Opinion: STAT+: Landmines await Vinay Prasad’s successor at the FDA

Vinay Prasad’s short yet two-act tenure at the FDA was wild. How does anyone follow him as the new leader of biologics oversight at the agency?

Someone I know at the FDA joked to me recently that I should be the new director of the Center for Biologics Evaluation and Research (CBER) after Prasad. I literally laughed out loud at how comical that sounded, but it got me thinking: Who would be both willing to do it and could get picked? Further, what’s awaiting them?

Prasad became a favorite punching bag of many, including the Wall Street Journal editorial board and right-wing activists like Laura Loomer. They are teed up to clobber the next person, too.

Continue to STAT+ to read the full story…

STAT+: Hospitals roll out chatbots, looking to reclaim their role in patients’ health conversations

Every day, more than 40 million people ask ChatGPT about health care, according to OpenAI. They’re asking questions about diet, exercise, insurance — and in some cases, serious symptoms that would typically get discussed on a 911 call or in a doctor’s office.

For some health systems, that’s creating an imperative. A small number of hospitals are trying to recapture some of those clinical conversations from commercial large language models like ChatGPT, Claude, and Gemini. They’re implementing their own patient-facing chatbots, ones that draw directly from their existing medical records and can funnel patients toward care in their own system. 

Hartford HealthCare this week will launch PatientGPT, a chatbot engineered by clinical AI company K Health, to its patients in Connecticut. Two health systems — California-based Sutter Health and Reid Health, serving Indiana and Ohio — have announced pilot versions of Emmie, the chatbot built by medical record mammoth Epic. The list is likely to grow rapidly.

Continue to STAT+ to read the full story…

Health Issues Linked to Obesity Differ Between Men and Women

A study of middle-aged adults carried out by researchers at Dokuz Eylul University in Turkey shows that health and metabolic profiles differ between men and women with obesity.

The results, which will be presented at the European Congress on Obesity in Istanbul in May, show men with obesity are more likely to develop abdominal fat and have high levels of liver enzymes and triglycerides in the blood than women.

In contrast, women with obesity had higher levels of total and low-density lipoprotein cholesterol and increased inflammatory markers such as C-reactive protein compared with men.

“Our findings reveal intriguing differences in the way men and women respond to obesity,” said presenting author Zeynep Pekel, from Dokuz Eylul University, Izmir, Turkey, in a press statement.

“They show just how important gender-specific research is. Not only are sex differences a powerful player in the pathology and course of obesity, but our results indicate that such differences could be a stepping stone toward finding targeted, sex-based therapies to help in the management of people living with obesity.”

Although it is known that men and women with obesity have different adipose tissue distribution and have differences in metabolism more generally, this knowledge is not widely applied in obesity care.

In this study, Pekel and colleagues carried out an analysis of 1134 adults living with obesity attending a tertiary obesity clinic, including 886 women and 248 men. They measured standard factors like age, body mass index (BMI), waist and hip circumference and blood pressure as well as blood-based biomarkers like lipids, liver enzymes and inflammatory markers such as C-reactive protein, erythrocyte sedimentation rate, and white blood cell count.

The results showed that women were slightly older at 45 years on average. Men had significantly greater waist circumference and systolic blood pressure than women, as well as higher levels of the liver enzymes alanine aminotransferase and gamma‑glutamyl transferase and the kidney health biomarker creatinine. Men also had higher levels of triglycerides than women in the study.

Women with obesity had significantly higher total and low-density lipoprotein cholesterol than men in the study. They also had greater erythrocyte sedimentation rate, C-reactive protein, and platelet count, than the men.

“It’s still early days and these findings need to be confirmed in other patient groups, but they offer important insight into how obesity may affect men and women differently,” said Pekel.

“These differences are likely influenced by biological factors such as hormones, immune responses, and fat distribution. Our next steps are to validate these findings in larger populations, better understand the biological processes behind these differences, and explore how these patterns relate to clinical risk.”

The post Health Issues Linked to Obesity Differ Between Men and Women appeared first on Inside Precision Medicine.

StockWatch: IPO Market Shows Sign of Life with Avalyn Filing

The initial public offering (IPO) market showed signs of life for the first time in more than a month as Boston-based Avalyn Pharma filed a registration statement on Wednesday seeking to raise capital to develop its pipeline of respiratory disease treatments.

It’s too early to know how much money Avalyn plans to raise—the registration statement includes a placeholder “$100 million” figure that will inevitably be revised, and doesn’t say how many shares will be sold. It’s also too soon to know how much of the proceeds will go toward each of the three pipeline candidates cited in the filing to the U.S. Securities and Exchange Commission:

  • AP01—An inhaled version of pirfenidone, a small molecule modulator of cytokines and growth factors whose development the IPO would advance through Phase IIb topline data and into Phase III. AP01 is under study in the Phase IIb MIST trial (NCT06329401) as a potential treatment for progressive pulmonary fibrosis.
  • AP02—An inhaled version of nintedanib, a small molecule inhibitor of multiple tyrosine kinases, being developed to treat idiopathic pulmonary fibrosis (IPF). Avalyn plans to advance AP02 into the Phase II AURA-IPF trial (NCT07194382) after completing single-ascending dose (SAD) and multiple-ascending dose (MAD) Phase I trials in healthy adult volunteers and IPF patients.
  • AP03—A preclinical inhaled fixed-dose combination of AP01 and AP02 designed to combine what Avalyn says is their ability to substantially reduce or eliminate the adverse effects of oral pirfenidone and oral nintedanib.

Pirfenidone is an IPF drug marketed as Esbriet® by Genentech, a member of the Roche Group, with several other companies selling generic versions. Nintedanib is a kinase inhibitor with indications in treating IPF and chronic fibrosing interstitial lung diseases (ILDs) and slowing the rate of decline in pulmonary function in adults, marketed as Ofev® by Boehringer Ingelheim, with generic versions approved this month.

“The change we aim to make in the treatment paradigm of pulmonary fibrosis and other ILDs parallels the decades-long evolution seen in the treatment of asthma and COPD,” Avalyn stated in its S-1 statement.

In those diseases, the company explained, treatments advanced from broad, systemic oral therapies to targeted inhaled treatments, and ultimately to combination inhalers.

Pulmonary fibrosis “opportunity”

“We see a similar opportunity in pulmonary fibrosis, where the field still relies on oral antifibrotics today. Our programs are designed to drive a similar evolution, first by shifting treatment toward inhaled, lung-targeted formulations of existing antifibrotics that aim to improve safety and efficacy,” Avalyn explained. “We aspire to deliver inhaled therapies that combine complementary mechanisms into a single device for even greater therapeutic impact.”

In discussing the use of its proceeds, Avalyn said it envisioned advancing AP01 and AP02 through Phase IIb and Phase II topline data, respectively, into Phase III trials. AP03 would be advanced into the clinic and Phase I topline data using capital from the IPO.

Whatever isn’t spent on the pipeline candidates will be set aside for R&D activities for additional programs, working capital, and general corporate purposes, Avalyn added.

Avalyn is the first biotech IPO filing since Generate: Biomedicines completed the year’s largest to date, raising $400 million in gross proceeds toward clinical trials, as well as platform and pipeline R&D efforts. To date, seven companies have completed biotech IPOs, raising just over $1.7 billion in combined proceeds, Jefferies analyst Andrew Tsai wrote in a research note.

“The IPO market has been more of a laggard but showed signs of strength this quarter, with Q1 offerings the largest in the past four years,” Tsai wrote. As a result, he added, the IPO market is on pace to exceed historical levels except for the 2020–2021 IPO boom due to the COVID-19 pandemic.

Mixed on IPO improvement

Heading into 2026, analysts were mixed on whether this year would see improvement in the IPO market compared to 2025, when 11 U.S. companies raised a total of $3 billion on Wall Street. “We think it will be slightly better, but we have not seen enough to suggest that it’s truly rebounding,” Subin Baral, EY global life sciences deals leader, told GEN.

However, Michael Allwin, head of biopharma investment banking, Truist Securities, told GEN that IPOs are typically “the last shoe to drop” after other non-IPO financings show signs of recovery, giving him hope and optimism that 2026 would see a much more active IPO market than 2025: “While we’re not anticipating a resurgence in activity to the tune of what we saw at all-time highs in 2020 and 2021, we are anticipating a more normalized level of activity, maybe on parity with 2019.”

As for Avalyn, should its planned IPO raise the placeholder $100 million amount, it would nearly double the $138.359 million in cash, cash equivalents, and marketable securities with which Avalyn finished 2025.

Avalyn ended last year with no revenue and a net loss of $85.204 million, a 71% increase over the $49.744 million net loss the company reported for 2024. As a result, Avalyn’s accumulated deficit rose from $180.2 million at the end of 2024 to $265.4 million on December 31, 2025.

The IPO comes nine months after Avalyn completed its last financing, an oversubscribed $100 million Series D round completed in July and led by investment firms Suvretta Capital Management and SR One.

Survetta and SR One are two of 18 firms that have invested in Avalyn. The 18 include Novo Holdings, the asset manager of the foundation that controls Novo Nordisk.

Novavax rises on shareholders’ opposition

Novavax (NASDAQ: NVAX) enjoyed a small but noticeable surge in its stock price this past week after its second-largest shareholder ramped up its opposition to the vaccine developer’s leadership on several fronts.

Shah Capital Opportunity Fund, which holds an approximately 9% stake in Novavax, said it will oppose the company’s nominees for re-election to the board of directors when Novavax holds its annual shareholder meeting, scheduled for June (no date had been announced at deadline).

In an open letter to Novavax’s board, Raleigh, NC-based Shah Capital also requested that Novavax:

  • Shrink the board from eight to five members and elect new members “with emphasis on pragmatic entrepreneurial experience to turn Novavax into an equity success story.”
  • Buy back 10 to 20 million shares.
  • Retire its outstanding $225 million convertible bond with cash on hand “at the earliest.” Novavax reported $244.213 million in convertible notes payable and $240.634 million in cash and cash equivalents as of December 31, 2025.
  • Persuade a strategic long-term investor to take a 10–20% ownership stake “to reshape Novavax entirely.”

Shah Capital cited a 27% drop in Novavax’s share price from $11 on January 1, 2023, when John C. Jacobs took over as president and CEO, to $8 on March 31, 2026. The fund also expressed frustration that the COVID-19/influenza combination vaccine Novavax is developing with Sanofi (Euronext Paris: SAN)—a potential $5+ billion category, according to Shah Capital—hasn’t yet begun Phase III trials. Sanofi shared positive Phase I/II data in December and told Novavax it is working with regulators on next steps.

“Management has failed to implement aggressive cost-cutting measures necessary to achieve consistent profitability,” Himanshu H. Shah, the fund’s managing partner and chief investment officer, advocated in an open letter to Novavax’s board. “The current senior management team should be reduced by 30% to reflect Novavax’s new royalty and partnership business model.”

“The board size should also be reduced to five from eight, including electing new members with emphasis on pragmatic entrepreneurial experience to turn Novavax into an equity success story,” Shah added.

At odds for months

Shah has been at odds with Jacobs and Novavax leadership for months, having called for a sale of the company last October. Shah has held off pursuing a proxy campaign since the board’s majority has favored current management.

Novavax is based in Gaithersburg, MD, and reported approximately 749 employees as of December 31, 2025, down 21% from 952 a year earlier, according to Form 10-K annual reports.

Novavax investors responded to the Shah Capital letter with a buying spurt that sent shares climbing 5.5% Wednesday, from $7.98 to $8.42 after rising to $8.60 during intraday trading. The momentum continued somewhat on Thursday as shares rose another 1.4%, to $8.54, though Novavax slumped 5% Friday to finish the week at $8.12.

Shah Capital’s letter also sparked a statement to GEN and other news outlets from Novavax, which asserted that its board and management team “are committed to progressing our growth strategy, which is designed to leverage partnerships and R&D innovation to maximize the value of our technology.”

The statement cited recent Novavax efforts that include its up-to-$530 million (plus royalties) partnership with Pfizer (NYSE: PFE), which entered into a non-exclusive license agreement with Pfizer for use of Novavax’s Matrix-M® adjuvant; additional and expanded material transfer agreements with pharmaceuticals; and what the company called “continued progress” on its partnership with Sanofi, from which Novavax generated $225 million in milestone payments last year.

“In addition, we continue to make targeted investments in R&D with the intention of driving further value from our technology, while continuing to significantly reduce costs in our lean and efficient operating model,” Novavax continued. “We maintain constructive dialogue with our shareholders, and we welcome collaborative input that is in the best interest of Novavax and all of its shareholders.”

Shah essentially controls 14,845,097 shares of Novavax stock, including 125,359 shares he owns personally, and 14,719,738 shares owned by Shah Capital and its investment adviser.

Leaders and laggards

  • Invivyd (NASDAQ: IVVD) shares jumped 32% from $1.35 to $1.78 Thursday after the company announced positive progress in its REVOLUTION clinical program for VYD2311, a monoclonal antibody candidate designed to prevent symptomatic COVID-19. As of April 6, when the first 1,500 of 1,818 subjects reached Day 45, clinical events supported statistical powering for the high end of anticipated VYD2311 efficacy levels in the Phase III DECLARATION trial (NCT07298434), with about half of the base study still to be carried out, Invivyd said. DECLARATION will enroll ~500 additional subjects, which, according to the company, will likely, depending on recruitment rates, push back the timing for data release by approximately two months, from mid-year to Q3 2026. Invivyd also announced the discovery and advancement of a “highly potent,” half-life-extended, high-resistance-barrier measles monoclonal antibody candidate, VMS063.
  • Replimune Group (NASDAQ: REPL) shares tumbled 19.5% from $5.91 to $4.76 Friday after the developer of oncolytic immunotherapies disclosed that the FDA for a second time had rejected the company’s biologics license application (BLA) for its lead product candidate RP1 (vusolimogene oderparepvec) in combination with nivolumab to treat advanced melanoma, instead issuing a complete response letter (CRL). Replimune criticized the FDA for an inconsistent review process, saying the agency contradicted earlier guidance to the company and assessed the resubmitted BLA through a different review team that replaced the team that previously interacted with the company. Replimune also defended the combination therapy’s data in the Phase II IGNYTE trial (NCT03767348)—a 34% response rate with a median duration of 24.8 months and a favorable safety profile, the basis of the combo’s breakthrough therapy designation. “We have no choice but to eliminate jobs, including substantially scaling back our U.S.-based manufacturing operations,” stated Replimune CEO Sushil Patel, PhD. Nivolumab is the cancer immunotherapy marketed as Opdivo® by Bristol Myers Squibb (NYSE: BMY).

The post StockWatch: IPO Market Shows Sign of Life with Avalyn Filing appeared first on GEN – Genetic Engineering and Biotechnology News.

Opinion: What STAT readers think about nutrition education in med school

First Opinion is STAT’s platform for interesting, illuminating, and provocative articles about the life sciences writ large, written by biotech insiders, health care workers, researchers, and others.

To encourage robust, good-faith discussion about issues raised in First Opinion essays, STAT publishes selected Letters to the Editor received in response to them. You can submit a Letter to the Editor here, or find the submission form at the end of any First Opinion essay.

Read the rest…

Opinion: Sports betting is creating a twofold public health crisis for some young men

Below is a lightly edited, AI-generated transcript of the “First Opinion Podcast” interview with Isaac Rose-Berman. Be sure to sign up for the weekly “First Opinion Podcast” on Apple PodcastsSpotify, or wherever you get your podcasts. Get alerts about each new episode by signing up for the “First Opinion Podcast” newsletter. And don’t forget to sign up for the First Opinion newsletter, delivered every Sunday.

Torie Bosch: Even if, like me, you don’t follow sports, it’s been impossible to miss the explosion in sports betting in recent years. With that rise is coming a new challenge for public health.

Read the rest…

Cryo-EM Structural Biology Facility Opened in San Diego by FairJourney Bio

FairJourney Bio (FJBio), a CRO, opened its advanced cryo-electron microscopy (cryo-EM) structural biology facility in San Diego. The new site significantly expands the company’s presence in the U.S. market and incorporates atomic-resolution structural biology directly into its antibody discovery platform, according to Christopher Arthur, PhD, CSO, structural biology, FairJourney Bio.

The facility houses a 300 kV cryo-EM infrastructure, including two ThermoFisher Titan Krios 5 systems, which enables native-state structure determination of antibody-target complexes. The technology is designed to provide detailed insights across the R&D value chain—from epitope mapping and hit generation to structure-guided lead optimization and candidate selection.

FairJourney Bio’s San Diego facility opening event. [FairJourney Bio]
FairJourney Bio’s San Diego facility opening event. [FairJourney Bio]

The cryo-EM services, launched in January 2026, complement FJBio’s antibody discovery and biologic development portfolio. The services enable scientists to visualize protein structures at atomic resolution, including protein-protein and protein-ligand complexes, providing high-quality and interpretable results to inform confident decision-making across programs.

The facility is strategically positioned within a leading global biotech hub, complementing FJBio’s existing U.S. presence in San Francisco and its operations across Europe.

“Structural biology has historically been a late-stage tool, used to confirm decisions already made,” notes Arthur. “We are redefining that paradigm. In San Diego, we are building a premier, full-service cryo-EM CRO that brings together decades of deep expertise in sample preparation, data collection, and computational analysis, embedding structural insight at the very start of discovery, where it shapes epitope selection and determines which leads are worth advancing.”

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Evaluating an Incentive-Based mHealth App for Physical Activity Promotion Using the Obesity-Related Behavioral Intervention Trial Model: Small Cohort Study

Background: Physical inactivity remains a public health concern, with 42% (around 1 in 2) of women and 34% (around 1 in 3) of men in the United Kingdom, for example, failing to meet moderate-to-vigorous physical activity guidelines. To promote physical activity (PA) at scale, smartphone-based mHealth (mobile health) software apps offer a promising solution. Objective: This study aims to evaluate the feasibility of implementing an mHealth app offering very small (“micro”) financial incentives for PA in Leeds, United Kingdom. Methods: A 5-week single-arm proof-of-concept study was conducted with rolling recruitment among Caterpillar Health app users between September 12 and December 12, 2022 (Obesity-Related Behavioral Intervention Trial model, phase IIa). Users earned microincentives in the form of “points,” redeemable for consumer rewards (eg, movie tickets and gym passes), for meeting personalized daily step goals (US $0.13 per goal achieved; set using data from a 5-day baseline) and completing educational quizzes (US $0.33 per quiz). Descriptive statistics assessed feasibility outcomes (ie, reach, recruitment, retention, engagement, and acceptability) and preliminary effectiveness. Paired-samples tests (<.05) examined changes in weekly mean daily step count (from baseline) and step goal achievement over 5 weeks. Results: Of 285 app downloads, 46 users consented to participate (recruitment rate: 16.1%). Participants (mean age: 39.9, SD 11.1 y; 71.1%, 33/46 woman) had a baseline step count of 5598 (SD 2664) steps/day. A total of 25 participants remained engaged (ie, completed at least 1 quiz) at study week 5 (retention rate: 54.3%). Acceptability was high, with 75% of respondents (12/16) indicating they would recommend the app. Weekly mean daily step count did not significantly increase from baseline (mean difference 317, SD 2273, =.53). Weekly daily step goal achievement rate (%) decreased from study week 1 to 5 (−23.23, SD 22.85, =.02). Conclusions: Despite lower-than-expected recruitment and no statistically significant PA increase, relatively high engagement and acceptability suggest future pilot testing (Obesity-Related Behavioral Intervention Trial model, phase IIb) of a refined intervention (eg, wider selection of loyalty reward partners) and modified study protocol (eg, simplified consent process) is warranted. Trial Registration: ClinicalTrials.gov NCT05294692; https://clinicaltrials.gov/study/NCT05294692

Epigenetics at Birth Links Microbiome to Neurodevelopment, Potentially ASD and ADHD

The results of a study headed by researchers at Li Ka Shing Institute of Health Sciences, The Chinese University of Hong Kong, indicate that the gut microbiome and epigenetics are intertwined, and that both contribute to neurodevelopment.

The researchers showed that epigenetic changes present at birth can impact how an infant’s gut microbiome develops during their first year. They also identified specific epigenetic changes and gut microbes that were associated with signs of autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD) when the children were three years old.

“Certain bacteria seem to offer protection, which is exciting because it suggests there could be ways to support a child’s development through diet or probiotics in the future,” said research lead and gastroenterologist Francis Ka Leung Chan, MD. Chan is co-senior author of the team’s published paper in Cell Press Blue, titled “Epigenome-microbiome interplay in early life associates with infants’ neurodevelopmental outcomes,” in which they stated, “We showed that epigenetic alterations at birth were associated with early-life microbiome development and that they determine the risks of neurodevelopmental consequences in children.”

The first years of life are critical for brain development and immune system maturation. Though previous studies have shown that both early epigenetic changes and gut microbiome development can impact health in later life, little is known about how these two systems interact. “Recent data suggest that epigenetic programming of gene expression profiles is sensitive to the early-life environment and can impact health outcomes in children,” the authors wrote. “One environmental cue known to trigger host epigenetic modifications is the genes of bacteria, fungi, and viruses inside the human body, collectively known as the microbiome.”

Co-senior author and public health researcher Hein Min Tun, PhD, of The Chinese University of Hong Kong, commented, “We wanted to see how the epigenome and microbiome interact in early life and if their interaction could influence a child’s risk of developing neurodevelopmental conditions like ASD and ADHD.” The authors added, “New understanding of host-microbe-epigenome interactions and mechanisms of epigenetic changes in early life can be leveraged for the prevention, early detection, and novel interventions of common childhood diseases.”

For their study the researchers characterized DNA methylation patterns from the umbilical cord blood of 571 infants. They paired this information with gut microbiome data collected from 969 infants at two, six, and 12 months of age, and from their parents during the third trimester of pregnancy. When the children reached 36 months of age, the researchers used a behavioral questionnaire to assess their neurodevelopment and investigate links between the microbiome, epigenome, and early signs of ASD and ADHD.

“This, to our knowledge, represents the first longitudinal study with multiple sample types to depict the intimate interplay between perinatal exposures, epigenetic hallmarks, and gut microbiome development and neurodevelopmental outcomes within the first three years of life,” the authors stated.

They found that an infant’s epigenome at birth was associated with birth mode, length of gestation, having older siblings, and maternal allergies, but it was not affected by their parents’ gut microbiomes. Microbiome development, on the other hand, was associated with birth mode, antibiotics, having older siblings, and breastfeeding. Infants who were born by Caesarean section (CS) showed different patterns of DNA methylation for several genes involved in immune responses and brain development. “Some of the changes in methylations of immune- and nervous-system-related genes, associated with CS delivery, are linked to neurodevelopmental outcomes,” they noted.

Their reported findings, the team suggested, “… resonate with studies linking CS to increased risks of immune-mediated and neurodevelopmental disorders, providing mechanistic plausibility through epigenomic and microbial dysbiosis.” The team also showed that an infant’s epigenome at birth impacted how their microbiome developed during their first year. Specifically, infants developed less diverse gut microbiomes at 12 months of age when they showed higher rates of DNA methylation in immune genes involved in recognizing pathogens. “We found that methylation rates in the major histocompatibility complex (MHC) region of infants at birth were linked to differences in the diversity of the infant gut microbiome at 12 months,” they commented.

The behavioral survey revealed that signs of ASD and ADHD in three-year-olds were associated with specific epigenetic patterns and the presence of certain gut microbes. “Importantly, we reported that epigenetic modifications were associated with an increased susceptibility to neurodevelopmental conditions in children, and these effects were in part mediated by microbial colonization.”

However, other microbial species seemed to mitigate these effects: infants with epigenetic patterns associated with ASD or ADHD were less likely to show signs of the disorders if they acquired Lachnospira pectinoschiza and Parabacteroides distasonis, respectively, during their first year. “We discovered a kind of conversation happening: a baby’s epigenetic setting at birth can influence their risk for neurodevelopmental disorders, but the presence of certain ‘good’ bacteria in their gut can step in and modify the risk,” Tun reported. “The foundations for brain health are laid very early, even before birth. However, we don’t want people to think this means a child’s developmental path is fixed at birth. These are complex conditions with many causes, and we’ve only uncovered a small piece of a very large puzzle.”

The researchers are continuing to follow the children who participated in the study to see how these early-life factors relate to their health as they grow. They note that laboratory experiments are needed to confirm the associations between gut microbes and neurodevelopment. In their discussion, the team wrote, “In conclusion, our findings revealed dual alterations to the neonatal epigenome and gut microbiome by perinatal factors and highlight the role of the ‘holo-epigenome’—the integrated host epigenome and microbiome—as a key mediator of neuro-immune outcomes. Interventions targeting microbial restoration or epigenetic modulation during critical developmental windows may mitigate risks of neurodevelopmental disorders.”

First author and gastroenterologist Siew Chien Ng, MD, PhD, added, “The ultimate goal is to develop safe, non-intrusive early interventions such as specific probiotics or live biotherapeutics, that could help nurture a healthy gut microbiome and potentially reduce the risk of neurodevelopmental challenges.”

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