The dorsomedial hypothalamic nucleus and perifornical area (DMH/PeF), historically identified as the hypothalamic defence area, plays a key role in orchestrating autonomic and respiratory adjustments during threat-related states. To investigate how activation of this region affects upper-airway and respiratory motor circuits, we examined its anatomical and functional interactions with laryngeal-related medullary nuclei using combined immunohistochemical mapping and physiological recordings in spontaneously breathing anaesthetised rats. Neuronal activation was assessed using c-Fos immunohistochemistry (c-Fos-ir) combined with ChAT and FoxP2 labelling to identify motoneurons and non-motoneuronal populations across the compact, semicompact and loose formations of the nucleus ambiguus (nA), as well as within the nucleus retroambiguus (nRA), during DMH/PeF electrical stimulation. Hypothalamic activation produced a clear subdivision-specific recruitment in the nA, with significant ipsilateral increases in c-Fos-ir within the semicompact (motoneurons, p < 0.001; non-motoneurons, p < 0.05) and compact formations (non-motoneurons, p < 0.05). The nRA also exhibited robust ipsilateral activation (non-motoneurons, p < 0.001). FoxP2-positive neurons remained stable across groups, indicating that FoxP2 reflects neuronal phenotype rather than acute activation. A second set of experiments evaluated the functional impact of electrical and chemical (glutamate) DMH/PeF activation on subglottic pressure, an index of laryngeal resistance. Both stimulation modalities produced a marked reduction in subglottic pressure (p < 0.001 and p < 0.01), accompanied by a reproducible autonomic–respiratory pattern characterised by tachypnoea, tachycardia and a pressor response. Overall, our results provide new insight into how hypothalamic circuits regulate subglottic pressure and laryngeal activity, suggesting that DMH/PeF activation is associated with the recruitment of specific nA and nRA domains, which may contribute to the adjustment of upper-airway patency during defensive responses.
The association between worry, rumination, and metacognitive beliefs in female adolescents with Anorexia Nervosa
BackgroundA growing body of literature has emphasized the role of worry and rumination in eating disorders (EDs). According to the metacognitive model, worry and rumination are maintained by dysfunctional metacognitive beliefs. Although metacognitive beliefs have been investigated in adults with EDs, their role in adolescents with EDs remains underexplored. The present exploratory study aimed to examine the specific association among worry, rumination, and metacognitive beliefs and eating disorder symptomatology in adolescents with AN.MethodsThirty Italian female adolescents (mean age ± SD: 15.387 ± 1.35 years, mean Body Mass Index (BMI): 16.34 ± 2.5 kg/m2) completed a self-report survey composed of the Penn State Worry Questionnaire (PSWQ), the Ruminative Response Scale (RRS), the Metacognitions Questionnaire – 30 (MCQ-30), and the Eating Disorder Inventory – 3 (EDI-3).ResultsThus, Model 1, including RRS and PSWQ, was significant (F = 17.5, p<0.001) and explained 57% of the variance (R² = 0.574). Within this model, RRS was the only significant predictor (p = 0.019) of the Eating Disorder Risk Composite (EDRC) of EDI-3, indicating that higher rumination scores were associated with greater eating disorder symptomatology. Once MCQ was entered as a predictor of EDRC, there was no significant incremental variance compared with Model 2 (ΔR² = 0.0034, p = 0.658), even though the model remained significant overall (F = 11.4, p < 0.001). The final model explained 58% of variance (R² = 0.578; Cohen’s f2 = 1.37).ConclusionRumination was significantly associated with eating disorder symptomatology. Although worry showed strong positive associations with eating disorder symptomatology at the correlational level, it did not maintain an independent role once rumination was included in the regression model. The final model showed a very large effect size (Cohen’s f² = 1.37), suggesting strong associations between predictors and eating disorder symptoms in the present sample. However, this estimate should be interpreted cautiously, given the limited sample size and the exploratory nature of the analysis. Contrary to our expectations, metacognitive beliefs did not significantly explain the variance of eating disorder symptomatology. This finding may reflect the more proximal role of RNT in explaining the variance in eating disorder symptomatology, or alternatively, the possibility that only specific metacognitive domains—rather than overall metacognitive functioning—are relevant in this population.
Clinical Decision Support for Digital Dietary Counseling Under GLP-1 Receptor Agonist Therapy: Convergent Mixed Methods Usability and Treatment Satisfaction Pilot Study of the Personalized Nutrition Advisor
Background: Dietary counseling is an essential complement to the growing use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) to achieve sustainable weight loss. Diverse patient needs, the demand for ongoing support, and limited resources underscore the potential of using digital support tools. Objective: This study aimed to evaluate the usability, treatment satisfaction, and weight effects of a personalized nutrition advisor (PNA), a prototype decision-support tool designed to facilitate personalized weight management counseling. Methods: We assessed usability, treatment satisfaction, and weight effects of a web-based PNA prototype dashboard designed to help dietitians deliver personalized remote dietary counseling in overweight adults (BMI ≥28 kg/m² at pharmacotherapy initiation) who had achieved ≥5% weight loss with GLP-1 RA therapy over 12-weeks. The PNA dashboard generated tailored nutritional recommendations to help participants achieve personalized weight loss goals based on an energy balance model that estimated daily caloric intake and nutritional quality using frequent body weight measurements, dietary logs, and physical activity data from a lifestyle-tracking app. To evaluate the PNA’s usability, we used a convergent parallel mixed-methods approach, combining a validated quantitative usability survey and qualitative focus-group interviews and feedback questionnaires with both dietitians and patients, alongside patient-reported satisfaction metrics for PNA-guided consultations (treatment satisfaction, general self-efficacy, and perceived health impact). Thematic analysis with a hybrid deductive-inductive methodology was applied to qualitative data, using 4 a priori themes derived from this study’s conceptual framework regarding prior expectations, perceived utility and satisfaction, usability challenges, and suggestions for clinical integration. Percent weight loss during the intervention was assessed as an exploratory outcome. Results: Among 78 participants (58/78, 74% women), on GLP-1 RA (mean weight loss of −13.3%, SD 6.7%, after 10, SD 5, months of treatment), between 3 and 5 remote nutrition consultations were delivered with PNA support. After the 3-month intervention period, weight loss was sustained in all participants (−0.2%, SD 2.5%), with 21% (16/78) suspending the GLP-1 RA due to drug shortages. Dietitians rated the PNA’s usability as moderate (62%) on the Healthcare Systems Usability Scale. Patients evaluated the perceived health impact of the PNA-assisted consultations at 19.1 (SD 3.5) of 25 on the user version of the Mobile Application Rating Scale. No significant differences were observed in patient-reported treatment satisfaction (=.78) or self-efficacy (=.57) before and after PNA-assisted care. Qualitative analysis identified convergence with quantitative findings across themes of usability, treatment satisfaction, and clinical integration, with divergence observed for self-efficacy and tracking motivation. Both patients and dietitians found the PNA valuable for generating actionable nutritional insights. Conclusions: While effective implementation of tools such as the PNA prototype demands dietitian training and workflow integration, they offer scalable, personalized nutrition or lifestyle guidance—as a therapeutic decision-support tool within weight loss interventions, with or without adjunct GLP-1 RA pharmacotherapy. Trial Registration: ClinicalTrials.gov NCT05997771; https://clinicaltrials.gov/study/NCT05997771
<img src="https://jmir-production.s3.us-east-2.amazonaws.com/thumbs/673e7709f46aa65c02e80d8ca5751306" />
STAT+: Novo Nordisk sues Eli Lilly over GLP-1 drug ads it calls ‘deceptive’
Novo Nordisk on Tuesday sued Eli Lilly for allegedly running a “deceptive” ad campaign that uses “outdated clinical trials” to make its obesity and diabetes drugs appear more effective, marking a new phase in one of the pharmaceutical industry’s most intense rivalries.
In a lawsuit filed in federal court in New Jersey, Novo argued that Lilly has been comparing the highest doses of its weight loss drug Zepbound and diabetes drug Mounjaro with lower doses of Novo’s Wegovy and Ozempic.
“What has brought us to this moment is what we now see as a nationwide pattern, by Lilly, of deceptive advertising. They are intentionally confusing consumers,” John Kuckelman, Novo’s general counsel and senior vice president, said in an interview.
STAT+: Pharmalittle: We’re reading about a telehealth firm and patient safety, PBMs overcharging, 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. …
Novo Nordisk, maker of Ozempic and Wegovy, lists the telehealth company LifeMD on its website as a provider that offers “legitimate medicine sourcing and patient support” for people seeking GLP-1 drugs. But some former employees describe LifeMD differently, as a company that has sought to maximize the volume of prescriptions it doles out at the expense of patient safety, STAT reports. Former workers told STAT that providers were pressed to expedite their work to a pace that was not clinically responsible, with two of them saying providers at times were expected to review the cases of 25 people per hour based only on electronic forms the patients filled out — the equivalent of spending about two minutes on each case.
A recent audit of Iowa Medicaid records revealed how pharmacy benefit managers are using complicated and sophisticated approaches for handling prescription drug claims that ultimately overcharge taxpayers, a finding that underscores controversy surrounding these crucial middlemen in the pharmaceutical supply chain, STAT explains. The audit found that one large pharmacy benefit manager appeared to have made more than $100 million by adjusting the amount of money paid to pharmacies without passing some of the savings back to managed care plans working on behalf of the state, according to Iowa officials. The review scrutinized records from 2019 through 2021.
HHS vaccine committee quietly gets new charter
Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here.
Good morning. Yesterday’s game wasn’t the most exciting, but luckily the third place game on Saturday had all the drama I’d hoped for. Before replaying the highlights, catch up on a bunch of news below.
STAT+: Telemedicine company touted by Novo Nordisk stressed profits over patient safety, ex-workers say
Novo Nordisk, maker of Ozempic and Wegovy, lists the telehealth company LifeMD on its website as a provider that offers “legitimate medicine sourcing and patient support” for people seeking GLP-1 drugs. But some former employees describe LifeMD differently, as a company that has sought to maximize the volume of prescriptions it doles out at the expense of patient safety.
Former workers told STAT that providers were pressed to expedite their work to a pace that was not clinically responsible, with two of them saying providers at times were expected to review the cases of 25 people per hour based only on electronic forms the patients filled out — the equivalent of spending about two minutes on each case.
The company also discouraged providers from asking what they felt were medically relevant questions to patients, so that they don’t “delay care,” former employees said.
E-diary vs Paper Diary in Binge Eating Disorder
Conditions: Binge Eating Disorder
Interventions: Other: The subject will complete e-diary for 2 weeks; Other: complete paper diary for 2 weeks
Sponsors: Lindner Center of HOPE; SignanthHealth; The Lindner Center of HOPE
Recruiting
Interventions: Other: The subject will complete e-diary for 2 weeks; Other: complete paper diary for 2 weeks
Sponsors: Lindner Center of HOPE; SignanthHealth; The Lindner Center of HOPE
Recruiting
StockWatch: Lilly’s Up-to-$3.8B Deal for AtaiBeckley a Good Trip for Psychedelic Drugs, Analysts and Investors Agree
It wasn’t too long ago that biopharma giants stayed away from developing psychedelic drugs—but positive clinical data plus a friendlier regulatory climate in Washington have prompted the largest drug developers to embrace the field.
The latest and most telling example of pharma embracing psych drugs came when Eli Lilly (NYSE: LLY) announced that it agreed to acquire AtaiBeckley (Nasdaq: ATAI) for up to $3.8 billion—of which Lilly will pay $2.8 billion upfront. The deal, set to close in the third quarter, expands Lilly’s neuroscience portfolio by adding the pipeline of AtaiBeckley led by BPL-003 (mebufotenin benzoate), a Phase III candidate for treatment-resistant depression (TRD) that is a synthetic form of 5-MeO-DMT administered intranasally. BPL-003 has been granted the FDA’s Breakthrough Therapy designation.
BPL-003 wowed analysts and others back in April after AtaiBeckley published positive data from a Phase IIa trial (NCT05660642) showing that a single intranasal dose of BPL-003 led to rapid and sustained reductions in Montgomery-Åsberg Depression Rating Scale (MADRS) scores from baseline in 12 TRD patients who remained on stable SSRI therapy throughout the study. Both the six patients dosed at 10 mg and six at 12 mg showed a 66.7% antidepressant response rate (defined as ≥50% reduction from baseline MADRS score) at Day 2, with five of six participants in the 10 mg cohort (83%) and four of six in the 12 mg cohort (66.7%) maintaining their response at Week 12.
“Especially with progress on BPL-003, we see the company as positioning itself well to becoming a significant player in the mental health therapeutics space,” Sumant Kulkarni, a senior analyst covering biotechnology with Canaccord Genuity, wrote on news of the positive data, adding: “We also still see this space as large enough to accommodate multiple approaches/competitors.”
$3.7B in projected peak sales
Kulkarni also raised Canaccord Genuity’s peak unadjusted U.S. sales forecast for BPL-003 to $3.7 billion by 2036 from $2 billion, after revising the firm’s model by raising the list price from $20,000 to $30,000 per annual treatment course (not accounting for insurance coverage), about the same price as Spravato® (esketamine), also a nasal spray marketed by Johnson & Johnson (NYSE: JNJ) for TRD plus some depressive symptoms in adults with major depressive disorder (MDD).
Spravato, a noncompetitive N-methyl D-aspartate (NMDA) receptor antagonist, crossed the $1 billion sales threshold during the second quarter, as it generated $584 million, up 25% quarter-over-quarter from $464 million in Q1—and up 43% from $734 million in the first half of 2025.
“Sales are tracking to reach annual sales guidance of $3-3.5B+ by 2027–28,” Jefferies equity analyst Andrew Tsai wrote in a research note focused on J&J’s second-quarter results. “Spravato’s trajectory supports the notion psychedelics can be commercially viable in hard-to-treat mental health disorders, by leveraging JNJ’s infrastructure.”
Given the data for BPL-003, Lilly got a bargain, Tsai wrote in a separate note on the Lilly-AtaiBeckley acquisition.
“We think the deal heavily favors LLY, as ATAI’s lead asset BPL-003 (intranasal 5-MeO-DMT) should have multibillion dollar peak sales potential,” Tsai wrote, rather than the $1 billion-plus that he thinks was implied by the deal price.
Tsai and Jefferies had previously forecast peak sales of between $1 billion and $2 billion—a range he said was “arguably conservative” since BPL-003 could, if it aces its Phase III trial, show superiority to Spravato, which is on track to reach up to $5 billion-plus in peak sales.
Positive implications
“At the same time, we appreciate LLY has significantly more resources to maximize the long-term value of ATAI’s psychedelic assets. In any case, the deal has (+) [positive] implications for the entire psychedelic space,” Tsai added.
Among pharma giants joining J&J in embracing psychedelic drug development in recent years:
- AbbVie (NYSE: ABBV), which last year acquired the lead pipeline program of privately held Gilgamesh Pharmaceuticals, the moderate-to-severe MDD candidate bretisilocin (GM-2505), for up to $1.2 billion.
- Otsuka Holdings (Tokyo Stock Exchange: 4578), which in 2023 acquired Mindset Pharma, a Canadian psych drug developer focused on psychiatric and neurological disorders, for C$80 million ($56 million).
With its deal for AtaiBeckley, Lilly becomes the latest pharma giant to perceive the positive implications Tsai cited.
“Treatment-resistant depression persists even after multiple treatments have failed. Millions of people are still searching for relief and desperately need a therapy that works,” Carole Ho, executive vice president and president, Lilly Neuroscience, said in a statement. “Advancing AtaiBeckley’s investigational therapies gives us a real chance to change that.”
Investors agreed with Lilly, giving the pharma a 1% increase Thursday, the day the acquisition was announced, from $1,156.63 to $1,169.17—no small feat since buyers typically stay flat or see their shares slide after announcing an acquisition. And not surprisingly, AtaiBeckley investors were enthusiastic about the deal, as its stock leaped 33% from $5.36 to $7.15. On Friday, Lilly inched up 0.8% to $1,178.58 while AtaiBeckley rose 1% to $7.22.
The AtaiBeckley buyout is Lilly’s eighth announced acquisition of a smaller biopharma this year.
Lilly is acquiring three infectious diseases vaccine developers—Vaccine Company for up to $1.55 billion, Curevo for up to $1.5 billion, and LimmaTech Biologics for up to $780 million—as well as in vivo chimeric antigen receptor T-cell (CAR T) developer Kelonia Therapeutics for up to $7 billion); JAK inhibitor developer Ajax Therapeutics for up to $2.3 billion; next-generation dual-payload antibody-drug conjugate (ADC) developer CrossBridge Bio for up to $300 million; and nonviral DNA delivery-focused drug developer Engage Biologics for up to $202 million cash.
The deal spree reflects Lilly’s desire to capitalize on the billions of dollars it is generating from sales of its obesity and diabetes drugs based on glucagon-like peptide 1 (GLP-1) receptor agonists alone or in tandem with a glucose-dependent insulinotropic polypeptide (GIP).
“If we see great ideas that we think we can use to help people that need them, of course we’ll do deals,” Daniel M. Skovronsky, MD, PhD, Lilly’s chief scientific and product officer and president of Lilly Research Laboratories, said on CNBC.
“Positive development”
David Risinger, a senior managing director and senior research analyst covering diversified biopharmaceuticals at Leerink Partners, said his firm viewed Lilly’s buyout of AtaiBeckley “as a positive development because it enhances LLY’s pipeline of potential neuroscience blockbuster candidates.”
That pipeline is led by five Phase III programs involving four drugs, none of them a psychedelic. Two of the programs belong to brenipatide, a dual agonist of both the GIP and GLP-1 receptors. Brenipatide is being developed for both MDD and alcohol use disorder.
Also in Lilly’s late-stage neuroscience pipeline are:
- Donanemab, which binds to deposited amyloid plaque in the brain and is being studied for the treatment of cognitively unimpaired Alzheimer’s disease.
- Ixoberogene Soroparvovec (Ixo-Vec), an intravitreal gene therapy being studied as a single one-time treatment for vision loss associated with neovascular (wet) age-related macular degeneration (AMD).
- Remternetug (LY3372993), which also binds to deposited amyloid plaque in the brain and is under study as a treatment of cognitively unimpaired/mild cognitive impairment due to Alzheimer’s disease, with potential for subcutaneous delivery.
In addition, AtaiBeckley “would provide differentiated exposure in psychiatry and reinforce [Lilly’s] broader effort to diversify beyond its cornerstone cardiometabolic franchise,” observed Evan David Seigerman, a managing director and head of healthcare research at BMO Capital Markets, as reported by Reuters.
AtaiBeckley was formed last November by the merger of atai Life Sciences and Beckley Psytech. The company’s stock has nearly doubled, soaring 98% over the past six months from $3.64 on January 16.
“Going mainstream”
“Psychedelic Medicine is going mainstream,” declared Steve Jurvetson, co-founder of Future Ventures, in a post on X. Jurvetson and Future were among early investors, along with Peter Thiel in atai Life Sciences.
AtaiBeckley is one of numerous psychedelic drug developers to show significant six-month gains since January: As of Friday’s closing bell, Compass Pathways (Nasdaq: CMPS) shares jumped 68% to $12.35, GH Research ballooned 69% to $28.71, while Definium Therapeutics (Nasdaq: DFTX) nearly tripled, zooming 194% to $44.29.
Interestingly, those three companies did not get a solid bounce from AtaiBeckley’s acquisition by Lilly. Since the deal was announced Thursday, Compass fell 7% from $13.31 pre-announcement, Definium dipped 3% from $45.66. GH rose 8% Thursday from $26.92 to $29.13, before sliding 1.4% the following day.
Bucking the trend was Cybin, d/b/a Helus Pharma (Nasdaq: HELP), which has climbed 11% since the Lilly-AtaiBeckley announcement, from $6.51 to $7.25. Its shares have slumped 6% since January—but soared 58% over the past month on positive news, such as the 88%+ enrollment rate of patients in Helus’ Phase III APPROACH pivotal trial (NCT06564818) of HLP003 in MDD, on track for topline data readout in Q4 2026.
“We see the potential for 150–200% upside [jump in stock price] if Phase III data in 4Q26 are positive,” Kulkarni wrote, making it the largest potential jump among psychedelic drug developers.
In addition to favorable data, the stock surges also reflect actions by President Donald J. Trump’s administration to encourage psychedelic drug development. In April, President Trump signed Executive Order 14401, directing the FDA and other federal agencies to accelerate research and improve access to psychedelic drugs, citing their potential as promising treatments for serious mental illnesses.
And on July 13, the FDA published “Psychedelic Drugs: Considerations for Clinical Investigations,” a final guidance designed to provide general considerations for developers of psych drugs, with recommendations for how to conduct clinical trials for the treatments.
“Rather than providing specific recommendations on study design, this guidance will present foundational constructs that all sponsors studying the therapeutic potential of psychedelic drugs, including sponsors without commercial drug development as primary interest (e.g., academic researchers), should consider,” the FDA wrote in the final guidance. “Sponsors are encouraged to request meetings with FDA for advice on a specific drug development program.”
Leaders and laggards
- Q32 Bio (Nasdaq: QTTB) shares nearly doubled, leaping 91% from $11.21 to $21.38 July 13 after the autoimmune and inflammatory disease drug developer announced positive 36-week topline results from Part B of the Phase IIa SIGNAL-AA trial (NCT06018428) assessing bempikibart in patients with severe or very severe alopecia areata. Q32 said it saw clinically meaningful efficacy data on the primary endpoint of mean percent change from baseline in SALT score, with a reduction from baseline of 35.3% in the prespecified modified intent to treat (mITT) analysis. The company also reported that 40.0% of patients (10/25) achieved SALT-20 response at Week 36 in the mITT analysis, while 30.3% of patients (10/33) achieved SALT-20 response at Week 36 in the ITT analysis of all enrolled patients.
- Veradermics (NYSE: MANE) shares yo-yoed this past week, climbing 12% from $110.17 to $123.70 Wednesday after the pattern hair loss drug developer announced positive topline results from its open-label Phase II Study 207 trial (NCT06527365) assessing VDPHL01, an extended-release oral minoxidil formulation, in women with mild-to-moderate pattern hair loss. Veradermics said most study participants reported improved hair coverage at Month 2, with approximately 88.9% of patients dosed once daily and 90.0% dosed twice daily reporting “improved” or “much improved” outcomes at Month 6. Participants dosed once daily showed a mean increase in non-vellus target area hair count (TAHC) of 22.7 hairs/cm² at Month 6, an average that rose to 23.3 hairs/cm² in twice daily dosed patients. The mini surge was short-lived, however, as investors more than gave back the gain, selling off shares to send them tumbling 14% to $105.83 Thursday amid possible investor questions about whether the good clinical news was already reflected in the stock price.
The post StockWatch: Lilly’s Up-to-$3.8B Deal for AtaiBeckley a Good Trip for Psychedelic Drugs, Analysts and Investors Agree appeared first on GEN – Genetic Engineering and Biotechnology News.
Opinion: STAT readers on the value of primary care, obesity as a disease, and more
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.