STAT+: A key Medicare Advantage announcement is due today

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Today’s the day

By law, the 2027 Medicare Advantage payment regulation must come out today. It will set the tone for how the Trump administration wants to work with the health insurance industry: as the “new sheriff in town” or just another friendly regulator.

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<![CDATA[As Canada approaches the planned implementation of their medical euthanasia program for patients with sole psychiatric illnesses, these authors make an argument as to why euthanasia should remain closed to patients with psychiatric disorders.]]>

Top 5 Firms Engineering Healthcare in the CNS Space

Central nervous system (CNS) treatments are having a major comeback. These five precision medicine players plan to ride the resurgence.

After a decade of stagnation, the CNS space is seeing a revival in sales and R&D spending as the market was last year projected to surpass $80 billion for the first time since 2013 and hit around $127 billion.

Recent landmark approvals have brought attention back to the CNS, including the U.S. Food and Drug Administration (FDA)’s greenlight of Eisai/Biogen’s lecanemab (Leqembi) for the treatment of Alzheimer’s disease in 2023, and the FDA approval of Bristol-Myers Squibb’s schizophrenia treatment xanomeline/trospium chloride (Cobenfy) in 2024.

At the same time, Johnson & Johnson’s depression treatment, esketamine (Spravato), is on its way to blockbuster status, showcasing the growth potential of the CNS market.

These successes accompany an emerging shift in psychiatry clinical trials from subjective rating scales to more objective endpoints, including digital and physiological measures, with the potential to better tailor treatments to a patient’s biological makeup.

Startups and scaleups are attracting increasing investor attention for their potential to change the way we treat CNS conditions. Check out our list of the most exciting companies that have netted the biggest investor dollars.

 

1. Aerska

Founded: 2025 | Headquarters: Dublin, Ireland

Aerska logo

Aerska’s name is derived from an Irish proverb stating that people survive in each other’s shelter, emphasising the strength of its team.

This team includes co-founder Jack O’Meara, previously co-founder of the liver-focused RNA interference (RNAi) biotech Ochre Bio, who is driven by the experience of loved ones suffering from Alzheimer’s disease.

Aerska is developing RNAi therapies for neurodegenerative conditions, including Parkinson’s and Alzheimer’s disease.

While there are already FDA-approved RNAi therapies on the market, such as Alnylam’s patisiran (Onpattro), these are typically focused on liver and cardiometabolic conditions rather than the CNS.

Aerska’s technology consists of antibody “brain shuttles” that bind to proteins on the blood-brain barrier (BBB). They then carry a payload RNA into the brain.

The payload, which is designed based on data-driven patient stratification and disease biomarkers, then silences specific genes driving the disease.

Aerska has already raised $60 million since its launch, including a $21 million seed round in October 2025 and a $39 million Series A round in February 2026, co-led by EQT Life Sciences and age1.

The company, which has research operations in the U.K., is using the latest funding to drive its pipeline programs toward clinical testing.

 

2. Beacon Biosignals

Founded: 2019 | Headquarters: Boston, Massachusetts, U.S.

Beacon Biosignals logo

Beacon Biosignals was co-founded by a team including its CEO—MIT neuroscientist Jacob Donoghue, MD, PhD—and its CTO, the machine learning researcher Jarrett Revels.

Boasting more than 100 employees, the company’s goal is to provide objective biomarkers in drug development that neurology and psychiatry have traditionally lacked compared with other areas of precision medicine.

Its FDA-cleared Waveband device measures the brain’s activity, known as electroencephalography (EEG), while patients sleep at home. The EEG data is then stored, quality-controlled, and fed into AI models that can guide the design of clinical trials.

For example, Beacon’s EEG data can identify patients with Alzheimer’s disease who have worse outcomes and might need a more targeted treatment or a different clinical trial than other patients.

Beacon raised $27 million in a Series A round in 2021 and an oversubscribed Series B round worth $86 million in November 2025.

The B round, which included investors such as Innoviva, Google Ventures, and Nexus NeuroTech, will help the startup to accelerate the discovery of neurobiomarkers and broaden clinical adoption of the technology.

Beacon acquired the French sleep monitoring company Dreem in 2023 to access its monitoring data and headband technology. Beacon then acquired the Ohio-based CleveMed in April 2025 to harness technology measuring breathing, oxygen, and other signals.

 

3. Brainomix

Founded: 2010 | Headquarters: Oxford, U.K.

Brainomix logo

Brainomix was founded by a team including CEO Michalis Papadakis, PhD, who was scientific director of the preclinical stroke lab at the University of Oxford.

Brainomix is dedicated to speeding up patient care in cases of stroke, where speedy treatment is key.

Brainomix’s flagship product, Brainomix 360 Stroke, is designed to harness AI to interpret brain scans and detect blood clots in patients with stroke, speeding up clinical decision-making.

The product involves a group of tools that automatically analyze images, including results from computed tomography (CT), CT angiography, magnetic resonance imaging (MRI), and CT perfusion.

Brainomix’s technology doubled the rate of thrombectomy treatment in patients with stroke and reduced hospital triage and transfer delays, according to a 2025 study.

The University of Oxford spinout is at a commercial stage, with operations in more than 20 countries, and is expanding into the U.S.

Brainomix raised a $21.2 million Series B round in 2021 and extended its Series C round from $6.5 million in March 2025 to $25.4 million in February 2026, with leading investors including Parkwalk Advisors and Hostplus. The proceeds will fuel the company’s expansion into the U.S. market.

Brainomix has also partnered with heavyweights, including Nvidia, Boehringer Ingelheim, Medtronic, and GE Healthcare.

Brainomix also has a product dedicated to disease monitoring in pulmonary fibrosis.

 

4. Circular Genomics

Founded: 2021 | Headquarters: San Diego, California, U.S.

Circular Genomics Logo

Circular Genomics was spun out of the University of New Mexico, with its founders including CSO Nikolaos Mellios, PhD, and Alexander Hafez, PhD.

The company later moved its headquarters from Albuquerque to San Diego in March 2025 to access scientific and operational know-how from Eli Lilly at Lilly Gateway Labs.

Circular Genomics aims to equip medical professionals with a blood test to detect CNS conditions early, in addition to stratifying and guiding the treatment of patients.

Its technology involves using a polymerase chain reaction (PCR) test of a patient’s blood sample to screen for specific circular RNA molecules produced in the brain that can cross into the blood and be measured as a biomarker of disease in the CNS.

Commercially launched in 2024, Circular Genomics’ MindLight SSRI Antidepressant Response Test predicts whether a patient will benefit from common antidepressants called SSRIs with around 77% accuracy. This is designed to predict a patient’s most suitable antidepressants without needing months of trial-and-error approaches.

The company is applying its technology in Alzheimer’s disease, where the approvals of disease-modifying therapies such as Leqembi have led to demand for tests that can detect the disease at earlier stages than traditional tests.

Circular Genomics raised $15 million in a Mountain Group Partners-led Series A round in December 2025 to finance the development of its technology and expansion of its technology in Alzheimer’s disease.

The company also has its sights on other CNS conditions, including multiple sclerosis and Parkinson’s disease.

 

5. Omniscient Neurotechnology

Founded: 2019 | Headquarters: Sydney, Australia

o8t logo

Omniscient (o8t)’s founders include CMO Michael Sughrue, MD, a neurosurgeon aiming to improve anatomy maps for other surgeons, and machine learning expert Stephane Doyen, PhD.

o8t’s FDA-approved product Quicktome involves using a patient’s MRI brain scans and AI models to map out a patient’s brain circuitry. These maps, accessible from an electronic tablet, can guide surgery to minimize the risk of brain damage compared to using a generalized anatomical diagram.

Quicktome is already in use at major hospitals around the world, including major centers in the U.S. Its partners include U.S. surgical support firm META Dynamic and the U.S. medical device innovation center, The Jacobs Institute.

o8t has raised more than $60 million, and bagged $14 million (AUD 20 million) in January 2026 as part of a Series D round targeted to reach $25 million (AUD 36 million). The round was led by Australia’s National Reconstruction Fund (NRFC) and OIF Ventures, with the aim of keeping the company based in Australia.

The funding is earmarked to fuel the development and commercialization of Quicktome, and grow o8t’s Australian workforce by more than 40. The company also has operations in Atlanta, Georgia, U.S.

o8t also plans to expand the technology into high-growth markets, including brain computer interface targeting, stroke and traumatic brain injury.

 

Jonathan Smith, PhD, is a freelance science journalist based in the U.K. and Spain. He previously worked in Berlin as a reporter and news editor at Labiotech, a website covering the biotech industry. Prior to this, he completed a PhD in behavioral neurobiology at the University of Leicester and freelanced for the U.K. organizations Research Media and Society of Experimental Biology. He has also written for medwireNews, Biopharma Reporter, and Outsourcing Pharma.

The post Top 5 Firms Engineering Healthcare in the CNS Space appeared first on Inside Precision Medicine.

<![CDATA[Should hospitals be required to integrate AI-driven risk stratification into emergency department workflows to maintain accreditation? Join the debate.]]>
<![CDATA[A relationship between inflammatory skin disease and depression revealed in new research.]]>

STAT+: Pharmalittle: We’re reading about an FDA delay forcing a biotech to close, a Neurocrine deal, and more

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. You knew this would happen, yes? To cope, we are relying, as always, on cups of stimulation. Our choice today is laced with traces of cocoa. Feel free to join us. Remember, no prescription is required. Meanwhile, here are some tidbits to help you along. Best of luck accomplishing your goals today and, of course, do keep in touch. …

In February, a small biotech company called Kezar Life Sciences reached a breakthrough with the U.S. Food and Drug Administration, agreeing to a plan for a clinical trial it hoped could lead to the approval of its treatment for a rare, debilitating liver disease called autoimmune hepatitis. The problem: The agreement came four months too late, STAT explains. The meeting to discuss trial design, a critical step in the drug development process, had been scheduled for last October. But the FDA abruptly canceled it without explanation. The company could no longer proceed as planned and, without clarity from regulators, its path forward was unclear. Kezar’s investors wanted out, and the biotech was forced to start the process of winding down.

Americans starting weight loss medicines for the first time want lower cost and greater convenience as they consider pills from Novo Nordisk and Eli Lilly, Reuters says, citing seven doctors who specialize in obesity. Novo’s Wegovy pill ​has been on the market since January, while Lilly’s newly approved Foundayo joins the fray this week. Interviews with the specialists show a promising landscape for oral weight loss drugs as ‌the companies compete for share in the fast-changing obesity treatment market that is seen topping $100 billion a year in the next decade. All seven doctors said they had begun prescribing oral Wegovy, and three said they have prescribed the pill to ⁠about 10% of their patients. Of those patients, most are taking a GLP-1 for the first time, rather than switching from injectables, and have not yet reached the highest dose. 

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STAT+: Stealth biotech Stipple bets on secretive ADCs

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A four-month FDA delay prompted a cash-strapped biotech company to shutter. The White House’s proposed NIH cuts are drawing bipartisan backlash. Peptide hype is outpacing evidence. And more!

The need-to-know this morning

  • Neurocrine Biosciences said this morning that it would buy Soleno Therapeutics and its treatment for Prader-Willi syndrome for $2.9 billion. Neurocrine is paying $53 a share for Soleno, a 34% premium to its closing price on Thursday.

A four-month FDA delay derailed a small biotech. Is it a sign of the times?

FDA delays can happen. For large drugmakers, they can be frustrating; for small drugmakers, they can be existential.

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Isatuximab, carfilzomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma: a randomized phase 3 trial

Nature Medicine, Published online: 06 April 2026; doi:10.1038/s41591-026-04282-0

In the phase 3 EMN24 IsKia trial, transplant-eligible patients with newly diagnosed multiple myeloma who received isatuximab with carfilzomib, lenalidomide and dexamethasone pretransplant induction and post-transplant consolidation showed higher rates of measurable residual disease negativity after consolidation than patients who received carfilzomib, lenalidomide and dexamethasone.

Nanotube Injector Boosts Mitochondrial Performance Through Cytoplasmic Transfer

Extracting cytoplasmic material such as proteins, RNA, and mitochondria often relies on cell lysis using detergents or enzymes, which destroy the cells. Ultrasound and other sophisticated physical disruption methods need to be carefully tuned to avoid damaging biomolecules, potentially rendering them too time-consuming.

Delivering material into cells presents further challenges. Lipid-based carriers are limited to small molecules, viral vectors are costly, and microinjection techniques are difficult to scale. To date, no approach allows for controlled and efficient cytoplasmic transfer without compromising cell viability, according to researchers from Waseda University in Japan.

The team published a study “A Nanotube Injector for Cytoplasmic Transfer and Enhanced Mitochondrial Function” in Small Science that reports the development of a nanotube membrane-based injector—a platform that combines nanomaterials and fluid physics to directly transfer cytoplasmic contents between cell populations. The system consists of a thin gold membrane with vertically aligned nanotubes mounted on a glass tube. When this membrane is carefully pressed against cultured cells, the nanotubes penetrate the phospholipid bilayer of the living cells without causing significant damage. By adjusting the internal air pressure of the glass tube, the researchers can “suck up” cytoplasmic material from the source cells, hold it as the tube is repositioned over the target cell culture, and gently flush it into this new population using microliters of a buffer solution.

Infographic from Waseda University in Japan
Credit: Waseda University

Through several experiments using fluorescent dyes and protein assays, the researchers say they confirmed that cytoplasmic contents could be extracted in a pressure-dependent manner. They also found that careful selection of nanotube diameter, nanotube density, and applied pressure was key to minimizing cellular damage. Notably, under optimized conditions, cell viability hovered around 95%, with a cytoplasmic transfer efficiency of well over 90%, note the scientists.

To further test the capabilities of their platform, the team investigated whether it could transfer intact mitochondria. To this end, they labeled mitochondria in donor cells with a fluorescent tag and observed them in the recipient cells via confocal microscopy. They found that dozens of mitochondria could be reliably delivered per cell.

Most importantly, according to Takeo Miyake, PhD, team leader, these mitochondria remained functional, as evidenced by markedly higher levels of adenosine triphosphate (ATP) produced in recipient cells compared to controls.

“This technology establishes a new paradigm for cell manipulation—transforming cells not by genetic modification but by reconstructing intracellular composition itself,” explains Miyake, adding that such controlled cytoplasmic engineering, enabled by the proposed nanotube injector, could support the development of next-generation cell therapies, improved disease models, and more precise drug screening platforms.

“Directly transferring healthy mitochondria or cytoplasmic components into target cells is particularly relevant for regenerative medicine, where therapeutic cells often suffer from reduced metabolic activity or functional heterogeneity after isolation and expansion,” highlights Miyake, “By restoring or augmenting mitochondrial function without genetic modification, the technology offers a new strategy to improve cell quality prior to transplantation.”

Overall, this innovative system paves the way for a new level of control in cell biology research, as well as bioengineering and biomedical applications, points out the research team.

The post Nanotube Injector Boosts Mitochondrial Performance Through Cytoplasmic Transfer appeared first on GEN – Genetic Engineering and Biotechnology News.

STAT+: Neurocrine Biosciences to buy Soleno Therapeutics in $2.9B deal

Neurocrine Biosciences said Monday that it would buy Soleno Therapeutics and its treatment for Prader-Willi syndrome for $2.9 billion. 

Neurocrine is paying $53 a share for Soleno, a 34% premium to its closing price on Thursday. 

Soleno’s drug, Vykat, was approved in March 2025 to treat hyperphagia in patients with the rare genetic disease. Hyperphagia is one of the defining features of Prader-Willi syndrome, causing relentless hunger and leading patients to overeat. Vykat is the only approved treatment for hyperphagia in Prader-Willi patients. 

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