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Pfizer's (PFE) Ulcerative Colitis Pill Velsipity Gets EU Nod
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Pfizer (PFE - Free Report) announced that the European Commission has granted marketing approval to its oral, once-daily pill called Velsipity (etrasimod) to treat moderately to severely active ulcerative colitis (UC).
The approval for the oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator (2 mg dose) is for UC patients who are 16 years of age and older and who have had an inadequate response, lost response, or were intolerant to either conventional therapy or injectable therapies like biologics.
The approval was expected in December 2023 as the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had given a positive opinion recommending its approval. The FDA had approved Velsipity (etrasimod) for UC in October 2023.
Velsipity’s approval was 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 at least one conventional, biologic or a JAK inhibitor. Both studies achieved their primary endpoint of clinical remission over placebo and all key secondary endpoints.
Velsipity (etrasimod) was added to Pfizer’s inflammation and immunology portfolio with the March 2022 acquisition of Arena Pharmaceuticals.
The oral, once-daily pill for UC, a chronic condition, is the only advanced therapy approved for use in patients 16 years of age or older in the EU.
Pfizer’s stock has declined 36.1% in the past year against an increase of 28.3% for the industry.
Image Source: Zacks Investment Research
Velsipity and Pfizer’s other new products, Abrysvo RSV vaccine, Penbraya pentavalent meningococcal vaccine and Zavzpret nasal spray for migraine, among others, are the key to reviving its growth. With the end of the pandemic, sales of Pfizer’s COVID-19 products declined steeply in 2023. Nonetheless, Pfizer expects better non-COVID operational revenue growth in the future quarters, driven by its in-line products like the Vyndaqel family, new launches like Abrysvo, Velsipity, Penbraya, Zavzpret and newly acquired products like Nurtec as well as those acquired from Seagen.
The December 2023 acquisition of Seagen has strengthened Pfizer’s portfolio of cancer drugs by adding four antibody-drug conjugates or ADCs — Adcetris, Padcev, Tukysa and Tivdak. ADCs are considered a disruptive innovation in the pharmaceutical industry as these will enable better treatment of cancer by harnessing the targeting power of antibodies to deliver cytotoxic molecule drugs to tumors.
In the past 60 days, estimates for Puma Biotechnology’s 2024 earnings per share have improved from 64 cents to 69 cents. In the past year, shares of PBYI have risen 63.1%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same once. PBYI delivered a four-quarter average earnings surprise of 76.55%.
In the past 60 days, estimates for AC Immune’s 2024 loss per share have narrowed from 58 cents to 54 cents. In the past year, shares of ACIU have risen 29.1%.
AC Immune delivered a four-quarter average earnings surprise of 6.15%.
In the past 60 days, earnings estimates for ADMA Biologics for 2024 have increased from 16 cents to 22 cents. In the past year, shares of ADMA have surged 45.5%.
ADMA Biologics beat estimates in three of the last four quarters and delivered in-line results on the remaining occasion. ADMA delivered a four-quarter earnings surprise of 63.57%, on average.
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Pfizer's (PFE) Ulcerative Colitis Pill Velsipity Gets EU Nod
Pfizer (PFE - Free Report) announced that the European Commission has granted marketing approval to its oral, once-daily pill called Velsipity (etrasimod) to treat moderately to severely active ulcerative colitis (UC).
The approval for the oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator (2 mg dose) is for UC patients who are 16 years of age and older and who have had an inadequate response, lost response, or were intolerant to either conventional therapy or injectable therapies like biologics.
The approval was expected in December 2023 as the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had given a positive opinion recommending its approval. The FDA had approved Velsipity (etrasimod) for UC in October 2023.
Velsipity’s approval was 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 at least one conventional, biologic or a JAK inhibitor. Both studies achieved their primary endpoint of clinical remission over placebo and all key secondary endpoints.
Velsipity (etrasimod) was added to Pfizer’s inflammation and immunology portfolio with the March 2022 acquisition of Arena Pharmaceuticals.
The oral, once-daily pill for UC, a chronic condition, is the only advanced therapy approved for use in patients 16 years of age or older in the EU.
Pfizer’s stock has declined 36.1% in the past year against an increase of 28.3% for the industry.
Image Source: Zacks Investment Research
Velsipity and Pfizer’s other new products, Abrysvo RSV vaccine, Penbraya pentavalent meningococcal vaccine and Zavzpret nasal spray for migraine, among others, are the key to reviving its growth. With the end of the pandemic, sales of Pfizer’s COVID-19 products declined steeply in 2023. Nonetheless, Pfizer expects better non-COVID operational revenue growth in the future quarters, driven by its in-line products like the Vyndaqel family, new launches like Abrysvo, Velsipity, Penbraya, Zavzpret and newly acquired products like Nurtec as well as those acquired from Seagen.
The December 2023 acquisition of Seagen has strengthened Pfizer’s portfolio of cancer drugs by adding four antibody-drug conjugates or ADCs — Adcetris, Padcev, Tukysa and Tivdak. ADCs are considered a disruptive innovation in the pharmaceutical industry as these will enable better treatment of cancer by harnessing the targeting power of antibodies to deliver cytotoxic molecule drugs to tumors.
Zacks Rank and Stocks to Consider
Pfizer currently has a Zacks Rank #3 (Hold).
Pfizer Inc. Price and Consensus
Pfizer Inc. price-consensus-chart | Pfizer Inc. Quote
Some better-ranked stocks in the healthcare sector are Puma Biotechnology (PBYI - Free Report) , AC Immune (ACIU - Free Report) and ADMA Biologics (ADMA - Free Report) . While Puma Biotechnology sports a Zacks Rank #1 (Strong Buy), AC Immune and ADMA Biologics have a Zacks Rank of 2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Puma Biotechnology’s 2024 earnings per share have improved from 64 cents to 69 cents. In the past year, shares of PBYI have risen 63.1%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same once. PBYI delivered a four-quarter average earnings surprise of 76.55%.
In the past 60 days, estimates for AC Immune’s 2024 loss per share have narrowed from 58 cents to 54 cents. In the past year, shares of ACIU have risen 29.1%.
AC Immune delivered a four-quarter average earnings surprise of 6.15%.
In the past 60 days, earnings estimates for ADMA Biologics for 2024 have increased from 16 cents to 22 cents. In the past year, shares of ADMA have surged 45.5%.
ADMA Biologics beat estimates in three of the last four quarters and delivered in-line results on the remaining occasion. ADMA delivered a four-quarter earnings surprise of 63.57%, on average.