Background: Community-based mobile health (mHealth) services are increasingly used to support chronic disease management in underserved rural populations facing workforce shortages, geographic isolation, and rapid aging. South Korea entered a super-aged society in December 2024, intensifying pressures in rural regions where multiple mHealth programs are embedded within primary care and public health systems. However, evidence on sustained use in real-world settings remains limited. Objective: This study aimed to explore user experiences and acceptance of community-based mHealth services in an underserved rural area of South Korea and identify facilitators and barriers to sustained engagement, using the Unified Theory of Acceptance and Use of Technology 2 (UTAUT2). Methods: A convergent mixed methods design was used, with qualitative and quantitative data collected in parallel, analyzed separately, and integrated at the interpretation stage. Overall, 24 participants with ≥6 months of experience using 1 of 4 publicly funded mHealth services in Pyeongchang County, Gangwon State, were purposively recruited. Semistructured interviews guided by the UTAUT2 were analyzed using directed content analysis, combining deductive and inductive coding. Structured questionnaires assessing usability and behavioral intention were analyzed using descriptive statistics. Findings were integrated through joint interpretation. Results: Participants had a mean age of 71.3 (SD 9.2) years, and 70.8% (17/24) were female; hypertension (18/24, 75%) and hyperlipidemia (15/24, 58.3%) were the most common. Perceived difficulty was low (mean 2.54, SD 2.06, on a 0‐10 scale), intention for continued use was high (23/24, 95.8%), and recommendation intention was unanimous (24/24, 100%). Willingness to pay was reported by 79.2% (19/24), most commonly KRW 1000‐5000 (US $1-3) per month. Qualitative findings identified performance expectancy, social influence, facilitating conditions, and habit as the most salient determinants of sustained use. Real-time monitoring enhanced health awareness, motivated dietary modification, and increased physical activity. Public health center nurses served as human-in-the-loop facilitators, providing continuous training, troubleshooting, and emotional support, while family and peers reinforced engagement. Habit formation emerged as a central mechanism, with 91.7% (22/24) integrating mHealth use into routines anchored to waking, exercise, and bedtime. Effort expectancy barriers among older participants were mitigated through nurse-led training, and hedonic motivation was driven by intrinsic satisfaction and peer interaction. Integrated analysis showed convergence for ease of use and behavioral intention, and partial divergence for willingness to pay. Conclusions: Community-based mHealth services were successfully integrated into daily life and supported chronic disease self-management among older adults in an underserved rural setting. Sustained engagement was driven by perceived health benefits, continuous human support, and habit formation rather than technology features alone, underscoring the importance of relationship-centered, human-in-the-loop implementation models. Strengthening intuitive design, hands-on onboarding, multidisciplinary primary care teams, and stable financing will be essential for equitable digital health adoption in rural and aging communities.
<img src="https://jmir-production.s3.us-east-2.amazonaws.com/thumbs/e9b539d08c64e136f02d41fc3a00cde6" />
Functional Outcome Prediction in Young Adults With Mental Health Symptoms Using Machine Learning and Large Language Models: Longitudinal Observational Study
Background: Functional impairments associated with mental health conditions are on the rise. Predicting functional outcomes may improve the targeting of preventive interventions. While prognostic models have primarily focused on psychosis, early recognition services require a transdiagnostic approach. Objective: This study aimed to predict global functioning within a 2-year follow-up using baseline clinical and structural magnetic resonance imaging (MRI) data in a population-based sample of young, help-seeking individuals presenting with affective and anxiety symptoms as well as attention-deficit hyperactivity disorder. Methods: We classified 357 help-seeking individuals aged 18‐35 years recruited from 9 sites as “impaired” (Global Assessment of Functioning [GAF] ≤60; n=228) or “nonimpaired” (GAF>60; n=129) at year 1 and/or year 2 follow-up. GAF classification group status at follow-up was predicted using linear support vector machine (SVM), decision tree, and large language model (LLM) Llama-3 using clinical assessments and/or structural MRI. Leave-one-site-out (SVM) or external sample (LLM) was used for validation. Results: SVM achieved balanced accuracy of 69.2% using clinical features only. Items related to baseline occupational functioning, interpersonal relationships, cognitive functioning, psychotic and affective symptoms, as well as the presence of anxiety disorder, were most predictive. The decision tree further reduced the feature set to 5 predictive items, achieving balanced accuracy of 76.6%. Although amygdala and hippocampal subregions achieved balanced accuracy of 57.1%, structural MRI did not improve the overall prediction. Llama-3 performed comparably well to SVM (balanced accuracy of 72.6%). Conclusions: Machine learning demonstrated good performance in predicting global functioning. Interestingly, the out-of-the-box LLM performed comparably well without being trained or fine-tuned, highlighting the potential of leveraging free-text data for mental health prognosis.
Sleep Habits Can Influence Effects of Alzheimer’s Disease Risk Genes
Research led by Edith Cowan University in Australia suggests the impact of genetic mutations that impact Alzheimer’s disease risk are influenced by a person’s sleep habits.
As reported in the journal Alzheimer’s & Dementia, the researchers confirmed links with aquaporin-4 gene (AQP4) variants and changes in brain volume, atrophy and cognition linked to Alzheimer’s disease.
The investigators also showed how long people sleep, how long it takes them to fall asleep, how often their sleep is disturbed, and how good or poor their sleep is overall contributed to the effect of these mutations.
“Our study shows that individuals carrying certain AQP4 variants showed faster grey matter loss when they reported shorter sleep,” said study co-author Ayeisha Milligan Armstrong, PhD, a researcher at Edith Cowan University, in a press statement.
“It’s not just which genes you carry—it’s how those genes interact with the world around you. The same variant can look protective or detrimental depending on how someone is sleeping. That’s important, because sleep is one of the few modifiable factors people can actually act on.”
Researchers now think the brain gets rid of amyloid‑beta using a kind of plumbing system that washes waste away along the outside of blood vessels. In this system, fluid moves through the spaces around blood vessels, helped by tiny water channels called aquaporin‑4, encoded by AQP4, which sit on the parts of astrocyte cells that wrap tightly around those vessels.
“Given that AQP4 has been identified as an important mediator of brain amyloid beta clearance, variation within the AQP4 gene has been investigated in relation to neurodegenerative diseases and their associated phenotypes,” write the authors.
“A bi-directional relationship has been observed between suboptimal sleep and increasing brain amyloid beta accumulation…Importantly, a previous study utilizing data from the Australian Imaging, Biomarker and Lifestyle cohort reported that the relationship between sleep and cross-sectional brain amyloid beta burden was moderated by genetic variants in AQP4.”
To investigate this link further, the researchers studied 351 cognitively normal people already showing ongoing build‑up of brain amyloid‑beta on positron emission tomography (PET) imaging. They genotyped the group for 13 mutations in the AQP4 gene and also assessed sleep duration and quality, brain volume, amyloid burden and cognition scores.
Several AQP4 variants interacted with sleep measures to predict gray‑matter atrophy, brain ventricular volume, white‑matter volume, and cognitive decline. For example, people carrying certain variants who also had shorter sleep duration were more likely to have faster grey‑matter loss, and other variants magnified the impact of poorer global sleep quality on ventricular enlargement in the brain.
One variant showed a direct association with better global cognitive performance and two other variants seemed to be linked to less cognitive decline as sleep disturbances increased.
“We’ve known for a while that poor sleep and Alzheimer’s risk are linked,” said first author Tenielle Porter, PhD, also a researcher at Edith Cowan University.
“What this shows is that rather than assuming everyone at risk follows the same pathway, a more targeted and personalized approach to Alzheimer’s prevention may be needed. But we’re not at the point of recommending genetic testing; our findings need replication in larger and more diverse cohorts.”
The post Sleep Habits Can Influence Effects of Alzheimer’s Disease Risk Genes appeared first on Inside Precision Medicine.
Magnetic Algae Microrobots Boost Chemotherapy Penetration in Bladder Tumors
Researchers from the University of Edinburgh and Xiamen University have developed microscopic algae-based robots capable of delivering chemotherapy directly into bladder tumors, significantly improving drug penetration and therapeutic efficacy in preclinical models.
The study, published in Nature Nanotechnology, describes a machine-guided drug delivery platform that combines biodegradable microalgae, magnetic control, real-time ultrasound imaging, and artificial intelligence-assisted navigation. In mouse models of bladder cancer, the system achieved more than a tenfold increase in drug penetration and reduced tumor burden to less than 3% of that observed with conventional chemotherapy delivery.
“Our microrobots are engineered from tablet-like microalgae, can be remotely guided to the tumor using real-time imaging feedback, and release drugs exactly where they are needed to drive rapid tissue penetration in a minimally invasive way,” said study co-lead Qi Zhou, PhD, of the University of Edinburgh.
Addressing a major challenge in bladder cancer therapy
Bladder cancer is one of the most common malignancies worldwide, with approximately 75% of cases diagnosed as non-muscle-invasive disease. Standard treatment typically involves surgical removal of visible tumors followed by intravesical chemotherapy, in which drugs are delivered directly into the bladder through a catheter.
While this approach limits systemic toxicity, its effectiveness is often constrained by poor penetration of drugs through the bladder’s protective barriers and into tumor tissue. Much of the chemotherapy remains near the surface, requiring prolonged exposure times and higher drug doses to achieve therapeutic benefit.
To overcome these limitations, the research team developed what they call a “drug-loaded magnetic Coscinodiscus granii” (DMCG) microrobot. The platform uses naturally occurring diatom algae, whose porous silica shells provide an ideal structure for carrying therapeutic cargo. The algae are coated with magnetic nanoparticles, loaded with the chemotherapy drug doxorubicin, and sealed with a protective polymer layer that enables controlled drug release.
Magnetic navigation and intelligent control
Unlike conventional drug carriers that rely on passive diffusion, the algae microrobots can actively move through the bladder under the influence of externally applied magnetic fields.
Researchers developed multiple modes of movement, including rolling, tumbling, spinning, and swirling. Rolling modes allow the robots to travel efficiently through the bladder while minimizing premature drug leakage. Once they reach a tumor, the robots switch to rotational modes that generate localized fluid flows around the porous algae structure, accelerating drug release and enhancing penetration into surrounding tissue.
The system incorporates real-time ultrasound imaging and deep learning-based tracking algorithms that identify both the tumor and the microrobot swarm. Using this feedback, robotic magnetic controllers can autonomously guide the swarm to target regions and trigger localized drug delivery.
The researchers liken the collective behavior of the microrobots to schools of fish or flocks of birds moving in coordinated swarms through complex environments.
Enhanced drug penetration
A key innovation of the platform is its ability to generate convective fluid flow around the tumor.
The rotating microrobots create microscopic currents that transport drug molecules more efficiently than diffusion alone. Laboratory experiments demonstrated that this mechanism substantially increased release of doxorubicin from the algae carriers and improved penetration through both hydrogel barriers and three-dimensional tumor spheroids.
In tumor spheroid models, the rotating microrobots increased drug penetration depth by approximately 150 micrometers and boosted overall fluorescence intensity, a measure of drug accumulation, by nearly 370% compared with non-actuated controls.
The approach also allowed researchers to separate transport and release functions. Swarms could travel rapidly in locomotion mode before switching to localized swirling behavior that increased drug release by more than threefold compared with transport mode alone.
Strong anti-tumor effects in mice
The team then evaluated the technology in an orthotopic mouse model of bladder cancer.
Using ultrasound guidance, the researchers navigated the microrobot swarms directly to bladder tumors, where they generated localized flow fields and released chemotherapy. Histological analysis revealed that tumor-specific accumulation of doxorubicin increased dramatically compared with free drug administration. Mean fluorescence intensity within tumors increased by more than 1,000%, while the tumor-to-normal tissue ratio rose from 0.56 to 3.6.
The researchers subsequently conducted a one-week treatment study consisting of four intravesical chemotherapy sessions delivered on alternating days.
The results were striking. Bioluminescence imaging showed that tumor burden in mice receiving microrobot-assisted therapy fell to just 2.36% of that observed in animals treated with free doxorubicin and 0.59% of that seen in untreated controls. The authors estimate this corresponds to more than a 40-fold improvement in therapeutic efficacy.
According to the researchers, the treatment did not produce detectable systemic toxicity. Body weight remained stable throughout the study, and analyses of major organs and blood chemistry revealed no significant adverse effects. Tumors treated with the microrobots also exhibited increased apoptosis and reduced cellular proliferation compared with controls.
Toward minimally invasive cancer therapy
The investigators believe the platform could eventually support more effective and less invasive treatment strategies for bladder cancer.
Current intravesical chemotherapy often requires patients to retain therapeutic agents in the bladder for extended periods. In contrast, the algae microrobot system achieved its therapeutic effects after approximately 30 minutes of active treatment while maintaining bladder tissue integrity and avoiding mechanical damage to the urothelium.
The authors suggest the technology may be particularly valuable for patients who are poor candidates for surgery or as an adjunctive therapy following tumor resection to reduce recurrence risk.
Future work will focus on refining the automated imaging-feedback system, studying long-term outcomes and pharmacokinetics, and evaluating the platform in larger animal models before potential clinical translation. Researchers also envision adapting the technology for drug delivery in other body cavities, including abdominal and gynecological applications.
“This study highlights a non-invasive approach to overcoming the biological barriers that limit drug penetration in bladder tumors,” said Professor Xiaohui Yan, PhD, of Xiamen University. “We are now discussing translational follow-up studies with hospitals, with the long-term aim of clinical trials after further preclinical validation and regulatory review.”
The post Magnetic Algae Microrobots Boost Chemotherapy Penetration in Bladder Tumors appeared first on Inside Precision Medicine.
When OCD Is Loud, Trust Your Higher Power
by Annabella Hagen, LCSW
When I met Marie, she shared how faith and her connection with a Higher Power had always been important in her life. Her parents taught her that faith could be an anchor during hard times.
But Marie also had a genetic predisposition to obsessive compulsive disorder (OCD). When doubts and fears began to take over, she slowly lost confidence that she could ever feel peace again. Without knowing it, the more she tried to reason with the thoughts, fight them, or seek reassurance, the stronger they became.
Her OCD changed themes as she grew up. The voice within whispered different fears at different times:
“You may hurt the kids you’re babysitting.”
“You caused your granny’s pneumonia because you didn’t wash your hands well enough.”
“Am I going blind?”
“Why do these ugly images come into my head in sacred places? I must stop them.”
She tried to “fix” her doubts. But the more she focused on them, the more they grew. They distracted her from what mattered most — including her relationship with her Higher Power. She blamed herself for not feeling close to God. She felt ashamed and spiritually broken.
Many people with OCD blame themselves for their unwanted thoughts. They panic.
“Why would I think this?”
“What does this say about me?”
“Am I a terrible person?”
No matter what Marie did, she could not find certainty. She could not get enough reassurance. She wished she could control her thoughts and feelings. Because she couldn’t, she became very hard on herself. Her self-compassion slowly disappeared.
But here is something important: every human being — whether they have OCD or not — experiences disturbing thoughts, images, or impulses at times. Research going back decades, including studies like Rachman and de Silva (1978), shows that intrusive thoughts are common in the general population.
The difference is not the content of the thoughts. The difference is how often they come, how intense they feel, and how much distress they cause.
When someone without OCD has a strange thought, they may feel uncomfortable and say, “That was weird,” and move on.
But someone with OCD feels a strong need to solve the doubt. They may analyze it, argue with it, pray repeatedly, seek reassurance, or try to push it away. Without realizing it, these efforts make the thoughts louder and more frequent. This is how the OCD cycle grows.
Understanding this can bring hope. It means the problem is not your faith. It is the pattern.
And the good news is that OCD is not only genetic or neurological. It is also behavioral. That means you can learn to respond differently!
Thoughts and feelings are like the weather. They come and go. When we fight them or try to control them, they often stay longer.
You can learn to let them be.
Through Exposure and Response Prevention (ERP), you can practice moving toward what matters most — your faith, your family, your values — even when doubt is present. Instead of trying to silence the thoughts, you can choose not to follow the urge to fix them.
The first step is awareness.
You may already notice the unwanted thoughts. But can you notice how you respond?
Ask yourself gently:
- Do I try to get rid of emotional pain right away?
- Do I avoid situations because they trigger anxiety and doubts?
- When I feel an urge, do I automatically act on it?
- Can I see that thoughts are just thoughts, not facts?
These small moments of awareness begin to weaken the cycle.
As you practice new responses, you can begin shaping new pathways in your brain. Slowly, you can move closer to the connection with your Higher Power that you have been longing for.
Thoughts come and go. What matters most is what you choose to do.
You can act in faith and trust your Higher Power, even when the OCD voice is loud. That voice feels powerful, but it is not your identity. It does not define your relationship with God.
Change takes time. It takes practice. But it is possible. And it is worth it!
And you can find your way back!
Remember, OCD may try to use your faith as a weapon, your faith is not the problem—the disorder is. OCD is a health condition that seeks certainty where faith invites trust.
If you find yourself in a cycle of “loud” thoughts and repetitive compulsions—like over-praying, seeking constant reassurance, or fearing you’ve lost your connection to the divine—know that healing is possible.
To help more individuals like Marie navigate these challenges, the International OCD Foundation has released a comprehensive new brochure specifically for people of faith.
Download the “OCD is Not What You Think It Is” Brochure here or visit the Faith & OCD Resource Page to find more specialized support and information.
The post When OCD Is Loud, Trust Your Higher Power appeared first on International OCD Foundation.
Three things to watch amid Anthropic’s latest feud with the government
This story originally appeared in The Algorithm, our weekly newsletter on AI. To get stories like this in your inbox first, sign up here.
For those of you enjoying your summer unaware of Anthropic’s latest feud with the US government, here’s a recap: In April the company said it had built an AI model called Mythos that was so good at working with code it could pose a global cybersecurity threat. Anthropic gave access to a small group of cybersecurity experts so they could see what they were up against. Then it released a modified version called Fable which it said was safer to the public on Tuesday, June 9. That Friday, the federal government told the company it was a threat to national security and placed export controls on the new release. Anthropic revoked access to both models hours later.
People worried about catastrophic effects of AI—broadly labeled “doomers”—have said for years that the technology poses a threat to humanity and published proposals for how the government should intervene in its development. The doomers just got their government intervention—not over a bioweapon or rogue AI, but in response to an AI model that’s basically just really good at coding. And the result so far looks less like a safety plan than like a superficial reaction.
There’s plenty to dissect about what happened in those few days that led to such drastic action from the government, and it’s notable that Amazon CEO Andy Jassy was the one who told government officials that Fable would be dangerous (Amazon is both invested in Anthropic and building its own competing AI models). It’s also possible this will be a short-lived ban from the government that doesn’t survive legal scrutiny (it’s not clear that Anthropic’s offering access to Fable really counts as “exporting” it, for example).
But there are ripple effects happening already.
For one, this is making a whole lot of people not want to rely on American AI companies. TheFrench politician Bruno Retailleau described it as a “wake-up call” that should motivate Europe to build more AI. But any vision of turning Paris into Silicon Valley—touted by many other European leaders following the shutdown of Anthropic’s models—is complicated by one big thing: China.
Open-source models from China are very capable and incredibly cheap, and they can be downloaded to run on anyone’s servers with no rules or guardrails. (This makes them attractive to companies that don’t want access turned off on the basis of a decision from the White House—but equally attractive to cybercriminals, the type that Anthropic hoped to fend off by building safety guardrails into its models.)
It’s possible that companies, including those in the US and Europe, will decide that working with Chinese models is just easier, as the skyrocketing of shares in the Chinese startup Zhipu suggests. Playing this forward, is it possible the government’s next drastic decision will be to say that US companies using models from China pose a threat to national security? I wouldn’t write it off.
Second, it’s possible that shutting off access to Anthropic’s models will leave the country morevulnerable to cybersecurity attacks, not less. Leading cybersecurity experts have said as much in an open letter to the government, writing that access to Anthropic’s models was helping researchers prepare defenses, and that the company’s models are no more dangerous than other leading models that are widely available. Such is the risk of applying the concept of nonproliferation to software—trying to control and restrict dangerous AI models in the manner of the uranium used for nuclear weapons.
The third thing worth watching is how US lawmakers will react. Remember that following Anthropic’s last feud with the government over how the Pentagon could or could not use its models, a slate of new bills was introduced that would define the limits of military AI.
Right now, the biggest players shaping how AI gets used are the companies and the White House. There’s been much talk about more federal AI regulation, and polling suggests most Americans want it. Lawmakers are still figuring out whether to form rules on how kids use chatbots and are far from a clear answer on the extent to which the government should vet the safety of AI models. But with every drastic action from the White House, the pressure for regulations rises.
To state the obvious, predictions are hard when the administration’s attitudes toward AI change with the wind. When President Trump took office, he threw out the restrictive rulebook for how to make AI safe and promised to get out of the way of tech companies. The White House has now called the most valuable AI startup a risk to national security once in the spring, and again in summer. What will fall bring?
AbbVie to Acquire Apogee Therapeutics for $10.9B
SAN DIEGO — AbbVie has agreed to acquire Apogee Therapeutics for $10.9 billion, the companies said today, in a deal designed to bolster the buyer’s pipeline with an atopic dermatitis (AD) candidate set to advance to Phase III trials during the second half of this year, and being positioned as a potential challenger to a top-selling drug.
Apogee’s lead candidate zumilokibart, an IL-13 inhibitor also called APG777, is a long-acting treatment that according to the company holds “pipeline-in-a-product potential” because of the opportunity it has for treating a variety of immunology and inflammation (I&I) diseases for which the drug is under study.
“We continue to believe that Apogee’s zumilokibart is one of the more attractive assets in the I&I space, and its current valuation proves this out,” Edward Nash, a managing director and senior biotechnology analyst with Canaccord Genuity, wrote this morning in a research note. “The company, since its 2022 inception, has continued to deliver strong clinical results for zumilokibart in atopic dermatitis. The BIG [emphasis in original] differentiator for the drug is its potential to be dosed once every three or six months, which was just demonstrated in recently announced updates from the Phase II trial.”
Last month, Apogee announced positive 16-week data from Part B of its Phase II APEX trial (NCT06395948) assessing zumilokibart in moderate-to-severe AD. The trial met its primary and secondary endpoints with high statistical significance, as 65.9% of patients treated with mid-dose zumilokibart achieved EASI-75 (41.9% placebo adjusted).
Based on these results and subject to positive regulatory feedback, Apogee said it planned to move forward in its Phase III trials with the mid-dose, which achieved the best clinical activity of the three doses tested and was well-tolerated.
To support those Phase III trials and continued late phase development and potential commercialization of zumilokibart, Apogee last month entered into a strategic financing for up to $1.3 billion in flexible, non-dilutive total capital.
The capital includes up to $800 million of synthetic royalty funding and access of up to $500 million in senior corporate debt available by mutual consent of Blackstone and Apogee. Blackstone agreed to provide the synthetic royalty funding in exchange for low-to-mid single digit tiered royalties for 15 years on worldwide annual sales of zumilokibart. The royalties decrease with increasing sales, with zero royalties paid out on global annual sales exceeding $8 billion.
Third-largest deal, so far
The $10.9 billion Apogee acquisition is the new third largest biopharma merger-and-acquisition (M&A) deal announced so far this year, behind the €10.7 billion ($12.268 billion) cash buyout offer for Italian-based Recordati being pursued by CVC Capital Partners and Groupe Bruxelles Lambert, which aim to take the company private; and Sun Pharmaceutical Industries’ planned $11.75 billion purchase of Organon, the women’s health drug developer spun out of Merck & Co., in a deal expected to close in early 2027.
The previous third-largest M&A deal this year, now fourth-largest, is GlaxoSmithKline (GSK)’s planned $10.6 billion buyout of Nuvalent, announced June 9 and expected to close in the third quarter.
For AbbVie, the deal for Apogee adds to its pipeline in I&I, a category the biopharma giant dominated when its multi-indication blockbuster Humira® (adalimumab) was the world’s best-selling drug, before it lost patent exclusivity in the European Union in 2018 and the U.S. in 2023—after which it slipped from the top of GEN’s annual A-Lists of Top 10 Best-Selling Drugs.
However, AbbVie has developed two successful I&I drugs in recent years, Skyrizi® (risankizumab) and Rinvoq® (upadacitinib)—with Skyrizi ranking No. 6 on GEN’s latest best-selling drugs A-List, generating $17.562 billion in sales last year (up 49.9% from 2024) and $4.483 billion in Q1 2026, up 30.9% from Q1 2025.
“For more than two decades, AbbVie has led and shaped the field of immunology bringing the science, scale and expertise needed to address some of the most complex diseases,” Robert A. Michael, AbbVie’s chairman and CEO, said in a statement. “The acquisition of Apogee further builds on our existing leadership, strengthening our ability to deliver innovative medicines to patients who need better options while also creating significant long-term value for shareholders.”
Apogee investors signaled support for the buyout with a surge of stock buying that sent the company’s shares soaring 47% in early day trading from $90.38 to $132.65 as of 10:21 am ET. AbbVie shares rose 4.5% from $216.49 to $226.24.
Potential Dupixent® challenger
Apogee is positioning zumilokibart as a potential challenger to Dupixent® (dupilumab), the blockbuster drug for AD and other indications that is co-marketed by Sanofi, which records global net sales, and Regeneron Pharmaceuticals.
Dupixent ranked No. 5 among “Top 10 Best-Selling Drugs” as ranked by GEN in a recent A-List, with $18.124 billion (€15.714 billion) in 2025 sales, up 20.2% from the $15.077 billion (€13.072 billion) that the drug racked up in 2024. Dupixent carried that momentum into the first quarter of this year, garnering $4.9 billion (€4.2 billion) in sales as recorded by Sanofi, up 33% from a year earlier.
However, Dupixent is set to lose key U.S. patent exclusivity in 2031, giving Apogee and other AD drug developers time, they hope, to bring new treatments to market that can successfully compete when Dupixent loses its IP protection.
In addition to AD, zumilokibart is also being developed to treat asthma and eosinophilic esophagitis (EoE). The EoE program is set to advance into mid-stage clinical study as Apogee plans to launch the Phase IIb ELEVATE trial in the second half of this year.
Apogee has generated positive Phase Ib data for zumilokibart in asthma, and is on course to advance that program into the Phase IIb ASPIRE trial, set to launch in the first half of 2027.
Two other programs, both of them combination therapies that include zumilokibart, round out Apogee’s pipeline. APG279, a combination of zumilokibart and APG990, an OX40L inhibitor, is an AD candidate now in a Phase I trial (NCT07027527) comparing the the safety, tolerability, and pharmacokinetic (PK) parameters of the combination vs. Dupixent in adults with moderate-to-severe atopic dermatitis (AD).
Apogee cites preclinical studies showing that APG279 has driven closer to JAK-like inhibition of Type 1, 2, and 3 signaling compared to approved or in-development biologics, with the potential for best-in-class dosing and better tolerability in AD and a variety of other I&I diseases.
One-two punch
Apogee reasons that its chances of treating AD are enhanced by a proverbial one-two punch combining deep and sustained inhibition of Type 2 inflammation through zumilokibart’s inhibition of IL-13 with broader inhibition of Type 1-3 inflammation through APG990’s inhibition of OX40L.
The other combination program, APG273, is a preclinical combination of zumilokibart with APG333, a TSLP (thymic stromal lymphopoietin) that is being developed to treat asthma and COPD. Apogee has said it plans to announce additional plans for clinical studies later this year.
“Apogee’s pipeline adds highly differentiated clinical-stage assets, further expanding our robust immunology portfolio in areas of significant patient need, including atopic dermatitis and asthma,” Michael added. With our deep scientific expertise and proven capabilities, we are uniquely positioned to rapidly advance these programs and continue to transform the standard of care in inflammatory diseases.”
AbbVie has agreed to acquire all outstanding shares of Apogee for $135.11 per share cash, a 49.5% premium from the stock’s closing price on Friday.
The boards of AbbVie and Apogee have unanimously approved the transaction, which is expected to close in the third quarter subject to customary closing conditions, including Apogee shareholder approval and receipt of regulatory approvals.
“This transaction reflects the strength of Apogee’s vision, our team’s dedication and the significant progress we’ve made advancing zumilokibart and our differentiated pipeline,” stated Apogee CEO Michael Henderson, MD. “Since our founding, we’ve focused on developing transformative therapies for patients with inflammatory diseases while creating value for shareholders. This transaction delivers substantial shareholder value and positions our programs to reach their full potential.”
“We believe AbbVie can advance zumilokibart and our portfolio while expanding their impact for patients worldwide,” Henderson added.
The post AbbVie to Acquire Apogee Therapeutics for $10.9B appeared first on GEN – Genetic Engineering and Biotechnology News.
STAT+: FDA to launch pilot program to speed up early-stage clinical trials
WASHINGTON — Federal health officials announced a pilot program Monday to speed up early-stage clinical trials, which they say will reduce development timelines by six to 12 months, in hopes of encouraging U.S.-based trials and combating Chinese dominance in the field.
The pilot comes as the Food and Drug Administration, through the president’s 2027 fiscal budget, asks Congress to establish a permanent, faster process for the existing Investigational New Drug pathway. That proposal was championed by former FDA Commissioner Marty Makary before he resigned last month, though officials said on a Monday morning call that this program had been in the works since the start of the administration.
In a Fox News op-ed, health secretary Robert F. Kennedy Jr. wrote that the U.S. is “losing ground” against China in clinical research and touted the actions as a way to reverse that trend.
<![CDATA[FDA issues CRL for cytisinicline, citing manufacturing issues. ]]>
The Role of Gender in Borderline Personality Disorder
Conditions: Borderline Personality Disorder (BPD)
Sponsors: University Hospital Heidelberg
Recruiting
Sponsors: University Hospital Heidelberg
Recruiting