US Greenlight for Datroway Marks First TROP2 ADC Approval in Frontline mTNBC Beyond PD-1/PD-L1 Candidates; Gilead’s Hepcludex Achieves Historic FDA Approval Milestone in Chronic HDV; Biogen and Denali Therapeutics Report Progress in Phase 2b Evaluation of BIIB122 for Parkinson’s Disease; Eli Lilly and Company Spotlights Foundayo’s Late-Stage Success in Obesity Studies; BioMarin Shares Successful Phase 3 Study Outcomes for VOXZOGO® in Children with Hypochondroplasia

US Approves Datroway as the First TROP2-directed ADC for 1L mTNBC Patients Unsuitable for PD-1/PD-L1 Therapy

AstraZeneca and Daiichi Sankyo have secured US approval for Datroway for treating adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are ineligible for PD-1/PD-L1 inhibitor therapy.

The approval was granted following Priority Review by the FDA and was supported by findings from the Phase III TROPION-Breast02 study, presented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology. In the study, Datroway achieved a statistically significant and clinically meaningful 5.0-month improvement in median overall survival compared with chemotherapy, while also reducing the risk of disease progression or death by 43% in the first-line setting. The therapy further demonstrated stronger clinical activity, with an objective response rate of 64% versus 30% for chemotherapy.

The safety profile observed in TROPION-Breast02 aligned with previous Datroway breast cancer studies. The application was assessed under Project Orbis, which enables simultaneous regulatory review of cancer therapies across multiple countries. Regulatory evaluations are continuing in Australia, Canada, Singapore, and Switzerland, while additional reviews remain underway in the EU, China, and Japan.

Following the TROPION-Breast02 results, Datroway has also been incorporated into the National Comprehensive Cancer Network Clinical Practice Guidelines as a Category 1 Preferred first-line treatment option for metastatic TNBC patients who are not suitable candidates for immunotherapy. Datroway is a TROP2-directed DXd antibody-drug conjugate (ADC) discovered by Daiichi Sankyo and co-developed and commercialized in partnership with AstraZeneca.

Gilead’s Hepcludex Receives FDA Accelerated Approval as the First-Ever Treatment for Chronic Hepatitis Delta

Gilead Sciences announced that the FDA has granted accelerated approval to Hepcludex (bulevirtide-gmod) 8.5 mg for the treatment of adults with chronic hepatitis delta virus (HDV) infection, marking it as the first and only FDA-approved therapy for HDV in the United States.

The accelerated approval was supported by reductions in HDV RNA levels and normalization of alanine aminotransferase (ALT), primarily based on findings from the pivotal Phase III MYR301 trial. At Week 48, Hepcludex demonstrated a statistically significant improvement in combined virologic and biochemical response compared with the delayed-treatment control group. However, clinical benefits related to disease outcomes have not yet been fully established, and continued approval may depend on confirmation of clinical benefit in subsequent studies.

Chronic HDV is regarded as the most aggressive form of viral hepatitis, carrying a substantially greater risk of rapid disease progression, liver failure, and death compared with hepatitis B virus (HBV) infection alone. In the U.S., HDV is estimated to affect approximately 2%–4% of individuals living with chronic HBV, translating to nearly 40,000–80,000 people.

The MYR301 study (NCT03852719) assessed the efficacy and safety of Hepcludex in adults with chronic HDV, with patients receiving treatment for up to 144 weeks followed by a 96-week off-treatment observation period. The therapy achieved its primary endpoint at Week 48 and showed durable efficacy with an acceptable safety profile throughout up to 144 weeks of treatment exposure.

Biogen and Denali Therapeutics Share Latest Findings from Phase 2b LUMA Trial of BIIB122 (DNL151) in Early Parkinson’s Disease

Biogen and Denali Therapeutics reported topline findings from the Phase IIb LUMA trial assessing BIIB122 (DNL151), an investigational small-molecule LRRK2 (leucine-rich repeat kinase 2) inhibitor, in patients with early-stage Parkinson’s disease. The study failed to demonstrate a slowing of disease progression compared with placebo, based on the primary endpoint evaluating Time to Confirmed Worsening in the modified MDS-UPDRS Part II and III combined score. No meaningful improvements were observed across secondary endpoints either.

Exploratory biomarker analyses showed more than 90% inhibition of peripheral LRRK2 kinase activity (phosphoserine 935), while a cerebrospinal fluid (CSF) substudy demonstrated up to nearly 30% reduction in phosphorylated Rab10, a biomarker associated with LRRK2 activity. BIIB122 achieved and maintained anticipated exposure levels in both plasma and CSF throughout the study period. The therapy was generally well-tolerated and exhibited an acceptable safety profile. In light of these findings, Biogen and Denali have decided to halt further development of BIIB122 for idiopathic Parkinson’s disease. However, Denali will continue independently advancing the Phase IIa BEACON study in individuals carrying pathogenic LRRK2 variants.

The LUMA trial was a global, multicenter, randomized, double-blind, placebo-controlled Phase IIb study involving 648 participants aged 30–80 years with early-stage Parkinson’s disease, regardless of LRRK2 mutation status. Participants received either BIIB122 or placebo for at least 48 weeks and up to 144 weeks. The trial was designed to determine whether LRRK2 inhibition could modify the underlying biology driving Parkinson’s disease progression.

Separately, the ongoing global Phase IIa BEACON study is evaluating the safety, pharmacokinetics, and biomarkers related to lysosomal pathway engagement in carriers of pathogenic LRRK2 variants. The study aims to better characterize the biomarker profile and biological effects of LRRK2 inhibition in this genetically defined population. Initial BEACON data are expected in the first half of 2027. The trial is being led operationally by Denali and funded through a Collaboration and Development Funding Agreement with a third party.

Biogen and Denali also stated that comprehensive results from the LUMA study will be presented at a future scientific meeting to support broader research efforts into Parkinson’s disease and LRRK2 biology.

Eli Lilly and Company Showcases Encouraging Late-Stage Foundayo Results at Global Obesity Summit

Eli Lilly and Company shared new post-hoc findings from the Phase III ATTAIN-1 and ATTAIN-2 studies demonstrating that Foundayo led to clinically meaningful weight reduction in adults aged 65 years and older with obesity or overweight, irrespective of whether they had type 2 diabetes. Foundayo is currently the only approved oral GLP-1 therapy that can be administered at any time of the day without dietary or water intake restrictions. The analysis was presented during European Congress on Obesity 2026 held in Istanbul, Turkey.

Key efficacy findings in adults aged ≥65 years

Across both ATTAIN trials, all evaluated doses of Foundayo achieved statistically significant body weight reductions versus placebo at week 72 in adults aged 65 years and above (all p<0.001; efficacy estimand analysis).

ATTAIN-1 (patients with obesity or overweight without type 2 diabetes):

At the highest evaluated dose, older adults experienced up to a 13.0% mean reduction in body weight in observed data. Among participants aged ≥65 years, mean weight reductions were -7.9% with 5.5 mg, -11.3% with 9 mg, and -13.0% with 17.2 mg, compared with -1.6% for placebo. Similar reductions were observed in participants younger than 65 years, with decreases of -7.7%, -9.2%, and -12.4% across the respective doses versus -0.8% for placebo.

ATTAIN-2 (patients with obesity or overweight and type 2 diabetes):

In participants aged ≥65 years, average body weight reductions reached -7.5% with 5.5 mg, -8.3% with 9 mg, and -12.2% with 17.2 mg, compared with -2.3% for placebo. In the subgroup aged below 65 years, reductions were -5.0%, -7.6%, and -9.9%, respectively, versus -2.2% with placebo.

Safety findings across age groups

The safety profile of orforglipron was generally comparable across age categories and remained consistent with the broader ATTAIN-1 and ATTAIN-2 trial populations. The most commonly reported adverse events were gastrointestinal in nature, including nausea, constipation, diarrhea, and vomiting, which aligns with the known profile of the GLP-1 receptor agonist class.

Serious adverse events (SAEs) in pooled analyses were reported in 5.6%, 6.2%, and 5.4% of participants younger than 65 years receiving orforglipron 5.5 mg, 9 mg, and 17.2 mg, respectively, compared with 5.4% in the placebo arm. Among participants aged 65 years and older, SAE rates were 9.9%, 13.0%, and 11.6% across the respective dose groups, versus 11.4% with placebo.

BioMarin Reports Positive Phase 3 Pivotal Trial Results for VOXZOGO® (vosoritide) in Pediatric Hypochondroplasia

BioMarin Pharmaceutical Inc. reported that its Phase III CANOPY-HCH-3 trial assessing VOXZOGO® (vosoritide) in pediatric patients with hypochondroplasia successfully achieved the primary endpoint. The study demonstrated a statistically significant improvement in annualized growth velocity (AGV) at Week 52 versus placebo, with a least squares mean difference of +2.33 cm/year (p<0.0001).

Children treated with VOXZOGO also experienced significant gains in standing height and height Z-score compared with placebo after one year of therapy, with both endpoints reaching strong statistical significance (p<0.0001).

In addition, the therapy showed meaningful improvement in arm span (p=0.004), an important prespecified secondary endpoint. These outcomes may be particularly beneficial for children with hypochondroplasia by potentially enhancing reach, functional independence, and performance of daily activities, factors considered highly meaningful by the patient community.

The safety profile observed for VOXZOGO in the trial remained consistent with previously established data in achondroplasia, and no new safety concerns were identified. Detailed findings from the CANOPY-HCH-3 study are expected to be shared at a forthcoming medical conference.

The company plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration in Q3 2026, with additional regulatory filings to the European Medicines Agency and other global health authorities to follow.