The newly public Evommune shared data showing that EVO301, an IL-18 targeting protein, cleared symptoms comparably to Regeneron and Sanofi’s mega-blockbuster in a mid-stage atopic dermatitis clinical trial.
Shares of Evommune, a member of the late-2025 biotech IPO class, rose 75% on Tuesday after the therapeutic protein EVO301 eased the severity of atopic dermatitis by 33% in a mid-stage trial.
Those numbers position Evommune to complete with the likes of Regeneron and Sanofi, which market one of the biggest drugs in the world for dermatitis, Dupixent, analysts at William Blair wrote on Tuesday.
Dupixent earned $17.8 billion in 2025, a 26% increase from 2024, according to Regeneron’s full-year 2025 earnings report.
Shares of Evommune climbed 75% to $29.87 in Tuesday morning trading.
In a Phase 2a trial that the company described in a Tuesday release as “proof-of-concept,” Evommune tracked 70 patients for 12 weeks after they were given an intravenous dose of EVO301 on the first day and the 28th day of the trial, both of the same dose level. There were 48 patients in the treatment arm and 22 in the placebo group.
After 12 weeks, patients in the treatment arm saw a 55% reduction in eczema severity versus 22% for patients in the placebo arm, a 33% placebo-adjusted rate.
EVO301’s results are “highly encouraging,” the William Blair analysts said, especially given that Dupixent showed a 35% to 36% placebo-adjusted improvement after 16 weeks in a Phase 3 trial, and that EVO301 was only tested at one dose level. “We believe greater efficacy could be achieved with a more optimized dosing regimen,” the analysts added.
Evommune plans to test just that in a Phase 2b dose-ranging trial using a subcutaneous formulation of EVO301. More data from the Phase 2a trial will be presented at an upcoming medical conference, according to Tuesday’s statement. Evommune is also evaluating the candidate in other indications like ulcerative colitis.
EVO301 is a fusion protein designed to bind IL-18, an inflammatory cytokine implicated in a number of immune conditions, including dermatitis.
In late October 2025, Evommune joined a sudden rush of biotechs attempting IPOs, raising $172.5 million to back its immunology and inflammation pipeline. The biotech’s lead molecule is EVO756, which blocks the MRGPRX2 receptor and is being tested for chronic spontaneous urticaria and atopic dermatitis.
The agency flagged several violations at a compounding pharmacy owned by Hims & Hers, including “infestation by rodents, birds insects, and other vermin.”
In a warning letter issued in June last year to MedisourceRx, a compounding pharmacy owned by Hims & Hers, the FDA cited clear violations of good manufacturing practices. The revelations, first reported Monday by STAT News, add to the troubles of the telehealth company, which has come under fire from both regulators and Novo Nordisk for selling compounded semaglutide.
An FDA inspector found that facilities for drug manufacturing, processing, packaging or storage “are not free of infestation by rodents, birds insects [sic], and other vermin,” according to the warning letter. The inspector also spotted a live spider in the area where MedisourceRx produced active pharmaceutical ingredients for human drugs.
Among these products, the warning letter specified, was Hims & Hers’ compounded semaglutide injection.
The FDA also flagged a dead cricket which “was observed in the middle of the incubator room.” MedisourceRx uses these incubators for fill vials as part of the manufacturing of drugs for human use.
Aside from the infestation, the FDA inspector also noted that one patient who had taken a dose of injectable compounded semaglutide experienced severe gastrointestinal issues that necessitated “three nights of hospital stay.” MedisourceRx “has not submitted an adverse event report” as required, the letter claimed.
“Patient safety and regulatory compliance are foundational to how we operate,” a spokesperson for Hims & Hers told STAT News, which reported that the FDA sent a second letter to MedisourceRx in December 2025, which has yet to be released publicly.
The spokesperson also told STAT that the company is working on addressing the FDA’s concerns about reporting of toxicities, but insisted that the issues of infestation enumerated in the June letter no longer appear in the December communique. The spokesperson did not provide STAT a copy of this latter letter.
The last few days have been rough for Hims. The company last week launched a compounded version of oral semaglutide, triggering a firestorm of backlash from regulatory authorities and Novo Nordisk. FDA Commissioner Marty Makary said in an X post that the agency will “take swift action against companies mass-marketing illegal copycat drugs.”
Mike Stuart, general counsel for the Department of Health and Human Services, also blasted Hims’ knockoff pill, saying in a Feb. 7 X post that he has referred the matter “to the Department of Justice for investigation.”
Novo has also sued Hims for allegedly infringing on key patents protecting semaglutide. John Kuckelman, the pharma’s general counsel, said that the company could seek trebled damages that could reach “hundreds of millions” of dollars.
The deal gets Lilly access to Orna’s in vivo CAR T technology. The biotech’s lead asset, which has yet to start clinical testing, is focused on B cell–driven autoimmune diseases.
Eli Lilly has long resisted the CAR T space despite admitting that the treatments have promise. Now, the weight loss juggernaut has found an entry point via a $2.4 billion deal to acquire in vivo CAR T biotech Orna Therapeutics.
CEO David Ricks has said in the past that issues with accessibility have limited the company’s interest in the modality. “The data is amazing,” Ricks told Reuters in 2019, “but practically, it’s not reaching many people.”
The Indianapolis-based pharma is betting on Orna’s technology to address those concerns, according Monday’s announcement. The acquisition also signals that Lilly is not specifically focusing on CAR Ts for cancer but on autoimmune disorders, which other CAR T developers have also begun to explore.
Orna’s pipeline is still preclinical, but lead asset Orna-252 is “clinical trial-ready,” according to the deal announcement. Orna-252 creates CD19-targeting CAR T cells, aimed at treating B cell–driven autoimmune diseases. That asset has shown its ability to deplete B cells in nonhuman primates, according to data presented in December 2025.
Orna’s approach involves delivering a circular RNA molecule via a lipid nanoparticle (LNP) to induce cells to make CAR T cells in the body, rather than removing, modifying and then reintroducing patients’ cells, as traditional CAR T does. The in vivo strategy “offers lower manufacturing cost and shelf-availability,” according to analysts at William Blair, writing to investors Monday morning.
“I’m very proud of what we achieved at Orna,” Tom Barnes, CEO of the Massachusetts-based biotech, wrote in a LinkedIn post Monday morning, “and of the team that did it. Orna . . . was the first circular RNA company and proselytized the value of circles over lines.” Using circular RNA to modify cells, instead of linear, simplifies manufacturing and purification processes, increases the half-life of the therapy and makes LNP formulations easier to make, according to Orna.
Other projects in Orna’s pipeline include a gene editing collaboration with Vertex Pharmaceuticals to develop treatments for sickle cell disease and beta thalassemia, and a partnership with Merck to develop RNA vaccines.
This is the latest bolt-on deal for Lilly this calendar year; In January, the pharma offered Seamless a potential $1.12 billion to develop gene editing therapies in hearing loss, Repertoire up to $1.9 billion to develop autoimmune treatments and InduPro could see a up to $950 million for cancer antibodies.
Orna is also the second full acquisition of the year for Lilly, after the $1.2 billion buy of inflammatory disease biotech Ventyx Biosciences in January.
On Feb. 8, Lilly also announced a collaboration with the Chinese firm Innovent Biologics, the seventh between the two companies. That deal has Lilly paying Innovent $350 million up front, with $8.5 billion in potential payments related to commercial milestones stemming from the partnership’s work on therapies in oncology and immunology.
Analysts, investors and scientists are eager for Biogen’s 2026 BIIB080 readout. Even if successful, executives warn that there are many more steps before the Alzheimer’s therapy could reach the market.
A major proof-of-concept readout for Biogen’s next big Alzheimer’s disease bet could unlock a major piece of the treatment puzzle for the intractable neurodegenerative disease. But even if—and it’s a big if—the Phase 2 trial is a runaway success, Biogen will only be at the beginning of answering the questions the scientific community has been asking for decades about the tau mechanism.
“What I can tell you is that the neurology community is going to be also looking at these data very closely,” Biogen CEO Chris Viehbacher said on the company’s fourth quarter earnings call on Friday. Scientists have long believed that there are two key targets in Alzheimer’s: amyloid beta and tau. Treatment of the first was opened up with the approval of Biogen and Eisai’s Leqembi and later Eli Lilly’s Kisunla.
Biogen is on the leading edge of companies hoping to bring a tau-targeting option to the market. Working together, both types of medicines may finally show real clinical improvements on cognition. A mid-stage readout of an anti-tau therapy from Johnson & Johnson was unsuccessful in November 2025, putting the pressure on Biogen to prove the theory is still valid.
The company is expecting results for BIIB080, a tau-targeting antisense oligonucleotide, from the Phase 2 CELIA program. On Friday, Biogen narrowed down the timeline for the readout to sometime in the second or third quarter, having previously advised sometime in 2026, William Blair said on Friday.
“Every Alzheimer’s expert I talked to really think tau is an important target. And if you look at the severity of Alzheimer’s, that’s really related to the level of tau,” Viehbacher said.
If the results are positive, Jefferies analysts expect that Biogen’s stock could move 5–15%, according to a Friday note. The trial is testing three doses out to week 76 with the primary endpoint assessing cognition.
Competitors are watching closely too. H.C. Wainright wrote on Friday that Biogen’s results “could validate tau knockdown as a therapeutic strategy even if the study is positioned as signal-finding rather than statistically definitive.”
Changing the Paradigm
Tau may be an important target, but in terms of how a tau-targeting treatment like BIIB080 could change treatment, Viehbacher doesn’t know yet. Biogen, with partner Eisai, already markets Leqembi, which became the first disease-modifying treatment for Alzheimer’s in 2023. While the drug can clear the amyloid beta plaques in the brain, the effects on the hallmark symptoms of Alzheimer’s, like cognition, are more subtle. Adding a tau agent to the mix could finally create meaningful impact for patients.
“With BIIB080, we know we can actually reduce tau. The question will be, How long do you have to reduce the tau to move the needle on cognition?” Viehbacher wondered.
Viehbacher pointed to the unsuccessful readout for Novo Nordisk’s semaglutide in Alzheimer’s, which failed to slow the disease in a pair of Phase 3 clinical trials that read out in November 2025. “It’s quite hard to move that level of cognition,” Viehbacher said.
Neurologists have long suggested that combination therapies could be the key to unlocking more disease modification and symptom alleviation in Alzheimer’s. BIIB080 could be that key, Viehbacher said, perhaps paired with one of the amyloid-targeting antibodies like Leqembi or Kisunla. But the sequence of those treatments is an open question, the CEO noted: Would you tackle tau first or amyloid beta, or would you dose them at the same time?
H.C. Wainright suggested the order would be amyloid first, with tau agents layered on top after to further slow progression. That means that success for one asset is helpful for others, “rather than direct competitive threats,” the firm wrote, specifically flagging Voyager Therapeutics’ programs.
Safety First
Biogen is also keenly interested in the side effect profile of BIIB080. Leqembi and Eli Lilly’s rival medicine Kisunla both have a known side effect called amyloid-related imaging abnormalities (ARIA), small blips on imaging results that can suggest bleeding or swelling in the brain. Several patient deaths have resulted from the adverse event and the FDA now recommends earlier MRI monitoring for patients taking Leqembi.
“There is a belief that we’re not going to have anything like ARIA” with BIIB080, Viehbacher said. But again, his team needs data to confirm. “This is Phase 2 data that is really breakthrough science. Nobody knows. Nobody has been able to move the needle so far.”
Priya Singhal, head of development, also emphasized the importance of looking at different subgroups of patients who may respond best to BIIB080. Biogen will be looking for nuance in high vs low tau burden, fluid biomarkers and other trends.
Viehbacher knows that, if the study is positive, the neurology community will be excited. But he warned those watching the results not put the cart before the horse.
“I would also remind everybody that we would then have to go into a Phase 3 program, and anything in Alzheimer’s doesn’t happen on a very quick basis, so this would take several years again to be able to do that Phase 3 and launch the product.”
Analysts are keenly awaiting the data. Jefferies said that tau reduction over 50% in the mid-stage test would instill confidence in that future Phase 3 readout. The therapy achieved 50% to 60% reduction in an earlier Phase 1b trial, plus a cognition benefit. These results were encouraging for Jefferies and Stifel.
“This program demonstrated meaningful and never-seen-before levels of tau PET reductions in the ph1,” Stifel said in a Friday note. “Tau continues to be a target that we and KOLs [key opinion leaders] really like given the pathology is more closely correlated with cognitive decline.”
How Is AI Changing Drug Discovery and What Does It Mean for Investors?
AI is reshaping drug discovery by improving efficiency in the earliest and most failure-prone stages of development, with implications for both biotech innovators and large pharmaceutical companies.
Drug discovery has traditionally been slow, expensive, and uncertain. Artificial intelligence is now being deployed to improve how potential drugs are identified, designed, and evaluated long before clinical trials begin. As the Economist recently highlighted in the article An AI revolution in drugmaking is under way, this shift is already altering the economics of research and development across healthcare.
What Problems Is AI Solving in Drug Development?
AI helps address inefficiencies in early-stage drug discovery, where most failures occur and costs are hardest to control.
Historically, companies have relied on trial-and-error approaches that require screening vast numbers of compounds with low success rates. AI tools are now being used to narrow the field earlier and more intelligently.
Key ways AI is being applied in drug development include:
Identifying biological targets using large-scale genomic and proteomic data
Designing molecules digitally rather than relying solely on lab-based experimentation
Predicting safety or efficacy issues before candidates enter costly trial phases
By improving decision-making earlier in the process, AI may help reduce wasted R&D spending while increasing the number of viable drug candidates.
Where Is AI Adoption Happening Across Healthcare?
AI is being adopted across both biotech and pharmaceutical companies, but in different ways.
Segment
How AI Is Used
Investment Implication
Biotechnology
AI-driven platforms for novel target discovery and early-stage innovation
Exposure to potential breakthroughs and licensing opportunities
Pharmaceuticals
AI applied across large pipelines to improve R&D efficiency and pipeline durability
Support for long-term revenue stability and capital discipline
Smaller biotech firms often lead innovation, while large pharma companies benefit from scale, data depth, and diversified pipelines.
Does AI Reduce Risk in Drug Discovery?
AI does not eliminate risk, but it may improve the odds of bringing a drug to market.
Drug development remains complex, highly regulated, and uncertain. However, even modest improvements in hit rates or development timelines can be meaningful in an industry where returns depend on a small number of successful drugs.
For investors, the key takeaway is not faster blockbuster creation, but better capital efficiency over time.
Why Is AI-Driven Healthcare Innovation Especially Important Now?
AI adoption in the healthcare space coincides with a major wave of pharmaceutical patent expirations.
Large, liquid pharma companies have the scale, clinical expertise, and global reach to participate meaningfully in the next generation of therapeutic innovation, including the expansion of peptide-based medicines. AI assisted drug discovery may also help these firms refresh pipelines more efficiently at a time when the industry is preparing for notable patent expirations.
Patent Expiration Risk for Total Worldwide Drug RX Revenues 2025-2030
If AI improves efficiency in the critical “0 to 1” phase, it may help established pharma companies refresh pipelines more consistently and respond more effectively to patent turnover.
How Is the AI-Enabled Healthcare Market Expected to Grow?
The market for AI-enabled drug discovery is expected to grow rapidly over the next decade as adoption expands across research, development, and clinical applications.
According to industry estimates, spending on AI tools in drug discovery is projected to accelerate meaningfully through 2032 as pharmaceutical and biotech companies increasingly embed AI into core R&D workflows. This growth reflects rising confidence that AI can improve productivity in early-stage research, where costs are high and failure rates are steep.
Forecasted Market Growth for Global AI Drug Discovery (2023-2032)
This growth underscores why AI is increasingly viewed as a structural shift rather than a niche tool within healthcare R&D.
How Can Investors Access These AI-Driven Healthcare Trends?
Investors can gain targeted exposure through biotech and pharmaceutical ETFs designed to capture different parts of the innovation cycle.
The VanEck Biotech ETF (BBH) offers access to the innovation side of AI-driven drug development:
Focuses on leading biotechnology companies
Provides exposure to firms at the forefront of drug discovery and innovation
Includes companies actively using AI-enabled research platforms
The VanEck Pharmaceutical ETF (PPH) is designed to capture established global drugmakers with scale, diversified revenue streams, and proven commercialization capabilities:
Highly liquid companies: Tracks the largest most liquid pharmaceutical companies
Industry leaders: Favors established industry leaders with meaningful scale
Global scope: Provides exposure to U.S. and international equities for global industry representation
The Bottom Line: Why AI Matters for Healthcare Investors
AI is not transforming drug discovery overnight, but it is steadily reshaping how innovation is pursued.
By improving efficiency at the earliest stages of development, AI may help:
Increase the productivity of R&D spending
Support pipeline replenishment amid patent expirations
Strengthen the long-term outlook for both biotech innovators and pharmaceutical leaders
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Stroke remains a leading cause of death and disability worldwide. Each year, approximately 12 million people experience a new stroke, and acute ischemic stroke (AIS) accounts for nearly 87 percent of all cases. Of those who survive a first stroke or high-risk transient ischemic attack (TIA), five to 16 percent will have a recurrent stroke within the first year, and up to 26 percent will experience a secondary stroke within five years. Recurrent strokes are often more severe, carry twice the risk of mortality, and are associated with poorer functional outcomes compared with first-ever strokes. For patients and families, this translates into increased disability, long-term cognitive decline, and a heavier healthcare burden.
To prevent another stroke, doctors often prescribe antiplatelet drugs, like aspirin, clopidogrel, or dipyridamole. These medications reduce the ability of platelets to stick together and form clots, lowering the risk of a blocked artery in the brain. In some high-risk patients, clinicians may use short-term dual-antiplatelet therapy (DAPT) — combining aspirin with clopidogrel or ticagrelor.
However, while these therapies help, they are far from perfect. Aspirin lowers the risk of recurrent stroke by roughly 22 percent, but many patients still have another stroke. More intensive therapies can offer extra protection in certain cases, but often increase the risk of serious bleeding, which limits long-term use. Older adults and patients with conditions such as atrial fibrillation or kidney and liver disease are particularly vulnerable, making it difficult to find treatments that balance safety and effectiveness.
Against this backdrop, new data unveiled today at the American Heart Association’s International Stroke Conference are drawing attention. Bayer announced Phase 3 results from the OCEANIC-STROKE trial, showing that its investigational drug asundexian significantly reduced the risk of recurrent ischemic stroke without increasing major bleeding.
Changing stroke prevention
Bleeding remains one of the biggest challenges in stroke prevention. Many patients have factors that make them prone to bleeding, including cancer, brain vessel conditions like cerebral amyloid angiopathy, older age, or organ dysfunction. Certain medications or procedures, such as multiple blood thinners after heart procedures, further increase the risk.
“After a stroke, the early period is a fragile time. The risk for bleeding, particularly in the brain, is at its highest, which makes it difficult to balance clot prevention with safety. Finding that balance has been a major challenge for the clinical community,” Sara Hegab, Head of Specialty and Pipeline, US Medical Affairs at Bayer, told DDN.
Clinicians must walk a fine line between lowering doses to reduce bleeding and increasing the chance of another stroke. A therapy that protects against recurrent strokes without increasing serious bleeding would offer a long-sought solution, allowing doctors to treat high-risk patients with greater confidence and fewer compromises.
Asundexian works alongside standard anti-platelet therapies by targeting factor XIa (FXIa), a protein involved in pathological clot formation. Unlike traditional anticoagulants, which interfere with the main clotting pathway and increase bleeding risk, FXIa inhibitors selectively prevent dangerous clots without affecting normal blood clotting. This makes the drug particularly promising for patients who are at high risk of bleeding but still need protection against recurrent strokes.
“Imagine cutting yourself in the kitchen. Your body needs to form a clot to stop bleeding — that’s healthy hemostasis. factor XIa doesn’t play a big role there, which is why asundexian can target pathological clotting while preserving normal clotting,” said Hegab.
What does this mean for patients?
OCEANIC-STROKE was a large, international trial of over 12,300 patients. Patients received once-daily asundexian 50mg alongside standard antiplatelet therapy. The drug reduced recurrent ischemic stroke by 26 percent compared with placebo (6.2 percent versus 8.4 percent with placebo), with similar reductions observed across all stroke types. The benefit was consistent across age, sex, stroke subtype, severity, and concomitant therapies. Rates of major bleeding were comparable to placebo, as were minor bleeding events and other safety outcomes.
“The trial included all non-cardioembolic stroke subtypes, with demographics representative of the US and global population. That means these results are broadly applicable,” noted Hegab.
Even with antiplatelet therapy, one in 10 patients still have a recurrent stroke in the first year. Asundexian’s trial showed it could reduce that further without increasing bleeding, a major limitation of other anticoagulants.
If approved, asundexian could give patients a safer, more effective option for long-term secondary stroke prevention, especially those who cannot tolerate prolonged dual therapy or traditional anticoagulants. As the first FXIa inhibitor to show both efficacy and safety in secondary stroke prevention, asundexian may reshape how clinicians approach the prevention of recurrent strokes, offering hope for millions of patients worldwide.
Studying the shape of tissues and organs is critical to understanding how they are formed. Embryonic development happens in three dimensions, but many studies are limited by the use of two-dimensional approaches and images to describe three-dimensional processes. To overcome this challenge, researchers at EMBL Barcelona have created LimbLab—an open-source pipeline made for three-dimensional visualization and analysis of growing limb buds.
A new tool for 3D limb research
The platform was primarily designed to study mouse limb development, but the concept can be useful for any researcher working with complicated volumetric imaging data. The researchers describe the platform in a new study published in the journal BMC Bioinformatics.
“We developed LimbLab because we realized that current tools miss crucial aspects of embryonic development and are not designed specifically for developmental biology,” said Laura Aviñó-Esteban, first author of the work and Ph.D. student in EMBL’s Sharpe Group.
Researchers studying limb development need specific software tools for their work. For instance, researchers may need to assign a developmental age to certain samples based on their visible features, or they might have to align or morph images of samples to allow accurate and consistent comparisons.
These tools exist in 2D, like eMOSS and LimbNET, but not in 3D. LimbLab bridges this gap by enabling 3D visualization of gene expression patterns. It achieves this through a modular workflow in Vedo, an open-source Python library developed at the Sharpe Lab that enables seamless 3D analysis and high-fidelity and aesthetic rendering of meshes and volumes.
Inside the LimbLab pipeline workflow
First, the pipeline cleans the raw volumetric data obtained from a microscope, removing noise and artifacts. Then it extracts information about tissue surfaces to build computational structures called “meshes,” which are computationally efficient to work with.
After this, the pipeline analyzes the sample to give it a developmental age and aligns or morphs the sample with a reference model. LimbLab also provides advanced visualization methods that help researchers to explore and present gene expression in full 3D. Each step is logged and standardized, which improves reproducibility.
Broader impact beyond limb development
The importance of this work goes beyond limb development. Many areas of biological research, like those using organoids, tumors, or engineered tissues, depend on 3D volumetric imaging. LimbLab shows how a specialized pipeline can organize messy 3D data and make it clear and aligned.
It also underscores the importance of reproducibility in imaging research, where small differences in processing can result in very different biological interpretations. LimbLab is also a proof-of-concept: it shows how special computational tools can change the way we analyze 3D biological data.
LimbLab is not only a technical improvement, it is a step towards making developmental biology research more quantitative, reproducible, and accessible. The pipeline is open source, easy to install, and has full documentation. While the present version is optimized for mouse limb buds, the researchers plan to adapt it for other species and tissues to help answer bigger questions about regeneration and evolution.
A new study has uncovered new genetic rules that determine how CD8 “killer” T cells choose between becoming long-lasting, protective immune cells or slipping into exhausted, dysfunctional states. Turning off just two of these genes allowed exhausted T cells to regain their tumor-killing capacity.
The paper published in Nature titled, “Atlas-guided discovery of transcription factors for T-cell programming,” establishes a predictive framework to reprogram T cells to sustain immune memory while preserving their ability to fight cancer and infections, offering broad implications for cancer immunotherapy and infectious disease research.
The multi-institutional study was led by researchers at the Salk Institute for Biological Studies, UNC Lineberger Comprehensive Cancer Center, and UC San Diego.
CD8 T cells play a central role in the immune system by identifying and attacking virus-infected cells and cancer cells. However, during chronic infections or within tumors, these cells can gradually lose their killing capacity and enter T-cell exhaustion.
The authors created a detailed genetic atlas of various CD8 T-cell states, capturing how these immune cells change across a spectrum from highly protective to deeply dysfunctional. The atlas distinguishes between protective and exhausted CD8 T-cell states based on the genetic level.
“Our long-term goal is to make immune therapies work better by creating clear ‘recipes’ for designing T cells,” said Susan Kaech, PhD, a professor at the Salk Institute and co-corresponding author of the study. “To do that, we first needed to identify which molecular ingredients are uniquely active in one T-cell state but not others. By building a comprehensive atlas of CD8 T-cell states, we were able to pinpoint the key factors that define protective versus dysfunctional programs—information that is essential for precisely engineering effective immune responses.”
The researchers analyzed nine distinct CD8 T-cell states and identified specific transcription factors that act like molecular switches, steering T cells toward either long-term function or exhaustion.
Two transcription factors, ZSCAN20 and JDP2, had not previously been linked to T-cell exhaustion. Disabling these transcription factors caused exhausted T cells to regain their ability to kill tumors without losing their capacity for long-term immune memory.
“We flipped specific genetic switches in the T cells to see if we could restore their tumor-killing function without damaging their ability to provide long-term immune protection,” said H. Kay Chung, PhD, assistant professor at UNC Lineberger and another co-corresponding author. “We found that it was indeed possible to separate these two outcomes.”
The study challenges the long-standing belief that immune exhaustion is an unavoidable consequence of prolonged immune activity.
This genetic atlas of T-cell states can guide the development of supercharged T cells for use in cellular therapies such as adoptive cell transfer (ACT) and CAR T-cell therapy.
“Once we had this map, we could start giving T cells much clearer instructions—helping them keep the traits that allow them to fight cancer or infection over the long term, while avoiding the pathways that cause them to burn out,” said Kaech. “By separating these two programs, we can begin to design immune cells that are both durable and effective in cancer and chronic infection.”
The researchers say the findings should be especially relevant for treating solid tumors, where separating protective immune responses from exhaustion is critical for effective therapy.
“Because genes work together in complex regulatory networks that are difficult to decipher, powerful computational tools are essential to pinpoint which regulators drive specific cell states,” said Wei Wang, PhD, professor at UC San Diego and co-corresponding author. “This study shows that we can begin to precisely manipulate immune cell fates and unlock new possibilities for enhancing immune therapies.”
With Biogen’s multiple sclerosis portfolio facing more generic pressure than ever, the company is eyeing a busy late-stage pipeline and hunting for deals to build its return to growth.
Biogen is not growing right now, but the company has established a “bridge to growth,” with an emphasis on a slew of Phase 3 readouts to come in the next few years and a careful hunt for acquisitions.
“To really return to growth, I think there’s two things that really need to happen. One is we do need to start seeing the positive Phase 3 results come out and the launch of products,” CEO Chris Viehbacher said on the company’s fourth quarter earnings call on Friday. “The other of course, is [business development], and we continue to look for potential acquisition opportunities.”
On the first point, Biogen is currently running 10 Phase III trials, which could one day turn into approved products. Viehbacher in particular pointed to litifilimab, which is due for mid- and late-stage readouts in two types of lupus this year. The first, a Phase 2 test for cutaneous lupus erythematosus, is expected around the end of the first quarter and the second, the late-phase systemic lupus erythematosus trial, will arrive in the fourth quarter. That product could launch in 2028, the CEO predicted.
On business development, Biogen is conducting a careful search for companies in the $5 billion to $6 billion range in the post-Phase 3 results stage—a goal that has not changed in recent quarters.
“The reality is that it’s hard to find things that actually generate value for our shareholders,” Viehbacher explained. “There are certainly companies out there, but we haven’t found one that we can acquire for a price that we think makes sense for our shareholders. But we continue to look. We are looking every day out there in the marketplace.”
So, for now, the existing late-stage pipeline is Biogen’s future.
“We have some pretty high conviction in our late-stage pipeline. Now, nothing is ever given in research and development, as we all know,” Viehbacher said. “But you know, 10 Phase 3 programs, that’s a real achievement from over the past year.”
At the end of 2024, the company only had litifilimab in that advanced a stage. Since then, they have added zorevunersen for Dravet syndrome, with a Phase III read out expected in mid-year 2027, and felzartamab for antibody-mediated rejection, which will also offer late-stage data in mid-2027.
“I think we’ve been able to really, again, create that bridge to growth. We’re generating cash, we’re generating profits, and we’re investing significantly in our growth brands,” Viehbacher said.
Under Pressure
The decline of growth comes as Biogen’s multiple sclerosis portfolio faces generic pressure around the world. This segment showed some “resilience,” according to CFO Robin Kramer, with $9.9 billion in revenue generated in 2025—a 2% increase over the year prior.
Generic erosion began for Tecfidera in 2025, and in 2026 the product will face the full weight of that pressure in Europe. A biosimilar of Tysabri entered the market at the end of the year as well, Viehbacher noted. The CEO is confident that Biogen can maintain the brand for a little while longer despite this new entrant.
“There’s a limited number of physicians who are very strong believers in the importance of Tysabri so that’s what we’re going to rely on,” Viehbacher said.
The growth products, including Alzheimer’s disease therapy Leqembi and post-partum depression drug Zurzuvae, did bring in $3.3 billion for 2025, a 19% increase over the previous year. This helped offset the declining MS portfolio.
Leqembi, which has been a slow and steady launch for Biogen, showed some strength in the fourth quarter with sales of $134 million, a 54% increase year-over-year.
Novo Nordisk has also spoken out strongly against Hims & Hers’ compounded Wegovy pill, with CEO Maziar Mike Doustdar telling investors the knockoff version is a waste of money.
The FDA will “take swift action against companies mass-marketing illegal copycat drugs,” FDA Commissioner Marty Makary wrote in an X post on Thursday. While he didn’t explicitly name a target, the statement appears directly aimed at consumer healthcare company Hims & Hers
Indeed, in a report from Endpoints News the same day, a government official who requested anonymity confirmed that Makary was referring to Hims. The wellness platform on Thursday launched a compounded version of oral Wegovy, which it said would be available at an introductory price of $49 for the first month, before going up to a regular monthly cost of $99.
“The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs,” Makary said in his post.
Novo has since bristled at Hims’ announcement. In an investor call in London Thursday to present its full-year 2025 results, CEO Maziar Mike Doustdar said, “you’re wasting $49, in my opinion,” on Hims’ compounded drug. “I have no idea what they have done with the compound . . . but assuming you just take the compound without the things around it and formulations and what have you, then this just doesn’t work.”
The Danish powerhouse has also threatened to “take legal and regulatory action to protect patients,” the pharma wrote in a Feb. 5 statement. “This is another example of Hims & Hers’ historic behaviour of duping the American public with knock-off GLP-1 products.”
Novo and Hims had previously been in a brief and fitful alliance. The companies signed a pact in April 2025, aiming to improve the accessibility and affordability of the pharma’s obesity care products through the telehealth company’s online platform. Through the partnership, the companies sought to offer an injectable form of Wegovy for $599.
The arrangement fell apart just eight weeks later, however, with Novo apparently incensed at how Hims continued to offer compounded versions of semaglutide even after the alliance was signed. At the time, Novo accused Hims of “deceptive promotion and selling of illegitimate, knockoff versions of Wegovy that put patient safety at risk.”
