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AstraZeneca's (AZN) Tagrisso sNDA Gets FDA's Priority Tag
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AstraZeneca (AZN - Free Report) announced that the FDA has accepted its supplemental new drug application (sNDA), seeking expanded use of its blockbuster lung cancer drug, Tagrisso (osimertinib) in EGFR-mutated lung cancer.
The sNDA is seeking approval for Tagrisso for the treatment of adult patients with unresectable, stage III EGFR-mutated non-small cell lung cancer (NSCLC) following treatment with chemoradiotherapy (CRT).
With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected in the fourth quarter of 2024.
If approved by the FDA, Tagrisso will be indicated for EGFRm patients whose tumors have exon 19 deletions or exon 21 (L858R) mutations.
The FDA has also granted a Breakthrough Therapy designation to Tagrisso for stage III EGFRm NSCLC.
The latest sNDA was based on data from the phase III LAURA study. Data from the study showed that treatment with Tagrisso reduced the risk of disease progression or death by 84% versus placebo.
Also, patients who were treated with Tagrisso experienced progression-free survival (PFS) of 39.1 months compared with 5.6 months in patients who received placebo.
Shares of AstraZeneca have risen 18.8% so far this year compared with the industry’s rally of 20.1%.
Image Source: Zacks Investment Research
Currently, Tagrisso is approved as a monotherapy for the first-line treatment of EFGR-mutated NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC and adjuvant treatment of early-stage EGFRm NSCLC.
The FDA approved Tagrisso in combination with chemotherapy for frontline EGFR mutated NSCLC based on data from the FLAURA2 study in February 2024.
Tagrisso has been one of the key revenue drivers for AstraZeneca. In the first quarter of 2024, Tagrisso recorded sales worth $1.60 billion, increasing 15% year over year at constant exchange rates, on strong demand as a first-line and adjuvant treatment. Label expansion of the drug in later line settings is likely to boost sales further in future quarters.
Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold).
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have improved from $1.61 to $2.06. Earnings per share estimates for 2025 have improved from $3.69 to $4.33. Year to date, shares of KRYS have surged 32.6%.
KRYS’s earnings beat estimates in two of the trailing four quarters and missed the same on the remaining two occasions, the average negative surprise being 21.46%.
In the past 60 days, estimates for Marinus Pharmaceuticals’ 2024 loss per share have narrowed from $2.43 to $1.87, while loss per share estimates for 2025 have narrowed from $1.97 to 90 cents. Year to date, shares of MRNS have plunged 86.1%.
MRNS’s earnings beat estimates in two of the trailing four quarters, met the same once and missed the same once, the average surprise being 3.27%.
In the past 60 days, estimates for Minerva Neurosciences’ 2024 loss per share have narrowed from $3.57 to $1.89. Loss per share estimates for 2025 have narrowed from $4.54 to $3.60. Year to date, shares of NERV have declined 47.6%.
NERV’s earnings beat estimates in one of the trailing four quarters while missing the same on the remaining three occasions, the average negative surprise being 54.43%.
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AstraZeneca's (AZN) Tagrisso sNDA Gets FDA's Priority Tag
AstraZeneca (AZN - Free Report) announced that the FDA has accepted its supplemental new drug application (sNDA), seeking expanded use of its blockbuster lung cancer drug, Tagrisso (osimertinib) in EGFR-mutated lung cancer.
The sNDA is seeking approval for Tagrisso for the treatment of adult patients with unresectable, stage III EGFR-mutated non-small cell lung cancer (NSCLC) following treatment with chemoradiotherapy (CRT).
With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected in the fourth quarter of 2024.
If approved by the FDA, Tagrisso will be indicated for EGFRm patients whose tumors have exon 19 deletions or exon 21 (L858R) mutations.
The FDA has also granted a Breakthrough Therapy designation to Tagrisso for stage III EGFRm NSCLC.
The latest sNDA was based on data from the phase III LAURA study. Data from the study showed that treatment with Tagrisso reduced the risk of disease progression or death by 84% versus placebo.
Also, patients who were treated with Tagrisso experienced progression-free survival (PFS) of 39.1 months compared with 5.6 months in patients who received placebo.
Shares of AstraZeneca have risen 18.8% so far this year compared with the industry’s rally of 20.1%.
Image Source: Zacks Investment Research
Currently, Tagrisso is approved as a monotherapy for the first-line treatment of EFGR-mutated NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC and adjuvant treatment of early-stage EGFRm NSCLC.
The FDA approved Tagrisso in combination with chemotherapy for frontline EGFR mutated NSCLC based on data from the FLAURA2 study in February 2024.
Tagrisso has been one of the key revenue drivers for AstraZeneca. In the first quarter of 2024, Tagrisso recorded sales worth $1.60 billion, increasing 15% year over year at constant exchange rates, on strong demand as a first-line and adjuvant treatment. Label expansion of the drug in later line settings is likely to boost sales further in future quarters.
Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Krystal Biotech, Inc. (KRYS - Free Report) , Marinus Pharmaceuticals, Inc. (MRNS - Free Report) and Minerva Neurosciences, Inc. (NERV - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have improved from $1.61 to $2.06. Earnings per share estimates for 2025 have improved from $3.69 to $4.33. Year to date, shares of KRYS have surged 32.6%.
KRYS’s earnings beat estimates in two of the trailing four quarters and missed the same on the remaining two occasions, the average negative surprise being 21.46%.
In the past 60 days, estimates for Marinus Pharmaceuticals’ 2024 loss per share have narrowed from $2.43 to $1.87, while loss per share estimates for 2025 have narrowed from $1.97 to 90 cents. Year to date, shares of MRNS have plunged 86.1%.
MRNS’s earnings beat estimates in two of the trailing four quarters, met the same once and missed the same once, the average surprise being 3.27%.
In the past 60 days, estimates for Minerva Neurosciences’ 2024 loss per share have narrowed from $3.57 to $1.89. Loss per share estimates for 2025 have narrowed from $4.54 to $3.60. Year to date, shares of NERV have declined 47.6%.
NERV’s earnings beat estimates in one of the trailing four quarters while missing the same on the remaining three occasions, the average negative surprise being 54.43%.