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.

Sharon Barr, Executive Vice President of BioPharmaceuticals R&D | Image Credit: NLS

 has announced its Priority Review acceptance of a New Drug Application (NDA) for baxdrostat, an investigative potential first-in-class small molecule aldosterone synthase inhibitor, for the treatment of 

Announced on December 2, 2025, by parent company AstraZeneca, the NDA submission was based on positive results from the BaxHTN phase 3 clinical trial. This study investigated multiple doses of baxdrostat compared to placebo in lowering systolic blood pressure among patients with uncontrolled hypertension despite the use of ≥2 antihypertensive medications.

“This Priority Review demonstrates our commitment to advancing baxdrostat as a potential first- and best-in-class aldosterone synthase inhibitor for the millions of people living with hard-to-control hypertension as quickly as possible,” Sharon Barr, executive vice president of BioPharmaceuticals R&D, said in a statement. “The substantial reduction in systolic blood pressure seen in the BaxHTN trial underscores baxdrostat’s novel mechanism of action and its potential to bring innovation to a disease area that has seen limited progress over two decades.”

BaxHTN was a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel group study aiming to evaluate the safety, tolerability, and efficacy of baxdrostat in patients with uncontrolled hypertension being treated with ≥2 different antihypertensive medications. The trial was conducted at 263 locations worldwide and saw patients randomly assigned in a 1:1:1 ratio to either baxdrostat 2 mg, baxdrostat 1 mg, or placebo once daily. The study’s primary efficacy endpoint was the difference in mean change from baseline in seated systolic blood pressure at week 12 between participants treated with baxdrostat and those treated with placebo. The efficacy’s persistence was assessed during a randomized withdrawal period from week 24 to 32.

To be eligible for inclusion, patients were required to have a mean sitting systolic blood pressure of ≥140 mmHg and ≤170 mmHg based on automated office blood pressure measurements, as well as an estimated glomerular filtration rate ≥45 mL/min/1.73m2 and a serum potassium level ≥3.5 and <5 mmol/L at screening. Patients also had to have a stable regimen of either 2 or ≥3 antihypertensive medications from different classes at the maximum dose, of which ≥1 must be a diuretic. Patients with a mean sitting systolic blood pressure ≥170 mmHg, a mean seated diastolic blood pressure ≥110 mmHg, serum sodium levels <135 mmol/L, or New York Heart Association functional 

 class IV at screening, among other criteria, were excluded.

A total of 796 patients were included in the study and were randomized to either baxdrostat 2 mg (n = 266), 1 mg (n = 264), or placebo (n = 264). At 12 weeks, investigators saw a -14.5 mmHg change from baseline in mean systolic blood pressure (95% CI, -16.5 to -12.5) with baxdrostat 1 mg, -15.7 mmHg (95% CI, -17.6 to -13.7) with baxdrostat 2 mg, and -5.8 mmHg (95% CI, -7.9 to -3.8) with placebo. The estimated difference from placebo was -8.7 mmHg (95% CI, -11.5 to -5.8) with baxdrostat 1 mg and -9.8 mmHg (95% CI, -12.6 to -7) with baxdrostat 2 mg (

“Many people continue to struggle with high blood pressure that is hard to control, even when taking multiple medications,” Bryan Williams, chair of medicine at University College London and a lead investigator in BaxHTN, said in a statement. “The highly promising BaxHTN phase 3 results show that once-daily baxdrostat on top of standard care can meaningfully lower systolic blood pressure and offer a potential new treatment approach for controlling hypertension, the leading risk factor for cardiovascular disease.”

According to the press release, AstraZeneca expects to receive the Prescription Drug User Fee Act date during the second quarter of 2026, following the use of a Priority Review voucher.

AstraZeneca. Baxdrostat New Drug Application accepted under FDA Priority Review in the US for patients with hard-to-control hypertension. December 2, 2025. Accessed December 2, 2025. 

https://www.astrazeneca-us.com/media/press-releases/2025/Baxdrostat-New-Drug-Application-accepted-under-FDA-Priority-Review-in-the-US-for-patients-with-hard-to-control-hypertension.html

AstraZeneca. A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension (BaxHTN). ClinicalTrials.gov Identifier: NCT06034743. Updated July 11, 2025. Accessed December 2, 2025. 

https://clinicaltrials.gov/study/NCT06034743

Flack JM, Azizi M, Brown JM, et al. Efficacy and safety of Baxdrostat in uncontrolled and resistant hypertension. New England Journal of Medicine. 2025;393(14):1363-1374. 

AstraZeneca. Baxdrostat met the primary and all secondary endpoints in BaxHTN Phase III trial in patients with uncontrolled or treatment resistant hypertension. July 14, 2025. Accessed December 2, 2025. 

https://www.astrazeneca-us.com/media/press-releases/2025/baxdrostat-met-the-primary-and-all-secondary-endpoints-in-BaxHTN-Phase-III-trial-in-patients-with-uncontrolled-or-treatment-resistant-hypertension.html

Articles

The FDA has accepted a Priority Review for baxdrostat, a novel aldosterone synthase inhibitor, for treating hard-to-control hypertension. AstraZeneca's NDA submission is based on positive BaxHTN phase 3 trial results, which demonstrated significant reductions in systolic blood pressure among patients with uncontrolled hypertension on multiple antihypertensive medications. The trial involved 796 patients and showed that baxdrostat significantly lowered systolic blood pressure compared to placebo. AstraZeneca anticipates a Prescription Drug User Fee Act date in the second quarter of 2026, following the Priority Review process.

The submission follows positive results from the BaxHTN trial, which saw the investigational aldosterone synthase inhibitor improve systolic BP versus placebo.

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The HCPLive hypertension page is a resource for medical news and expert insights on high blood pressure. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for hypertension, and more.

Baxdrostat NDA for Uncontrolled Hypertension Receives FDA Priority Review

Tim Smith joined the MJH Life Sciences team as an assistant editor for HCPLive in August 2022. He graduated from UC Berkeley with a degree in political science, working in multimedia journalism as a staff writer prior to joining MJH. In his spare time, he enjoys reading, watching TV, listening to podcasts, and rock climbing. You can contact him at 

Biofrontera Inc. announced the submission of a supplemental New Drug Application (sNDA) to the 

 for Ameluz-PDT (photodynamic therapy) as a treatment for superficial basal cell carcinoma (sBCC).

This December 2 announcement highlights Biofrontera’s sNDA and its incorporation of the complete efficacy results from recent phase 3 research and 1-year follow-up. The company also highlighted its combined safety analysis drawing from both European and US clinical trials in basal cell carcinoma.

“The efficacy, tolerability, and aesthetic outcomes demonstrated in the Phase 3 study and highlighted in our publication reinforce the value of Ameluz-PDT for the treatment of sBCC,” Todd Schlesinger, MD, director of the Clinical Research Center of the Carolinas in Charleston, South Carolina, and first author of the recent phase 3 results, said in a statement.

 “I look forward to potentially having this as an approved option for my patients with sBCC.”

Actinic keratosis (AK) is a precancerous lesion known to result from long-term sun exposure, with related lesions most often appearing on chronically sun-exposed sites. AK can also progress to squamous cell carcinoma if the condition remains untreated. An estimated 58 million people in the US in 2020 were impacted by AK, with about 13 million treatments taking place.

In Biofrontera’s announcement, they highlighted basal cell carcinoma (BCC) as the most frequently diagnosed skin cancer nationally, pointing to the over 3 million new cases reported each year. Ameluz-PDT is designed to help address sBCC, a subtype of BCC. If the treatment is cleared by FDA officials, its updated label would permit the use of Ameluz with either the BF-RhodoLED or RhodoLED XL red-light devices for sBCC.

In Biofrontera’s recent phase 3 analysis prior to their sNDA, a double-blind, randomized, placebo-controlled, multicenter study design was used. There were a total of 187 individuals who had at least a single clinically and histologically confirmed superficial BCC included in the study.

 These subjects were given a treatment cycle consisting of 2 PDT sessions with Ameluz-PDT or placebo-PDT. These sessions were administered 1 - 2 weeks apart, with a second cycle provided 3 months later if warranted.

The investigative team’s main endpoint evaluated in their analysis was complete clinical and histologic clearance of a designated main target lesion (MTL) at the 12-week mark following the last cycle of PDT. This benchmark was attained by 65.5% of study participants treated with Ameluz-PDT (95 of 145) as opposed to only 4.8% of subjects in the placebo arm of the analysis.

 This was a difference shown by the investigators to be statistically significant (P < .0001).

In their secondary analyses, even greater relative benefits to Ameluz-PDT were demonstrated by investigators. Histologic clearance of the MTL was observed among 75.9% of those on the treatment, compared with 19.0% in the placebo cohort. Attainment of clinical clearance of the MTL was also observed among 83.4% of the those in the treatment cohort versus 21.4% of those on placebo. Complete clearance of all superficial BCC lesions was also observed by the investigative team in 64.1% of those on Ameluz, compared with 4.8% of participants on the placebo.

 All such comparisons achieved high statistical significance (P < .0001).

The investigators pointed to the alignment of patient-reported outcomes with these clinical findings. Specifically, they highlighted 85.5% of individuals who had rated their satisfaction with Ameluz-PDT and its cosmetic effects to be good or very good. Results from the company’s 1-year follow-up interactions supported the persistence of response. These data would indicate a low rate of recurrence along with sustained cosmetic benefits.

“We are delighted that these highly significant results align with those found in the European studies and that we were able to submit this data package to FDA and seek an extension of the label to include sBCC,” Hermann Luebbert, PhD, CEO and Chairman of Biofrontera Inc., said in a statement.

 “If approved, this would expand the Ameluzindication to cutaneous oncology and would represent a significant milestone in our mission to become market leaders in the field of PDT.”

Biofrontera Inc. Announces Filing of Supplemental New Drug Application (sNDA) for the Treatment of Superficial Basal Cell Carcinoma (sBCC) with Ameluz®-PDT. Biofrontera Inc. December 2, 2025. 

https://www.globenewswire.com/news-release/2025/12/02/3197970/0/en/Biofrontera-Inc-Announces-Filing-of-Supplemental-New-Drug-Application-sNDA-for-the-Treatment-of-Superficial-Basal-Cell-Carcinoma-sBCC-with-Ameluz-PDT.html

Actinic Keratosis Overview. The Skin Cancer Foundation. 

https://www.skincancer.org/skin-cancer-information/actinic-keratosis/

Biofrontera Inc. has submitted a supplemental New Drug Application to the FDA for Ameluz-PDT, targeting superficial basal cell carcinoma (sBCC). The application includes efficacy results from a recent phase 3 study and a 1-year follow-up, demonstrating significant clinical and histologic clearance rates. The study showed Ameluz-PDT's superiority over placebo in achieving clearance of sBCC lesions. Patient satisfaction with the treatment's cosmetic effects was high, and the data indicated a low recurrence rate. Approval would expand Ameluz's indication to include cutaneous oncology.

Biofrontera announced its submission of a supplemental New Drug Application to the FDA for Ameluz-PDT in superficial basal cell carcinoma (sBCC).

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.

sNDA for Ameluz-PDT as a Treatment for Superficial Basal Cell Carcinoma Submitted to FDA

Victoria Johnson joined the MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and now HCPLive. You can reach her at vjohnson@mjhlifesciences.com

Pulmonary rehabilitation (PR) significantly reduced fractional exhaled nitric oxide (FeNO) levels in people with 

 with high baseline FeNO, supporting the role of PR as a complementary strategy to manage asthma.

“The role of FeNO in monitoring non-pharmacological interventions like PR remains unclear. Since PR may reduce airway inflammation through mechanisms independent of corticosteroids, FeNO could help assess these effects. Therefore, the aim of this study was to evaluate FeNO changes during a PR program in patients with asthma and different levels of airway inflammation,” study investigator Rainer Gloeckl, PhD, Philipps-Universität Marburg, Marburg, Germany, and colleagues wrote.

Gloeckl and colleagues evaluated PR in a prospective, single-center study that enrolled 62 people with asthma undergoing a comprehensive 3-week inpatient PR program. The 15-day observation period included thrice-daily FeNO measurements, with patients stratified into 3 baseline FeNO categories: low (<25 ppb), intermediate (25–50 ppb), and high (>50 ppb). a FeNO is a biomarker of type 2 airway inflammation.

A significant FeNO reduction was observed only in the high-FeNO subgroup (n = 22), with levels decreasing by 40% from 93 ± 29 ppb to 56 ± 27 ppb (

.001), independent of changes in medication. FeNO values remained stable in the low (17 ± 8 ppb to 16 ± 10 ppb) and intermediate groups (39 ± 12 ppb to 30 ± 10 ppb). Asthma control and exercise capacity improved across all subgroups, with the most pronounced improvements seen in patients with initially high FeNO. No meaningful changes in FeNO were seen in the low or intermediate FeNO groups.

“Our findings align with previous studies demonstrating the beneficial effects of PR on asthma control and exercise performance while providing novel insights into its impact on airway inflammation. To our knowledge, this is the first study to show that PR exerts an anti-inflammatory effect in asthma patients with high baseline FeNO levels, independent of medication changes. These results highlight the potential role of PR as a complementary strategy in asthma management, particularly for patients with persistent airway inflammation despite optimized pharmacological therapy,” Gloeckl and colleagues said.

In other recent news in asthma treatment, new findings from the WAYFINDER phase 3 trial demonstrated that almost all patients with oral corticosteroid (OCS)-dependent severe, uncontrolled asthma achieved a maintenance OCS dose of 5 mg per day or less and more than half completely discontinued OCS while maintaining asthma control after 52 weeks of open-label tezepelumab treatment.

Participants in WAYFINDER had a mean baseline maintenance OCS dose of 10.8 mg per day (SD, 6.5). Investigators found that the proportion of participants who had a maintenance OCS dose of 5 mg per day or less without loss of asthma control was 88.9% (n = 265; 95% CI, 84.8–92.3) at week 28 and 89.9% (n = 268; 95% CI, 85.9–93.1) at week 52. Furthermore, 32.2% of participants (n = 96; 95% CI, 26.9–37.8) were able to discontinue OCS without loss of asthma control by week 28, increasing to 50.3% (n = 150; 95% CI, 44.5–56.2) by week 52.

Paola Rogliani, MD, and Luigino Calzetta, PhD, both from University of Rome “Tor Vergata” in Italy, took the findings with a grain of salt with their related editorial.

“In conclusion, although WAYFINDER4 provides suggestive evidence that tezepelumab might reduce OCS dependence in severe asthma, methodological limitations, baseline imbalances, and the influence of the placebo effect indicate that these findings are not definitive; well-designed randomized, placebo-controlled trials or high-quality pooled analyses are needed to confirm the OCS-sparing effect of tezepelumab,” Rogliani and Calzetta wrote.

Gloeckl R, Kroll D, Abdulleyev G, et al. Pulmonary Rehabilitation Reduces Airway Inflammation in Asthma Patients with High FeNO Levels. 

2025; Volume 18:1651-1660. doi: 10.2147/jaa.s555317

‌Johnson V. Tezepelumab Drastically Reduces OCS Use for Asthma in Open-Label Trial. Article. HCPLive. November 28, 2025. 

https://www.hcplive.com/view/tezepelumab-drastically-reduces-ocs-use-asthma-open-label-trial

Rogliani P, Luigino Calzetta. Efficacy of tezepelumab in reducing oral corticosteroid use in severe asthma. 

Published online November 1, 2025. doi: 10.1016/s2213-2600(25)00395-9

Pulmonary rehabilitation (PR) has shown promise in reducing airway inflammation in asthma patients with high baseline fractional exhaled nitric oxide (FeNO) levels, independent of medication changes. A study involving 62 asthma patients demonstrated significant FeNO reduction in the high-FeNO subgroup, alongside improved asthma control and exercise capacity. Additionally, the WAYFINDER phase 3 trial revealed that tezepelumab treatment allowed many patients with severe, uncontrolled asthma to reduce or discontinue oral corticosteroids (OCS) while maintaining asthma control, though further research is needed to confirm these findings.

PR was seen to reduce FeNO, a biomarker of type 2 inflammation, in a new study.

Asthma

The HCPLive asthma page is a comprehensive resource for clinical news and insights on asthmatic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for allergic and severe asthma, and more.

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Pulmonary Rehabilitation Reduces Type 2 Inflammation in High Inflammation Asthma

VICTORION-INCEPTION and the Evolving Role of Inclisiran in ASCVD

The panelists review findings from the VICTORION-INCEPTION trial, which investigated the effects of initiating inclisiran during hospitalization for acute coronary syndrome (ACS) rather than waiting for outpatient follow-up. The experts note that the study demonstrated significantly improved LDL-C goal attainment and greater treatment persistence when inclisiran was started at discharge. By leveraging its twice-yearly dosing schedule, patients were more likely to maintain therapy adherence compared with traditional daily oral regimens. The trial also highlighted the practicality of integrating inclisiran into inpatient workflows, with strong feasibility and acceptance among both clinicians and patients. The panelists emphasize that this “start early, stay on” approach may help close the gap between evidence-based LDL-C targets and real-world implementation. They agree that VICTORION-INCEPTION supports the evolving role of inclisiran as an effective, durable option to improve long-term lipid control and secondary prevention outcomes in high-risk ASCVD populations.

Videos

A groundbreaking trial reveals the effectiveness of aggressive LDL lowering in high-risk patients, showcasing significant improvements in cholesterol management.

Video Series

Sayna Norouzi, MD, is an assistant professor of medicine, clinical nephrologist, and founder and director of the glomerular disease and polycystic kidney disease clinics at Loma Linda University Medical Center.

Chee Kay Cheung MBChB PhD, is a consultant nephrologist and honorary senior lecturer at the University of Leicester.

Pathophysiology of IgAN

This episode focuses on the underlying biology of IgA nephropathy, particularly the “multi-hit hypothesis.” The panel explains that the disease is driven not by a single event but by several interconnected immune steps, beginning with the production of galactose-deficient IgA1, followed by the formation of circulating autoantibodies, immune complex deposition in the kidney, and subsequent inflammatory injury. They discuss how each of these biological stages represents a potential therapeutic target. The clinicians emphasize that understanding the mechanism helps guide treatment choices, especially as newer agents are designed to intervene earlier in the disease pathway. They contrast older, broad immunosuppressive drugs with emerging therapies that more selectively modulate specific immune steps. This mechanistic framing helps reinforce why some patients continue to worsen even when proteinuria is controlled: the deeper immune dysregulation may remain active. The segment helps connect pathophysiology directly to clinical decision-making.

This episode focuses on the underlying biology of IgA nephropathy, particularly the “multi-hit hypothesis.”

Chelsie Derman is an associate editor for 

who covers psychiatry, sleep medicine, geriatrics, migraine, and allergy. 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.

This month in review spotlights 5 top allergy headlines published in November, including late-breaking data at ACAAI 2025.

Allergy

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5 Allergy Headlines You Missed in November 2025

Discover the critical importance of early LDL lowering with PCSK9 inhibitors to reduce cardiovascular risks and improve patient outcomes.

Expanding the Role of PCSK9 Inhibitors in ASCVD Treatment

In this segment, the panel focuses on what “optimized supportive care” truly means for patients with IgA nephropathy.

Optimizing Supportive Care for IgAN

Abigail Brooks is an assistant managing editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

Catch up on GI FDA news, new American Gastroenterological Association Crohn’s disease guidelines, and more gastroenterology updates from November.

Gastroenterology

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, IBS and IBD, Crohn's disease, and more.

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5 Gastroenterology Headlines You Missed in November 2025

Paul Sorajja, MD, is the associate director of the Banner – University Medicine Heart Institute and professor of medicine at the University of Arizona. 

Sorajja discusses the results of this groundbreaking trial investigating a new implant for patients with severe mitral annular calcification.

Heart Failure

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SUMMIT-MAC: Tendyne System Improves Mortality in MAC, With Paul Sorajja, MD

New data support firsekibart's efficacy over colchicine for preventing acute gout flares.

Gout

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Firsekibart Beats Colchicine as Gout Flare Prophylaxis When Initiating ULT

Gerard Criner, MD, is chair and professor of thoracic medicine and surgery at Lewis Katz School of Medicine at Temple University and director of the Temple Lung Center.

Discover how precision medicine reshapes COPD treatment, focusing on inflammation and patient-specific traits for improved outcomes in airway diseases.

COPD

COPD condition center page, resources on the topics of medical news and expert insight into chronic obstructive pulmonary disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on COPD research, treatment, and drug development.

This Year In Medicine

Rewriting Airway Disease With Trait-Based Care: 2025’s Convergence of Asthma and COPD Management 

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.

A competing mortality-risk model improves calibration and captures more true 5-year kidney failure events.


Nephrology

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

Chronic Kidney Disease

Refining KFRE With Mortality Risk Boosts Prediction Accuracy in Multimorbidity, CKD

Explore groundbreaking advancements in healthcare as 2025 concludes, featuring expert insights and dynamic multimedia. 

Endocrinology

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Hepatology

This Year in Medicine 2025: Recognizing Top Advances in Healthcare

The oral C5aR inhibitor produced durable responses across multiple doses in an 8-week trial, prompting InflaRx to move forward with phase 2b development.


Latest News

Baxdrostat NDA for Uncontrolled Hypertension Receives FDA Priority Review

sNDA for Ameluz-PDT as a Treatment for Superficial Basal Cell Carcinoma Submitted to FDA

Pulmonary Rehabilitation Reduces Type 2 Inflammation in High Inflammation Asthma

VICTORION-INCEPTION and the Evolving Role of Inclisiran in ASCVD

Pathophysiology of IgAN