Vera Builds ‘Compelling Profile’ for Atacicept in IgAN, Eyes Q4 Filing

 

The Phase III results impressed Guggenheim Partners analysts both in terms of efficacy and safety. If approved, atacicept would become the first APRIL/BAFF inhibitor for IgAN to make it to the market.

Vera Therapeutics is planning an FDA submission for its drug atacicept by the end of the year after it significantly lowered urinary protein levels in a Phase III study of IgA nephropathy.

In the late-stage ORIGIN study, atacicept treatment led to a 46% reduction in proteinuria at 36 weeks versus baseline. When compared to placebo, atacicept’s benefit remained high at 42%. The trial also cleared its secondary endpoints, a 68% drop in a disease biomarker and cessation of blood in urine in 81% of patients.

Reacting to these data, analysts at Guggenheim Partners on Thursday said that Vera has established a “compelling profile” for atacicept, bolstered by “an excellent safety profile that is comparable to placebo.” Findings from ORIGIN pointed to fewer serious adverse events in atacicept-treated patients versus placebo, with no safety signals that could indicate immunosuppression.

The ORIGIN readout “reinforces atacicpet’s potential as a first-line disease-modifying therapy,” Guggenheim said, “and validates our view that long-term eGFR preservation will be a key differentiator in the increasingly competitive IgAN landscape.” ORIGIN is ongoing and is scheduled to complete in 2028.

Vera is planning to file a biologics license application (BLA) for atacicept in IgAN in the fourth quarter, which according to Guggenheim could mean a product launch in mid-2026.

Such a timeline, the analysts said, would place Vera and atacicept “approximately 6–9 months behind Otsuka’s sibeprenlimab,” which has an FDA decision date of Nov. 28. Phase III data released in June showed that sibeprenlimab decreased proteinuria by 51.2% versus placebo, which at the time Guggenheim said “represents the strongest numerical result reported to date in IgAN Phase 3 trials.”

Nevertheless, an approval by mid-2026 would put Vera “ahead” of other firms developing similar therapies, according to Guggenheim. One such competitor Vertex Pharmaceuticals, whose povetacicept is also in line for a potential approval next year. Analysts and investors appear optimistic about that drug’s prospects. In a Nov. 3 note to investors, BMO Capital Markets said that povetacicept is set to “become a focal point” for Vertex’s pipeline.

Vertex has fully enrolled its Phase III RAINIER study for povetacicept and expects to complete its rolling application in the first half of 2026.

If atacicept is approved, Vera will beat Vertex to the market by a few months. “We believe that atacicept has the potential to advance the standard of care in IgAN as the first dual BAFF/APRIL inhibitor,” Vera CEO Marshall Fordyce said in a statement on Thursday.

https://www.biospace.com/drug-development/vera-builds-compelling-profile-for-atacicept-in-igan-eyes-q4-filing

Fear Is Coming Back to the Junk Bond Market

 

Junk bond investors are getting more skittish about risk.

An index of CCC rated bonds in the US has dropped nearly 0.8% over the month ended Thursday, underperforming the broader high-yield market as investors increasingly avoid the riskiest debt. Distressed US dollar loans jumped to $71.8 billion at the end of October — the highest since President Donald Trump outlined his tariff policy in April.

https://www.bloomberg.com/news/articles/2025-11-08/fear-is-coming-back-to-the-junk-bond-market-credit-weekly

Norway Urged To Tap €1.8 Trillion Sovereign Wealth Fund To Help Ukraine

By Jacob Wulff Wold of Euractiv

Calls are mounting for Norway to use its €1.8 trillion sovereign wealth fund to help move forward the EU’s stalled €140 billion loan for Ukraine, after a Danish newspaper revived a once far-fetched idea during last month’s EU leaders’ meeting.

Five Norwegian political parties, including three backing Labour Prime Minister Jonas Gahr Støre’s next government, have now urged Oslo to step in to overcome Belgium’s concerns about using immobilised Russian sovereign assets to fund a €140 billion reparation loan to Kyiv.

EU leaders discussed the issue on 23 October at a summit in Brussels, without reaching an agreement, as Belgium insists that other EU countries must share the legal and financial risks associated with the plan before it agrees to proceed. The assets are held by Euroclear, a Brussels-based clearing house.

Last week, Støre ordered a “full review” of Norway’s possible involvement.

Oil-rich Norway is sitting on the world’s largest sovereign wealth fund, worth €1.8 trillion, including an estimated €109 billion earned from soaring gas prices in 2022 and 2023 following Russia’s invasion of Ukraine.

“We are paying close attention and are continuing our dialogue with EU colleagues,” state secretary at the Norwegian finance ministry, Ellen Reitan, told Euractiv.

The comments come as EU countries are eyeing Russian frozen assets rather than their own budgets to meet Kyiv’s financial needs, which the International Monetary Fund estimates are around €55 billion for the next two years.

Brussels intends to present options to finance Ukraine’s needs but will “intensify discussions with like-minded partners and allies … at a later stage”, a European Commission spokesperson told Euractiv.

Politiken activism

The push for Norway’s involvement, however, did not originate in Brussels or Oslo but in Copenhagen.

As EU leaders gathered in Brussels to discuss the loan on 23 October, Politiken published an interview with two Norwegian economists urging their country to use its vast wealth and triple-A credit rating to break the impasse.

“That would be great,” said Danish Prime Minister Mette Frederiksen when a Politiken reporter asked her about it some hours later in Brussels, but added that she hadn’t heard anything suggesting Oslo was considering the idea.

The same reporter later asked Ukrainian President Volodymyr Zelenskyy whether he had discussed the proposal with the Norwegian leader Støre during their meeting earlier that week.

https://www.zerohedge.com/political/norway-urged-tap-eu18-trillion-sovereign-wealth-fund-help-ukraine

All Ukraine's State Thermal Power Plants Down After 'Largest Ever Attack' By Russia

 Friday night witnessed more heavy Russian airstrikes on Ukrainian cities, which has left a reported eleven people killed and large swathes of Ukraine without power. Moscow said its attacks targeted the country's energy infrastructure.

Ukraine's military confirmed Saturday morning that Russia launched hundreds of drones and missiles from the air, land, and sea, primarily targeting vital energy infrastructure, ahead of a potentially severe winter.

AFP via Getty Images

In total some 500 aerial attacks were detected overnight, including 45 missiles and over 450 drones. Ukraine's military said just nine missiles were intercepted, but air defenses managed to shoot down 406 UAVs.Gas and power facilities, including thermal energy sites, were damaged, leading to widespread outages across several regions - something which has started to become the norm as Russia escalates these strikes.

An attack on eastern Dnipro region included a building being hit, which killed three people and injured 11 others, with Ukrainian media saying children were among the casualties. This was the result of a drone ripping through a residential building.

"Russian strikes once again targeted people's everyday life. They deprived communities of power, water and heating, destroyed critical infrastructure, and damaged railway networks," Foreign Minister Andriy Sybiha said in the aftermath.

Emergency management crews are working overtime to restore power to the impacted grids, but this has been a growing problem as badly needed parts are hard to constantly replace after years of accumulated damage.

Reports say Kiev has been plunged into darkness, and swathes of the city and region could be without power for some 9-hours or more:

The scenes of blackout in the capital of Ukraine, Kyiv, following a large-scale Russian attack on Ukrainian energy infrastructure last night.

The only visible light is provided by the passing cars. pic.twitter.com/DmVl4WxSLA

— Status-6 (Military & Conflict News) (@Archer83Able) November 8, 2025

"We are working to eliminate the consequences throughout the country. The focus is on the rapid restoration of heat, light and water," Svyrydenko said.

Ukraine's southern Odesa was also impacted, with outages reported. The southern Black Sea port city has come under growing attacks, though it was mostly sparred from any major direct military action throughout the war. But as things keep escalating that could change.

Kyiv Post has cited authorities who say that all state thermal power plants are now offline:

All thermal power plants (TPP) operated by Ukraine's state-owned energy company Centrenergo are down following "the largest Russian attack" which targeted all of them, the company announced on Nov. 8.

According to the company, the same thermal power plants that had been restored after attacks in 2024 were struck again, with multiple Russian drones targeting them "each minute" overnight on Nov. 8.

APOCALYPTIC scenes at Ukraine’s Zmievskaya Thermal Power Plant

HUGE black smoke columns rise after missile strike

One of Ukraine’s LARGEST power plants — operated by Centrenergo, now ALL plants SHUT down https://t.co/T4JaHyNSAB pic.twitter.com/UQqdiB5LHE

— RT (@RT_com) November 8, 2025

In the north, the mayor of Kharkiv has also reported a "noticeable shortage of electricity." The Kremlin has confirmed this has been systematic and intentional so long as Kiev refuse to make significant compromise, including territorial concessions, to end the war.

While President Trump has recently approved some escalatory measures, such as providing Ukraine with intelligence for long-range attacks on Russian territory, the US president has by and large seemed to have washed his hands of involvement in a rapid peace process or any kind of lasting solution for that matter.

https://www.zerohedge.com/geopolitical/all-ukraines-state-thermal-power-plants-down-after-largest-ever-attack-russia

BridgeBio Pharma, Inc. Presents Data from the ATTRibute-CM Study

 - Simultaneously published in JAMA Cardiology along with moderated posters at AHA, acoramidis demonstrated:

• 59% risk reduction in ACM in the ATTR-CM variant population at Month 42 (p=0.032) compared to patients initially randomized to placebo in the ATTRibute-CM study
• 69% risk reduction in ACM/ first CVH through Month 30 compared to placebo (p=0.016) and a 69% risk reduction in ACM through Month 42 (p=0.045) in ATTR-CM participants with the genetic variant p.Val142Ile (V142I, V122I) compared to patients initially randomized to placebo in the ATTRibute-CM study

- This is the first report of clinical benefit of this magnitude observed in this high-risk population with significant unmet need

https://www.globenewswire.com/news-release/2025/11/08/3184066/0/en/Acoramidis-Significantly-Reduces-All-cause-Mortality-in-the-Overall-ATTR-CM-Variant-and-V142I-V122I-Populations.html

https://dailyreckoning.com/bidens-autopen-pardon-scandal/

CRISPR Gene Editing Therapy Cut Cholesterol Levels by Half

In a step toward the wider use of gene editing, a treatment that uses Crispr successfully slashed high cholesterol levels in a small number of people.


In a trial conducted by Swiss biotech company Crispr Therapeutics, 15 participants received a one-time infusion meant to switch off a gene in the liver called ANGPTL3. Though rare, some people are born with a mutation in this gene that protects against heart disease with no apparent adverse consequences.



The highest dose tested in the trial reduced both “bad” LDL cholesterol and triglycerides by an average of 50 percent within two weeks after treatment. The effects lasted at least 60 days, the length of the trial. The results were presented today at the American Heart Association’s annual meeting and published in The New England Journal of Medicine.



The Nobel Prize–winning Crispr technology has mostly been used to address rare diseases, but these latest findings, while early, add to the evidence that the DNA-editing tool could be used to treat common conditions as well.

“This will probably be one of the biggest moments in the arc of Crispr’s development in medicine,” Samarth Kulkarni, CEO of Crispr Therapeutics, tells WIRED. The company is behind the only approved gene-editing treatment on the market, Casgevy, which treats sickle cell disease and beta thalassemia.


The American Heart Association estimates that about a quarter of adults in the US have elevated LDL levels. A similar number have high triglycerides. LDL cholesterol is the waxy substance in the blood that can clog and harden arteries over time. Triglycerides, meanwhile, are the most common type of fat found in the body. High levels of both raise the risk of heart attack and stroke.


The Phase I trial was conducted in the UK, Australia, and New Zealand between June 2024 and August 2025. Participants were between the ages of 31 and 68 and had uncontrolled levels of LDL cholesterol and triglycerides. The trial tested five different doses of the Crispr infusion, which took about two and a half hours on average to administer.

“These are very sick people,” says Steven Nissen, senior author and chief academic officer of the Heart, Vascular and Thoracic Institute at Cleveland Clinic, which independently confirmed the trial’s results. “The tragedy of this disease is not just that people die young, but some of them will have a heart attack, and their lives are never the same again. They don't get back to work, they develop heart failure.”


One trial participant, a 51-year-old man, died six months after receiving the lowest dose of the treatment, which was not associated with a lowering of cholesterol and triglycerides. The death was related to his existing heart disease, not the experimental Crispr treatment. The man had a rare, inherited genetic form of high cholesterol and previously had several procedures to improve blood flow to his heart.

“That's the trajectory these people are on, and we want to get them off that trajectory,” Nissen says.

Three people had minor reactions such as back pain and nausea that cleared up with medication. One participant, who had elevated liver enzymes before getting the Crispr infusion, had a temporary further rise in liver enzymes that lasted a few days and returned to normal without needing treatment.

Researchers will continue to monitor study participants for a year following the trial, with an additional long-term safety follow-up of 15 years, as recommended by the Food and Drug Administration for all gene-editing therapies.

The team is planning Phase II studies for 2026 that will include a broader patient population and longer follow-up period. The hope is that the effects of a single Crispr infusion would last years, even permanently, replacing the need for a daily pill or regular injection.

This isn’t the first trial to use gene-editing to address cardiovascular disease. Verve Therapeutics is using a newer type of Crispr called base editing to target a different gene, called PCSK9, in people with a hereditary form of high cholesterol levels and premature heart disease. Verve halted a trial of its gene-editing candidate in 2024 after one participant had a concerning rise in liver enzymes, but this year it showed positive safety data from 14 patients with a newly formulated therapy. Earlier this year, Eli Lilly announced a deal to acquire Verve for over $1 billion.

Safety is a key concern with new gene-editing therapies. Intellia Therapeutics has paused trials of a Crispr treatment after a patient died from liver damage. Because many Crispr therapies target the liver, damage to that organ has been a known risk.

If further trials confirm safety and efficacy, however, Nissen thinks that in the relatively near future, it will be possible to treat patients at an earlier stage, before they develop heart disease. “This is a revolution in progress here,” he says.

https://www.wired.com/story/a-gene-editing-therapy-cut-cholesterol-levels-by-half/