Chelsie Derman is an associate editor for 

who covers allergy and  psychiatry. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

Q2 2026 brought regulatory movement, phase 3 data, and structural change to depression care. The 

 expanded lumateperone (Caplyta) for schizophrenia relapse prevention, issued a complete response letter for Cingulate's CTx-1301 in ADHD, and saw a White House order accelerate psychedelic research for serious mental illness. Definium Therapeutics also reported phase 3 Emerge data showing DT120 (lysergide) produced rapid, durable relief in 

TMS is moving past its 36-session schedule, with accelerated protocols and the at-home device ProlivRx expanding access for treatment-resistant depression, while psychiatrists confront patients turning to AI for mental health support. Here is a look back at the psychiatry drug approvals, phase 3 data, and neuromodulation advances that defined the quarter.

FDA Regulatory Roundup: Schizophrenia, ADHD, and Psychedelic Policy News

FDA Approves Lumateperone sNDA With 63% Relapse Risk Reduction In Schizophrenia

The FDA approved a supplemental New Drug Application (NDA) for lumateperone (Caplyta, Johnson & Johnson), expanding the label to include relapse prevention in schizophrenia. The approval, announced April 27, 2026, was based on phase 3 Study 304, a randomized withdrawal trial showing a 63% reduction in relapse risk versus placebo over 26 weeks, with 84% of patients remaining relapse-free at 6 months. Christoph U. Correll, MD, of the Zucker School of Medicine at Hofstra/Northwell, noted in a press release that relapse often undoes treatment progress and raises hospitalization risk. Lumateperone is already approved for schizophrenia, bipolar depression, and adjunctive MDD.

FDA Issues CRL for CTx-1301 in ADHD Over Manufacturing Concerns

The FDA issued a complete response letter for CTx-1301 (dexmethylphenidate HCl), Cingulate's investigational once-daily ADHD treatment, on June 2, 2026, citing chemistry, manufacturing, and controls concerns rather than clinical safety or efficacy issues. CTx-1301 uses a multi-core, precision timed-release tablet delivering three timed doses over 12 to 16 hours. Pivotal phase 3 trials in adults and in children and adolescents ages 6 to 17 years met primary endpoints on the ADHD-RS-5 and PERMP scales, with safety consistent with the broader methylphenidate class. Cingulate CEO Shane Schaffer called the response focused and resolvable.

White House Order Accelerates Psychedelic Research for Mental Illness, With Gus Alva, MD

A White House executive order signed April 18, 2026, directs the FDA and Drug Enforcement Administration to accelerate research and regulatory pathways for psychedelic drugs treating serious mental illness, including ibogaine compounds. The order authorizes national priority vouchers, Right to Try access, and ≥ $50 million in federal funding for state psychedelic research programs. Gus Alva, MD, medical director of ATP Clinical Research, told 

that clinicians should treat patient questions about psychedelics as reflecting unmet treatment needs rather than dismiss them. Alva cautioned that therapist training and infrastructure must keep pace with policy change.

Phase 3 Pipeline: DT120 Delivers Rapid Relief in Major Depressive Disorder

Emerge Phase 3 Data Show DT120 Lysergide Delivers Rapid, Durable MDD Relief, Says John Sonnenberg, PhD

Definium Therapeutics reported positive phase 3 Emerge results for DT120 (lysergide) ODT 100 µg in major depressive disorder, meeting the primary endpoint and all key secondary endpoints. The multicenter, randomized, double-blind trial enrolled 149 adults across 20 sites, with a single dose producing an 8.1-point placebo-adjusted MADRS improvement at week 6 and 24% remission versus 3% on placebo.

Investigator John Sonnenberg, PhD, of Northwestern University Feinberg School of Medicine, said the data convinced him of psychedelics' genuine antidepressant efficacy. No serious adverse events or suicidality signals emerged, and Definium's second phase 3 study, Ascend, will add a low-dose arm.

Clinical Features: TMS Innovation and AI's Expanding Role in Psychiatry

TMS for MDD Is Changing Fast. Here's What Psychiatrists Need to Know

Linda Carpenter, MD, of Brown University; Andrew Leuchter, MD, of UCLA TMS Clinical and Research Services; and Scott Wilke, MD, PhD, of UCLA Health, discussed how accelerated TMS protocols and the FDA-cleared at-home device ProlivRx are reshaping care for treatment-resistant depression. Standard TMS requires 36 sessions over 6 to 8 weeks, a schedule Medicare limits to 2 reimbursed sessions daily, leaving accelerated 5-or-more-session protocols largely uncovered. Carpenter, who led the MOOD trial behind ProlivRx (Neurolief), explained the physician-directed at-home model, while Wilke described how accelerated theta burst stimulation may target specific prefrontal cortex cell types.

TMS for MDD Reimagined: Faster, Fewer Visits, and Now at Home

Accelerated TMS Moves Toward Circuit-Based Depression Treatment

Your Patient's New Therapist Is an AI. Now What?

As mental health care waitlists stretch 3 to 6 months, growing numbers of patients turn to AI chatbots like ChatGPT for support, raising concerns among psychiatrists.

Richard Miller, MD, of Elwyn Adult Behavioral Health, cautioned that AI-cherry-picked, decontextualized information can be deleterious rather than helpful. Bioethicist Dominic Sisti, PhD, from Penn Medicine, called for guardrails around age restrictions, suicide risk detection, and HIPAA compliance. Psychiatrist Darlene King, MD, of UT Southwestern, compared AI mental health advice to consulting a well-meaning but unreliable friend. Clinicians are encouraged to ask patients about AI use non-judgmentally and keep a human in the loop.

Articles

Regulatory and clinical developments reshaped depression and broader psychiatry care in Q2 2026. Lumateperone secured a relapse-prevention label expansion in schizophrenia on the strength of a randomized-withdrawal phase 3 trial. Cingulate’s once-daily dexmethylphenidate formulation for ADHD hit a manufacturing-focused complete response letter despite positive pivotal efficacy. Federal policy signaled faster psychedelic pathways and funding, as phase 3 Emerge data suggested single-dose DT120 lysergide can deliver durable MDD improvement. Meanwhile, TMS shifted toward accelerated and at-home models, and clinicians grappled with patient use of AI chatbots.

Q2 2026 psychiatry recap: Lumateperone expands for schizophrenia relapse, DT120 shows phase 3 promise in MDD, and 3 TMS advances for depression care.

News

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Clinical

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Psychiatry

Psychiatry condition center page is a comprehensive resource for clinical news and insights on mental illnesses. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for depression, schizophrenia, bipolar disorder, anxiety, and more.

Major Depressive Disorder

Major Depressive Disorder condition center page, resources on the topics of medical news and expert insight into depression can be found. Content includes articles, interviews, videos, podcasts, and breaking news on MDD research, treatment, and drug development.

Q2 2026 Recap: Psychiatry News & Updates

Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

Although recent months have seen a substantial uptick in approvals, the first half of 2026 was a relatively quiet period for the US Food and Drug Administration (FDA). However, this dearth of regulatory updates was balanced out by a significant number of clinical trials reaching statistical significance in everything from heart failure to atherosclerotic cardiovascular disease (ASCVD), with major readouts presented at a slew of conferences across the country.

With so much data being revealed in the last 6 months, the editorial team at 

 has collected 9 of the most impactful headlines from this period to help you catch up on anything you may have missed:


FDA Approves Olezarsen (Tryngolza) for Severe Hypertriglyceridemia


On June 24, 2026, 6 days ahead of its scheduled PDUFA date, the FDA announced its approval of olezarsen as an adjunct to diet to reduce triglycerides and the risk of acute pancreatitis in adult patients with severe hypertriglyceridemia. This decision makes olezarsen the first therapy approved for this specific indication. The once-monthly, self-administered subcutaneous drug will be available in the US at some point in July, according to the announcement by parent company Ionis.


FDA Approves Baxdrostat for Uncontrolled Hypertension on Background Therapy


On May 18, 2026, the FDA approved baxdrostat as an add-on treatment for adults with hypertension inadequately controlled with other antihypertensive agents. Parent company AstraZeneca announced that the decision was based on positive data from the phase 3 BaxHTN trial, which showed substantially greater reductions in mean seated systolic blood pressure in patients treated with baxdrostat compared to placebo.


FDA Clears AI Program Powering Kardia 12L Electrogram for 5 New Cardiac Determinations


On January 13, 2026, parent company AliveCor announced that the FDA cleared the next generation of KAI 12L, the program powering the Kardia 12L Electrocardiogram System, for 5 additional determinations including 3 rhythm modifiers – short PR interval, atrial bigeminy, and ventricular bigeminy – and 2 axis-related morphology determinations – left axis deviation and right axis deviation. The clearance allows the smaller, more portable version of a standard 12-lead ECG machine to provide care to a wider group of patients.


ACACIA-HCM: Aficamten Beats Placebo in Non-Obstructive Hypertrophic Cardiomyopathy


Announced on May 5, 2026, by parent company Cytokinetics, aficamten significantly outperformed placebo among patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM), based on topline data from ACACIA-HCM. The trial saw patients receiving aficamten display substantial improvements in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score and maximal exercise performance compared to placebo recipients.


Asundexian Reduces Stroke Incidence Without Increasing Bleeding, With Ashkan Shoamanesh, MD


The OCEANIC-STROKE trial has displayed asundexian’s significant efficacy in reducing stroke risk among patients who have recently experienced non-cardioembolic stroke or a transient ischemic attack (TIA) without increasing bleeding. Topline results demonstrated that patients in the asundexian group exhibited significantly lower ischemic stroke incidence than the placebo group, with major bleeding incidence similar between both arms. This indicates asundexian’s revolutionary lack of bleeding increase among these patients.


CORALreef Lipids: Enlicitide Reduces LDL-C in Patients With ASCVD, With Ann Marie Navar, MD, PhD


The CORALreef Lipids trial has demonstrated enlicitide decanoate’s efficacy in reducing LDL-C levels compared to placebo in patients with or at risk of atherosclerotic cardiovascular disease (ASCVD) events. The oral macrocyclic peptide PCSK9 inhibitor was examined over a 52-week period, a substantial extension compared to prior trials of enlicitide for this indication.


HFmrEF as a Unique Phenotype of Heart Failure, With Jane Wilcox, MD, MSc


The Heart Failure Society of America released in May an official scientific statement recategorizing HFmrEF as an individual, unique phenotype of HF, distinct from HFpEF or HFrEF. The document suggests that clinicians view HFmrEF as all patients with HF and a left ventricular ejection fraction between 40% and 49%. Given the similarity of their structure and symptoms, clinicians agree that HFmrEF is a milder form of HFrEF and can be treated similarly.


Addressing the Limitations of Quadruple Therapy in HFrEF, With Stephen Greene, MD


Although clinical trials have shown promising results, quadruple therapies for HFrEF are not yet sufficient to reduce mortality and hospital readmission risks among older patients. Known as the four pillars of heart failure, ARNIs, beta-blockers, MRAs, and SGLT2 inhibitors are strongly recommended across all cases of heart failure. However, despite treatment with these medications, absolute risk of cardiovascular mortality remains largely unaffected.


Addressing Fenofibrates’ Lack of Cardiovascular Benefit, With Payal Kohli, MD, FACC


Despite substantially increasing evidence of their ineffectiveness and the FDA’s updating of their labeling information to reflect this, fenofibrates are still being prescribed to reduce cardiovascular risk at a significant volume. The editorial team at 

 spoke with Payal Kohli, MD, FACC, founder and medical director of Cherry Creek Heart and associate adjunct professor in the division of cardiology at Duke University School of Medicine, to discuss the need to phase out these ineffective and potentially dangerous medications.

A first-half 2026 regulatory lull still produced several notable FDA actions and practice-shaping datasets across cardiometabolic disease. Approvals included olezarsen for severe hypertriglyceridemia to reduce pancreatitis risk and baxdrostat as add-on therapy for uncontrolled hypertension, alongside expanded AI-enabled determinations for a portable 12-lead ECG platform. Key trial readouts showed aficamten improving symptoms and exercise capacity in non-obstructive HCM, asundexian lowering ischemic stroke without excess major bleeding, and oral PCSK9 inhibition reducing LDL-C over 52 weeks in ASCVD-risk populations.

Catch up on key FDA approvals, major trial updates, and critical clinician insights from the last 6 months.

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

Cardiomyopathy

Heart Failure

The HCPLive heart failure page is a resource for medical news and expert insights on HF. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for heart disease, reduced and preserved ejection fraction, and more.

Atherosclerotic Cardiovascular Disease

Stroke

On the HCPLive stroke page, resources on the topics of medical news and expert insight into CVA can be found. Content includes articles, interviews, videos, podcasts, and breaking news on stroke medicine, and more.

First Half 2026 Recap - Cardiology

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.

In the month of June 2026, the dermatology field saw a significant number of major developments in terms of new treatment data, 

 covered 3 notable dermatology conferences: the 

2026 Revolutionizing Atopic Dermatitis (RAD) Conference

SDPA 2026 Annual Summer Dermatology Conference

, and Maui Derm NP+PA Summer 2026. Coverage of these meetings included a number of significant studies and informative on-site interviews.

From new data to conference coverage to FDA developments, the final month of 2026’s second quarter proved to be a substantial one in the skin health space. The following iteration of 

’s Month in Review series highlights the top stories from June 2026:

FDA Approves Roflumilast 0.3% Cream for PsO in Children 2-5 Years

Roflumilast cream 0.3% (Zoryve), by Arcutis Biotherapeutics, was approved in June for the treatment of pediatric patients as young as 2 years of age with plaque psoriasis. This move expands the topical phosphodiesterase 4 (PDE4) inhibitor's current indications in the psoriasis space, which had previously been limited to patients aged 6 and older. The drug is now the first and only topical PDE4 inhibitor indicated for psoriasis in patients under 6 years of age.

FDA Approves Risankizumab for Pediatric Plaque Psoriasis, Psoriatic Arthritis

AbbVie announced the risankizumab-rzaa (SKYRIZI) approval in June for children aged 6 years or older with moderate to severe plaque psoriasis. Such children must also be candidates for systemic therapy or phototherapy. In this announcement, risankizumab was also approved for those aged 6 years or older with active psoriatic arthritis (PsA). The approval also adds a 55-mg prefilled syringe designed to support weight-based dosing for those less than 40 kg.

FDA Adds Bemotrizinol as First New Sunscreen Ingredient in Decades

In another June FDA announcement, bemotrizinol was added as an active ingredient in its list of over-the-counter (OTC) sunscreen products for skin cancer protection. The decision by FDA officials marks the first addition of a new active ingredient to the OTC sunscreen monograph in decades. Bemotrizinol, approved in Europe and various other international markets, is an ingredient designed to provide broad-spectrum protection against the sun’s ultraviolet A (UVA) and ultraviolet B (UVB) radiation.

The Medical Sisterhood: The Strength Nobody Talks About, with Saakshi Khattri, MD

 podcast, host Mona Shahriari, MD, associate clinical professor of dermatology at Yale University, spoke with Saakshi Khattri, MD, a triple board-certified physician in dermatology, rheumatology, and internal medicine. Khattri is also an associate professor at the Icahn School of Medicine at Mount Sinai and the director of Mount Sinai’s Dermatology/Rheumatology service. The topics of career contentment, reinvention, boundaries, and what success means for women in medicine were all highlighted.

Skin of Color Savvy: Patient Power—Voices Driving Change in Skin of Color Care

 and hosted by Skin of Color Savvy (SOCS) leaders, a conversation was held by host Elizabeth A. Kiracofe, MD, a board-certified dermatologist and founder of Airia Comprehensive Dermatology. Avery LaChance, MD, MPH, of Brigham and Women’s Hospital, and Barry Gardner, a biologic coordinator and medical assistant with LARK Dermatology who is currently completing his path toward becoming a physician assistant, joined her to discuss advancing equitable dermatologic care for patients with skin of color and other topics.

ABCs in Dermatology: Updates in Atopic Dermatitis Live at RAD 2026

 was held by co-hosts Christopher Bunick, MD, PhD, and Lindsay Ackerman, MD, FAAD. The pair discussed the maturing interleukin-4 (IL-4)/interleukin-13 (IL-13) biologic landscape in atopic dermatitis. The talk was recorded live at the RAD 2026 meeting in Nashville, Tennessee. Tralokinumab (Adbry), dupilumab (Dupixent), and lebrikizumab (Ebglyss) were all highlighted.

Dupilumab Improves Growth, Skin, & Caregiver Burden Across Pediatric AD Spectrum

At the RAD 2026 Conference, a set of analyses from LIBERTY AD PEDS, LIBERTY AD PRESCHOOL, and the long-term PED-OLE extension study were presented demonstrating dupilumab’s improvement as far as growth attainment in school-age children. The drug was shown to provide rapid caregiver-reported relief of symptoms in both infants and toddlers. It was also was shown to result in sustained regional skin improvements for up to 3 years in children with atopic dermatitis.

Zasocitinib Bests Deucravacitinib on PsO Skin Clearance in Phase 3 Head-to-Head

Topline results announced in June by Takeda suggest zasocitinib, a once-daily oral tyrosine kinase 2 (TYK2) inhibitor, showed statistically superior rates of complete plaque psoriasis skin clearance versus deucravacitinib across all primary and key secondary endpoints. These data were the result of a phase 3 head-to-head trial in adults with moderate-to-severe disease known as the LATITUDE Atlas study.

June 2026 delivered multiple dermatology inflection points spanning regulatory actions, pivotal trial readouts, and conference-driven clinical insights. FDA cleared roflumilast 0.3% cream for plaque psoriasis down to age 2, expanded risankizumab to pediatric plaque psoriasis and psoriatic arthritis with weight-based dosing support, and added bemotrizinol to the OTC sunscreen monograph for broad-spectrum UV protection. Meeting coverage emphasized evolving IL‑4/IL‑13 biologics in atopic dermatitis and pediatric dupilumab outcomes, while phase 3 LATITUDE Atlas results favored zasocitinib over deucravacitinib for complete PsO clearance.

This review of June 2026 headlines covers the most notable stories in dermatology, including FDA news, new data, and podcast updates.

Dermatology

The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

Plaque Psoriasis

The HCPLive plaque psoriasis page is a resource for medical news and expert insights on psoriasis. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for psoriatic disease, and more.

8 Dermatology Headlines You Missed in June 2026

has accepted Pharvaris' New Drug Application (NDA) for deucrictibant immediate-release (IR) capsules, an oral bradykinin B2 receptor antagonist intended for on-demand treatment of 

 attacks, with a Prescription Drug User Fee Act (PDUFA) target action date of April 23, 2027.¹ If approved, deucrictibant IR would become the first oral agent in its drug class for acute HAE attack treatment.

The submission is supported by data from the phase 3 RAPIDe-3 trial, a global, randomized, double-blind, placebo-controlled, crossover study evaluating deucrictibant IR in patients aged ≥ 12 years with HAE, including those with normal C1 inhibitor levels.

 According to Pharvaris, the trial met its primary endpoint and all 11 secondary efficacy endpoints with statistical significance.¹ Reported median times were 1.28 hours to onset of symptom relief, 17.48 minutes to end of progression, and 11.95 hours to complete resolution of attack symptoms.¹

The company describes the safety profile as well tolerated, though granular adverse event rates and comparator data have not yet been published in a peer-reviewed format. The NDA package reportedly draws on treatment data from > 1300 HAE attacks across the deucrictibant development program.¹

HAE is a rare genetic disorder, with an estimated prevalence of approximately 1 in 50,000 people worldwide, caused most often by C1 inhibitor deficiency that leads to excess bradykinin generation and episodic, potentially life-threatening swelling of the skin, gastrointestinal tract, and upper airway.³ Current on-demand options include plasma-derived and recombinant C1 inhibitor concentrates, the subcutaneous B2 antagonist icatibant, and the plasma kallikrein inhibitor ecallantide, most of which require injection or infusion.

 Sebetralstat, an oral kallikrein inhibitor, was approved in 2025 as the first oral on-demand HAE therapy, based on the phase 3 KONFIDENT trial.

 An oral B2 antagonist would offer a different mechanism within the same “oral on-demand” category rather than a first-in-kind route of administration.

Deucrictibant works by blocking bradykinin signaling at the B2 receptor, the same target validated by icatibant, but is formulated for oral absorption rather than injection.¹ Pharvaris is also developing an extended-release tablet formulation of the same molecule for long-term prophylaxis, currently in phase 3 testing (CHAPTER-3, NCT06669754). The FDA granted deucrictibant orphan drug designation in 2022, a status also conferred by the European Commission and Swissmedic.¹

For prescribers, the reported symptom-relief and resolution times are similar in magnitude to those described for sebetralstat and for icatibant in prior trials, though cross-trial comparisons are limited by differences in study design, endpoint definitions, and patient populations.

 The clinical value of an oral B2 antagonist will depend on how it performs against these existing options in practice, including in patients who do not respond adequately to kallikrein inhibition, and on longer-term safety data as more patients are exposed.

“After 10 years of dedicated effort by the team at Pharvaris, this FDA acceptance of deucrictibant IR’s NDA represents a major milestone in our journey to develop a differentiated therapy with the potential to improve the standard of care for people living with HAE,” said Berndt Modig, chief executive officer of Pharvaris, in a statement.

 “By leveraging this trusted mechanism and its chemical properties, deucrictibant IR has the potential to be an oral on-demand medicine that addresses unmet needs of those living with HAE.”

Pharvaris N.V. Pharvaris announces FDA acceptance of New Drug Application for deucrictibant IR for on-demand treatment of hereditary angioedema attacks. GlobeNewswire. July 6, 2026. 

https://www.globenewswire.com/news-release/2026/07/06/3322293/0/en/pharvaris-announces-fda-acceptance-of-new-drug-application-for-deucrictibant-ir-for-on-demand-treatment-of-hereditary-angioedema-attacks.html

ClinicalTrials.gov. Study of oral deucrictibant soft capsule for on-demand treatment of angioedema attacks in adolescents and adults with hereditary angioedema. NCT06343779. Updated 2026. 

https://clinicaltrials.gov/study/NCT06343779

Jones D, Narsipur N, Wade SW, et al. Patient-reported disease burden and health care utilization of HAE-nl-C1INH: insights from a real-world survey. 

. 2026;26(1):108. Published 2026 Jan 14. 

Li HH, Aygören-Pürsün E, Magerl M, et al. Indirect treatment comparison of oral sebetralstat and intravenous recombinant human C1 esterase inhibitor for on-demand treatment of hereditary angioedema attacks. Allergy Asthma Clin Immunol. 2025;21:19. doi:10.1186/s13223-025-00955-6. 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11909897/

Johnson V. Sebetralstat FDA-Approved as First Oral, On-Demand for Hereditary Angioedema. HCPLive. Published on July 7, 2025. Accessed on July 6, 2026. 

https://www.hcplive.com/view/sebetralstat-fda-approved-as-first-oral-on-demand-for-hereditary-angioedema

Pharvaris’ NDA for deucrictibant immediate-release oral capsules, an on-demand bradykinin B2 receptor antagonist for hereditary angioedema (HAE) attacks, was accepted by the FDA with a PDUFA date of April 23, 2027. Phase 3 RAPIDe-3 reportedly achieved the primary endpoint and 11 secondary endpoints, with median 1.28 hours to symptom relief, 17.48 minutes to end of progression, and 11.95 hours to complete resolution across >1300 treated attacks. If approved, it would be the first oral acute B2 antagonist.

Phase 3 RAPIDe-3 data show rapid, sustained relief of hereditary angioedema attacks; PDUFA date set for April 23, 2027. 

FDA News

Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

FDA Accepts NDA for Oral Deucrictibant for HAE Attacks

Victoria Johnson joined MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and is now an assistant managing editor for HCPLive and RheumatologyLive. She doesn’t have enough time for her numerous hobbies. You can reach her at vjohnson@mjhlifesciences.com.

H1 2026 was a defining period for pulmonology, bookended by a landmark COPD biologic program, a first-in-class antifibrotic context from late 2025 entering routine practice, and the most consequential IPF trial readout in years. The 

2026 American Thoracic Society (ATS) International Conference

 served as the half-year's clinical centerpiece in May, while the 

American Academy of Allergy, Asthma & Immunology

 meeting in February and CHEST's first severe asthma biologic guideline in January set the tone for a field actively translating emerging evidence into prescribing frameworks. 

Tozorakimab's triple phase 3 win across the OBERON, TITANIA, and MIRANDA trials positioned the IL-33 inhibitor as the first COPD biologic with a biomarker-agnostic efficacy signal, while nebulized treprostinil's TETON-1 data — including the first significant DLCO improvement in any phase 3 IPF trial — arrived at ATS with a supplemental NDA planned for summer 2026. Across asthma, real-world PASSAGE data extended tezepelumab's reach into populations long excluded from pivotal trials, ralinepag demonstrated a 55% PAH worsening reduction in ADVANCE OUTCOMES, and the BGF triple inhaler gained approval for patients as young as 12. 

Here's a concise overview of the key pulmonology stories from H1 2026.

New CHEST Recommendations Guide Biologic Use for Severe Asthma

CHEST published its first guideline dedicated to choosing and sequencing biologics in severe asthma in January 2026, offering 7 evidence-based recommendations that give clinicians long-needed structure for managing patients who fail initial therapy. The guideline conditionally favors dupilumab for patients with frequent exacerbations or steroid dependence, while recommending anti–IL-5/5Rα agents in steroid-dependent patients with very high eosinophil counts; tezepelumab is positioned as a preferred switch option for patients failing dupilumab with low eosinophils or low FeNO. It also uses post-treatment FeNO ≥25 ppb as a signal to guide switching from anti–IL-5/5Rα to dupilumab — the first guideline to operationalize this marker in the step-therapy decision.

Eosinophils, Exacerbations, and Endpoints: Biologic Therapy Selection in COPD and Asthma

Phase 2 VALIANT: Verekitug Reduces Annual Asthma Flare-Ups

Upstream Bio announced in February 2026 that verekitug met its primary endpoint in the phase 2 VALIANT trial, demonstrating statistically significant reductions in annualized asthma exacerbation rate compared with placebo in adults with severe asthma. The TSLP receptor antagonist — which blocks TSLP signaling at the receptor level rather than targeting the cytokine directly — achieved a 56% exacerbation reduction at the 100 mg every-12-weeks dose, a less frequent administration schedule than any currently approved biologic in the class. Upstream Bio has announced plans to advance verekitug into phase 3 trials in severe asthma and chronic rhinosinusitis with nasal polyps.

IL-33 Inhibitor Tozorakimab Cuts COPD Exacerbations in Phase 3 OBERON and TITANIA

AstraZeneca announced in March 2026 that tozorakimab met its primary endpoint in both the phase 3 OBERON and TITANIA trials, becoming the first IL-33–targeting biologic to demonstrate statistically significant reductions in COPD exacerbations across 2 replicate confirmatory trials. Efficacy extended across all blood eosinophil levels and lung function severity stages, positioning tozorakimab as a potential biomarker-agnostic option for the large proportion of COPD patients who remain ineligible for or inadequately served by current eosinophil-gated biologics. Full efficacy and safety data had not yet been published in peer-reviewed form at the time of the announcement.

Reducing COPD Exacerbations With Tozorakimab, With Frank Sciurba, MD

Phase 3 MIRANDA Trial Links Tozorakimab to Fewer COPD Exacerbations

AstraZeneca announced in April 2026 that tozorakimab met its primary endpoint in the phase 3 MIRANDA trial — a third consecutive positive COPD exacerbation readout within the LUNA program — reducing annualized moderate-to-severe exacerbation rates vs placebo in former smokers and in the overall population, including current smokers across all eosinophil levels and lung function severity stages, with 300 mg subcutaneously every 2 weeks on top of inhaled standard of care. MIRANDA evaluated a more frequent dosing regimen than OBERON and TITANIA and further consolidates the evidence base ahead of anticipated regulatory submissions. Two additional LUNA trials — PROSPERO, a long-term extension, and UMBRIEL, a dose-ranging asthma study — remain ongoing.

OBERON and TITANIA Showcase Tozorakimab's Emerging Benefit for COPD, With Frank Sciurba, MD

FDA Approves BGF Triple Inhaler for Patients Aged 12 and Older

The FDA approved budesonide/glycopyrrolate/formoterol fumarate (BREZTRI Aerosphere; AstraZeneca) as the first single-inhaler ICS/LABA/LAMA triple combination for patients aged 12 and older in April 2026, extending a treatment paradigm previously limited to adults into adolescent patients with asthma or COPD. The approval was grounded in phase 3 KALOS and LOGOS data, published in The Lancet Respiratory Medicine, which showed a pooled 76 mL improvement in trough FEV₁ and a reduction in severe exacerbations compared to dual therapy. The pediatric and adolescent label expansion addresses a population previously managed with separate controller agents, reducing inhaler complexity.

BGF Triple Therapy FDA Approval Expands Asthma Options for Underserved Patients, With Juanita Mora, MD

Inhaled Treprostinil Improves IPF Outcomes in Phase 3 TETON-1 Trial

Nebulized treprostinil (Tyvaso; United Therapeutics) reduced FVC decline by 130.1 mL vs placebo (95% CI, 82.2 to 178.1; 

 <.001) and cut the risk of composite clinical worsening by 33% (HR, 0.67; 

 =.003) in the phase 3 TETON-1 trial, presented at ATS 2026 in May. In a combined analysis with TETON-2 enrolling more than 1000 patients, the program met 5 of 6 secondary endpoints — including a 48% reduction in acute exacerbations (

 =.0223) and the first statistically significant DLCO improvement demonstrated by any IPF therapy in a phase 3 trial. United Therapeutics plans to submit a supplemental NDA by summer 2026 seeking priority review for the IPF indication, which would make nebulized treprostinil the first inhaled therapy approved for the condition.

Tezepelumab Reduces Severe Asthma Across Phenotypes in Phase 4 PASSAGE

Phase 4 PASSAGE data presented at ATS 2026 showed tezepelumab, an anti-TSLP monoclonal antibody, reduced annualized asthma exacerbation rates by 70% (95% CI, 63 to 75) over 52 weeks in a 286-patient real-world US cohort that included active smokers, patients with mild-to-moderate comorbid COPD, and Black or African American patients — populations historically excluded from biologic trials. Exacerbation reductions ranged from 54% to 77% across subgroups regardless of eosinophil count or allergic status, with clinically meaningful gains also seen in lung function and validated asthma control and quality-of-life measures. The findings may inform biologic eligibility decisions for patients previously excluded from pivotal programs on the basis of smoking history or airflow obstruction.

Ralinepag Achieves 55% Risk Reduction in PAH in Phase 3 ADVANCE OUTCOMES

Ralinepag, an investigational once-daily oral prostacyclin receptor agonist, reduced the risk of clinical worsening in pulmonary arterial hypertension by 55% vs placebo (HR, 0.45; 

 <.0001) in the phase 3 ADVANCE OUTCOMES trial, presented at ATS 2026 by Vallerie McLaughlin, MD, director of the pulmonary hypertension program at the University of Michigan. Secondary endpoints demonstrated significant NT-proBNP reductions, improved 6-minute walk distance, and 47% greater odds of clinical improvement; United Therapeutics has announced plans for an FDA new drug application submission in the second half of 2026. The agent's higher potency relative to existing prostacyclin pathway agents may offer more complete pathway activation, though head-to-head comparative data are not yet available.

FDA Clears LEADOPTIK's LIA System for Higher-Accuracy Lung Biopsy

The FDA granted 510(k) clearance in January 2026 to LEADOPTIK's Last Inch Assessment (LIA) system, a first-of-its-kind device that embeds high-resolution depth imaging directly into biopsy needles to provide real-time confirmation of tissue sampling at the target site. Preclinical data showed biopsy accuracy exceeding 95%, with the system offering approximately 50-fold better imaging resolution than existing technologies — addressing a persistent limitation in bronchoscopic biopsy procedures where off-target sampling contributes to diagnostic delays in lung cancer. The clearance arrives as expanded screening programs continue to identify more patients with early pulmonary lesions requiring tissue characterization, making procedural accuracy an increasingly consequential variable in the diagnostic workflow.

Mepolizumab COPD Pooled Analysis Supports Use Across Broader Eosinophil Range

A pooled analysis of the phase 3 METREX, METREO, and MATINEE trials presented at AAAAI 2026 in February found that mepolizumab reduced the annualized rate of COPD exacerbations requiring emergency department visits or hospitalization by 23% vs placebo (rate ratio, 0.77; 95% CI, 0.60 to 0.99; 

 =.044) in a combined population of 1713 patients with blood eosinophil counts ≥150 cells/µL at screening and/or ≥300 cells/µL in the prior year. The 19% reduction across the broader moderate-to-severe exacerbation endpoint supports mepolizumab's clinical utility at eosinophil thresholds below those most commonly discussed in prescribing practice;

H1 2026 accelerated translation of pulmonary innovation into practice, anchored by new severe asthma biologic sequencing guidance and multiple pivotal readouts. IL‑33 blockade with tozorakimab delivered three phase 3 COPD exacerbation wins with efficacy across eosinophil strata, implying a biomarker-agnostic option. In IPF, nebulized treprostinil slowed FVC decline, reduced clinical worsening, and uniquely improved DLCO, enabling a planned supplemental NDA. Real-world and midstage data broadened anti-TSLP strategies, while PAH outcomes improved with oral ralinepag. Regulatory actions expanded single-inhaler triple therapy to adolescents and cleared needle-based depth imaging for biopsy accuracy.

June 2026 pulmonology news includes conversations with experts at the ATS and APAPP conferences, and cytisinicline's CRL.

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