 2H 2024
  • Taldefgrobep alfa has demonstrated direct effects on reducing adipose tissue (including lipid storage and mitochondrial content) independent of increases in muscle mass
  • In a MAD study, conducted in healthy adults, taldefgrobep alfa (45 mg SC QW) produced significant reductions in total body fat while increasing total body lean mass
  • Preclinical data released at the 2024 American Diabetes Association conference demonstrated that taldefgrobep alfa, as a monotherapy or in combination with a GLP-1 agonist, demonstrated significant reductions in fat and total body weight. Taldefgrobep alfa-treated animals showed significant increases in lean muscle, despite co-administration with a GLP-1 receptor agonist
• Tyrosine Kinase 2/Janus Kinase 1 (TYK2/JAK1) selective inhibitor, BHV-8000, completed Phase 1 and confirmed biomarker target engagement with reductions in inflammatory markers and demonstrated central nervous system penetration with confirmed cerebrospinal fluid (CSF) target exposures in healthy subjects
  • Advancing registrational programs for Parkinson's disease and prevention of Amyloid-Related Imaging Abnormalities (ARIA) following interactions with the FDA
• Expect interim data analysis from second ongoing Phase 3 OCD trial with troriluzole in 2H 2024; topline data from first Phase 3 OCD trial expected in 1H 2025
• SCA interactions with troriluzole filing in Europe ongoing and constructive interactions in the US with the FDA
  • New real-world evidence (RWE) protocol, incorporating feedback from the FDA, assessing 3-years of treatment with troriluzole expected to deliver topline results in 2H 2024
• Biohaven antibody drug conjugate (ADC) portfolio positioned to deliver differentiated profiles and address unmet needs in oncology:
• BHV-1510 currently dosing cancer patients in Phase1/2 study and now advancing towards combination with Libtayo® by 4Q 2024
• Portfolio of multiple advanced nonclinical BHVN ADCs demonstrate improved plasma stability and in vitro/in vivo differentiation

https://www.prnewswire.com/news-releases/biohaven-reports-second-quarter-2024-financial-results-and-recent-business-developments-302218343.html