AstraZeneca's (AZN) Tagrisso Combo Gets FDA's Priority Review
AstraZeneca PLC AZN announced that the FDA has accepted for review its supplemental new drug application (sNDA), seeking expanded use for its blockbuster drug Tagrisso (osimertinib) as a combination treatment in advanced lung cancer.
The company is looking to get approval for Tagrisso in combination with chemotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR mutations.
With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected in the first quarter of 2024.
The FDA generally grants a priority review to drugs with the potential to treat a serious condition. These, if approved, would substantially improve safety or effectiveness.
Currently, Tagrisso is already approved as a monotherapy for treating EFGR-mutated NSCLC.
The latest sNDA was based on data from the phase III FLAURA-2 study.
Data from the study showed that treatment with the Tagrisso+chemotherapy combination reduced the risk of disease progression or death by 38%. The study data also suggested that the Tagrisso+chemotherapy combination extended median progression-free survival by nearly nine and a half months.
Shares of AstraZeneca failed to deliver any returns to investors in the year-to-date period compared with the industry’s increase of 8.5%.
Image Source: Zacks Investment Research
Tagrisso has been one of the key revenue drivers for AstraZeneca. In the first six months of 2023, Tagrisso generated sales worth $2.9 billion, reflecting an increase of 12% year over year at constant exchange rates (“CER”). If approved for the new indication, sales of the drug are likely to rise further as it will be able to address a broader patient population.
AstraZeneca remains focused on strengthening its oncology product portfolio through label expansions of existing products. The company’s oncology franchise clocked sales worth $8.3 billion during the first half of 2023, increasing 21% year over year at CER.
AstraZeneca’s oncology business is now annualizing at almost $15 billion. Constant label expansion for key cancer drugs is likely to boost sales further in the days ahead.
Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Neurocrine Biosciences, Inc. NBIX, Sarepta Therapeutics, Inc. SRPT and MEI Pharma, Inc. MEIP, sporting a Zacks Rank #1 (Strong Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Neurocrine Biosciences’ 2023 earnings per share have risen from $2.17 to $2.19. During the same period, estimates for 2024 have risen from $4.77 to $4.86 per share. Year to date, shares of NBIX have lost 4.9%.
Earnings of Neurocrine Biosciences beat estimates in one of the last four quarters and missed the same on the other three occasions. NBIX delivered a four-quarter negative average earnings surprise of 105.45%.
In the past 60 days, estimates for Sarepta’s 2023 loss per share have improved from $9.73 to $9.19. During the same period, loss per share estimates for 2024 have narrowed from $1.66 to $1.00. Year to date, shares of SRPT have declined 9.3%.
Earnings of Sarepta Therapeutics beat estimates in three of the trailing four quarters and missed the mark on the other occasion. On average, SRPT delivered a negative earnings surprise of 5.15% in the last four quarters.
In the past 60 days, estimates for MEI Pharma’s 2023 loss per share have improved from $6.54 to $4.89. During the same period, loss per share estimates for 2024 have narrowed from $5.14 to $4.02. Year to date, shares of MEIP have rallied 40.4%.
Earnings of MEI Pharma beat estimates in three of the trailing four quarters and met the same on the other occasion. On average, MEIP came up with an average four-quarter earnings surprise of 53.58%.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
AstraZeneca PLC (AZN) : Free Stock Analysis Report
Neurocrine Biosciences, Inc. (NBIX) : Free Stock Analysis Report
Sarepta Therapeutics, Inc. (SRPT) : Free Stock Analysis Report
MEI Pharma, Inc. (MEIP) : Free Stock Analysis Report
