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  • Follow-Up Study Confirms Omlyclo Biosimilarity to Xolair in Treatment of CSU

    Follow-Up Study Confirms Omlyclo Biosimilarity to Xolair in Treatment of CSU

    Results from a follow-up study demonstrate support for the biosimilarity of omalizumab-igec (Omlyclo; Celltrion Healthcare) to its reference product, omalizumab (Xolair; Novartis), when treating patients with chronic spontaneous urticaria (CSU). It showed similarity in efficacy, pharmacokinetics, pharmacodynamics, safety, quality of life, and immunogenicity.1

    Image credit: wisely | stock.adobe.com

    About the Trial

    Trial Name: To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria (omalizumab)

    ClinicalTrials.gov ID: NCT04426890

    Sponsor: Celltrion

    Completion Date: April 27, 2023

    Xolair and Omlyclo

    Xolair was initially approved in 2014 for the treatment of patients with CSU who exhibit symptoms despite H1-antihistamine treatment. It is a humanized monoclonal antibody drug that suppresses mast cell and basophil activation by selectively binding to human immunoglobulin E (IgE). This action reduces the level of free IgE, downregulating the high-affinity IgE receptor and leading to the mitigation of allergic cascades.1

    Although omalizumab is an effective treatment, access to the therapy may be limited because of its high cost, wrote the authors. To alleviate this cost burden while receiving similar efficacy and safety of treatment, patients may initiate biosimilars. These have no clinically meaningful differences compared with their reference product.

    Omlyclo was approved in March 2025 as the first and only biosimilar specifically designated as interchangeable with Xolair, indicated for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy, and CSU.2 Its approval and designation of interchangeability were based on clinical evidence, including those from a global, multicenter, double-blind, randomized, active-controlled, parallel-group phase 3 clinical trial (NCT04426890)3 in which Omlyclo demonstrated comparable efficacy and safety to Xolair during treatment and off-dose periods.2,3 The current study details the 16-week off-treatment follow-up period of the phase 3 trial.1

    The Phase 3 Clinical Trial (NCT04426890)

    In the trial, patients aged 12 through 75 years were randomly assigned to either treatment period 1 (TP1; n = 619) or treatment period 2 (TP2; n = 579), both of which were 12 weeks in duration. In TP1, patients were randomly assigned to receive either 300 mg or 150 mg of Omlyclo (300 mg: n = 204; 150 mg: n = 107) or Xolair (300 mg: n = 205; 150 mg: n = 103). In TP2, patients who were treated with 300 mg of Xolair were randomly assigned again to switch to Omlyclo (n = 96) or continue Xolair (n = 97); patients initially randomized to 300 mg of Omlyclo continued the same treatment regimen (n = 187); and patients initially randomized to 150 mg of Omlyclo or Xolair continued receiving the same treatment at an increased dose of 300 mg (Omlyclo: n = 101; Xolair: n = 98). Treatments were administered subcutaneously via a prefilled syringe at weeks 0, 4, and 8 and weeks 12, 16, and 20 of TP1 and TP2, respectively.1,3

    Study Findings

    The mean change from baseline in itch severity score (ISS7) was similar across treatment groups at week 40. After notable improvement in ISS7 was observed after the overall 24-week treatment period, improvement in ISS7 score had gradually decreased up to week 40; however, it did not return to baseline mean values, and there were no notable differences among the treatment groups during follow-up. Similar findings were observed for the weekly urticaria activity score and the weekly hives severity score.1

    Additionally, changes in the number of antihistamine tablets used as rescue therapy per week were similar across the treatment groups. During the follow-up period, less than 10% of patients in all treatment groups had initiated an additional nonsedating H1-antihistamine as a second background medication (n = 11, 5.4%; n = 11, 5.4%; n = 6, 6.3%; n = 5, 5.2%; n = 4, 3.7%; and n = 10, 9.7% in the Omlyclo 300 mg, Xolair 300 mg, initial Xolair: switched to Omlyclo 300 mg, initial Xolair: Xolair 300 mg maintenance, Omlyclo 150 mg, and Xolair 150 mg groups, respectively).1

    Safety and Adverse Events

    During the follow-up period (weeks 24–40), the proportions of patients who experienced at least 1 treatment-emergent adverse event (TEAE) were similar across treatment groups, with most considered unrelated to the study drug. The most frequently reported TEAEs (≥2% patients in any group) were COVID-19 infection, headache, nasopharyngitis, tonsillitis, and upper respiratory tract infection. Additionally, rates of serious TEAEs ranged from about 0% to 3.1% across the treatment groups, and like TEAEs, these were considered unrelated to the study drug. There were no TEAEs that led to death or study drug discontinuation, and none of them were classified as allergic reaction type I or anaphylaxis, injection site reactions, serum sickness or serum sickness-like reaction, or parasitic (helminth) infections.1

    Further, there were no notable differences between treatment groups in mean change from baseline for all clinical chemistry, hematology, and urinalysis laboratory parameters throughout the study’s duration. Most patients had normal results for physical examination and electrocardiogram assessments at the end-of-study visit during week 40.1

    “[Omlyclo] was previously shown to have equivalent efficacy and comparable pharmacokinetics, pharmacodynamics, safety, and immunogenicity versus [Xolair] after 24 weeks of treatment, or after switching from [Xolair] to [Omlyclo] at week 12, in patients with CSU who had symptoms despite treatment with H1-antihistamines,” the authors concluded. “Our [16-week follow-up] findings provide further confirmatory evidence that [Omlyclo] is a validated biosimilar for [Xolair].”1

    REFERENCES
    1. Grattan C, Dytyatkovska Y, Springer M, et al. Efficacy and safety of CT-P39, an omalizumab biosimilar, in chronic spontaneous urticaria: 16-week follow-up study. Clin Transl Allergy. 2025;e70069. doi:10.1002/clt2.70069
    2. Celltrion. U.S. FDA approves Celltrion’s OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR®. March 10, 2025. Accessed July 1, 2025. https://www.celltrion.com/en-us/company/media-center/press-release/3778
    3. To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria (omalizumab). ClinicalTrials.gov identifier: NCT04426890. Updated June 22, 2023. Accessed July 1, 2025. https://clinicaltrials.gov/study/NCT04426890

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  • Score the Samsung Galaxy Watch 7 at its Prime Day price

    Score the Samsung Galaxy Watch 7 at its Prime Day price

    SAVE 39%: As of July 16, you can get the Samsung Galaxy Watch 7 (44mm) for $199.99, down from $329.99. That’s a 39% discount and a $130 savings. It’s also the best price we’ve seen on this model since its release.

    This year, we saw some pretty impressive deals during Prime Day (which was a full four-day event this go-round). Apple products saw some record lows, and Samsung’s phones dropped to prices we’ve never seen before. Now, we’re seeing some lingering Prime Day deals sticking around even after the event, and the Samsung Galaxy Watch 7 is one of them.

    As of July 16, you can get the Samsung Galaxy Watch 7 (44mm) for $199.99, down from $329.99. That’s a 39% discount for $130 in savings. It’s also the best price we’ve seen on this model since its release.

    SEE ALSO:

    Shop the best Samsung deals this week: Galaxy Watch 7, Z Flip7, Buds 3 Pro

    The Samsung Galaxy Watch 7 (44mm) is a smartwatch for anyone who’s looking for a fitness tracker and smartphone rolled into one. Each day, you’ll start with an “Energy Score” that’ll determine your physical readiness based on the day before. It also features an improved heart rate tracking function that filters out your body’s movements to give you a clearer and more accurate reading, which will be helpful for anyone who wants to know exactly how hard they’re working during a workout.

    Mashable Deals

    You’ll also get personalized suggestions from Samsung’s Wellness Tips and be able to see how well you’re actually sleeping with the sleep tracking function. According to Samsung, this watch can also help detect moderate to severe sleep apnea. While it’s not meant to replace traditional diagnosis methods from a doctor, it can provide helpful on-demand insights over a two-night monitoring period.

    Even more smartwatch deals

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  • A Mysterious World Has Been Discovered Lurking in Our Solar System—Meet ‘Ammonite’

    A Mysterious World Has Been Discovered Lurking in Our Solar System—Meet ‘Ammonite’

    Researchers just got a step closer to understanding the origins of our solar system, with the discovery of an object orbiting the sun—dubbed “Ammonite.” The findings were recently published in the peer-reviewed scientific journal Nature Astronomy.

    Ammonite, or its scientific name 2023 KQ14, is known as a sednoid, which is a type of cosmic body circling the sun beyond Neptune with a highly eccentric orbit. It’s only the fourth sednoid ever discovered. It comes as close as 66 astronomical units (AU) from the sun and as far away as 252 AU. One astronomical unit is equal to the average distance between Earth and the sun, or about 93 million miles.

    Ammonite was discovered by the survey project “FOSSIL” (Formation of the Outer Solar System: An Icy Legacy), which is led by researchers from Japan and Taiwan who explore the outer solar system to learn about its past. The research team used the powerful Subaru Telescope, located at the Mauna Kea Observatory in Hawaii. The telescope has wide-field imaging capabilities that are uniquely suited for scanning large patches of the sky for faint, slow-moving objects like Ammonite.

    Computer simulations show that Ammonite’s orbit has remained stable for billions of years, unaffected by gravitational interactions with other solar system objects. This long-term stability makes Ammonite one of the best-preserved “fossils” of our solar system’s distant past, suggesting that it originates from the solar system’s early formation and retains a fossil record of the orbital configuration.

    Ying-Tung Chen, one of the authors of the study and a support scientist at the Institute of Astronomy and Astrophysics, Academia Sinica (ASIAA), in Taiwan, said in a statement that while previously known sednoid objects all share roughly similar orbital orientations, Ammonite’s orbit is oriented in the opposite direction, suggesting that the outer solar system is more diverse and complex than previously thought.

    What caused this clustering of objects is still unclear, with scientists hypothesizing about the possibility of a passing star or an ejected planet.

    “The significance of discovering Ammonite goes far beyond adding one more distant object,” Shiang-Yu Wang, one of the study’s authors and a research fellow at ASIAA, said in a statement. “Ammonite’s orbit tells us that something sculpted the outer solar system very early on. Whether it was a passing star or a hidden planet, this discovery brings us closer to the truth.”

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  • Behold, ‘The Beast’: Gigantic animal-like plasma plume 13 times wider than Earth hovers over the sun

    Behold, ‘The Beast’: Gigantic animal-like plasma plume 13 times wider than Earth hovers over the sun

    A giant plasma plume dubbed “The Beast” was recently spotted dancing above the sun as it showered our home star with blobs of impossibly fast fire. The shapeshifting projection, which stretched more than 13 times wider than Earth, was the first of several sizable solar structures to emerge in recent days.

    The animalistic mass appeared Saturday (July 12) over the northwestern limb of the sun, allowing photographers from around the world to snap some stunning shots, including Michael Jäger, who captured the plume from Martinsburg in Austria (see above); and Simon Metcalfe, who saw it from near his home in Gloucestershire, England (see below).


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  • England’s Beth Mead and Ella Toone find strength in new bond after losing parents to cancer

    England’s Beth Mead and Ella Toone find strength in new bond after losing parents to cancer

    Beth Mead and Ella Toone are top players for England at the UEFA Women’s EURO 2025. But there is more that connects the two women than a love of football and the national jersey.

    Both have lost parents to cancer since winning the last edition of the tournament in 2022. Mead’s mother June passed away to ovarian cancer in January 2023 while Toone’s father passed away in September 2024 after a fight with prostate cancer.

    As each grieved their loss, the teammates discovered new strength through their growing bond.

    “We have really bonded over such a terrible thing but it’s nice to have someone who has been through it as well and who understands and knows exactly what is going on and what is going on in my head,” Toone said of her teammate, ESPN reported from a post-match press conference in St. Gallen, Switzerland.

    “We definitely have each other’s backs. We are proud of each other and it’s nice we are constantly talking about them. It’s nice to have someone in the same situation and we know we are doing them proud.”

    The 2022 European champions Mead and Toone struggled in England’s opening match against France. The players were used to seeing their parents in the stands at major tournaments, but this time the familiar faces were not there. Sharing that moment and sense of loss helped them to move forward, Mead said.

    Mead and Toone celebrated England’s 6-1 victory over Wales on Sunday, 13 July, by pointing to the sky in tribute to their parents.

    “I’ve been a shoulder to be there for her,” Mead said after the match in which she and Toone scored a goal each. “There have been moments where she has asked, ‘Is this normal? Does that feel normal? Why am I thinking this?’ I’m like, ‘It’s completely normal. I’ve been there and I still feel it now’.

    “We have conversations about it and talk so easy about it but ultimately I’ve had a bit longer to process it compared to her. We all deal with it differently but she is dealing with it pretty amazingly now.”

    The victory against Wales earned England a ticket to the quarter-finals where they will face the 1984 European champions Sweden.

    Toone has two goals and two assists in the tournament so far while Mead has one goal and one assist.

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  • Google Search Can Now Call Local Businesses Using AI

    Google Search Can Now Call Local Businesses Using AI

    Google has introduced a new AI-powered calling feature in Search that contacts local businesses on a user’s behalf to gather pricing and availability details.

    The feature, rolling out to all U.S. Search users this week, allows people to request information from multiple businesses with a single query.

    When searching for services like pet grooming or dry cleaning, users may now see a new option to “Have AI check pricing.”

    How It Works

    After selecting the AI option, users are guided through a form to provide details about the service they need.

    Google’s AI then calls relevant local businesses to gather information such as pricing, appointment availability, and service options. The responses are consolidated and presented to the user.

    The experience starts with a typical local search, such as “pet groomers near me.” If the AI calling feature is available, users can specify details like:

    • Pet type, breed, and size
    • Requested services (e.g., bath, nail trim, haircut)
    • Time preferences (e.g., within 48 hours)
    • Preferred method of communication (SMS or email)

    According to a Google spokesperson, the AI determines which businesses to contact based on traditional local search rankings. Only those that appear in results for the relevant query and match the user’s criteria will be contacted.

    What It Looks Like

    Examples show a multi-step process where users enter information and confirm their request.

    Screenshot from: blog.google/products/search/deep-search-business-calling-google-search, July 2025.
    Screenshot from: blog.google/products/search/deep-search-business-calling-google-search, July 2025.
    Screenshot from: blog.google/products/search/deep-search-business-calling-google-search, July 2025.

    Google displays responses from participating businesses, including prices and availability, all gathered through automated calls.

    Before submitting a request, users must confirm that Google can call businesses and share the submitted details. The process is governed by Google’s privacy policy, and users are informed of how their data will be used.

    Business Participation & Control

    Businesses can manage whether they receive these AI-driven calls via their Business Profile settings.

    Google describes the feature as creating “new opportunities” to connect with potential customers, while also giving businesses control over participation.

    Available to All (With Premium Perks)

    The AI calling feature is available to all users in the U.S., though Google AI Pro and AI Ultra subscribers benefit from higher usage limits.

    Google says more agentic AI features will debut for these subscribers before expanding globally.

    What This Means

    Because the AI selects businesses using standard local search rankings, maintaining strong local SEO becomes even more important.

    Businesses with optimized listings and higher rankings are more likely to receive calls and capture leads.

    This could also shift how businesses handle inbound requests. Those that rely on phone calls may want to prepare staff or systems to handle more frequent, possibly scripted, AI-initiated inquiries.

    Looking Ahead

    By automating time-consuming tasks like gathering service quotes, Google aims to make Search more actionable.

    Adoption will depend on how well the AI handles real-world complexity, as well as how many businesses opt in.

    For marketers and local service providers, it’s another sign that search visibility directly connects to lead generation. Keeping Business Profile data accurate and staying visible in local results could increasingly determine whether a business gets contacted at all.

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  • Google rolls out AI-powered business-calling feature, brings Gemini 2.5 Pro to AI Mode

    Google rolls out AI-powered business-calling feature, brings Gemini 2.5 Pro to AI Mode

    Google is rolling out an agentic AI-powered business-calling feature to all users in the United States, the company announced on Wednesday. The tech giant is also enhancing Google Search’s AI Mode by bringing its Gemini 2.5 Pro model to the search experience and introducing deep research capabilities.

    The new business-calling feature uses AI to call local businesses on your behalf to collect information about availability and pricing. The idea behind the feature is to help you access information without having to actually pick up the phone and talk to someone.

    Google began testing the feature back in January with users who opted into the company’s Search Labs experiments.

    Image Credits:Google

    To get started, you need to search for something like “pet groomers near me,” and you’ll see a new option in the results to “Have AI check pricing.” From there, you answer a couple of questions to receive information about appointments and services from different local businesses. For example, you will be asked which type of pet you have, which services you need, and when you need the service.

    A Google spokesperson told TechCrunch in an email that every call to a business begins by announcing that it’s an automated system calling from Google on behalf of a user.

    It’s worth noting that Google faced backlash a few years ago for a similar business-calling feature that simulated human speech, as some users were concerned that the company was misleading people into thinking they were speaking with another human. Following the backlash, Google said its AI would identify itself as a robot when placing these calls.

    The new business-calling feature is starting to roll out to all Search users in the United States, with higher limits for Google AI Pro and AI Ultra subscribers.

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    Google is also supercharging AI Mode, the Google Search feature that lets you ask complex and multi-part questions via an AI interface, with Gemini 2.5 Pro for Google AI Pro and AI Ultra subscribers. The tech giant says the model excels at advanced reasoning, math, and coding questions. Subscribers will be able to select the 2.5 Pro model from a drop-down menu in AI Mode.

    Image Credits:Google

    As for the new “Deep Search” feature in AI Mode, Google says it will save subscribers hours by conducting hundreds of searches and issuing reasoning across differing pieces of information to create a comprehensive and fully cited report in minutes.

    Google notes that Deep Search is useful for in-depth research related to jobs, hobbies, or studies. The company says it’s also useful in instances where you’re making big life decisions, like buying a new house or seeking assistance with a financial analysis.

    Since its launch earlier this year, Google has been building out AI Mode with additional capabilities as it continues to take on popular services like Perplexity AI and OpenAI’s ChatGPT Search. For example, Google last month rolled out the ability to have a back-and-forth voice conversation with AI Mode. In May, Google introduced a shopping experience in AI Mode to allow you to view product visuals and other AI-powered guidance that leverages product data.

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  • JWST finds unusual black hole in the center of the Infinity Galaxy: ‘How can we make sense of this?’

    JWST finds unusual black hole in the center of the Infinity Galaxy: ‘How can we make sense of this?’

    Using the James Webb Space Telescope (JWST), astronomers have discovered an oddball galaxy, dubbed the Infinity Galaxy, that could be host to a “direct collapse black hole.” That is, a black hole originally created directly from a vast cloud of collapsing gas and dust rather than a dying star.

    The Infinity Galaxy gets its name from the fact that its shape resembles an infinity symbol (a sideways 8) with two red lobes or “nuclei.” This shape is thought to have arisen because the Infinity Galaxy was formed as two disk galaxies engaged in a head-on collision.

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  • Layton Williams Joins Season 2 as Filming Gets Underway

    Layton Williams Joins Season 2 as Filming Gets Underway

    Production is now underway on the second season of Netflix‘s Geek Girl.

    The cast recently celebrated the start of filming in London with an exclusive look at their first-read through. Joining the cast for series two is British theater star Layton Williams, playing the role of Onassis.

    Returning cast members include House of the Dragon‘s Em Carey as well as Emmanuel Imani, Liam Woodrum, Rochelle Harrington, and Zac Looker. Sarah Parish, Tim Downie, Jemima Rooper and Hebe Beardshall also star.

    Based on Holly Smale’s internationally bestselling novels, Geek Girl follows socially awkward but endearing teenager Harriet Manners as she’s unexpectedly thrust into the fashion world — navigating runway chaos, mean girls, and personal growth along the way.

    “Season two picks up as Harriet continues to juggle school life with the ever-escalating demands of modelling, friendships, and discovering who she truly wants to be,” a plot synopsis reads.

    Season one spent four weeks in the streamer’s Global Top 10 TV (English) list and reached the top 10 in 89 countries across the platform.

    Geek Girl is produced by RubyRock Pictures and Boat Rocker, created by Holly Smale and Jessica Ruston, and directed by Declan O’Dwyer.

    Executive producers include showrunner Zoë Rocha and Robbie von Werz for RubyRock Pictures, along with Holly Smale, Jessica Ruston, Jeff Norton, Declan O’Dwyer, and David Fortier, Ivan Schneeberg, Nick Nantell, and Jon Rutherford for Boat Rocker.

    Season two of Geek Girl comes to Netflix in 2026.

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  • Neurons Store Backup Energy for Stressful Times

    Neurons Store Backup Energy for Stressful Times


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    A new Yale study has revealed that neurons — the energy-hungry cells that connect and direct activity in the brain — are equipped with “backup batteries” that kick in to keep the brain running during periods of metabolic stress.

    Writing in Proceedings of the National Academy of Sciences, researchers describe how neurons store their own glycogen, a form of sugar that helps neurons stay resilient when their main energy sources falter.

    The findings illustrate how neuron cells can adapt their metabolism, researchers say, and could shape new treatments for neurological conditions like stroke, neurodegeneration, and epilepsy, all disorders in which energy failure plays a role.

    “Traditionally, it was believed that glial cells served as ‘energy warehouses,’ storing glycogen and supplying neurons with fuel as needed,” said co-lead author Milind Singh, a doctoral student in cell biology at the Yale School of Medicine (YSM). “But we now know that neurons themselves store glycogen and can break it down when the pressure is on. It’s like discovering that your car is a hybrid — it’s not just reliant on gas stations, it’s been carrying an emergency battery the whole time.”


    For the study, the research team used a microscopic roundworm called Caenorhabditis elegans (C. elegans) — a type of worm commonly used in research — and a genetically encoded fluorescent biosensor called HYlight, which glows in response to changes in glycolysis (the process cells use to break down sugar for energy.) With custom-built devices, researchers precisely controlled the level of oxygen the living worms experienced and monitored how neurons responded to energy stress in real time.

    A breakthrough came when researchers discovered the enzyme PYGL-1, the worm’s version of the human glycogen phosphorylase enzyme that converts glycogen into fuel for neurons. When researchers removed PYGL-1, the worm neurons could no longer ramp up energy during low-oxygen stress conditions; when the enzyme was specifically restored in neurons, that failure was reversed.

    “We discovered that neurons use two different strategies to adapt to energy stress: one that’s glycogen-dependent, and one that isn’t,” explained co-lead author Aaron Wolfe, a postdoctoral neuroscience researcher. “The glycogen-dependent pathway is particularly critical when the mitochondria — one of the cell’s primary energy producers — aren’t functioning well. In those situations, glycogen serves as a backup system to provide energy via glycolysis.”

    The team coined the term “glycogen-dependent glycolytic plasticity” (GDGP) to describe this phenomenon. They found that GDGP is especially important when mitochondrial function is compromised — such as during hypoxia, a condition of limited oxygen supply. Under these conditions, glycogen serves as a low-cost, rapid-access fuel source, helping neurons stay active when other systems might stall. This metabolic adaptability, known as “glycolytic plasticity,” helps neurons maintain their core functions under stress.

    “Our work challenges the textbook model of how the brain fuels itself. Neurons are more self-sufficient than we thought,” Singh said.

    Reference: Singh M, Wolfe AD, Vishwanath AA, et al. Glycogen supports glycolytic plasticity in neurons. PNAS. 2025;122(28):e2509003122. doi: 10.1073/pnas.2509003122

    This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source. Our press release publishing policy can be accessed here.

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