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Pfizer (PFE - Free Report) announced that its regulatory submissions in the United States and European Union (EU) seeking approval for etrasimod to treat moderately-to-severely active ulcerative colitis (UC) have been accepted for review.
While a final decision of the FDA is expected in second-half 2023, a decision from the European Medicines Agency (EMA) is anticipated in first-half 2024.
The regulatory filings for etrasimod in both markets are based on data from two pivotal phase III studies, ELEVATE UC 52 and ELEVATE 12. These studies evaluated the safety and efficacy of a daily 2mg dose of oral etrasimod in UC patients who had failed treatment with a JAK inhibitor. Both studies achieved their primary endpoint of clinical remission over placebo and all key secondary endpoints.
Shares of Pfizer have lost 12.5% in the year against the industry’s 11.0% rise.
Image Source: Zacks Investment Research
A sphingosine 1-phosphate (S1P) receptor modulator, etrasimod, is being evaluated in multiple clinical stages for immuno-inflammatory indications. Apart from UC, etrasimod is being studied across multiple gastroenterology and dermatology indications, including atopic dermatitis, eosinophilic esophagitis, Crohn’s disease and alopecia areata.
If approved by the FDA, etrasimod will face competition from Bristol-Myers’ (BMY - Free Report) S1P receptor modulator, Zeposia, which was approved as an oral medicine for treating moderately to severely active UC last year. Bristol Myers’ Zeposia is also approved for treating adults with relapsing forms of multiple sclerosis. The Bristol-Myers drug is also approved for indications in the EU.
S1P receptor modulators like etrasimod and Bristol-Myers’ Zeposia represent a different mechanism of action than available UC therapies and represent a new treatment option that can provide symptom relief and remission to patients.
Etrasimod was added to Pfizer’s inflammation and immunology pipeline with the acquisition of Arena Pharmaceuticals, which was completed earlier this year in March. The addition of etrasimod helped Pfizer develop a new drug with a different mechanism of action than its currently approved drugs for inflammatory indications. Last year, Pfizer faced a regulatory setback when the FDA asked to add warnings on the label of its key immuno-inflammatory drug Xeljanz about an increased risk of serious heart-related events, cancer, blood clots and even death.
Pfizer currently carries a Zacks Rank #3 (Hold).A couple of better-ranked stocks in the overall healthcare sector include Kamada and Sanofi (SNY - Free Report) . While Kamada sports a Zacks Rank #1 (Strong Buy), Sanofi carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Kamada’s 2022 loss per share have narrowed from 14 cents to 7 cents. During the same period, the earnings estimates per share for 2023 have risen from 26 cents to 42 cents. Shares of Kamada have declined 38.2% in the year-to-date period.
Earnings of Kamada beat estimates in two of the last four quarters and missed the mark twice, witnessing a negative earnings surprise of 62.50%, on average. In the last reported quarter, Kamada’s earnings beat estimates by 433.33%.
In the past 60 days, estimates for Sanofi’s 2022 earnings per share have risen from $4.02 to $4.27. During the same period, the earnings estimates per share for 2023 have risen from $4.22 to $4.31. Shares of Sanofi have declined 3.7% in the year-to-date period.
Earnings of Sanofi beat estimates in each of the last four quarters, witnessing an earnings surprise of 9.50%, on average. In the last reported quarter, Sanofi’s earnings beat estimates by 9.85%.
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Pfizer's (PFE) Etrasimod Filings Receive Review Acceptance
Pfizer (PFE - Free Report) announced that its regulatory submissions in the United States and European Union (EU) seeking approval for etrasimod to treat moderately-to-severely active ulcerative colitis (UC) have been accepted for review.
While a final decision of the FDA is expected in second-half 2023, a decision from the European Medicines Agency (EMA) is anticipated in first-half 2024.
The regulatory filings for etrasimod in both markets are based on data from two pivotal phase III studies, ELEVATE UC 52 and ELEVATE 12. These studies evaluated the safety and efficacy of a daily 2mg dose of oral etrasimod in UC patients who had failed treatment with a JAK inhibitor. Both studies achieved their primary endpoint of clinical remission over placebo and all key secondary endpoints.
Shares of Pfizer have lost 12.5% in the year against the industry’s 11.0% rise.
Image Source: Zacks Investment Research
A sphingosine 1-phosphate (S1P) receptor modulator, etrasimod, is being evaluated in multiple clinical stages for immuno-inflammatory indications. Apart from UC, etrasimod is being studied across multiple gastroenterology and dermatology indications, including atopic dermatitis, eosinophilic esophagitis, Crohn’s disease and alopecia areata.
If approved by the FDA, etrasimod will face competition from Bristol-Myers’ (BMY - Free Report) S1P receptor modulator, Zeposia, which was approved as an oral medicine for treating moderately to severely active UC last year. Bristol Myers’ Zeposia is also approved for treating adults with relapsing forms of multiple sclerosis. The Bristol-Myers drug is also approved for indications in the EU.
S1P receptor modulators like etrasimod and Bristol-Myers’ Zeposia represent a different mechanism of action than available UC therapies and represent a new treatment option that can provide symptom relief and remission to patients.
Etrasimod was added to Pfizer’s inflammation and immunology pipeline with the acquisition of Arena Pharmaceuticals, which was completed earlier this year in March. The addition of etrasimod helped Pfizer develop a new drug with a different mechanism of action than its currently approved drugs for inflammatory indications. Last year, Pfizer faced a regulatory setback when the FDA asked to add warnings on the label of its key immuno-inflammatory drug Xeljanz about an increased risk of serious heart-related events, cancer, blood clots and even death.
Pfizer Inc. Price
Pfizer Inc. price | Pfizer Inc. Quote
Zacks Rank & Stocks to Consider
Pfizer currently carries a Zacks Rank #3 (Hold).A couple of better-ranked stocks in the overall healthcare sector include Kamada and Sanofi (SNY - Free Report) . While Kamada sports a Zacks Rank #1 (Strong Buy), Sanofi carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Kamada’s 2022 loss per share have narrowed from 14 cents to 7 cents. During the same period, the earnings estimates per share for 2023 have risen from 26 cents to 42 cents. Shares of Kamada have declined 38.2% in the year-to-date period.
Earnings of Kamada beat estimates in two of the last four quarters and missed the mark twice, witnessing a negative earnings surprise of 62.50%, on average. In the last reported quarter, Kamada’s earnings beat estimates by 433.33%.
In the past 60 days, estimates for Sanofi’s 2022 earnings per share have risen from $4.02 to $4.27. During the same period, the earnings estimates per share for 2023 have risen from $4.22 to $4.31. Shares of Sanofi have declined 3.7% in the year-to-date period.
Earnings of Sanofi beat estimates in each of the last four quarters, witnessing an earnings surprise of 9.50%, on average. In the last reported quarter, Sanofi’s earnings beat estimates by 9.85%.