Alex Hillenbrand is an assistant editor for 

. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

In results from the phase 2 VALIANT trial, verekitug met its primary endpoint of statistically significant reductions in annualized 

 exacerbation rate (AAER) compared with placebo.

The positive topline results were announced by Upstream Bio, Inc, on February 11, 2026, exhibiting clinically meaningful efficacy and a consistent safety profile in adults with severe asthma.

“Severe asthma, when unable to be controlled by standard of care measures, can significantly and chronically disrupt patients’ quality of life, and put them at risk for potentially life-threatening exacerbation events that can lead to emergency room visits and hospitalizations,” said Michael Wechsler, MD, MMSc, a professor of medicine, and director of the National Jewish Cohen Family Asthma Institute, in a statement. “These data suggest that verekitug can potentially offer patients meaningful improvements in their breathing and asthma symptoms with less frequent dosing than the currently available biologics, and I believe that verekitug could represent an important advancement for individuals living with severe asthma.”

As of now, verekitug, a novel, high-affinity, fully human monoclonal antibody, is the only known antagonist targeting the receptor for thymic stromal lymphopoietin in clinical stage development. Besides VALIANT, verekitug is currently in phase 2 development in the VIBRANT study for chronic rhinosinusitis with nasal polyps, and VENTURE for chronic obstructive pulmonary disease.

The phase 2 VALIANT trial was a multicenter, randomized, placebo-controlled parallel group study designed to assess the efficacy and safety of subcutaneously administered verekitug. The study consisted of a 4-week screening period, a 60-week treatment period, and a follow-up period ending 16 weeks after the last dosage.

In the trial, study investigators randomized participants in a 1:1:1:1 ratio to receive 100 mg every 12 weeks (Q12W), 400 mg every 24 weeks (Q24W), 100 mg every 24 weeks (Q24W), or placebo. At each dosing visit, all participants received 2 subcutaneous injections to maintain the blinding of different doses.

VALIANT included a total of 478 patients with severe asthma.

The study’s primary endpoint of a statistically significant and clinically meaningful reduction at AAER was met at Q12W and Q24W dosing. Veretikug demonstrated a 56% reduction of AAER (

< .0003) at 100 mg Q12W and 39% at 400 mg Q24W compared with placebo.

At week 60, the placebo-adjusted improvement in lung function, measured by the forced expiratory volume in one second (FEV1), was 122mL with 100 mg Q12W and 139 mL with 400 mg Q24W. Investigators observed suppressed exhaled nitric oxide (FeNO) by 20.4 ppb (

 <.0001) at 400 mg Q24W. From baseline, these data exhibited a mean reduction of 43.5% (

= .03) in the 100 mg Q12W group and a mean reduction of 44.9% (

= .03) in the 400 mg Q24W group. Additionally, a dosage of 100 mg Q24W demonstrated a statistically significant effect on AAER, but no other endpoints.

At week 24, in prespecified analysis of secondary outcomes, investigators also noted the significant placebo-adjusted improvements compared to baseline in both FEV1 and FeNO with the 100 mg Q12W and 400 mg Q24W dose regimens.

Across all active doses, study investigators reported verekitug was generally well tolerated and demonstrated a favorable safety profile consistent with previous studies.

“We intend to rapidly advance verekitug into Phase 3 trials in severe asthma and CRSwNP. In parallel, we also continue to progress verekitug in our ongoing Phase 2 VENTURE trial in patients with COPD, where we have enrolled more than 60% of patients to date,” said Rand Sutherland, MD, Chief Executive Officer of Upstream Bio, in a statement. “As we transition into a late clinical-stage company pursuing substantial market opportunities, our focus remains on disciplined execution and expanding Upstream Bio’s capabilities to support long-term growth.”

Upstream Bio Reports Positive Top-line Results from the Phase 2 VALIANT Trial of Verekitug for the Treatment of Severe Asthma — Wed, 02/11/2026 - 06:00. Upstream Bio. Published 2026. Accessed February 11, 2026. 

https://investors.upstreambio.com/news-releases/news-release-details/upstream-bio-reports-positive-top-line-results-phase-2-valiant

Singh D, Brickman CM, Lloyd P, et al. Verekitug, a Novel Antibody Antagonist to the TSLP Receptor in Adults with Asthma: A 32-Week Randomized Phase 1b Multiple Ascending-Dose Trial. 

. Published online Winter 2025:10.1002/cpt.70156. doi:

‌Clinicaltrials.gov. Published 2026. Accessed February 11, 2026. 

https://clinicaltrials.gov/study/NCT06196879

Articles

Verekitug, a fully human high-affinity monoclonal antibody antagonizing the thymic stromal lymphopoietin receptor, demonstrated statistically significant and clinically meaningful AAER reductions versus placebo in adults with severe asthma in the phase 2 VALIANT trial. In 478 patients treated for 60 weeks, 100 mg Q12W and 400 mg Q24W reduced AAER by 56% and 39%, respectively, with placebo-adjusted FEV1 gains and FeNO suppression. Safety was generally favorable across doses, supporting rapid progression to phase 3.

Upstream Bio announced positive topline results from the phase 2 VALIANT trial evaluating the efficacy and safety of verekitug in adults with severe asthma.


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Phase 2 VALIANT: Verekitug Reduces Average Annual Asthma Flare-Ups 

David Golden, MD, clinical associate professor of medicine at Johns Hopkins University School of Medicine.

Jay Lieberman, MD, from University of Tennessee

Brian Schroer, MD, is an allergist-immunologist at the Cleveland Clinic Children's Hospital.

Expanding Epinephrine Options to Reduce Barriers, Improve Early Use

Part 4 of the special report explores one of the most rapidly evolving areas in 

 care: the expanding range of epinephrine delivery options and their potential to overcome long-standing barriers to timely treatment. Panelists reviewed both currently available products and emerging alternatives that may reshape how patients carry and use epinephrine.

The discussion began with a review of injectable options. In the United States, epinephrine autoinjectors are available in 0.1 mg, 0.15 mg, and 0.3 mg doses, while a 0.5 mg autoinjector is available in Europe but not yet in the US. Golden noted that this raises concerns about underdosing in larger adults and underscores the importance of promptly administering a second 0.3 mg dose if symptoms do not improve. Using weight-based dosing (0.01 mg/kg), a 0.3 mg dose is theoretically appropriate for a patient weighing approximately 30 kg (66 pounds), highlighting the need for repeat dosing in adolescents and adults with severe reactions.

Both experts emphasized that syringe-and-needle intramuscular epinephrine remains appropriate in healthcare settings, where dosing can be precisely tailored, even though autoinjectors achieve faster absorption in pharmacokinetic studies. However, many of the persistent gaps in anaphylaxis outcomes stem not from pharmacology but from human factors, including fear of needles, reluctance to carry devices, uncertainty about diagnosis, and hesitation to use epinephrine early.

The panel highlighted the significance of newly approved and emerging non-injectable options. Golden described the first FDA-approved intranasal epinephrine spray (neffy), which has been on the market for over a year.1 Because placebo-controlled anaphylaxis trials are not feasible, approval relied on pharmacokinetic data demonstrating plasma epinephrine levels comparable to existing intramuscular products.2 The nasal spray falls within the therapeutic range between manual intramuscular injection and autoinjectors, and early real-world experience has been encouraging.

The experts discussed additional products in development, including other nasal formulations and a sublingual oral film (Anaphylm) using a prodrug approach to overcome epinephrine’s absorption challenges.3 Lieberman noted that many patients strongly prefer oral medications, making a sublingual option particularly appealing if efficacy is maintained. Newer formulations may also offer practical benefits such as longer shelf life and greater temperature stability.

In closing, Golden and Lieberman returned to the core message of the entire series. Improving anaphylaxis outcomes requires earlier epinephrine use, fewer barriers to administration, and abandoning outdated reliance on antihistamines and corticosteroids in acute care. As Lieberman summarized succinctly: “Epinephrine, epinephrine. Let's stop using steroids for anaphylaxis, and let's use epinephrine early on and get rid of barriers to use.”

, of Cleveland Clinic Children’s Hospital

, of the University of Tennessee Health Science Center

Disclosures include Novartis Pharmaceuticals, Regeneron Pharmaceuticals, BioCryst, GlaxoSmithKline, Amgen, GENZYME Corporation, AstraZeneca Pharmaceuticals, and LEO Pharma for Schroer; Novartis Pharmaceuticals, ABBVIE, Genentech, Aquestive Therapeutics for Lieberman; and Phadia US and Genentech USA for Golden.

Greenhawt M, Schroer B, Kraft C, et al. One Year Later: How Intranasal Epinephrine Is Changing Emergency Allergy Treatment. HCPLive. Published on August 8, 2025. Accessed on February 10, 2026. 

https://join.hcplive.com/view/one-year-later-how-intranasal-epinephrine-is-changing-emergency-allergy-treatment

Smith T. FDA Approves Epinephrine Nasal Spray for Emergency Treatment of Allergic Reactions. HCPLive. Published on August 9, 2024. Accessed on February 10, 2026. 

https://www.hcplive.com/view/fda-approves-epinephrine-nasal-spray-for-emergency-treatment-of-allergic-reactions

Golden D. Anaphylm Remains Promising for Anaphylaxis Despite FDA CRL, With David Golden, MD. HCPLive. Published on February 3, 2026. Accessed on February 10, 2026. 

https://www.hcplive.com/view/anaphylm-remains-promising-anaphylaxis-despite-fda-crl-david-golden-md

Videos

Part 4 highlights how expanding epinephrine delivery options can reduce barriers, support earlier administration, and improve real-world anaphylaxis outcomes.

Special Reports

Anaphylaxis

The HCPLive anaphylaxis page is a comprehensive resource for clinical news and insights on acute allergic reactions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for preventing anaphylaxis, and more.

Recognizing, Managing Anaphylaxis in Infants

Part 3 of the special report turns to an increasingly important and nuanced topic: identifying and managing 

in infants. As early food introduction becomes standard practice, clinicians are encountering allergic reactions at younger ages, making infant-specific guidance more clinically relevant than ever.

Jay Lieberman, MD, opened the discussion by noting that while most reactions seen during early food introduction are mild and not anaphylaxis, the overall number of reactions has increased. This naturally raises the likelihood of encountering true anaphylaxis in infants. Unlike older children or adults, infants cannot verbalize classic symptoms such as throat tightness or oral itching, which complicates recognition and increases reliance on observable signs and caregiver intuition.

Both Lieberman and David Golden, MD, emphasized that infant anaphylaxis often presents through behavioral and nonspecific symptoms. These can include unusual or inconsolable fussiness, lethargy, persistent crying, tongue thrusting, ear pulling, and changes in appearance that parents frequently recognize before clinicians do. Although the current practice parameters still recommend using standard anaphylaxis criteria, the 2024 update acknowledges that it is reasonable to incorporate these infant-specific behavioral cues when assessing reactions in this age group.

From a management standpoint, the experts stressed that treatment principles in infants are fundamentally the same as in older patients. Epinephrine remains first-line therapy, and hesitation around dosing should not delay treatment. Golden highlighted that although autoinjectors are labeled for children above certain weight thresholds, the guidelines clearly support using whatever epinephrine dose is available, even in very small infants, because treating anaphylaxis takes precedence over concerns about relative dosing.

Lieberman reinforced this point succinctly: if a 0.1 mg device is available, use it; if only a 0.15 mg device is on hand, use that instead. Fear of “overdosing” should never prevent timely epinephrine administration in an infant with a concerning reaction.

The panel also noted emerging efforts to align updated infant recognition criteria, newer epinephrine delivery options, and post-epinephrine observation guidance into revised anaphylaxis action plans. The discussion concluded with a broader reminder that education is central to infant anaphylaxis care. Prescribing epinephrine alone is insufficient; clinicians must also teach caregivers how to recognize visual and auditory signs of systemic allergic reactions and when—and how—to act.

Golden DBK, Wang J, Waserman S, et al. Anaphylaxis: A 2023 practice parameter update. 

In this segment, experts emphasize the importance of giving an infant experiencing anaphylaxis epinephrine at whatever dose may be available rather than delaying treatment.


Delinking Epinephrine Use From Mandatory ED Visits

Part 2 of the special report focuses on one of the most practice-changing elements of the 2024 

 guideline update: whether patients must automatically go to the emergency department after using epinephrine.

David Golden, MD, explained that for decades, patients were universally instructed to seek emergency care after any epinephrine use, a message reinforced by package inserts and clinical dogma. However, during early COVID-19, patients and clinicians were reluctant to send otherwise stable individuals to emergency departments. Interim guidance developed during that period prompted a careful re-review of the evidence, ultimately leading to a permanent change in the 2024 practice parameters.

The updated guidance states that if epinephrine is administered promptly, the reaction is not severe, symptoms resolve, and the patient remains well, an emergency department visit is not always necessary. Golden emphasized that most anaphylaxis cases are mild to moderate, that approximately 90% respond to a single dose of epinephrine, and that biphasic reactions are uncommon, generally occurring in 5% to 10% of cases and often associated with delayed treatment.

By delinking epinephrine use from automatic emergency care, clinicians can reduce fear that delays treatment. Golden stressed that patients should focus on the reaction itself, not on meeting strict diagnostic criteria or worrying about the consequences of using epinephrine. The updated parameters explicitly note that epinephrine can be given even if anaphylaxis criteria are not fully met, and that giving epinephrine does not retrospectively confirm that the reaction was anaphylaxis.

The experts said factors such as patient comfort, access to emergency care, availability of a second epinephrine dose, presence of a caregiver, and individual risk factors all influence whether observation at home is appropriate. Severe presentations, such as hypotension, loss of consciousness, or significant respiratory distress, still warrant urgent medical evaluation.

The discussion concludes by reinforcing that the goal of the updated guidance is not to discourage emergency care, but to remove barriers to early epinephrine use. By shifting control to patients and families and tailoring decisions to individual circumstances, the 2024 update aims to improve outcomes while reducing unnecessary fear and hesitation.

In the second part of the special report, panelists delink epinephrine use from mandatory emergency department visits.

Updated Anaphylaxis Guidelines, Early Management Priorities

In part 1 of this 4-part special report from 

HCPLive, Contemporary Pediatrics, and Patient Care

, experts examine how recent guideline updates are reshaping the clinical approach to 

, with a particular emphasis on early recognition and first-line treatment. Moderated by Brian Schroer, MD, of Cleveland Clinic Children’s Hospital, the discussion features Jay Lieberman, MD, of the University of Tennessee Health Science Center, and David Golden, MD, of Johns Hopkins University.

The conversation centers on the evolution of the anaphylaxis practice parameters, particularly the focused 2020 update and the broader 2024 supplemental update from the American Academy and College of Allergy, Asthma & Immunology.

 Golden explained that while the 2020 update addressed narrowly defined clinical questions using a GRADE framework, most notably the role of epinephrine versus antihistamines and corticosteroids, the 2024 update took a more comprehensive look at the last decade of evidence. That review resulted in updated recommendations on emergency treatment, risk stratification, recognition of anaphylaxis in infants, and decision-making around emergency department referral.

One of the most consequential shifts highlighted by both panelists is the continued move away from routine use of corticosteroids and antihistamines in the acute management of anaphylaxis. Lieberman noted that accumulating evidence shows no clear benefit of steroids in preventing biphasic reactions or improving acute outcomes, while their adverse effects and delayed onset make them poorly suited for emergency treatment. As a result, some emergency departments have begun removing steroids from standardized anaphylaxis order sets as part of quality improvement initiatives.

The panel also addressed common misconceptions that delay treatment, including uncertainty about diagnostic criteria and fear of adverse effects. Both experts stressed that epinephrine should be used at the first concern for a systemic allergic reaction, even if formal anaphylaxis criteria are not yet met.

Shaker MS, Wallace DV, Golden DBK, et al. Anaphylaxis-a 2020 practice parameter update, systematic review, and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) analysis. 

In the opening segment of this special report, panelists discuss updated anaphylaxis guidelines and early management priorities.

Updated Anaphylaxis Guidelines, Early Management Priorities 

Lina Jia, MD, PhD, from Beth Israel Deaconess Medical Center, Harvard Medical School, and Xuanwu Hospital in China.

A prospective study finds adolescents with MDD show faster response, fewer cognitive effects, and better tolerability with magnetic seizure therapy than adults.


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Peter Friedmann, MD, MPH, is a professor of quantitative health sciences at UMass Chan Medical School.

Friedmann describes his research exploring the benefits of mobile telemedicine for HCV infection among persons who inject drugs in rural areas.

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Bringing Hepatitis C Care to Rural Communities Through Mobile Telemedicine, With Peter Friedmann, MD, MPH

Vlado Perkovic is Dean and Scientia Professor of Medicine at UNSW Sydney. He is also a Professorial Fellow at The George Institute and a Staff Specialist in Nephrology at the Royal North Shore Hospital in Sydney.

FLOW/SELECT suggest. GLP-1 receptor agonists may protect kidneys beyond glucose control

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Inflammation Emerges as Promising CKD Treatment Target, With Vlado Perkovic, MBBS, PhD

Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for HCPLive. He is also the executive producer of two podcasts: Skin of Color Savvy and The Medical Sisterhood. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

These positive results of Ameluz photodynamic therapy suggest the treatment is effective in actinic keratoses on the neck, trunk, and extremities.

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New Phase 3 Findings Support Ameluz-PDT for Patients with Actinic Keratosis

Shakia Hardy, PhD, MPH, is an associate professor in the department of epidemiology at the University of North Carolina at Chapel Hill.

Hardy discussed the disparity between treatment access and usage, highlighting the fact that most patients are within 10 mmHg of guideline recommendations.

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Most US Adults With Uncontrolled Blood Pressure Not Taking Medication, With Shakia Hardy, PhD, MPH

In their closing remarks, Auchus and DeFronzo emphasize routine screening of high-risk patients, the persistent cardiovascular burden of hypercortisolism despite risk-factor treatment, and the necessity of targeting cortisol excess itself.

Video Series

Final Takeaways: Screening, Cardiovascular Risk, and Treating Cortisol as the Root Cause

Auchus and DeFronzo survey the broader pharmacologic armamentarium for Cushing syndrome and hypercortisolism, including metyrapone, osilodrostat, ketoconazole, levoketoconazole, pasireotide, and investigational agents such as relacorilant and ACTH receptor antagonists.

Beyond Mifepristone: Enzyme Inhibitors, Pituitary-targeted Agents, and Emerging Therapies

DeFronzo and Auchus underscore the magnitude of metabolic benefit with mifepristone, the complexity of managing withdrawal and electrolyte issues, and the importance of specialist support and education for primary care physicians.

Practical Use of Mifepristone and the Need for Endocrinology–Primary Care Collaboration

Auchus and DeFronzo review mifepristone (RU-486) as a glucocorticoid receptor antagonist for Cushing syndrome and refractory hypercortisolism, detailing its effects on glycemic control, weight, and safety considerations from the SEISMIC and CATALYST trials.

Mifepristone in Hypercortisolism: Mechanism, Metabolic Benefits, and Management Challenges

Auchus and DeFronzo use the CATALYST trial to illustrate that both tumor-related and non-neoplastic hypercortisolism are common in refractory diabetes and respond to glucocorticoid receptor blockade, redefining “pseudo-Cushing” as a clinically important disease state.

Latest News

Phase 2 VALIANT: Verekitug Reduces Average Annual Asthma Flare-Ups

Expanding Epinephrine Options to Reduce Barriers, Improve Early Use

Recognizing, Managing Anaphylaxis in Infants

Delinking Epinephrine Use From Mandatory ED Visits

Updated Anaphylaxis Guidelines, Early Management Priorities