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AstraZeneca (AZN) Imfinzi Gets FDA Nod for Biliary Tract Cancer

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AstraZeneca (AZN - Free Report) announced that the FDA has approved its PD-L1 inhibitor, Imfinzi plus chemotherapy for treating locally advanced or metastatic biliary tract cancer (BTC).

The approval was based on data from the TOPAZ-1 phase III study, which showed that Imfinzi plus chemotherapy led to a 20% reduction in the risk of death versus chemotherapy alone.

Imfinzi plus chemotherapy (gemcitabine plus cisplatin) becomes the first immunotherapy regimen to be approved for this group of rare and aggressive cancers that occur in the bile ducts and gallbladder. Patients with BTC have historically faced a poor prognosis, creating the need for more effective treatment options. The approval of Imfinzi plus chemo offers a new treatment option that meaningfully extends survival.

This year so far, AstraZeneca’s shares have risen 4.2% against a decrease of 4.8% for the industry.


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Imfinzi is presently approved for unresectable, stage III non-small-cell lung cancer (NSCLC) and first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Imfinzi is also being evaluated for multiple cancers, either alone or in combination with other regimens, including phase III studies in earlier settings in NSCLC and SCLC, bladder cancer, several GI cancers, ovarian cancer, endometrial cancer, and other solid tumors. Regulatory applications seeking approval for Imfinzi in combination with tremelimumab in advanced hepatocellular carcinoma (HCC, liver cancer) are under priority review with the FDA, with a decision expected this year.

Imfinzi recorded sales of $1.29 billion in the first half of 2022, up 16% at a constant exchange rate. The approval for expanded use in BTC should further boost sales in future quarters.

Zacks Rank & Stocks to Consider

AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Some better-ranked stocks in the same sector are Morphic (MORF - Free Report) , Sesen Bio (SESN - Free Report) and Agenus (AGEN - Free Report) , all carrying a Zacks Rank #1 at present.

In the past 30 days, estimates for Morphic’s 2022 loss per share have narrowed from $2.38 to $1.75. Loss estimates for 2023 have narrowed from $3.87 to $3.77 during the same period. Shares of Morphic have lost 40.2% in the year-to-date period.

Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average.

Estimates for Sesen Bio for 2023 have narrowed from a loss of 27 cents per share to a loss of 1 cent per share over the past 30 days. Shares of Sesen Bio have declined 19% this year so far.

Earnings of Sesen Bio beat estimates in all the last four quarters, delivering a four-quarter surprise of 89.49%, on average.

Estimates for Agenus’ 2022 bottom line have narrowed from a loss of 89 cents to 70 cents in the past 30 days. Loss estimates for 2023 have narrowed from 64 cents per share to 60 cents per share over the same time frame. Agenus’ stock is down 20.2% in the year-to-date period.

Earnings of Agenus beat estimates in three of the last four quarters while missing in one. The stock delivered a four-quarter average negative surprise of 12.02%.

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