Axsome breaks new ground in Alzheimer's with Auvelity OK

 Axsome Therapeutics' Auvelity has become the first non-antipsychotic therapy for agitation in patients with Alzheimer's disease to be approved by the FDA, which called the drug a "significant advancement" in care.

Auvelity (dextromethorphan/bupropion) – a first-in-class oral NMDA receptor antagonist and sigma-1 receptor agonist – is already approved to treat major depressive disorder (MDD) and made more than $500 million in sales last year.

The new indication is expected to lead to an acceleration in growth, as more than 7 million people are living with Alzheimer's in the US, and agitation – which can include verbal and physical aggression – is a very common symptom that affects an estimated 50% to 70% of all patients.

Antipsychotic medications are currently the main therapy for Alzheimer's agitation, but carry serious risks, including an increased risk of death, due to side effects. They also offer only modest, short-term benefits and may also accelerate cognitive decline, so are typically used as a last resort; for example, when there is a risk of harm to the patient or those around them.

While many antipsychotics are used off-label, the only FDA-approved option is Otsuka/Lundbeck's dopamine- and serotonin-targeting Rexulti (brexpiprazole), which got a green light for this use in 2023.

Auvelity is thought to target pathways involved in mood regulation and stress responses in the brain. In the ADVANCE-1 trial, it outperformed placebo in improving agitation scores over five weeks' follow-up, while in ACCORD-2 patients who switched from Auvelity to placebo had a shorter time to relapse than those who continued treatment with the drug.

According to geriatric psychiatry expert George Grossberg of Saint Louis School of Medicine in the US, Auvelity is the only FDA-approved product to show a statistically significant increase in time to relapse of agitation symptoms, compared to placebo, in a long-term study.

"Agitation in patients with dementia due to Alzheimer's disease is distressful, consequential, and challenging for patients, their caregivers and healthcare providers," he said, adding that Auvelity also showed "a compelling safety and tolerability profile, with rates of discontinuation due to adverse events that were low and matched those of placebo."

That profile should give Auvelity an immediate edge over Rexulti, which carries a boxed warning that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

Analysts have said that Alzheimer's agitation could be a $1.5 billion market for Auvelity, on top of its potential in MDD, which has been estimated at between $1 billion and $3 billion at peak. Axsome, meanwhile, is hoping to extend the label for Auvelity even further, with a phase 2/3 clinical trial already running in smoking cessation.

Shares in the company rose nearly 13% on the news, driving its market cap to almost $10.7 billion.

https://pharmaphorum.com/news/axsome-breaks-new-ground-alzheimers-auvelity-ok

FDA's ODAC delivers one loss, one win for AstraZeneca

 In its first meeting for months, the FDA's Oncologic Drugs Advisory Committee (ODAC) voted against AstraZeneca's oral selective oestrogen receptor degrader (SERD) drug camizestrant.

By a margin of six votes to three, the panel concluded that the results of the SERENA-6 trial of camizestrant did not support use of camizestrant in combination with CDK inhibitors – Pfizer's Ibrance (palbociclib), Novartis' Kisqali (ribociclib), or Eli Lilly's Verzenios (abemaciclib) – as a first-line treatment for HR-positive, HER2-negative breast cancer with ESR1 mutations.

AZ had proposed a biomarker-based approach to treatment that involved measuring circulating tumour DNA (ctDNA) to detect ESR1 mutations – which point to the emergence of resistance to treatment – and switching patients from their current therapy to its oral SERD.

According to SERENA-6 data reported at last year's ASCO congress, that approach reduced the risk of disease progression or death by 56% compared to the CDK 4/6 inhibitors given in combination with an aromatase inhibitor. Mutations in ESR1 are the most common mechanism of acquired resistance to that treatment regimen.

The sticking point for panellists appeared to be that the improvement in progression-free survival (PFS) was not accompanied by a statistically significant gain in overall survival (OS), which is considered a more rigorous outcome measure. Some panellists suggested that an OS benefit should be seen before approval, given that AZ is proposing a step-change in established clinical practice for these patients.

That view was also laid out in the FDA review document (PDF), which suggested that there is not sufficient evidence from SERENA-6 to show the clinical benefit from a strategy in which patients receive camizestrant at ESR1 mutation detection, rather than at radiographic progression as at present.

"We are disappointed with the mixed outcome of today's ODAC meeting," said Susan Galbraith, AZ's head of oncology and haematology R&D.

"We strongly believe in the results of the SERENA-6 trial, and are encouraged that the committee saw camizestrant as a safe and effective potential new medicine," she added. "We remain confident in the clinical benefit the combination can bring to patients by changing therapeutic strategy at the earliest opportunity."

The company may have an opportunity to make its case when additional results from SERENA-6 are presented at this year's ASCO congress, which will start later this month in Chicago. Meanwhile, regulatory applications for camizestrant in this setting are also under review in the EU, Japan, and several other countries.

The FDA does not have to abide by the advice of the ODAC, but the vote suggests the ongoing SERENA-4 clinical trial of camizestrant in an all-comer HR-positive breast cancer population, with and without ESR1 mutations, is likely to be crucial for AZ as it tries to position the SERD as a new first-line treatment option for the disease – and build towards peak sales it has modelled at $5 billion a year. SERENA-4 data is due to read out in the latter half of this year.

There are currently two marketed drugs in the oral SERD class – Menarini/Stemline's Orserdu (elacestrant) and Eli Lilly's Inluriyo (imlunestrant) – which are both approved for second-line treatment of HR+, HER- breast cancer with ESR1 mutations.

Truqap backed for prostate cancer

The ODAC delivered better news for AZ with a seven-to-one vote in favour of its AKT inhibitor Truqap (capivasertib) in combination with Johnson & Johnson's Zytiga (abiraterone) and androgen deprivation therapy (ADT) for PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC).

This form of prostate cancer is known to be aggressive, progressing quickly to more advanced disease, and has limited treatment options. Estimates for the frequency of PTEN mutations in prostate cancer vary widely, between around 15% and 60%, depending on the type and stage of the disease, but testing for the biomarker isn't widespread at the moment.

Truqap is already approved for relapsed or refractory HR+/HER2- advanced breast cancer, but AZ's efforts to expand its use into other indications like triple-negative breast cancer have so far been unsuccessful.

The mHSPC filing is based on the results of the CAPItello-281 study, which showed that Truqap achieved a statistically significant 19% reduction in the risk of radiographic disease progression or death compared to placebo.

https://pharmaphorum.com/news/fdas-odac-delivers-one-loss-one-win-astrazeneca

UK Navy: Hormuz traffic dropped by 90%

 The United Kingdom's Royal Navy said on Friday that ship traffic through the Strait of Hormuz has dropped by 90% since the war in Iran began on February 28.

The Navy noted that the UK Maritime Trade Operations (UKMTO) reported 41 incidents in regional waters, particularly in the Strait of Hormuz, with vessels attacked, damaged, or forced to turn back.

"The most distressing calls are those from ships under attack," UKMTO Head of Operations Commander Jo Black commented. "It's an absolutely terrifying experience for them – they're civilians, they're not prepared for this – drones, missiles, small arms fire aimed at their bridge or engine room, and threats to their safety – so they're stressed," he added.

https://breakingthenews.net/Article/UK-Navy:-Hormuz-traffic-dropped-by-90/66200372

Amgen beats, raises guidance as growth drivers offset Prolia/Xgeva erosion

 

• Amgen beat Q1 2026 estimates with non-GAAP EPS $5.15, up 5% YoY, on revenue $8.6B, up 6% YoY.
• Key growth drivers grew 24% YoY to $5.6B and now represent ~70% of sales.
• Overall product sales rose 4% YoY despite a 32% decline in Prolia/Xgeva from biosimilar erosion.
• Repatha, EVENITY and TEZSPIRE all posted strong double-digit growth, with Repatha sales up 34% YoY.
• Non-GAAP operating margin was 45%, while cost of sales increased to 19.5% on mix and royalties.
• 2026 revenue guidance was raised to $37.1–$38.5B and non-GAAP EPS to $21.70–$23.10.
• Management reiterates 2026 as a "springboard year," ramping R&D 16% to fund MariTide, IMDELLTRA, Olpasiran.
• MariTide Phase III program expanded with switch and maintenance studies targeting less-frequent dosing and better GI tolerability.
• TAVNEOS faces an FDA proposal to withdraw approval; Amgen defends its benefit‑risk and plans further engagement.
• IRS draft tax adjustments for 2016–2018 could be material if upheld, but Amgen strongly contests the methodology.
• Free cash flow was $1.5B; capex of $700M supports expanded manufacturing, including for an eventual MariTide launch.
• Main concern: Regulatory and tax overhangs (TAVNEOS withdrawal proposal, IRS disputes) amid accelerating Prolia/Xgeva erosion.
• Strong quarter, driven by diversified growth assets that more than offset loss-of-exclusivity headwinds.

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

Senators ban themselves from betting in prediction markets

 The U.S. Senate has passed a bipartisan resolution that bans senators from making bets on prediction markets like Kalshi (KALSHI) and Polymarket (POLYMARKET) amid mounting insider trading concerns.

The ban was passed unanimously and is effective immediately. The measure applies to senators, officers and staff at the Senate.

"Serving in Congress is an honor, not a side hustle," Sen. Bernie Moreno (R-OH), who introduced the resolution, posted on X after the vote. "Americans deserve to know that their leaders are here for the right reason!"

Polymarket (POLYMARKET) said it is in full support of this. "Our Rulebook & Terms of Service already prohibit such conduct, but codifying this into law is a step forward for the industry," it added.

"Kalshi (KALSHI) already proactively blocks members of Congress and enforces against insider trading," its CEO Tarek Mansour said. "This is a great step to increase trust in our markets by making it an industry standard. Now, let's pass this in the House!"

The Senate ban comes a week after a U.S. soldier involved in the capture of Nicolás Maduro was charged with using classified information to make $400,000 by betting on the Venezuelan leader's ouster.

Earlier this month, the White House warned staffers against using confidential, privileged information to trade on prediction markets.

https://www.msn.com/en-us/money/general/senators-ban-themselves-from-betting-in-prediction-markets/ar-AA228TQ9

Moderna beats Q1 estimates with non-GAAP loss $1.18 per share on revenue of $389M

 

Moderna beats Q1 estimates with non-GAAP loss $1.18 per share on revenue of $389M

• Q1 GAAP loss of $3.40 per share includes a $0.9 billion non-recurring litigation settlement charge.
• Moderna reiterates guidance for up to 10% 2026 revenue growth and expects lower operating expenses.
• The company projects a year-end cash balance totaling $4.5–$5.0 billion in aggregate.

https://finviz.com/quote?t=MRNA&p=d#google_vignette

British Police Raid Islamic Group Accused Of Sex Trafficking And Slavery

 At least nine members of a Cheshire Islamic group have been arrested in a raid of 500 British police officers as part of an investigation into sexual offenses, slavery and forced marriage. 

Officers received reports of human trafficking, rape, and other crimes involving members of a group known as the Ahmadi Religion of Peace and Light, based in Crewe.  Seven men and three women were taken into custody, according to a statement from the Cheshire Police, who said the investigation was initiated because of allegations made by a woman who was previously part of the group in 2023.

Chief Superintendent Gareth Wrigley, of Cheshire Constabulary, said: 

"Today’s operation is the outcome of a detailed and robust investigation into reports of serious sexual offenses, forced marriage and modern slavery involving members of a religious group called Ahmadi Religion of Peace and Light in Crewe. 

While those arrested are members of the group, I want to make clear that this is not an investigation into the religion, this is an investigation into the serious allegations which have been reported to us..."

The AROPL's is a religious movement founded in 2015 by Abdullah Hashem Aba Al-Sadiq (Egyptian-American raised Sunni Muslim). It draws heavily from Shia Islamic traditions.  The group self-identifies with Islamic roots, uses Islamic terminology (referring to their leader as the Qaim/Mahdi appointed in relation to Prophet Muhammad), and maintains many Islamic practices.

British authorities in the UK have been quick to disconnect the sect from the wider Islamic migrant community.  The reasons for this are obvious - The British government is under considerable pressure to stop hiding migrant crime and Islamic crime, but their political agendas are deeply intertwined with third-world immigration.  Islamic groups consistently deny that the actions of grooming gangs have any connection to Muslim culture.     

Islamic fundamentalism justifies the abuse and exploitation of "non-believers", using the "Doctrine of Abrogation" and a series of passages from the Quran specifically allowing for the humiliation or enslavement of foreigners and non-believers as a means to force them into religious submission.  The Islamic slave trade operated throughout Africa and the Middle East until it was disrupted by the British Empire from 1833 to 1937.    

The surprising level of transparency of the latest raid may be part of a British government effort to clean up their image after it was revealed in 2025 that pro-multicultural authorities had spent the past decade covering up numerous reports of Islamic "grooming gangs" kidnapping and assaulting young British girls.  The government had been aware of this criminal activity as early as 2015 and did nothing.  

It should be noted that many British activists have been threatened by law enforcement, attacked by the establishment media and even jailed over the years simply for exposing this ongoing problem common among third world migrants.  The grooming gangs were ignored because their activities were inconvenient to the liberal open borders narrative dominating social politics in Europe since 2014.

Today, however, polling shows that both the left wing Labour Party and the Conservatives Party (which is also left wing) are facing political obliteration in the next general election (held in 2029) due to their mishandling of the immigration problem as well as the UK economy.  Unless they offer substantial changes to their policies, they stand to be swept out of Parliament.

The multiculturalists may very well be removed from government regardless.      

https://www.zerohedge.com/political/british-police-raid-islamic-group-accused-sex-trafficking-and-slavery