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Thursday, January 2, 2025

Neumora Therapeutics Depression Drug Fails In First Of Three Pivotal Phase 3 Trials

 On Thursday, Neumora Therapeutics, Inc. (NASDAQ:NMRA) stock traded lower after the company released data from the Phase 3 KOASTAL-1 Study of navacaprant for major depressive disorder.

The KOASTAL-1 Study is the first of three replicate Phase 3 studies that comprise the pivotal KOASTAL program.


The study did not demonstrate a statistically significant improvement on the primary endpoint of change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6 or the key secondary endpoint of a change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) scale.

MADRAS is a measure of depressive severity and SHAPS is a clinical assessment tool used to measure anhedonia, which is the inability to experience pleasure from activities usually found enjoyable.

Navacaprant and placebo led to a -12.5 change from baseline on the primary endpoint.

Navacaprant showed a decline of 5.8 points on the secondary endpoint versus a decline of 5.5 on the placebo.

“We are disappointed by the results from KOASTAL-1 as they were not consistent with the body of evidence supporting this mechanism in MDD. There is a lot to investigate from this study, in particular the contrast in drug and placebo responses in depressed mood and anhedonia in female participants compared to male participants,” said Rob Lenz, executive vice president, head of research and development, Neumora.


The company highlights its cash balance of $342 million as of the end of the third quarter, providing a runway into mid-2026. It looks forward to providing additional updates on the Navacaprant development program and pipeline at the J.P. Morgan Healthcare Conference.

Navacaprant was shown to be safe and generally well-tolerated, and no serious adverse events were reported. There was no signal for increased suicidal ideation or suicidal behavior compared to placebo.

The Phase 3 KOASTAL-2, KOASTAL-3, and KOASTAL-LT studies are ongoing.


https://finance.yahoo.com/news/neumora-therapeutics-depression-drug-fails-133028449.html

Wednesday, January 1, 2025

Trump Should Terminate The Bilateral Security Agreement Between The US & Ukraine

 by Andfrew Korybko via substack,

New York Times contributor Rajan Menon wrote in a mid-December op-ed that Trump is unlikely to agree to give Ukraine the security guarantees that Zelensky is demanding in temporary lieu of NATO membership. He’s apparently unaware that Trump will soon inherit the bilateral security agreement that the Biden Administration reached with Ukraine in June. It essentially institutionalizes existing US military aid for Ukraine and obligates it to resume the present scale and scope of such if the conflict reignites.

Nevertheless, Menon’s factually inaccurate assessment raises the question of whether Trump would terminate that agreement as part of his plan to “Pivot (back) to Asia” for more muscularly containing China, which his administration could never do in full if it maintains such commitments to Ukraine. Last June’s document stipulates that “Either Party may terminate this Agreement by providing a written notification through diplomatic channels to the other Party” within six months of planning to abandon it.

It's therefore legally feasible, but Trump would predictably get a lot of flak from his “deep state’s” Russophobic hawks, though he’d then free the US up to “Pivot (back) to Asia” without worrying about being dragged back into another proxy war with Russia in Europe. Moreover, by depriving Ukraine of the US security guarantees that it took for granted, he’d make it less likely that Kiev would violate the ceasefire in an attempt to manipulate America and others into fighting Russia on its behalf afterwards.

Far from reducing the chances for peace, Trump would greatly raise them by withdrawing the US from the so-called “coalition of the willing” that Ukraine aims to pit against Russia through its machinations. Without American participation, Ukraine would be much less likely to provoke another conflict with Russia since it couldn’t take for granted that its other security guarantee partners (e.g. the UKGermanyPoland, etc.) would risk war with Russia if NATO’s core member isn’t willing to do so anymore over this.

Another important point is that Trump’s reported plan for NATO, whereby he’d pressure them to spend more on defense and assume more responsibilities for their own security, would automatically become a fait accompli in this scenario. He wouldn’t have to bargain with or threaten them since they’d do this on their own out of their self-interests. Knowing that there’d be no chance of the US directly intervening to save Ukraine if the conflict reignites, they’d step up and begin doing what they should have decades ago.

The years of freeloading off of the US would instantly end, thus enabling Trump to accelerate America’s “Pivot (back) to Asia” and redirect the resources that he’d save in Europe to that theater instead. It’s therefore a win-win from the perspective of the US’ grand strategic interests, albeit one that requires tremendous political will. If Trump is serious about implementing his foreign policy agenda, then he should terminate the US’ bilateral security agreement with Ukraine on his first day of office.

https://www.zerohedge.com/geopolitical/trump-should-terminate-bilateral-security-agreement-between-us-ukraine

'What is Islamic State, the group implicated in the New Orleans attack?'

 The radical Islamic State group, which once imposed a reign of terror over millions of people in Syria and Iraq, has been implicated in the truck attack on a New Orleans crowd, which killed 15 people and injured about 30.

The suspect, identified as Shamsud-Din Jabbar, 42, a U.S. citizen from Texas who once served in Afghanistan, was flying an Islamic State flag during the assault.

U.S. President Joe Biden said that the FBI reported to him that a mere hours before the attack that Jabbar posted videos on social media indicating that he's inspired by Islamic State.

Following are facts about the movement, considered to be more violent and extremist than Al Qaeda.

RECENT OPERATIONS

The Islamic State group on Wednesday claimed responsibility for an attack on a military base in Somalia's northeastern region of Puntland a day earlier, the group posted on its Telegram channel.

In its statement, Islamic State said the attack was conducted by 12 militants and two booby-trapped vehicles, adding that it killed around 22 military personnel from the Puntland forces and injured dozens of others.

Though largely crushed by a U.S.-led coalition several years ago, IS has managed some major attacks while seeking to rebuild.

They include an assault on a Russian concert hall in March 2024, that killed at least 143 people and two explosions in the Iranian city of Kerman in January that killed nearly 100 people.

It also claimed responsibility for an assault by suicide attackers on a mosque in Oman last year that killed at least nine people.

Aside from its bloody operations in the Middle East, Islamic State also inspired lone wolf attacks in the West.

In August of 2024, authorities said a 19-year-old Austrian suspected of masterminding a planned attack on a Taylor Swift concert in Vienna had vowed allegiance to the leader of Islamic State.

HISTORY

At the height of its power from 2014-2017, the IS "caliphate" held sway over a wide area of Syria and Iraq, imposing death and torture on opponents of its radical brand of Islam. Its fighters repeatedly defeated both countries' armies and carried out or inspired attacks in dozens of cities around the world.

Its then leader Abu Bakr al-Baghdadi, killed in 2019 by U.S. special forces in northwestern Syria, rose from obscurity to lead the ultra-hardline group and declare himself "caliph" of all Muslims. 

The caliphate collapsed in Iraq, where it once had a base only a 30-minute drive from Baghdad, and in Syria, after a sustained military campaign by a U.S.-led coalition.

The new leader, known by a pseudonym Abu Hafs al-Hashimi al-Quraishi, remains shrouded in secrecy.

NEW TACTICS IN THE MIDDLE EAST

IS has switched tactics since the collapse of its forces and a string of other setbacks in the Middle East.

Once based in the Syrian city of Raqqa and the Iraqi city of Mosul, from which it sought to rule like a centralised government, the group took refuge in the hinterlands of the two fractured countries.

Its fighters are scattered in autonomous cells, its leadership is clandestine and its overall size is hard to quantify. The U.N. estimates it at 10,000 in its heartlands.

The movement went underground with sleeper cells that launch hit-and-run attacks, according to an Iraqi government security adviser who helps track IS.

All key foreign fighters fled Iraq for countries such as Afghanistan, Syria and Pakistan. Most have joined Islamic State's Khorasan branch (ISIS-K), named after an old term for the region that included parts of Iran, Turkmenistan and Afghanistan.

It is active along Iran's borders with Afghanistan and Pakistan.   

Sanaullah Ghafari, the 29-year-old leader of the Afghan branch of IS, has overseen its transformation into one of the most fearsome branches of the global Islamist network, capable of operations far from its bases in the borderlands of Afghanistan.

AFRICA

Islamic State - often called ISIS, ISIL, or the pejorative Daesh - has also made its mark in parts of Africa.

In Uganda, militants from IS-connected rebel Allied Democratic Forces (ADF), staged a series of attacks including a massacre at a boarding school, the murder of a honeymooning couple and a raid on a village that killed at least three people.

The group, which started as an uprising in Uganda, has largely moved its operations to neighbouring Democratic Republic of Congo where it has staged multiple attacks.

Several other groups have pledged allegiance to IS in West Africa and across the Sahel. Affiliates have control of large areas of rural Mali, Niger and northern Burkina Faso and into North Africa.

In January 2023, the U.S. military carried out an operation that killed a senior IS leader in northern Somalia. The U.N. fears militant groups could exploit the political instability in Sudan, which is gripped by a civil war.

OVERALL STRENGTH

The U.S. National Counterterrorism Center has said the threat posed by IS and another militant group al Qaeda "is at a low point with the suppression of the most dangerous elements".

But it went on to warn that half of IS's branches are now active in insurgencies across Africa and "may be poised for further expansion".

It said the group had lost three overall leaders and at least 13 other senior operatives in Iraq and Syria since early 2022 "contributing to a loss of expertise and a decline in ISIS attacks in the Middle East".

https://www.marketscreener.com/news/latest/What-is-Islamic-State-the-group-implicated-in-the-New-Orleans-attack-48671887/

Tesla Cybertruck explosion an 'isolated incident' - officials

 Officials probing the Cybertruck explosion

in Las Vegas call it an 'isolated incident'

:: January 1, 2025

:: Las Vegas, Nevada

:: Jeremy Schwartz, FBI Special Agent, Las Vegas

"As of right now, our number one goal is to ensure that we have the proper identification of the subject involved in this incident. Following that, our second objective is to determine whether this was an act of terrorism or not. I know everybody is interested in that word and trying to see if we can say, hey, this is a terrorist attack. That is our goal and that's what we're trying to do."

"We believe this is an isolated incident. We do not believe that there is a bunch of folks out there supporting this or helping this. And we don't believe that there's any other danger to the community right now."

Videos taken by witnesses inside and outside the hotel showed the vehicle exploding and flames pouring out of it, as it sat just outside the hotel.

The incident occurred just hours after a man drove a truck into crowds of New Year's Day revelers in New Orleans, killing 15.

The Trump International Hotel in Las Vegas is part of the Trump Organization, the company of President-elect Donald Trump, who will return to the White House on Jan. 20. Tesla CEO Elon Musk was a key backer of Trump in his 2024 presidential campaign and is also an adviser to the incoming president.

FBI special agent in charge Jeremy Schwartz later told reporters that it was not yet clear whether the blast was an act of terrorism.

He added that the FBI had identified the person driving the vehicle, which had been rented in Colorado, but was not yet ready to publicly identify the driver.

Musk said the blast was unrelated to the Cybertruck itself.

https://www.marketscreener.com/quote/stock/TESLA-INC-6344549/news/Tesla-Cybertruck-explosion-an-isolated-incident-officials-48671588/

Malaysia grants WeChat, TikTok licences to operate under new law

 Malaysia's communications regulator said it granted Tencent's WeChat and ByteDance's TikTok licences to operate in the country under a new social media law, but that some other platforms had not applied.

The law, aimed at tackling rising cybercrime, requires social media platforms and messaging services with more than 8 million users in Malaysia to obtain a licence or face legal action. It came into effect on Jan. 1.

In a statement on Wednesday, the Malaysian Communications and Multimedia Commission said messaging platform Telegram was in the final stages of obtaining its licence, while Meta Platforms, which owns Facebook, Instagram and WhatsApp, had begun the licensing process.

The regulator said X had not submitted an application because the platform said its local user base did not reach the 8 million threshold. The regulator said it was reviewing the validity of X's claim.

Alphabet's Google, which operates video platform YouTube, had also not applied for a licence after raising concerns about the video sharing features of YouTube and its classification under the licensing law, the regulator said. It did not state the concerns or how they relate to the law but said YouTube must adhere.

"Platform providers found to be in violation of licensing requirements may be subject to investigation and regulatory actions," the regulator said. 

Malaysia reported a sharp increase in harmful social media content in early 2024 and urged social media firms, including Meta and short video platform TikTok, to step up monitoring of their platforms.

Malaysian authorities deem online gambling, scams, child pornography and grooming, cyberbullying and content related to race, religion and royalty as harmful.

The companies do not publish the number of users per country on their platforms.

According to independent data provider World Population Review, WeChat has 12 million users in Malaysia.

Advisory firm Kepios said YouTube had about 24.1 million users in Malaysia in early 2024, TikTok 28.68 million users aged 18 and above, Facebook 22.35 million users, and X had 5.71 million.

https://www.marketscreener.com/quote/stock/META-PLATFORMS-INC-10547141/news/Malaysia-grants-WeChat-TikTok-licences-to-operate-under-new-law-48671727/

A U.S. Marine And An American Hero

 by Breck Henderson via RealClearDefense,

When I woke up on the morning of November 6, I felt that America had changed.  A new spirit was suddenly alive.  The day before I had been afraid my country would be forced to endure more years of living out the lies of “wokeism,” the ideology of the radical Left and the current government.  What’s bad about that?  The best and most concise description of wokeness I’ve found comes from professor of philosophy Edward Fesser who wrote:

Wokeness is] a paranoid delusional hyper-egalitarian mindset that seems to see oppression and injustice where they do not exist or greatly exaggerate them where they do exist.

In general, wokeness . . . is essentially about the radical subversion of normal human life in the name of a paranoid metaphysical delusion. It is fueled by a seething envy and resentment directed against the natural order of things.

The repercussions of trying to live out a “paranoid delusion” are widespread.  For those who resist the delusions, it can mean alienation from family and friends or the destruction of one’s professional life.  Basically, becoming a victim of cancel culture.  A woke oligarchy in charge of American institutions brings a multitude of threats — from having gender dysphoric children taken away from parents to the destruction of our military’s morale and readiness.           

But maintaining a paranoid delusion is strenuous.  It requires a great deal of mental energy, and as a nation I sense that we are exhausted from the effort.  Among the delusions have been that human gender is fluid and multifaceted, that we must adopt BLM’s racist ideology, that America is incurably racist, that Diversity Equity and Inclusion (DEI) is the solution to American racism, that masculinity is somehow toxic, and much more.  When something simply can’t go on any longer, it ends, and I’m beginning to sense that wokeism can’t go on.

The decisiveness of Trump’s victory signaled a huge shift in American politics, a mass retreat from wokeism, and I believe a big factor in that shift was plain old exhaustion with the lies and delusions foisted upon us by the radical, woke Left. 

When such a seismic shift occurs, it reverberates throughout America and then throughout the world.  It means it’s safe to acknowledge the truth again, and that goes right down to the local level.

There is not a clearer example of this than Daniel Penny’s recent acquittal on manslaughter charges by a New York jury.  After living through a period during which courage has been defined as going public with one’s homosexuality or gender dysphoria, real courage has been vindicated in a very public way.

The nature of the event that landed Penny in court was absolutely clear.  A courageous young man, a former U.S. Marine, protected people in a New York subway car from a dangerous, threatening psychotic.  Penny had no intention of killing that man — Jordan Neely — he only wanted to prevent him from carrying out the threats he was making. 

Penny should never have been indicted.  Had this happened in Texas, or most other places outside of New York, no Grand Jury would have returned an indictment.  Had Neely been white, no indictment would have been brought.  Only in the supercharged racial atmosphere evoked by the paranoid delusions of BLM politics could such a charge have gained traction.  If you haven’t done so, I urge you to watch the interview with Penny streaming now on Fox Nation here.

Penny recounts that Neely barged into the subway car and immediately began demanding things, then threatening to kill people, saying he was going to jail for life. Penny said that, in the subway car, there was a mother with a child in her arms, young school children, and others, and they were all scared.  He was scared as well.

Penny said he removed his ear buds and handed them along with his cell phone to someone sitting next to him and then grabbed Neely, pulling the man down to the floor on top of himself.  They struggled there for several minutes.  Penny said Neely was extremely strong and had amazing endurance.

Penny suspected Neely had been using a drug called K2.  According to information from American Addiction Centers, K2 is a synthetic cannabinoid, 660 times more potent than marijuana.  It is strongly associated with psychosis, agitation and irritability, and can lead to seizures, convulsions, stroke, elevated blood pressure, heart rhythm abnormalities, kidney failure, heart attack, and sometimes death.  The autopsy showed that Penny was correct, K2 was in his system and likely caused his death.

Daniel Penny is a talented, thoughtful, courageous, and highly moral young man.  He became a U.S. Marine because he wanted to serve his country, and he credits this decision for bringing out the best in himself.  He said: “I became who I am in the Marine Corps.  I met amazing people who brought out who I truly am.  “There’s this image of a Marine as a stone-faced jarhead, but you have to have compassion to be a competent Marine,” he said.

I asked retired Marine Corps Major General Bob Hollingsworth if he would expect every Marine to act the way Daniel Penny did: “Marines are taught to analyze a situation and if there is danger to take action.  I pray that every Marine would do that.”

Penny’s platoon sergeant testified at his trial, saying that all Marines are taught to uphold the Marine Corps values of “honor, courage and commitment.”  “If you don’t uphold those values, you don’t get promoted,” he said.  Penny was promoted to Sergeant (pay grade E-5) during his four-year service.

General Hollingsworth mentioned that he was also proud back in 2015 of U.S. Air Force Airman First Class Spencer Stone, Oregon National Guard Specialist Alek Skarlatos and college senior Anthony Sadler, all friends from childhood, who subdued a radical Islamic terrorist on a train in France.  Read about it here.

The three were on leave and taking a high-speed train from Amsterdam to Paris when they saw a man get on the train with an AK-47 and a handgun.  They immediately rushed to tackle him, disarmed him and prevented what could easily have been a massacre had they not acted.  Airman Stone was seriously injured by the terrorist who wielded a box cutter during the struggle.  In this case, the three plus a British man who assisted them, were hailed as heroes and congratulated by President Obama and European leaders.       

Neither New York nor the mainstream media were so discerning or kind to Daniel Penny.  Since leaving the Marine Corps he has been studying to become an architect.  He has always lived in or near New York City and he said the buildings and skyline have inspired him to study architecture as a career.  What a tragedy it would have been had this young man been convicted and his life destroyed by a lie. 

Penny said when asked why he chose to physically subdue Neely: 

If I didn’t do something the guilt I would have felt if someone did get hurt, if he did what he was threatening to do — I would never be able to live with myself — and I’ll take a million court appearances, people calling me names, people hating me, just to keep one of those people from getting hurt or killed.

General Hollingsworth praised that sentiment. “Daniel Penny has my respect,” he said.

The facts surrounding Penny’s actions were obvious to any clear thinking American citizen from the start, but BLM delusions have been so vigorously enforced since the summer of 2020’s George Floyd riots, that the Manhattan jury apparently had a tough time reaching its verdict.  I don’t believe those jurors could have felt empowered to act on the truth had President Trump not won a decisive victory on November 5.

In the end, Daniel Penny is an American hero — a man who could not sit by and let a psychotic man hurt others when it was within his power to prevent it.  The prosecutors denigrated his military training and experience.  In a rational society people should admire and encourage willingness to train and become a “compassionate warrior” — the world would be a far better place if every young man aspired to and trained for that ethic.

Is Penny bitter because his good deed resulted in his life being disrupted for more than a year, and weeks in court with the threat of being sent to prison?  Not at all.

People who were in the [subway] car remained on the platform and were thanking me.  Throughout the whole trial, I only cared about what those witnesses said.  I love America and that people have a right to protest, but they [protestors] didn’t have any of the facts.  They weren’t there.  The witnesses were there and they thanked me.  It’s disheartening that the prosecutor tried to discredit my military service and my awards.  I gave up four years of my life for no other reason than to serve my country.  It’s frustrating that there are people like this in our government, who do this [indict him for a good deed] who are supposed to be protecting people and our rights.

Penny said he doesn’t want praise or fame.  “Friends and everyone I’ve met have been supportive of me.  It’s been very humbling and I’m grateful for that.  Throughout the whole process I had faith in the system and my team and in God.”

I’m reminded of the famous poem “If” by Rudyard Kipling.  The first verse:

If you can keep your head when all about you
Are losing theirs and blaming it on you,
If you can trust yourself when all men doubt you,
But make allowance for their doubting too;
If you can wait and not be tired by waiting,
Or being lied about, don’t deal in lies,
Or being hated, don’t give way to hating,
And yet don’t look too good, nor talk too wise;

Daniel Penny kept his head during a tense situation.  He trusted in himself and in God when it seemed everyone was against him.  He was patient, he told the truth, and he did not return the hate of those who hated him.  And he refuses to consider himself a hero.  As Kipling says in the final lines of the poem: 

Yours is the Earth and everything that’s in it,

And — which is more — you’ll be a man, my son!

 Daniel Penny is a man in the best sense — we should all be proud of him.

Breck Henderson is a retired Navy Reserve Officer, retired nuclear engineer for the Nuclear Regulatory Commission, and retired journalist for Aviation Week & Space Technology magazine.  He writes regularly on Substack, and crafts fiction in the form of short stories, plays and screenplays when he's not enjoying being a grandfather to eight grandchildren.

https://www.zerohedge.com/political/us-marine-and-american-hero

NYC anti-Israel protest urges ‘intifada revolution’ hours after ISIS-flag-wielding terrorist struck NOLA

 Hundreds of anti-Israel protestors gathered in Times Square on New Year’s Day — waving Palestinian flags and calling for “intifada revolution” on the same day a terrorist carried out a deadly car attack in the French Quarter of New Orleans.

The protest — organized by the Palestinian Youth Movement, the Party for Socialism and Liberation and the People’s Forum — was led in a chant of “There is only one solution: Intifada revolution.”

One angry protestor shouted that they were going to send
people back to Europe.X/@luketress
The woman shouted back and forth with counter protestors
some of whom jeered Hamas in the background.X/@luketress

“We’re sending you back to Europe you white b–ches,” one female demonstrator wearing a keffiyeh shouted at counter-protestors outside the event, video posted to social media shows. “Go back to Europe! Go back to Europe,” she repeated.

“2024 was a year of struggle against the crime of Zionism,” one speaker shouts through a megaphone in the heart of the Big Apple.

“We will be here every single year for generation after generation until total liberation and return,” they said, according to Times of Israel.

Protestors carried signs with messages like “End All US aid to Israel,” “End Zionism,” and “No war on Iran.”

Suspected terrorist, Shamsud-Din Jabbar, plowed a pickup truck bearing an ISIS flag into New Year’s Eve revelers.Obtained by the NY Post

The crowd also chanted “We will honor all our martyrs.”

The demonstration happened just hours after a suspected terrorist, Shamsud-Din Jabbar, plowed a pickup truck bearing an ISIS flag into New Year’s Eve revelers on Bourbon Street in New Orleans, killing at least 15 people.

Jabbar, 42, was then shot dead by cops in a gunfight. Three improvised pipe bombs were found nearby in the tourist-drawing French Quarter, including one in Jabbar’s truck,

The horrific attack left at least 15 people dead.

The FBI is searching for any possible accomplices in the New Orleans attack.

The Post exclusively reported that Jabbar, a US-born military veteran, lived in a trailer-park community in Houston that is home to mostly Muslim immigrants. 

The rundown home is within walking distance of local mosque Masjid Bilal.

Jabbar traveled to Egypt for 10 days last year, officials told The Post.

He served active duty in the US Army from March 2007 until January 2015 and was a reservist from 2015 until July 2020.

https://nypost.com/2025/01/01/us-news/anti-israel-protestors-take-over-times-square-call-for-intifada-revolution/