AstraZeneca AZN announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) recommended approving its blockbuster cancer drug Tagrisso (osimertinib) for expanded use across a new setting in the non-small cell lung cancer (NSCLC) setting.

The CHMP has recommended approving Tagrisso for treating adult patients with locally advanced, unresectable NSCLC with EGFR exon 19 deletions (ex19del) or exon 21 L858R substitution (L858R) mutations, whose disease has not progressed during or following platinum-based chemoradiation therapy. The FDA approved this combination in September for a similar indication.

This recommendation is based on data from the phase III LAURA study, which showed that treatment with Tagrisso reduced the risk of disease progression or death by 84% versus placebo. Patients treated with the drug experienced a median progression-free survival of 39.1 months compared with 5.6 months for patients in the placebo group.

Tagrisso is currently approved in the EU for four indications, all across different settings in the NSCLC indication. The drug is considered the current standard of care for EGFR-mutated NSCLC in the first-line setting.

AZN Stock Performance

Year to date, AstraZeneca’s shares have lost 5.9% against the industry’s 3.3% growth.

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Tagrisso — A Key Top-line Driver for AZN

Tagrisso is approved in more than 100 countries worldwide, including the United States, European Union and Japan, for use in different NSCLC settings. In the first nine months of 2024, the drug added sales worth $4.9 billion to AstraZeneca’s top line, up 15% year over year. Sales of this drug have been rising, driven by strong demand as a first-line and adjuvant treatment.

AstraZeneca is also evaluating the drug in multiple label expansion studies in lung cancer indication. This includes two late-stage studies, one evaluating the drug in the neo-adjuvant setting and another in the early-stage adjuvant resectable setting. Continued label expansion for Tagrisso into additional indications and patient populations should boost drug sales in the future.

AZN’s Zacks Rank

AstraZeneca currently carries a Zacks Rank #3 (Hold).

AstraZeneca PLC Price

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Key Picks Among Biotech Stocks

Some better-ranked stocks from the sector are Castle Biosciences CSTL, CytomX Therapeutics CTMX and Spero Therapeutics SPRO, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. During the same timeframe, loss per share estimates for 2025 have narrowed from $2.13 to $1.88. Year to date, shares of Castle Biosciences have surged 30.2%.

CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.

In the past 60 days, estimates for CytomX Therapeutics’ 2024 loss per share have narrowed from 29 cents to 13 cents. Estimates for 2025 loss per share have narrowed from 56 cents to 46 cents. Year to date, shares of CytomX Therapeutics have lost 41.3%.

CytomX Therapeutics’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average surprise of 115.70%.

In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.38. Estimates for 2025 loss per share have narrowed from $1.54 to $1.16. Year to date, shares of Spero Therapeutics have lost 19.7%.

Spero Therapeutics’ earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 94.42%.

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