Neurocrine Touts Phase III Huntington’s Data, Posts 29% YoY Growth

 In support of a New Drug Application, Neurocrine Biosciences on Thursday posted interim results from the ongoing Phase III KINECT-HD2 study showing that its Ingrezza (valbenazine) capsules can improve chorea in patients with Huntington’s disease.

The FDA approved the use of Ingrezza, a vesicular monoamine transporter 2 (VMAT2) inhibitor, for the treatment of chorea in Huntington’s disease (HD) in August 2023. A month later, the regulator accepted an NDA proposing to administer the drug as oral granules. The target action date for the application is April 30, 2024.

According to the latest data, scheduled for presentation at this week’s Annual Meeting of the Huntington Study Group, 60.9% of patients deemed their chorea symptoms “much improved” or “very much improved” after six weeks of treatment with Ingrezza. At the same time point, 58.9% of study investigators similarly rated the patients’ symptomatic improvements.

By week 50, around 75% of patients and investigators said that symptoms were “much improved” or “very much improved.”

Chorea refers to the involuntary movement disorder that is common in HD. It is characterized by irregular, unpredictable and uncontrollable jerky motions, often involving the arms, legs and facial muscles, and typically compromising gait, speech and swallowing.

Thursday’s interim findings from KINECT-HD2 suggest that Ingrezza treatment can elicit improvements in chorea as early as week two—even when taking the lowest dose of 40 mg—and that these benefits persist through 50 weeks of follow-up, according to Neurocrine’s announcement.

In terms of safety, the most common treatment-emergent adverse events in KINECT-HD2 were falls, fatigue and somnolence, all of which were consistent with what had been established for Ingrezza in prior trials.

Neurocrine CMO Eiry Roberts in a statement said that these safety and efficacy data point to the “clinically meaningful and sustained improvements” in chorea symptoms that patients can derive from Ingrezza treatment.

Earlier this week, ahead of the KINECT-HD2 readout, Neurocrine released its third-quarter financial report, touting net product sales of $486 million for Ingrezza, which represents 29% year-over-year growth. This was driven by strong prescription demand for the drug and the “continued high level of new patient scripts” in the third quarter, according to the company.

Neurocrine can expect to see an even better market performance from Ingrezza, especially as the FDA recently greenlit a label expansion and might soon allow a new formulation of the drug. Buoyed by strong demand, Neurocrine raised its net sales guidance for Ingrezza to $1.82 billion to $1.84 billion.

https://www.biospace.com/article/neurocrine-posts-positive-phase-iii-huntington-s-data-for-ingrezza-touts-29-percent-yoy-growth/

JPMorgan Overhauls Loan for Amneal Pharmaceuticals After Investor Backlash

• Non-extending lenders no longer at risk of losing protections
• Terms of the deal have been sweetened; spread boosted

 

A leveraged loan deal from Amneal Pharmaceuticals LLC has been revamped after facing investor pushback.

JPMorgan Chase & Co., which is leading the proposed transaction, has boosted the spread on the loan and is knocking the price down to 95 cents on the dollar, according to people familiar with the matter. The minimum loan amount is now $2.25 billion, and commitments were due November 3 at 11:00 a.m. New York time, said the people who are not authorized to speak publicly.

https://www.bloomberg.com/news/articles/2023-11-03/jpmorgan-overhauls-loan-for-amneal-after-investor-backlash

Downdetector Shows Service Disruptions At US Banks

 Update (1315ET):

*   *   * 

Update (1300ET):

A Chase spokesperson told CNN:

"We know some direct deposits haven't updated because a payroll company has not sent them to us yet," the spokesperson said. "We will post them as soon as we can but we don't know the timing yet."

An industry insider told the media outlet: "The issue appears to be related to the Automated Clearing House (ACH), which is a network for processing transactions." 

*   *   * 

Downdetector has reported that several US banks are facing service disruptions on Friday morning. Meanwhile, users on the 'free speech' social media platform X complain that the Automated Clearing House system is down. 

Downdetector shows Truist, Bank of America, Chase, US Bank, and Wells Fargo are experiencing widespread outages and disruptions that began around 0800 ET. 

Bank of America started experiencing problems around 0800 ET. 

A message on Bank of America's webpage reads, "Some deposits may be temporarily delayed ... Some deposits from 11/03 may be temporarily delayed due to an issue impacting multiple financial institutions. Your accounts remain secure, and your balance will be updated as soon as the deposit is received. You do not need to take any action."

Here's what X users are saying:

*Developing

https://www.zerohedge.com/markets/some-deposits-may-be-temporarily-delayed-downdetector-shows-service-disruptions-us-banks

Feds Probe NYC Mayor's Campaign Over Possible Illegal Money From Turkey

 The federal government is conducting a broad corruption probe into the 2021 campaign of New York City Mayor Eric Adams. The focus: Determining if his campaign plotted with the Turkish government to bypass campaign laws and funnel foreign cash into the campaign through the use of "straw donors" -- that is, through the names of other people or entities who may otherwise legally make contributions.  

Thursday morning brought the jarring first public indicator of the investigation, as federal agents raided the home of Brianna Suggs, the principal fundraiser of the 2021 campaign. The New York Times, which obtained a copy of the search warrant and broke the news of the focus on Turkey, reports that agents seized phones, computers, papers and binders. 

Adams hasn't been accused of any illegal conduct -- not yet, anyhow. At the time of the raid, Adams was in Washington DC for several meetings with senior White House officials, federal legislators and others. When he learned about the raid on his fundraiser's home, he cancelled them all and rushed back to New York. 

I hold my campaign to the highest ethical standards,” said Adams at an event Thursday night. "Any inquiry that is done, we are going to fully participate and make sure that it’s done correctly. I have not been contacted by anyone from any law enforcement agency. And that’s why I came back from D.C. to be here, to be on the ground and look at this inquiry as it was made.”

Among the documents sought by investigators were those relating to Bay Atlantic University. The Times describes it as "a tiny Turkish-owned institution that opened in Washington, D.C., in 2014. In 2015, Adams visited its sister school in Turkey. 

In addition to Suggs -- who is just 25 years old -- the investigation also involves a Brooklyn construction company: KSK Construction Group, which specializes in luxury New York City condo projects. It's not clear what role the company may have allegedly played in funneling money from the Turkish government. Further, there's been no reporting on Turkey's potential motive for securing his election. 

The federal probe isn't the first criminal inquiry into Adams' campaign: Manhattan DA Alvin Bragg indicted six people in July, charging them with conspiring to funnel illegal foreign money into the campaign's coffers. On top of that, Adams' former senior advisor was indicted by Bragg on 16 felony charges -- among them, accusations of taking bribes.

Adams is up for reelection in 2025, and the swarm of investigations is chumming the waters for challengers who sense growing vulnerability. Republican Curtis Sliwa had already announced his intent to take on Adams again. When Politico asked him about his 2025 plans in light of the Thursday's federal raid, Sliwa said, "He may be in the Big House by then. Not the White House like he hoped for.”

In an era in which Democrats are credibly accused of weaponizing federal law enforcement against political adversaries, it's worth nothing that Adams has been a gadfly of the Biden administration, frequently and pointedly condemning its negligence in the face of a migrant crisis that has overwhelmed New York City.

Indeed, on the very morning of the federal raid, that's what he was in Washington to talk about:  

https://www.zerohedge.com/political/feds-probe-nyc-mayors-campaign-over-possible-illegal-money-turkey

Allogene Presents Preclinical Data on Next Generation Cloak™ and Dagger™ Tech

 

• Cloak™ and Dagger™ Technologies Show Potential to Reduce Dependence on Standard Lymphodepletion and Enhance Performance of AlloCAR T™ Cells
• Data from Preclinical Study of Cloak™ Technology Highlights Ability to Engineer Allogeneic Cells to Evade Detection by the Host Immune System
• Dagger™ Technology, a Feature of ALLO-316 Currently Being Investigated in a Phase 1 Study for Solid Tumors, Enables Dual AlloCAR T™ Cells to Selectively Eliminate CD70 Positive, Alloreactive Host Immune Cells While Simultaneously Killing CD19-Positive Tumor Cells

https://www.globenewswire.com/news-release/2023/11/03/2773321/0/en/Allogene-Therapeutics-Presents-Preclinical-Data-on-Next-Generation-Cloak-and-Dagger-Technologies-at-the-Society-for-Immunotherapy-of-Cancer-Annual-Meeting.html

US hospital groups sue Biden administration to block ban on web trackers

 The biggest U.S. hospital lobbying group on Thursday sued the Biden administration over new guidance barring hospitals and other medical providers from using trackers to monitor users on their websites.

The American Hospital Association (AHA), along with the Texas Hospital Association and two nonprofit Texas health systems, filed a lawsuit against the U.S. Department of Health and Human Services (HHS) in federal court in Fort Worth, Texas. The lawsuit accuses the agency of overstepping its authority when it issued the guidance in December.

The guidance warns healthcare providers that allowing a third-party technology company like Google or Meta to collect and analyze internet protocol (IP) addresses and other information from visitors to their public websites or apps could be a violation of the Health Insurance Portability and Accountability Act (HIPAA). That federal law bans the public disclosure of individuals' private health information to protect them against discrimination, stigma or other negative consequences.

AHA Deputy General Counsel Chad Golder told Reuters his group, which represents more than 5,000 hospitals nationwide, knows that HHS has instigated several enforcement actions under the guidance. The penalties for violating HIPAA can be hefty, as the fines -- which could be in the thousands, according to HHS -- would be assessed for each IP address disclosed to a third party, Golder said.

Court records show several hospitals have been hit with proposed class actions that cite the guidance, accusing them of mishandling personal health information through the use of these trackers.

Thursday's lawsuit seeks a declaration that the information collected by third-party trackers, like Google Analytics or Meta Pixel, is not “individually identifiable health information,” which is protected by HIPAA. It is also asking for a permanent injunction barring HHS from enforcing the guidance.

https://news.yahoo.com/us-hospital-groups-sue-biden-151435608.html

Putin says some Western weapons for Ukraine are ending up in the Taliban's hands

 Russian President Vladimir Putin said on Friday that some Western weapons supplied to Ukraine were finding their way to the Middle East through the illegal arms market and being sold to the Taliban.

"Now they say: weapons are getting into the Middle East from Ukraine. Well of course they are because they are being sold," Putin said. "And they are being sold to the Taliban and from there they go onto wherever."

Since Russia sent troops into Ukraine on Feb. 24 last year, Western powers have sent Ukraine tens of billions of dollars worth of weapons in an attempt to defeat Russian troops.

Ukraine says it keeps tight control over any weapons supplied to it, but some Western security officials have raised concerns and the United States has asked Ukraine to do more to tackle the broader issue of corruption.

In June 2022, the head of Interpol, Jürgen Stock, warned that some of the advanced weapons sent to Ukraine would end up in the hands of organised crime groups.

A report about the Ukraine war and the illegal arms trade by the Global Initiative Against Transnational Organized Crime said in March that there was "currently no substantial outflow of weapons from the Ukrainian conflict zone.

"However, every precedent suggests that, especially if the threat is not addressed proactively and imaginatively, when the current war ends, Ukraine’s battlefields could and will become the new arsenal of anarchy, arming everyone from insurgents in Africa to gangsters in the streets of Europe," the report said.

The eight biggest Western donors to Ukraine led by the United States have made military commitments to Ukraine totalling at least 84 billion euros ($90 billion), according to the Kiel Institute for the World Economy, which tracks donors.

U.S. military support includes 160 155mm howitzers, 109 Bradley fighting vehicles, more than 111 million rounds of small arms ammunition and 38 high mobility artillery rocket systems.

https://news.yahoo.com/putin-says-western-weapons-ukraine-131649947.html