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AstraZeneca's (AZN) Truqap Gets EU Nod for Breast Cancer

AstraZeneca AZN announced that the European Commission (EC) has approved Truqap (capivasertib) in combination with Faslodex (fulvestrant) for a breast cancer indication.

The EC has approved Truqap in combination with Faslodex for treating adult patients with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer whose tumors have qualifying alterations in the PIK3CA, AKT1 or PTEN genes following recurrence or progression on or after an endocrine-based regimen.

Following the nod in the EU, Truqap became the first and only AKT inhibitor to be approved for treating breast cancer patients with the PIK3CA, AKT1 or PTEN biomarker alterations.

The EC’s approval was based on data from the phase III CAPItello-291 study. Data from the study showed that treatment with Truqap plus Faslodex reduced the risk of disease progression or death by 50% compared with Faslodex in combination with placebo in the given patient population.

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The approval in Europe was expected as the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended the approval of Truqap in combination with Faslodex for treating advanced ER-positive breast cancer in April.

Shares of AstraZeneca have risen 16.4% so far this year compared with the industry’s rally of 20.3%.

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Truqap, in combination with Faslodex, was approved for HR-positive, HER2-negative locally advanced or metastatic breast cancer in the United States in November 2023 and in Japan in March 2024.

Truqap generated sales of $50 million in the first quarter of 2024 and $6 million in the fourth quarter of 2023. The latest approval in the EU should boost the drug’s sales in the upcoming quarters.

Truqap is also being evaluated in various other late-stage studies for treating breast cancer and in combination with other therapies for treating prostate cancer.

Earlier this week, AZN announced data from the phase III CAPItello-290 study, which investigated the safety and efficacy of Truqap in combination with paclitaxel (chemotherapy) versus placebo in combination with paclitaxel for the first-line treatment of patients with locally advanced (inoperable) or metastatic triple-negative breast cancer. The study failed to meet its dual primary endpoints.

Zacks Rank & Stocks to Consider

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

Some better-ranked stocks in the healthcare sector are Acrivon Therapeutics, Inc. ACRV, Aligos Therapeutics, Inc. ALGS and RAPT Therapeutics, Inc. RAPT, 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 Acrivon Therapeutics’ 2024 loss per share have narrowed from $3.30 to $2.47. Loss per share estimates for 2025 have narrowed from $3.13 to $2.55. Year to date, shares of ACRV have surged 34.8%.

ACRV’s earnings beat estimates in three of the trailing four quarters and missed the same on the remaining one occasion, the average surprise being 3.56%.

In the past 60 days, estimates for Aligos Therapeutics’ 2024 loss per share have narrowed from 84 cents to 73 cents, while loss per share estimates for 2025 have narrowed from 82 cents to 71 cents. Year to date, shares of ALGS have declined 36.7%.

Aligos Therapeutics’ earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, the average surprise being 7.83%.

In the past 60 days, estimates for RAPT Therapeutics’ 2024 loss per share have narrowed from $3.19 to $2.93. Loss per share estimates for 2025 have narrowed from $2.40 to $2.05. Year to date, shares of RAPT have plunged 87.2%.

RAPT’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 3.19%.

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AstraZeneca PLC (AZN) : Free Stock Analysis Report

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Aligos Therapeutics, Inc. (ALGS) : Free Stock Analysis Report

Acrivon Therapeutics, Inc. (ACRV) : Free Stock Analysis Report

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