AstraZeneca AZN announced that the FDA has approved its blockbuster drug, Imfinzi (durvalumab), for a bladder cancer indication in the United States.
Imfinzi is approved in combination with gemcitabine and cisplatin as a neoadjuvant treatment for muscle-invasive bladder cancer (MIBC), a type of bladder cancer that has spread into the muscle wall of the bladder. The regulatory filing for the drug was reviewed under the FDA’s Priority Review Pathway. This marks the first approval for Imfinzi for a bladder cancer indication.
AstraZeneca’s Imfinzi, either as a monotherapy or in combination with chemotherapy, is presently approved for stage III non-small cell lung cancer, extensive-stage small cell lung cancer, locally advanced or metastatic biliary tract cancer and endometrial cancer that is mismatch repair deficient and in combination with Imjudo in unresectable hepatocellular carcinoma in some countries. The drug has also recently been approved for limited-stage small cell lung cancer in the United States and the EU.
AZN’s Imfinzi Approval Based on NIAGARA Study Data
The FDA approval of AstraZeneca’s Imfinzi for the MIBC indication was based on data from the phase III NIAGARA study. Data from the study showed that Imfinzi, when used in combination with neoadjuvant chemotherapy before radical cystectomy and continued as an adjuvant monotherapy afterward, led to a 32% reduction in the risk of disease progression or recurrence compared to the standard treatment, which is neoadjuvant chemotherapy with radical cystectomy alone. The study also demonstrated a 25% reduction in the risk of death in patients treated with Imfinzi.
MIBC patients face high recurrence rates and poor prognosis even after undergoing aggressive treatments like cystectomy, which creates demand for new options for MIBC treatment. This is the first time an immunotherapy regimen has been approved in a perioperative setting, which makes Imfinzi a potential transformative option for the MIBC patient population.
Regulatory applications seeking approval for Imfinzi for similar use are under review in the EU, Japan and several other countries.
Year to date, AZN stock has risen 12.2% compared with the industry’s 3.5% growth.
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AZN Gets CHMP NOD for Calquence Expanded Use in EU
In a separate press release, AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the approval for the expanded use of Calquence (acalabrutinib) in mantle cell lymphoma (MCL).
The company is seeking approval for Calquence for the treatment of adult patients with previously untreated MCL, a rare and aggressive form of non-Hodgkin lymphoma.
In the EU, Calquence is presently approved for previously untreated chronic lymphocytic leukaemia (CLL) and in CLL patients who have received at least one prior therapy, but not approved for any MCL indication.
In the MCL indication, Calquence is already approved for first-line MCL in the United States and other countries, as well as for MCL patients who have received prior therapy in the United States, China and several other regions. The drug is also approved for treating CLL and small lymphocytic lymphoma in several countries across the world.
The CHMP nod for Calquence in first-line MCL was based on data from the phase III ECHO study. Per findings, treatment with the drug in combination with chemoimmunotherapy significantly delayed disease progression and showed a trend to improve survival in patients with untreated MCL.
The study data showed that treatment with Calquence plus bendamustine and Rituxan (rituximab) reduced the risk of disease progression or death by 27% as compared to standard-of-care (SoC) chemoimmunotherapy. Patients who were treated with the Calquence combination experienced a median progression-free survival of 66.4 months as compared to 49.6 months for patients receiving SoC.
This recommendation for the approval of Calquence as a first-line combination treatment for MCL in the EU follows the recent positive CHMP opinion supporting its use as a monotherapy for adult patients with relapsed or refractory MCL.
Upbeat Data From AZN’s Phase II Cholesterol Drug Study
AstraZeneca presented positive data from a mid-stage study of its investigational once-daily oral PCSK9 inhibitor, AZD0780, at the annual session of the American College of Cardiology. Per the data readout from the phase IIbPURSUIT study, the candidate significantly reduced LDL cholesterol (LDL-C) when added to standard-of-care statin therapy compared to a placebo. High LDL-C, a common form of dyslipidemia, is a major risk factor for atherosclerotic cardiovascular disease, including heart attacks and strokes. Globally, over 70% of patients fail to achieve guideline-recommended LDL-C targets, making it a significant public health concern.
Patients receiving the 30mg dose of AZD0780 achieved a 50.7% reduction in LDL-C when added to standard statin therapy, with similar effectiveness across moderate- and high-intensity statin users, at week 12. Additionally, 84% of participants reached guideline-recommended LDL-C targets compared to 13% on background statin therapy alone.
AZD0780 was overall well-tolerated in the PURSUIT study and demonstrated a favourable safety profile.
AstraZeneca currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks from the sector are Bayer BAYRY, Dynavax Technologies Corporation DVAX and Corcept Therapeutics CORT, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
In the past 30 days, estimates for Bayer’s earnings per share have increased from $1.14 to $1.19 for 2025. During the same time, earnings per share have increased from $1.23 to $1.28 for 2026. Year to date, shares of Bayer have gained 23.4%.
BAYRY’s earnings matched estimates in two of the trailing three quarters while missing the same on the remaining occasion, the average negative surprise being 19.61%.
In the past 30 days, estimates for Dynavax’s earnings per share have remained constant at 33 cents for 2025. During the same time, earnings per share have remained constant at 57 cents for 2026. Year to date, shares of DVAX have gained 1.6%.
DVAX’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 9.58%.
In the past 30 days, the estimate for Corcept Therapeutics’ 2025 earnings per share has declined from $1.95 to $1.87. The estimate for 2026 earnings per share has declined from $3.25 to $3.11. Year to date, shares of Corcept Therapeutics have gained 126.7%.
CORT’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 20.08%.
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