Astrazeneca Plc Stock Price, News & Analysis

ULTOMIRIS (ravulizumab-cwvz) has received FDA approval for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-AChR antibody positive, representing 80% of gMG cases. This approval, stemming from the CHAMPION-MG Phase III trial, showed significant improvement in daily living activities. ULTOMIRIS is the first long-acting C5 complement inhibitor approved for gMG, enabling dosing every eight weeks. The trial involved 175 patients and presented a favorable safety profile, aligning with prior studies in similar conditions.

AstraZeneca and Daiichi Sankyo's ENHERTU received Breakthrough Therapy Designation in the US for treating HER2-low metastatic breast cancer. This designation is based on positive results from the DESTINY-Breast04 trial, which showed significant improvements in progression-free and overall survival compared to chemotherapy. ENHERTU, which has now secured five BTDs, aims to address the unmet need in breast cancer treatment, especially for patients with lower HER2 expression. The FDA’s expedited review process highlights the potential benefits for patients in urgent need of new therapies.

Daiichi Sankyo and AstraZeneca's ENHERTU has received its fifth Breakthrough Therapy Designation (BTD) from the FDA for treating adult patients with unresectable or metastatic HER2 low breast cancer. This designation follows positive results from the DESTINY-Breast04 trial, which demonstrated significant improvements in progression-free survival and overall survival compared to standard chemotherapy. The safety profile of ENHERTU remains consistent with previous trials. This designates ENHERTU as a potential game-changer for patients with lower HER2 expression, addressing a critical unmet medical need.

AstraZeneca announced that the FDA has accepted its Biologics License Application for a single priming dose of tremelimumab combined with Imfinzi for treating unresectable hepatocellular carcinoma (HCC). This STRIDE regimen aims to improve overall survival, supported by the Phase III HIMALAYA trial results showing a 22% reduction in death risk compared to sorafenib. The FDA decision is expected in Q4 2022. HCC is a major global health concern, with about 26,000 new advanced cases annually in the US. AstraZeneca continues to explore additional cancer treatment strategies.

AstraZeneca's EVUSHELD (tixagevimab and cilgavimab) has shown a significant reduction in symptomatic COVID-19 risk by 77% in the primary analysis and 83% in follow-ups, according to the PROVENT Phase III trial. No severe cases or COVID-19 related deaths occurred in the EVUSHELD group over six months. More than 75% of trial participants had high-risk comorbidities. The drug demonstrated long-term efficacy with elevated serum concentrations lasting six months. EVUSHELD is authorized for emergency use, particularly benefiting immunocompromised individuals unable to adequately respond to vaccination.

AstraZeneca and Daiichi Sankyo have received acceptance for the supplemental Biologics License Application (sBLA) of ENHERTU for treating adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a HER2 mutation. The FDA has granted Priority Review status, indicating potential significant improvements over current treatments. Results from the DESTINY-Lung01 trial showed a 54.9% tumor response rate, with a disease control rate of 92.3%. Approval could provide a new targeted therapy for patients currently lacking options.

Daiichi Sankyo and AstraZeneca announced that their sBLA for ENHERTU, a HER2-targeted therapy for metastatic non-small cell lung cancer, has been accepted by the FDA for Priority Review. Based on the DESTINY-Lung01 trial, ENHERTU achieved a remarkable 54.9% tumor response rate and a confirmed disease control rate of 92.3%. The median overall survival was 17.8 months, promising for patients with HER2 mutations. This therapy marks a significant advancement, as currently, no HER2 directed therapies exist for this specific cancer type.

Blueprint Medicines announced promising early results from the Phase 1/2 SYMPHONY trial for BLU-945, aimed at treating advanced EGFR-mutant non-small cell lung cancer (NSCLC). The data indicate dose-dependent reductions in circulating tumor DNA and tumor burden, with BLU-945 showing good tolerability—mostly Grade 1 or 2 adverse events. A partnership with AstraZeneca has been established for osimertinib in combination studies. Plans to initiate new trial cohorts and expand development by year-end 2022 were also highlighted, showcasing the potential for BLU-945 as a combination therapy.

ULTOMIRIS (ravulizumab-cwvz) demonstrated long-term efficacy in adults with generalized myasthenia gravis (gMG) from the Phase III CHAMPION-MG trial. Key findings showed significant improvements in muscle strength and quality of life sustained through 60 weeks. Results presented at the American Academy of Neurology Annual Meeting on April 5 emphasized that 99.4% of participants transitioned to an open-label extension, showing rapid response after switching from placebo. ULTOMIRIS was well-tolerated, with common adverse events including headache (16.6%) and diarrhea (13.6%). Regulatory submissions are under review globally.