AstraZeneca AZN announced that the FDA has accepted and granted priority review to its supplemental biologics license application (sBLA) seeking expanded use of its blockbuster drug, Imfinzi (durvalumab), for a bladder cancer indication.
The sBLA seeks approval of Imfinzi for the treatment of patients with muscle-invasive bladder cancer (MIBC), a type of bladder cancer that has spread into the muscle wall of the bladder. The FDA’s decision on the sBLA is expected during the second quarter of 2025. If approved, this will be the first approval for Imfinzi in a bladder cancer indication.
Year to date, the stock has risen 1.2% compared with the industry’s 9.5% rise.
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AZN’s sBLA Based on NIAGARA Study
The sBLA 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 25% reduction in 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 sBLA has been filed for an immunotherapy regimen in this perioperative setting, which can make Imfinzi a potential transformative option for this patient population.
Regulatory applications seeking approval for Imfinzi for similar use are under review in the EU, Japan and several other countries.
Imfinzi: A Key Revenue Driver for AZN
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.
Last week, the FDA granted approval to Imfinzi for treating limited-stage small cell lung cancer, an aggressive form of lung cancer, in the United States. The approval was based on data from the ADRIATIC phase III study.
Imfinzi is a key revenue driver for AZN’s oncology portfolio, having generated sales worth $3.46 billion in the first nine months of 2024, up 22% year over year at constant exchange rates, driven by demand growth across all approved indications.
AZN’s Zacks Rank
Currently, AstraZeneca has a Zacks Rank #3 (Hold).
AstraZeneca PLC Price and Consensus
AstraZeneca PLC price-consensus-chart | AstraZeneca PLC Quote
Some better-ranked drugmakers are Pfizer PFE, Gilead GILD and Exelixis EXEL, with a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Estimates for Pfizer’s 2024 earnings have risen from $2.62 to $2.91 per share over the past 60 days. For 2025, earnings estimates have risen from $2.84 to $2.91 per share over the same timeframe. Year to date, Pfizer’s stock has declined 10.7%.
Pfizer beat estimates in each of the last four quarters, delivering an average earnings surprise of 74.50%.
Estimates for Gilead’s 2024 earnings per share have increased from $3.79 to $4.32 over the past 60 days, while those for 2025 have risen from $7.24 to $7.38 per share. Gilead’s shares have risen 13.8% year to date.
Gilead beat estimates in three of the last four quarters while missing in one, delivering an average earnings surprise of 15.46%.
The Zacks Consensus Estimate for Exelixis’ earnings has risen from $1.83 to $1.93 per share for 2024 over the past 60 days, while that for 2025 has risen from $1.85 to $2.00 per share over the same timeframe. Exelixis’ shares have risen 49.3% year to date.
Exelixis beat estimates in three of the last four quarters while missing in one, delivering an average earnings surprise of 26.52%.
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