Zealand Bets up to $2.5B in Metabolic Pact With Chinese Biotech

 

Also on Thursday, Zealand held its Capital Markets Day in London, outlining the strategy for its weight management franchise in the near-term, including launching five products by 2030.

Already one of the leading biotechs in the obesity space, Zealand Pharma has teamed up with China’s OTR Therapeutics to advance next-generation drugs for the condition and other metabolic disorders in a partnership worth up to $2.5 billion.

The back-heavy deal involves a $20 million upfront payment from Zealand, which could increase to $30 million under certain unspecified conditions. OTR Therapeutics will be eligible for preclinical, development, regulatory and sales milestones that could hit up to $2.5 billion, the bulk of which will come from the partnership’s potential commercial performance. The Chinese biotech will also receive tiered single-digit royalties on worldwide net sales of any product under the agreement that reaches the market.

The deal marks an expansion into oral small-molecule therapeutics for Zealand, but keeps the biotech within molecular targets where it already has experiense, Chief Scientific Officer Utpal Singh said in a statement.

In exchange for the investment, Zealand will be able to leverage OTR’s proprietary small-molecule platform to advance novel therapies for several metabolic disease targets. The partners did not say which indications they plan to prioritize, though Singh in his statement noted that the agreement is in line with the company’s strategy to bring new treatment options to “people who are overweight, with obesity, and other metabolic diseases.”

Zealand already has two powerhouse partners behind it, securing the biotech’s place as a leader in the obesity space. In March this year, Roche fronted $1.65 billion and promised up to $3.6 billion in milestones to partner with the Danish biotech and gain the right to co-develop and co-commercialize the amylin analog petrelintide for weight loss. Zealand’s presence in the metabolic disease space stretches as far back as 2011, when Boehringer Ingelheim took notice of survodutide (then called ZP2929), a dual-acting agonist of the GLP-1 and glucagon receptors.

Zealand anticipates two late-stage topline readouts for survodutide in the front half of 2026, while petrelintide will deliver Phase II data next year.

Also on Thursday, Zealand held its Capital Markets Day in London, outlining the strategy for its weight management franchise in the near-term, with an eye toward becoming a leader in the metabolic health space in the coming years.

To achieve this goal, Zealand will work to speed its discovery and development process such that by 2030, the company will be able to launch five products and build a “robust” pipeline of more than 10 investigational therapies.

“We are redefining weight management for a new era,” CEO Adam Steensberg said in a statement, “moving beyond the weight loss Olympics toward solutions that support the everyday needs, aspirations, and overall well-being of people living with overweight, obesity, and metabolic imbalance.”

https://www.biospace.com/business/zealand-bets-up-to-2-5b-in-metabolic-pact-with-chinese-biotech

AC Immune’s Parkinson’s Immunotherapy Appears to Slow Disease Progression

 

In a first for the Parkinson’s field, AC Immune’s immunotherapy has stabilized key biomarkers that suggest an effect on the disease’s course.

An immunotherapy developed by AC Immune appeared to slow the progression of Parkinson’s disease in a mid-stage trial, representing a first for the disease and a key win for the biotech which tackles intractable neurodegenerative disorders.

In part one of the Phase II VacSYn trial, AC Immune’s anti-alpha-synuclein (a-syn) active immunotherapy, ACI-7104.056, was tested against placebo in 34 patients with early Parkinson’s disease for at least 12 months. Twenty participants stayed on treatment for 18 months.

At the interim analysis, AC Immune found that the immunotherapy stabilized known Parkinson’s biomarkers such as a-syn and neurofilament light chain, which are signs of neuronal damage or neurodegeneration in the brain.

Brain imaging after treatment suggested “trends toward disease modification,” the company said in a press release Thursday, and there was a suggested trend of stabilization on patient-reported movement scores. ACI-7104.056 also induced a robust antibody response in all patients at week 76.

Shares of AC Immune rose 14% to $3.17 in pre-market trading on Thursday morning, but stablized once trading began to $2.90.

“For the first time, we are seeing signals that targeting the underlying pathology of Parkinson’s with active immunotherapy could slow disease progression,” Werner Poewe, emeritus Professor of Neurology at Innsbruck Medical University and an expert in Parkinson’s disease, said in the same press release.

AC Immune will need to layer on the evidence to show that ACI-7104.056 can impact the underlying disease, Poewe noted. But today’s results are “highly encouraging,” he said.

CEO Andrea Pfeifer said the results “hold the promise of a tremendous step forward for millions of patients.”

AC Immune trimmed its pipeline earlier this year in an effort to extend its cash runway into the third quarter of 2027 and focus on the most important assets in the pipeline—ACI-7104.056 included. At the same time, 30% of staff were let go.

Another focus is ACI-24.060, a vaccine for Alzheimer’s disease that targets abeta and has been dubbed a “first mover effort” by HCW Research analysts. The biotech is expecting a readout for the program in the first half of 2026.

https://www.biospace.com/drug-development/ac-immunes-parkinsons-immunotherapy-appears-to-slow-disease-progression

Pfizer Builds Case for Tukysa as ‘New Standard Regimen’ in First-Line Metastatic Breast Cancer

 

While new late-stage data point to some liver toxicity signals, analysts at BMO Capital Markets said Tukysa’s efficacy outcomes “appear to more than make up for any safety concerns.”

Pfizer’s oral kinase inhibitor Tukysa significantly cut the risk of death or disease progression in patients with metastatic breast cancer in the frontline setting.

Tukysa’s performance in this indication positions it to “become a new standard regimen” in HER2-positive metastatic breast cancer, analysts at BMO Capital Markets said in a Wednesday note. “Results today are a positive advancement. . .demonstrating more upside from expansion in oncology in the near term,” they added.

The Phase III trial was not without its setbacks, however, as BMO noted liver toxicities.

BMO considered the incidence of liver toxicity to be “meaningfully higher” with Tukysa treatment, something they expect doctors to take into account when deciding whether to prescribe the regimen. Still, “We expect most physicians to be comfortable with this risk trade-off,” the analysts wrote, “as efficacy outcomes appear to more than make up for any safety concerns.”

In the HER2CLIMB-05 study, Pfizer tested a combination of Tukysa and Roche’s Herceptin and Perjeta in more than 320 patients with HER2-positive metastatic breast cancer who had undergone pre-study induction treatment with Herceptin, Perjeta and taxane, and had shown no sign of disease progression thereafter. Patients in the control arm were treated with just Herceptin and Perjeta.

Results, announced Wednesday and presented at the 48th San Antonio Breast Cancer Symposium (SABCS), showed the Tukysa-based combo cut the risk of disease progression or death by 35.9% versus controls. Median progression-free survival (PFS) hit 24.9 months in the Tukysa arm, versus 16.3 months for comparators. Overall survival, which was immature at the time of the readout, leaned numerically in favor of Tukysa.

Pfizer also noted that Tukysa’s PFS benefit remained consistent across different patient subgroups, including those with recurrent or de novo diagnoses, with or without brain metastasis and whose disease was either HR-positive or HR-negative.

“Improvements in PFS of this magnitude are clearly significant and clinically meaningful,” BMO added in its note, “potentially opening the opportunity for [Tukysa] to be added as a standard 1L treatment option.”

Data from HER2CLIMB-05 also revealed potential safety concerns, including a higher rate of grade 3 and higher elevations in liver transaminases—though Pfizer insisted these were “typically manageable and reversible” with dose modifications. More detailed data published in the Journal of Clinical Oncology showed that 13.5% of patients dropped out due to treatment-emergent adverse events.

https://www.biospace.com/drug-development/pfizer-builds-case-for-tukysa-as-new-standard-regimen-in-first-line-metastatic-breast-cancer

'Incurable deadly disease caused by a fancy kitchen design feature confirmed in Mass.'

 Luxe quartz countertops have surged in popularity in recent years, with an 800% rise in imports to the US alone, thanks to their durability, heat resistance and smooth, natural look.

But that beauty may come at a price to the workers who install them.

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While quartz countertops are all the rage in kitchen design, they could come at a cost to the workers installing them.SB Arts Media – stock.adobe.com

The Massachusetts Department of Public Health issued a safety alert on Tuesday regarding silicosis, a progressive and incurable lung disease.

The state confirmed the first case of silicosis in a Massachusetts employee of the stone countertop fabrication industry.

Historically associated with mining and construction, the disease has become more prevalent among stone fabricators working with engineered stone, which contains significantly more silica than natural materials like granite or marble.

About 2.3 million US workers are exposed to silica in the workplace, according to the American Lung Association.

Silicosis is caused by inhaling crystalline silica dust, which is generated by cutting, polishing or grinding stones, especially high-silica engineered quartz.

Symptoms can include an irritating cough, mucus, shortness of breath, trouble breathing, fatigue, chest pain and leg swelling.

While there are treatments to manage symptoms, there’s no cure for silicosis. The disease can worsen as it progresses, potentially leading to lung cancer, tuberculosis and even death.

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Silicosis, an incurable and deadly disease, is caused by inhaling crystalline silica when installing stone.New Africa – stock.adobe.com

The Massachusetts resident had worked for stone countertop fabrication and installation companies for 14 years, the state said. He’s a Hispanic man in his 40s.

The first US case of silicosis linked to engineered stone was reported in Texas in 2015.

In a 2023 study, California researchers identified 52 California quartz countertop workers with silicosis.

Twenty of them had advanced silicosis, and 10 died before the study concluded.

While the disease is potentially deadly, there hasn’t been an outright ban on quartz in the kitchen.

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The disease can result in trouble breathing, fatigue and chest pain, potentially progressing to lung cancer or even death.Dr_Microbe – stock.adobe.com

Rather, public health officials and researchers are asking for stricter regulations and safety precautions.

“The confirmation of this case in Massachusetts is a tragic reminder that silicosis is not just a distant threat — it is here, and it is seriously impacting the health of workers in Massachusetts,” Emily H. Sparer-Fine, director of the Massachusetts Department of Public Health’s Occupational Health Surveillance Program, said in a statement.

“Beyond the critical role employers play, everyone involved in the supply chain can help reduce the danger by opting for materials that contain less silica and pose fewer health hazards,” she added.

Precautions such as proper ventilation and a medical surveillance program for workers have been floated as possible solutions.

“Our paper raises the alarm,” said Dr. Sheiphali Gandhi, a UC San Francisco pulmonologist and co-author of the California study. “If we don’t stop it now, we’re going to have hundreds, if not thousands, of more cases. Even if we stopped it now, we’re going to be seeing these cases for the next decade because [silicosis] takes years to develop.”

In 2016, the federal Occupational Safety and Health Administration issued two respirable crystalline silica standards to protect workers.

These standards require employee exposures to be below the permissible limit of 50 micrograms of respirable crystalline silica per cubic meter of air over an eight-hour workday.

In 2019 and 2020, however, California safety officials found that about 72% of the 808 fabrication shops operating in the state were “likely out of compliance with the existing silica standard,” putting hundreds of workers at risk of silicosis, according to NPR.

Since then, the California Division of OSHA adopted emergency rules for respirable crystalline silica in 2023, which were made permanent in late 2024.

https://nypost.com/2025/12/10/health/incurable-disease-caused-by-kitchen-design-idd-in-massachusetts/

Wall Street giants ‘debanked’ coal, gas, other politically sensitive businesses, regulator says

 Nine of the biggest banks in the country, including JPMorgan Chase and Bank of America, improperly refused to do business with a range of politically controversial industries — from coal and tobacco to private prisons — according to a top banking regulator.

The report from the Office of the Comptroller of the Currency stems from an investigation that could back up claims by President Trump that the country’s largest banks took part in what the administration has called “politicized or unlawful debanking activities.”

Debanking refers to banks closing accounts or denying services to customers.

Along with JPMorgan and Bank of America, the banks named by the Comptroller were Citibank, Wells Fargo, US Bank, Capital One, PNC Bank, TD Bank, and BMO Bank.

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Jonathan Gould, the comptroller of the Currency, said the investigation continues and that the agency could refer its findings to the Attorney General.REUTERS

All have denied debanking allegations on multiple occasions in the past.

“It is unfortunate that the nation’s largest banks thought these harmful debanking policies were an appropriate use of their government-granted charter and market power,” Comptroller of the Currency Jonathan Gould, a Trump appointee, said in a statement.

A bank charter is a government license that allows a bank to operate.

The report stated the victims of debanking worked in areas from firearms manufacturer to oil and gas, though it did not name the alleged victims.

The document focused in particular on environmental or sustainability-related decisions that banks made in prior years, in an effort to satisfy investors who said the industry needed to do more to address climate change and racial inequality. The Comptroller stopped short of calling those actions unlawful.

“While many of these policies were undertaken in plain sight and even announced publicly, certain banks have continued to insist that they did not engage in debanking,” Gould said. “Going forward, the OCC will hold banks accountable for these actions and ensure unlawful debanking does not continue.”

Banks have said they do not close accounts for political or religious reasons.

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Trump lashed out at banks such as Bank of America in a speech in Davos earlier this year.REUTERS

They maintain that decisions to avoid certain industries or clients follow laws that make banks watch for criminal activity and money laundering.

Banks also say such practices respond to other regulatory pressures meant to protect the banks.

The Bank Policy Institute, a lobbying group for banks, said Wednesday that the industry supports creating new rules to ensure fair access to banking.

“It’s in banks’ best interest to take deposits, lend to, and support as many consumers and businesses as possible to drive economic growth,” the group said.

The White House in August issued an executive order accusing banks of discriminating against conservatives and cryptocurrency companies. It also threatened fines for lenders that dropped customers for political reasons.

Trump has said he and his businesses were debanked after he left office following the Jan. 6, 2021 riots at the US Capitol. The issue prompted the president to give a fiery dressing-down to Bank of America CEO Brian Moynihan in an online speech at Davos, Switzerland, earlier this year.

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Bank of America was one of the lenders accused of debanking. The lender has always denied the allegations.AP

Debanking has since become one of the few points of conflict between banks and the White House, which has otherwise pushed a deregulatory agenda that is poised to benefit the industry.

The Office of the Comptroller of the Currency released preliminary its findings on Wednesday after asking the nine largest banks it oversees to submit reports on whether they had taken part in unlawful debanking.

The office said the investigation continues and that the agency could refer its findings to the attorney general.

https://nypost.com/2025/12/10/business/wall-street-giants-debanked-coal-gas-other-politically-sensitive-businesses-regulator-says/