‘Cervix-on-a-Chip’ Brings STI Research Closer to Real Human Biology

Studying sexually transmitted infections (STIs) has long been constrained by a fundamental problem: the available models fail to fully capture the complexity of the human body. Traditional cell cultures oversimplify biology, while animal models often do not accurately reflect human infection dynamics.

Now, scientists at the University of Maryland School of Medicine and collaborators have developed the first immune-capable “cervix-on-a-chip,” a microengineered system that recreates the human cervical environment with unprecedented realism. The work, published in Science Advances, could significantly accelerate the development of new treatments and prevention strategies for STIs.

A long-standing gap in STI research

STIs remain a major global health burden. According to the World Health Organization, nearly one million new infections occur every day worldwide, with chlamydia alone accounting for roughly 129 million cases annually. In the United States, chlamydia and gonorrhea together generate an estimated $1 billion in direct medical costs each year.

Beyond their prevalence, these infections can lead to serious complications, particularly in women, including infertility, pelvic inflammatory disease, and adverse pregnancy outcomes.

Despite this, researchers have struggled to study how infections develop and progress in the human cervix, a key site of infection, under realistic conditions.

“This new model will revolutionize how scientists study STIs,” said Jacques Ravel, PhD, co-lead author of the study. “By integrating engineering, microbiology, immunology, and microbiome science, we were able to build a model that more closely reflects human biology and the complexity of the cervical microenvironment.”

Recreating the cervix in the lab

The newly developed system belongs to a class of technologies known as organ-on-a-chip models, or microphysiological systems. These platforms are designed to mimic the structure and function of human tissues using living cells and controlled physical environments.

In this case, the researchers constructed a miniature model of the cervix using human cervical epithelial cells layered on a porous membrane, with supportive tissue cells beneath. Fluids flow across both sides of the membrane, replicating the dynamic conditions found in the body.

The model also incorporates immune cells and microbial communities, allowing scientists to study how these components interact during infection.

“A key goal was to develop a complex model system that is both practical and accessible,” said Jason Gleghorn, PhD, who led the model development. “The need for this model was particularly critical for studying the vaginal microbiome, which we know plays an important role in susceptibility to STIs.”

Capturing the role of the microbiome

One of the defining features of the cervix-on-a-chip is its ability to include different types of vaginal microbiomes, something that has been difficult to replicate in previous models.

The researchers tested the system using two of the most common STIs: chlamydia (Chlamydia trachomatis) and gonorrhea (Neisseria gonorrhoeae). They found that the outcome of infection depended strongly on the type of microbiome present.

In models dominated by Lactobacillus crispatus, a bacterial species commonly associated with vaginal health, infections were significantly limited. In contrast, when less protective microbiomes were introduced, infections became more severe.

“One of the most exciting findings was that just like in women, protective microbiomes dominated by Lactobacillus crispatus limited infection in the model,” Ravel said. “In contrast, when we introduced ‘nonoptimal’ microbiomes, infections worsened.”

These results reinforce growing evidence that the vaginal microbiome plays a central role in determining susceptibility to STIs.

Toward better treatments—and prevention

Beyond improving understanding, the new model provides a practical platform for testing potential therapies.

Because it closely mimics human biology, the cervix-on-a-chip can be used to evaluate new treatments under realistic conditions. This includes not only traditional antimicrobial drugs but also emerging approaches such as probiotics and live biotherapeutics designed to restore protective microbiomes.

“This model provides a powerful new tool to develop faster, more effective, and personalized treatments,” Ravel said. “For the first time, we can simulate what happens in the human body rather than relying solely on petri dish systems or inadequate animal models.”

A platform for broader applications

The implications of the technology extend beyond the infections tested in the study. The cervix-on-a-chip could be adapted to study a wide range of pathogens, as well as broader questions about reproductive health, inflammation, and host–microbe interactions.

The researchers emphasized accessibility in the model’s design, aiming to make it usable by scientists outside of specialized bioengineering labs. This could accelerate adoption and expand its impact across the field.

A step toward more human-relevant science

The development of immune-capable organ-on-a-chip systems represents a broader shift in biomedical research toward more human-relevant experimental models. By integrating multiple components of human biology—cells, tissues, immune responses, and microbiomes—these systems offer a more accurate view of disease processes.

In the context of STIs, where subtle interactions between host and microbes can determine outcomes, such realism is particularly valuable.

As researchers continue to refine these platforms, they may help bridge the gap between laboratory studies and real-world biology—ultimately enabling earlier, more precise, and more effective interventions.

For now, the cervix-on-a-chip marks a significant step forward, providing scientists with a tool that captures the complexity of the human cervix in a way that was previously out of reach.

The post ‘Cervix-on-a-Chip’ Brings STI Research Closer to Real Human Biology appeared first on Inside Precision Medicine.

Top 5 Firms Engineering Healthcare in the CNS Space

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

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

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

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

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

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

 

1. Aerska

Founded: 2025 | Headquarters: Dublin, Ireland

Aerska logo

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

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

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

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

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

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

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

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

 

2. Beacon Biosignals

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

Beacon Biosignals logo

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

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

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

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

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

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

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

 

3. Brainomix

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

Brainomix logo

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

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

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

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

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

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

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

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

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

 

4. Circular Genomics

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

Circular Genomics Logo

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

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

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

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

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

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

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

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

 

5. Omniscient Neurotechnology

Founded: 2019 | Headquarters: Sydney, Australia

o8t logo

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

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

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

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

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

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

 

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

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

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

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

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

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

Continue to STAT+ to read the full story…

StockWatch: Price War Dampens Lilly Surge After Oral GLP-1 Wins FDA Nod

Eli Lilly (NYSE: LLY) won the approval it sought when the FDA authorized the company’s oral obesity drug Foundayo™ (orforglipron), but the pharma giant’s post-approval stock bounce was short-lived.

Lilly shares rose 4% from $919.77 to $954.52 on the day of the announcement. But the momentum reversed into a 2% loss to $935.58 on Thursday, and for one important reason beyond simply the overall market decline triggered by investors losing confidence in a speedy end to the Iran war.

Investors (as reflected in analysts’ mixed observations) appeared divided on how quickly Lilly can generate sales this year for Foundayo, a small molecule glucagon-like peptide-1 (GLP-1) receptor agonist. That division results from the competition shaping up on the drug’s price with obesity arch-rival Novo Nordisk (shares traded on Nasdaq Copenhagen as NOVO-B; ADRs traded on NYSE as NVO).

Novo Nordisk got a jump on Lilly in the oral obesity drug front in December when the Danish biotech giant won FDA approval for oral Wegovy® (semaglutide), a once-daily 25 mg tablet indicated for chronic weight management. Analysts consider oral Wegovy sales to have started strong, with total prescriptions reaching 577,000 and 52,000 filled during the week ending March 20.

Lilly is expected to make Foundayo available directly to patients through its LillyDirect direct-to-consumer services and support platform starting Monday. There, a starting dose of 0.8 mg is being priced at $149/month, rising to $199/month for 2.5 mg, $299/month for the 5.5 mg and 9 mg doses, and up to $349/month for the highest doses of 14.5 mg and 17.2 mg. However, high-dose patients will automatically receive the $299/month price on their first purchases and keep it if they refill their prescription within 45 days of their previous prescription.

Patients paying through commercial insurance plans will be eligible for discounts that reduce Foundayo’s out-of-pocket cost to patients for 1-, 2-, or 3-month prescription fills to $5 a month.

“A positive surprise is that the approval was for a tablet formulation, which is less expensive to manufacture” than the capsule versions studied by Lilly during clinical trials, David Risinger, a senior managing director and senior research analyst covering diversified biopharmaceuticals at Leerink Partners, shared in a research note.

Lilly told Risinger that it conducted a bioequivalence study comparing capsules to tablets, which, according to the company, can be manufactured more efficiently than capsules and use less active pharmaceutical ingredient. The high dose studied in Lilly’s Phase III trials of orforglipron, 36 mg, corresponds to the highest capsule dose of 17.2 mg.

Price competition

Lilly has sought to price its oral obesity drug competitively with Novo Nordisk’s oral Wegovy, which starts at $149/month for the lowest dose of 1.5 mg, then rises to $199/month for the 4 mg dose, with new patients paying $149/month through August 31. Prices rise to $299/month for 9 mg and 25 mg doses.

However, patients who sign up for a 12-month subscription to oral Wegovy through Novo Nordisk’s telemedicine partner-providers enjoy a $50 discount that brings their monthly cost down to $249. And commercial insurance patients who agree to local pharmacy pickup with a savings offer can pay as little as $25/month, subject to a maximum savings of $100/month.

The price competition explains why buyers of securities for themselves or clients—the “buy side” in Wall Street jargon—have lowered their 2026 forecasts for Foundayo sales by more than half, from about $4 billion to less than $2 billion, Trung Huynh, an analyst with RBC Capital Markets, wrote in a research note. Huynh cited a consensus of analysts which is projecting approximately $1.6 billion in 2026 sales, though a Reuters spot check of investment brokerages found a range for this year’s projected sales of $1.5 billion to $2.8 billion.

“Although there have been headwinds on pricing erosion in the GLP-1 space, we believe there is substantial upside with the expected Medicare Part D expansion later this year,” Huynh added. The expansion of sales to the Medicare Part D program would cap patient copays at $50 per month.

Huynh and RBC Capital have projected Foundayo will reach peak-year sales of $36 billion—14% above the $31.68 billion racked up by last year’s best-selling prescription drug, the multi-indication cancer immunotherapy blockbuster Keytruda® (pembrolizumab) marketed by Merck & Co. (NYSE: MRK).

The highest peak sales forecast comes from Citi Research, where Geoff Meacham, PhD, the firm’s head of healthcare research and a managing director specializing in U.S. pharma and biotech research, has projected more than $40 billion. At the low end, a consensus of analysts surveyed by Bloomberg News expects Foundayo peak sales to reach $18 billion by 2030.

$50M upfront

Both ends are a far, far cry from the $50 million upfront that Lilly paid in 2018 to license orforglipron, then called OWL833, from Chugai Pharmaceutical, which discovered the drug and is owned by Roche Holding (SIX Swiss Exchange: ROP and RO; OTCQX: RHHBY). Lilly also agreed to pay Chugai up to $390 million in potential payments tied to achieving milestones.

At the time, OWL833 was deemed Phase I ready for clinical studies in type 2 diabetes—the indication for which Lilly markets its GLP-1/GIP (glucose-dependent insulinotropic polypeptide) receptor agonist tirzepatide as Mounjaro®, and Novo Nordisk markets its GLP-1 receptor agonist semaglutide as Ozempic®.

“Overall, we continue to believe that injectable anti-obesity medications will retain the majority of market share (roughly 80%, based on our estimates) in the United States due to the high potency of injectables coupled with a more elevated U.S. BMI population,” Andy T. Hsieh, PhD, a partner and biotechnology analyst with William Blair, wrote in a research note.

Beyond competitive pricing and lower manufacturing costs, Lilly has emphasized a convenience advantage over oral Wegovy—starting with its public announcement of the approval, whose headline referred to Foundayo as “the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictions.”

While Foundayo can be taken morning, afternoon, or evening, oral Wegovy, by contrast, requires patients to take the pill with up to 4 ounces of water on an empty stomach as soon as they wake up, then fast for 30 minutes before they can eat or drink.

“Accordingly, we expect Foundayo to blunt the uptake of oral Wegovy upon its availability (starting on April 6), though oral Wegovy retains a pricing advantage,” Hsieh concluded.

Huynh of RBC Capital agreed, citing a survey by his firm of about 200 patients, payers, and prescribers: “Our recent survey indicated that Foundayo would be a preferred oral option amongst patients since it has no dosing restrictions.”

Not so, Novo Nordisk CEO Maziar (Mike) Doustdar told CNBC last month: “People are really interested because it’s the most efficacious pill right now in the market.”

Novo Nordisk cites efficacy

Novo Nordisk sought to reinforce that message via an announcement trumpeting that its 25 mg dose of oral Wegovy showed “significantly” greater mean weight loss than the 36 mg dose of Foundayo, according to a population-adjusted indirect treatment comparison using data from two clinical trials:

  • OASIS 4 (NCT05564117), a 307-patient randomized study which evaluated once-daily oral Wegovy 25 mg in overweight or obese adults with at least one self-reported unsuccessful dietary effort to lose body weight, to measure their percentage change in body weight and whether it was ≥5% at the end of treatment at week 64.
  • ATTAIN-1 (NCT05869903), a 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of orforglipron (6 mg, 12 mg, and 36 mg) as monotherapy vs. placebo in 3,127 adults with obesity, or overweight with at least one of the following comorbidities: hypertension, dyslipidemia, OSA, or cardiovascular disease, who did not have diabetes.

Novo Nordisk plans to present details of its study, called ORION, at the Obesity Medicine Association’s annual Obesity Medicine 2026 conference, set for April 10-12 in San Diego.

News of the FDA approval for Foundayo caused Novo Nordisk shares to dip 0.1% Wednesday from DKK 231.15 ($35.65) to DKK 230.90 ($35.61). But the shares finished the trading week climbing nearly 3% Thursday to DKK 236.90 ($36.53).

U.S. and major European markets were closed on Friday in observance of Good Friday.

Foundayo is the fifth prescription drug to be authorized under the FDA’s Commissioner’s National Priority Voucher program, through which the agency awards vouchers to drug developers whose work will address a health crisis in the United States, deliver more innovative cures, address unmet public health needs, and increase domestic drug manufacturing as a national security issue.

The approval came nearly 10 months ahead of Foundayo’s target decision date of January 20, 2027, under the PDUFA (Prescription Drug User Fee Act) program, and just 50 days after Lilly filed a new drug application (NDA) for the oral obesity drug with the FDA.

Leaders and laggards

  • Inovio Pharmaceuticals (NASDAQ: INO) shares nosedived 35% from $1.74 to $1.13 Thursday after the developer of DNA therapies to treat and prevent HPV-related diseases, cancer, and infectious diseases announced that it priced at $1.40 a share an underwritten public offering of 12.5 million shares of common stock, plus accompanying Series A and Series B warrants, each series enabling potential purchase of up to 12.5 million shares (or pre-funded warrants in lieu thereof). The dilutive offering is projected to raise $17.5 million in gross proceeds—$16 million in net proceeds, rising to $18.4 million if underwriter Piper Sandler exercises in full its 30-day option to purchase up to 1.875 million additional shares and all Series A and Series B warrants (1.875 million shares each series). Net proceeds are intended to fund a potential commercial launch of INO-3107, a recurrent respiratory papillomatosis candidate under FDA review with a target decision date of October 30, as well as a confirmatory trial for INO-3107 if required, pipeline development, and general corporate purposes.
  • Oric Pharmaceuticals (NASDAQ: ORIC) shares tumbled 19% from $12.67 to $7.47 Wednesday after the cancer drug developer said it will advance rinzimetostat (ORIC-944) into a 600-patient Phase III trial (Himalaya-1 ) after generating positive data from its Phase Ib trial (NCT05413421) assessing rinzimetostat plus the Bayer (XETRA: BAYN)-marketed Nubeqa® (darolutamide) as a once-daily treatment for metastatic castration-resistant prostate cancer (mCRPC) in patients previously treated with abiraterone acetate (abiraterone). At a median follow-up of 4.9 months, the combination showed radiographic progression-free survival (rPFS) rates of 93% at 3 months, 84% at 4 months, and 84% at 5 months—rates consistent, Oric said, with the competitor PRC2 inhibitor currently in Phase III in post-abiraterone mCRPC patients and superior to available standard-of-care therapies showing rPFS rates of approximately 60% to 75%. Also, 47% of patients (7/15) achieved a PSA50 response, with 33% (5/15) confirmed, while 71% of patients (10/14) achieving >50% circulating tumor (ctDNA) reduction. Jefferies analyst Maury Raycroft, PhD, reported that some investors viewed rinzimetstat as “a better fit strategically” with Johnson & Johnson (NYSE: JNJ)-marketed Erleada® (apalutamide).
  • Sangamo Therapeutics (NASDAQ: SGMO) shares climbed 20% from 25 cents to 30 cents between Tuesday and Thursday after the genetic medicine developer said it expects to complete this summer its rolling Biologics License Application (BLA) submission seeking FDA approval for isaralgagene civaparvovec (ST-920), a gene therapy candidate being developed to treat Fabry disease, subject to securing adequate additional funding, while continuing business development discussions for a potential Fabry commercialization agreement. Sangamo said it is advancing the chemistry, manufacturing, and controls (CMC) module ahead of completion of the rolling BLA submission. Since launching its rolling BLA submission in December under an Accelerated Approval pathway, Sangamo has submitted preclinical and clinical modules, as well as submitted its antibody assay companion diagnostic, designed to screen patients for eligibility with isaralgagene civaparvovec, to the FDA’s Center for Devices and Radiological Health (CDRH), seeking Premarket Approval (PMA).

The post StockWatch: Price War Dampens Lilly Surge After Oral GLP-1 Wins FDA Nod appeared first on GEN – Genetic Engineering and Biotechnology News.

Low Birthweight Increases Risk of Early Stroke

Research led by the University of Gothenburg in Sweden suggests that low birthweight is a risk factor for having a stroke in younger adulthood.

In a study including just under 800,000 people, the investigators found that risk for early stroke events was 18-23% higher in men and women who had a birth weight under the median level than those with a higher birth weight.

Around 795,000 people in the U.S. have a stroke each year. Although it can affect people of any age, it is much more common in older individuals with estimates of prevalence suggesting that 0.9% of 18–44 year olds have strokes versus 3.8% of those in the 45–64 year age group and 7.7% of people aged 65 and over.

Low birth weight has been previously linked to an increased risk for stroke in several studies. Researchers think that low birth weight is an indicator of exposure to an adverse environment in the womb that may adversely affect the cardiovascular system of the fetus in a way that increases stroke risk—for example, by increasing the risk of high blood pressure.

Over the last 10-15 years, stroke prevalence has stayed the same in older adults but has gone up by 14-16% in 18-64 year-olds. Lina Lilja, a doctoral student at the University of Gothenburg, and colleagues aimed to investigate whether low birth weight increased the risk of stroke in younger adults.

They included 420,173 men and 348,758 women from Sweden who were born between 1973 and 1982 and followed up from birth until 2022. The researchers collected data on birth weight, gestational age, and body mass index in young adulthood, as well as information on first stroke and the type of stroke.

Overall, 2252 first stroke events were recorded at an average age of 36 years. Of these, 1624 were ischemic stroke (average age 37 years) and 588 were intracerebral hemorrhage (average age 33 years).

The results, which will be presented at the European Congress on Obesity in Istanbul later this year, showed that birth weight below the median (3.5kg) increased the risk for all stroke by 21%. The rates of stroke were slightly higher in men with a low birthweight at 23% versus women with a low birthweight at 18%.

Notably, gestational age at birth and young adult body mass index were not linked to stroke risk in this study.

The post Low Birthweight Increases Risk of Early Stroke appeared first on Inside Precision Medicine.

STAT+: Pharmalittle: We’re reading about Trump’s drug tariffs, a U.S.-U.K. pharma trade deal, and more

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is rather modest so far. We plan to tidy up around the castle, promenade with the official mascots, and catch up on our reading. We also plan another listening party, where the rotation will likely include this, this, this, this and this. And what about you? The change of seasons opens up all sorts of possibilities, from long walks through woods to strolling along city streets to drives through the countryside. Of course, if the weather fails to cooperate, you could open a book, watch the telly, or spin a platter and dance about. Or maybe it is an opportunity to connect with someone special. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

The Trump administration announced 100% tariffs on imported brand-name drugs — but with significant caveats, STAT explains. Many large drugmakers will not have to pay the tax because they struck deals with the U.S. to build manufacturing facilities here and lower the prices of their medications. Drugmakers that have not struck such deals but pledge to bring production to the U.S. can have tariffs reduced to 20% for the remainder of Trump’s term. The tariffs open a new front in the Trump administration’s efforts to rein in the pharmaceutical industry and in its push to bring manufacturing back to the U.S. The announcement comes as Trump has looked to emphasize his administration’s work to make prices — especially for medicines — more affordable ahead of the midterm elections.

Meanwhile, the Trump administration is negotiating more drug-pricing deals, now with smaller companies, according to STAT. The new talks offer a pathway for smaller pharmaceutical companies — those not included in the first round of deals — to pledge lower prices and potentially avoid tariffs or new pricing policies through Medicare. The negotiations suggest the administration is looking to replicate the strategy it used with larger drugmakers: extract voluntary, confidential agreements in pursuit of lower prices and more domestic manufacturing. They also offer smaller players in the sector the chance to cut a deal and gain more certainty about how they might be affected by federal policies. But the number of companies in talks with the administration remains unclear, as does whether or when the sides will reach agreement.

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Supreme Court conversion therapy decision could ripple through medicine

The U.S. Supreme Court ruling this week against Colorado’s ban on licensed mental health providers engaging in gender and sexuality “conversion therapy” could narrow the authority of state medical boards to regulate aspects of health providers’ care that involves speech, according to legal experts. The implications could extend far beyond matters related to LGBTQ+ rights to other forms of talk therapy, telehealth, and physician advice on Covid-19, vaccines, or reproductive care.

Because the therapist who challenged the law, Kaley Chiles, engages in talk therapy — without prescribing medications or having any physical contact with patients — the majority decided that the Colorado law constitutes a restriction on her speech due to her particular viewpoint, or opinion. In an 8-1 decision, the judges sent the case back to a lower court for a higher level of judicial scrutiny, which will likely result in the ban being overturned. 

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AGBT 2026 Recap: NGS Big Bets and Spatial’s Rising Momentum

For most people, February in Florida means school breaks, water parks, and trips to Disney. But for the genomics community, that combination means the season of big announcements as the Advances in Genome Biology and Technology (AGBT) meeting—which has earned a reputation for breaking field-shaping news—takes place. The meeting is packed not only with technology announcements in the sponsor suites, but also with scientific talks in the sessions to showcase how the technology is being used to address new biological questions.

The first piece of news was the weather. Not in Orlando, although it was uncharacteristically cold. But for the nail-biting attendees traveling from the Northeast who were watching the prediction of inches of snow grow with each forecast. Those of us who bumped up our flights to beat the storm and make some of the last flights out of the Northeast were lucky enough to arrive in time for the opening session.

The meeting was, as usual, a constant stream of announcements and advancements. Some grumbled that the meeting was slower than usual, but that seems unfounded to this attendee. One NGS company launched two new instruments just two years after its first instrument; the very first 3D spatial instrument was launched commercially, while other spatial news showed a maturing of the field. Many attendees could not stop talking about some of the research presented—including the “bat talk” given by Emma Teeling, PhD, from the University College Dublin, during the opening session (which was officially named, “Bats: new models of extended healthspan and disease resistance”).

Also included in the opening session was an award presentation to Eric Green, MD, PhD, the former National Human Genome Research Institute (NHGRI) director. Green was sorely missed at last year’s 25th anniversary meeting because he (and many others working at the NHGRI and NIH) were not in attendance due to travel restrictions on government staff. A short time later, Green’s 15-year stint at the NHGRI was terminated, becoming the first of multiple NIH directors to be ousted by the Trump administration. But now, Green has completed his transition from government work to a new role as Illumina’s CMO. However, this transition also means that Green can no longer serve as a program committee co-chair for the AGBT General Meeting, which he has done for over 25 years, making the Distinguished Service Award a fitting end to his tenure. The meeting, Green noted on LinkedIn, has “always been about charting a course for the future.”

Sequencing steals the spotlight

Next Generation Sequencing (NGS) dominated the buzz at the meeting this year. Ultima Genomics made news just before the meeting started, revealing two new instruments: the UG 200 single-wafer and the UG 200 Ultra dual-wafer. Both boxes are less expensive and have higher throughput than the original iteration—the UG 100. Gilad Almogy, PhD, Ultima’s CEO, told GEN that the UG 200 series is more mature because it has been developed through “a ton of learning of how [the UG 100] performed in the field.” But it was a quick learning cycle, as the UG 100 was only launched in 2024.

In contrast, AGBT attendees had to wait patiently for the most anticipated news from the meeting: Roche filling in missing details about its sequencing by expansion (SBX) nanopore instrument, the Axelios. The company’s lunch talk was scheduled on the last day of the meeting, with many people rolling their luggage around in preparation to depart. Roche had already announced the cost of the Axelios instrument at $750,000, but the pricing for the consumables and the launch date remained unknown. Roche did offer some information, announcing a whole genome price of $150 (in duplex mode), a simplex price of $0.06 per million reads, and availability sometime this summer. A few new, notable discussion points were raised, including the length and complexity of the duplex sequencing library prep.

Illumina, the gold sponsor of the meeting, doubled down on its multiomics theme by presenting a complete multiomics workflow with a focus on the company’s longer read TruPath product. The kit, which uses an on-flow cell library preparation to obtain long-read insights, was first presented in 2024 as constellation mapped read technology. In short, the DNA spans multiple wells that are spaced under 100 nm apart. The DNA is fixed and then undergoes clustering and sequencing, connected throughout the DNA molecule. TruPath enables haplotyping, structural variant detection, and short tandem repeat analysis, which Steve Barnard, PhD, CTO of Illumina, said is “creating a new category of sequencing and giving the insights we need to diagnose patients.” The company emphasized TruPath’s ease of use during their talk by including a photo of Green using it at the bench and noting that it is so easy, even an executive can use it.

Element Biosciences did not wait until AGBT to reveal its latest innovation. The company announced its new high-throughput benchtop sequencing system, VITARI, in a webinar the week before the conference. The company noted that the instrument will begin shipping in the second half of 2026 and had a roadmap that included future multiomic capabilities.

In other industry news, Complete Genomics confirmed that it had entered into a definitive agreement to be acquired by Swiss Rockets AG, a Switzerland-based life sciences group. This move splits the company from Chinese ownership by MGI/BGI, and it will become a subsidiary of the Swiss life sciences group. Rade Drmanac, PhD, Complete’s co-founder and CSO, told GEN that this news allows the company to continue its focus on NGS instrumentation but also grow the focus into applications.

Expansion of spatial biology

Despite the wave of high-profile NGS announcements, spatial biology held its ground as a major focus at AGBT with updates reinforcing the technology’s maturity and expansion into new areas.

Vizgen announced updates on its MERSCOPE Ultra platform, including expanding its portfolio of predesigned panels and introducing a new customization capability. In addition, the company covered upcoming workflow innovations for upstream sample preparation and downstream bioinformatics. But perhaps the coolest update was the company’s work on organoids—a field where spatial analysis has proven challenging. Several characteristics of Vizgen’s platform are now enabling spatial analysis of organoids.

Singular Genomics’ new G4X Spatial Sequencer was on display in its suite, which the company launched the week before the meeting. At AGBT, the G4X platform was featured in a talk on SPOT-Met (Spatial Predictors of Tropism and Metastasis) by Jiwoon Park, PhD, from the lab of Christopher Mason, PhD, at Weill Cornell Medicine. SPOT-Met is a 1,000-tumor colorectal cancer program described as the largest colorectal cancer multimodal spatial initiative. “Population-scale spatial has arrived and is on center stage at AGBT 2026,” said Mason.

Attendees who visited the Stellaromics suite, which many did, judging from the activity, were encouraged to forget about 2D spatial and start thinking 3D. A Boston-based AGBT newcomer, Stellaromics is leading the 3D spatial wave with the launch of the first 3D commercially available spatial imager—the Pyxa. Although it may have been Stellaromics’ first time in Florida for the meeting, the company is led by genomics veteran Todd Dickinson, PhD (previously from Illumina, Bionano, Dovetail Genomics), who is no stranger to AGBT.

Last year, Bruker Spatial Biology established its place as a contender in the spatial world, just one year after the NanoString acquisition. This year, the company solidified its place as a leader by launching two products that it spoke about last year: CellScape (for spatial proteomics) and PaintScape (for visualization of the 3D genome). It also noted the mouse whole transcriptome for the CosMx Spatial Molecular Imager with 64 proteins. The technology was highlighted in multiple talks, including that of Miranda Orr, PhD, from Washington University, as she delved into the world of 3D reconstruction of neuropathology in the Alzheimer’s brain.

10x Genomics chocolate barAlthough 10x Genomics is typically a top-tier sponsor at AGBT, the company was relatively quiet this year. However, it still managed to create buzz by delivering chocolate bars to each attendee’s hotel room stamped with a date: 4/18/26. Mid-April falls at the beginning of the American Association for Cancer Research (AACR) meeting, leaving something to look forward to.

Multiomics and more

BD Biosciences (now Waters) made a strong presence in the single-cell multiomics space with a focus on multimodal cellular profiling using its Rhapsody System. The new roadmap for this system piqued interest. In addition, the new hire of spatial veteran Luciano Martelotto, PhD, as director of global market development (single cell), working in the suite from morning until night, helped highlight the company’s place at the meeting.

Newcomer Syndex Bio introduced its mcPCR (methyl-copying PCR) platform, which enables copying of both DNA and methylation during amplification. Codetta Bio’s Concerto multiomic system, which detects DNA, RNA, and protein biomarkers in a single run, became commercially available (after being introduced at AACR last year), and the company spoke about the upcoming launch of new customizable panels for immunology and neuroscience.

In other innovative technologies, Gary Schroth, PhD, CSO of Cellanome, presented the company’s CellCage technology for the first time, which can study cells to understand their history and collect transcriptome data over time. Schroth showed a video of glial cells phagocytosing bacteria, and measuring the functional changes with the cells’ gene expression changes. Volta Labs announced the expansion of the capabilities of its Callisto platform, collaborations with Roche and Watchmaker

Genomics, and unveiled a growing pipeline of applications rolling out through 2026.

And that is the real takeaway from AGBT: innovation does not stop when people fly home. All of these announcements, made over four days, are significant advances and the excitement is palpable. But the truth is, innovators in the genomics field continue to push the boundaries all year long. For those of us who are passionate about genomics, we will look forward to seeing what they’ll unveil next year.

The post AGBT 2026 Recap: NGS Big Bets and Spatial’s Rising Momentum appeared first on GEN – Genetic Engineering and Biotechnology News.

STAT+: Trump announces 100% tariffs on brand-name drugs, with plenty of carveouts

WASHINGTON — The Trump administration announced Thursday 100% tariffs on imported brand-name drugs — but with significant caveats.

Many large drugmakers won’t have to pay the tax because they’ve struck deals with the U.S. to build manufacturing facilities here and lower the prices of their medications. Drugmakers that haven’t struck those deals but pledge to bring production to the U.S. can have their tariffs reduced to 20% for the remainder of Trump’s term. 

The tariffs open a new front in the Trump administration’s efforts to rein in the pharmaceutical industry and in its push to bring manufacturing back to the U.S. The announcement comes as Trump has looked to emphasize his administration’s work to make prices — especially medicines — more affordable ahead of the midterms.

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