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Pfizer's (PFE) Ulcerative Colitis Pill Etrasimod Gets FDA Nod
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Pfizer (PFE - Free Report) announced that the FDA has granted approval to its oral, once-daily pill called etrasimod to treat moderately-to-severely active ulcerative colitis (UC). The oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator will be marketed by the brand name of Velsipity (2 mg dose).
The approval for etrasimod 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 a JAK inhibitor. Both studies achieved their primary endpoint of clinical remission over placebo and all key secondary endpoints.
An application seeking the approval of etrasimod is also under review in the EU, with a decision from the European Medicines Agency anticipated in first-half 2024.
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 an advanced therapy, which, if approved, will offer patients an opportunity to achieve steroid-free remission.
Pfizer’s stock has declined 37.4% so far this year against an increase of 8.5% for the industry.
Image Source: Zacks Investment Research
Pfizer is seeing the largest number of new product and indication launches in 2023. Some key new product approvals/launches are Cibinqo for atomic dermatitis, Abrysvo RSV vaccine, Zavzpret nasal spray for migraine, Litfulo (ritlecitinib) for severe alopecia areata, Elrexfio (elranatamab) for relapsed/refractory multiple myeloma and Ngenla for pediatric growth hormone deficiency.
Pfizer believes new products like its RSV vaccine, Velsipity,and its pentavalent meningococcal vaccine (under review in Europe and the United States), coupled with business development activities, including the proposed acquisition of Seagen position Pfizer strongly for operational growth in 2025 and beyond.
Pfizer offered to buy cancer drugmaker Seagen for approximately $43 billion in March. Seagen’s acquisition is expected to strengthen Pfizer’s portfolio of cancer drugs by adding a class of antibody-drug conjugates. The Pfizer/Seagen transaction is expected to be closed in late 2023 or early 2024. Shareholders of Seagen have already approved the deal.
In a separate press release, Pfizer announced that it is slashing its previously issued revenue guidance for 2023 due to lower-than-expected demand for its COVID products, COVID-19 vaccine, Comirnaty and its oral antiviral pill for COVID, Paxlovid.
Pfizer records direct sales and alliance revenues from its partner, BioNTech (BNTX - Free Report) for Comirnaty and product revenues from Paxlovid.
The revenue guidance was lowered from $67.0 to $70.0 billion to $58.0 to $61.0 billion, which includes a $7 billion cut in Paxlovid revenues and a $2 billion reduction in Comirnaty revenues.
With the demand for COVID products coming in lower than expected, Pfizer announced cost cuts, including layoffs, which are expected to deliver targeted savings of at least $3.5 billion. Of this, approximately $1.0 billion is expected to be realized in 2023 and at least $2.5 billion is expected to be realized in 2024. In the third quarter, Pfizer is expected to record a non-cash charge of $5.5 billion as COVID inventory write-offs in cost of goods sold. As a result of lower-than-expected COVID revenues and the inventory write-offs, adjusted EPS is expected in the range of $1.45 to $1.65, down from $3.25 to $3.45 expected previously.
In the past 90 days, the consensus estimate for Alpine Immune Sciences’ 2023 loss has narrowed from $1.43 per share to $1.18 per share, while the same for 2024 has narrowed from $1.73 per share to $1.47 per share. Year to date, shares of Alpine Immune Sciences have rallied 39.6%.
ALPN’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average negative earnings surprise of 79.65%.
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Pfizer's (PFE) Ulcerative Colitis Pill Etrasimod Gets FDA Nod
Pfizer (PFE - Free Report) announced that the FDA has granted approval to its oral, once-daily pill called etrasimod to treat moderately-to-severely active ulcerative colitis (UC). The oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator will be marketed by the brand name of Velsipity (2 mg dose).
The approval for etrasimod 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 a JAK inhibitor. Both studies achieved their primary endpoint of clinical remission over placebo and all key secondary endpoints.
An application seeking the approval of etrasimod is also under review in the EU, with a decision from the European Medicines Agency anticipated in first-half 2024.
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 an advanced therapy, which, if approved, will offer patients an opportunity to achieve steroid-free remission.
Pfizer’s stock has declined 37.4% so far this year against an increase of 8.5% for the industry.
Image Source: Zacks Investment Research
Pfizer is seeing the largest number of new product and indication launches in 2023. Some key new product approvals/launches are Cibinqo for atomic dermatitis, Abrysvo RSV vaccine, Zavzpret nasal spray for migraine, Litfulo (ritlecitinib) for severe alopecia areata, Elrexfio (elranatamab) for relapsed/refractory multiple myeloma and Ngenla for pediatric growth hormone deficiency.
Pfizer believes new products like its RSV vaccine, Velsipity,and its pentavalent meningococcal vaccine (under review in Europe and the United States), coupled with business development activities, including the proposed acquisition of Seagen position Pfizer strongly for operational growth in 2025 and beyond.
Pfizer offered to buy cancer drugmaker Seagen for approximately $43 billion in March. Seagen’s acquisition is expected to strengthen Pfizer’s portfolio of cancer drugs by adding a class of antibody-drug conjugates. The Pfizer/Seagen transaction is expected to be closed in late 2023 or early 2024. Shareholders of Seagen have already approved the deal.
In a separate press release, Pfizer announced that it is slashing its previously issued revenue guidance for 2023 due to lower-than-expected demand for its COVID products, COVID-19 vaccine, Comirnaty and its oral antiviral pill for COVID, Paxlovid.
Pfizer records direct sales and alliance revenues from its partner, BioNTech (BNTX - Free Report) for Comirnaty and product revenues from Paxlovid.
The revenue guidance was lowered from $67.0 to $70.0 billion to $58.0 to $61.0 billion, which includes a $7 billion cut in Paxlovid revenues and a $2 billion reduction in Comirnaty revenues.
With the demand for COVID products coming in lower than expected, Pfizer announced cost cuts, including layoffs, which are expected to deliver targeted savings of at least $3.5 billion. Of this, approximately $1.0 billion is expected to be realized in 2023 and at least $2.5 billion is expected to be realized in 2024. In the third quarter, Pfizer is expected to record a non-cash charge of $5.5 billion as COVID inventory write-offs in cost of goods sold. As a result of lower-than-expected COVID revenues and the inventory write-offs, adjusted EPS is expected in the range of $1.45 to $1.65, down from $3.25 to $3.45 expected previously.
Zacks Rank and Stock to Consider
Pfizer currently has a Zacks Rank #3 (Hold).
Pfizer Inc. Price and Consensus
Pfizer Inc. price-consensus-chart | Pfizer Inc. Quote
A better-ranked drug/biotech company is Alpine Immune Sciences (ALPN - Free Report) , which has 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 90 days, the consensus estimate for Alpine Immune Sciences’ 2023 loss has narrowed from $1.43 per share to $1.18 per share, while the same for 2024 has narrowed from $1.73 per share to $1.47 per share. Year to date, shares of Alpine Immune Sciences have rallied 39.6%.
ALPN’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average negative earnings surprise of 79.65%.