We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Pfizer (PFE) Stock Rises on FDA Nod for Expanded Use of Padcev
Read MoreHide Full Article
Pfizer’s (PFE - Free Report) shares were up around 1.6% on Monday after the FDA approved the expanded use of Padcev, an antibody-drug conjugate (ADC) added from its recently closed acquisition of Seagen.
The FDA approved Padcev in combination with Merck’s (MRK - Free Report) Keytruda for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC). This marked the first approval for a combination of an ADC product plus PD-L1 inhibitor for the treatment of advanced bladder cancer, offering an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC, for years.
Antibody-drug conjugates are considered a disruptive innovation in the pharmaceutical industry as these are expected to enable better treatment of cancer by harnessing the targeting power of antibodies to deliver cytotoxic molecule drugs to tumors. These are poised to replace chemotherapy in many tumor types.
The approval was based on data from the phase III EV-302 (also known as KEYNOTE-A39) study. Data from the study showed that Padcev plus Keytruda nearly doubled the median overall survival (OS) and median progression-free survival (PFS) in the abovementioned advanced bladder cancer patient group compared to platinum-containing chemotherapy. Treatment with the combination led to a 53% reduction in the risk of death (OS) and a 55% reduction in the risk of cancer progression or death (PFS). Pfizer believes the survival benefit seen in the study shows the potential of Padcev plus Keytruda for the first-line treatment of patients with la/mUC.
At present, Padcev, in combination with Keytruda, is approved, on an accelerated basis, for treating la/mUC in adult patients who are not eligible to receive cisplatin-containing chemotherapy. The EV-302 study was the confirmatory study for converting this accelerated approval to full approval. With the latest approval, Padcev in combination with Keytruda is eligible for expanded use in patients with la/mUC who are eligible to receive cisplatin chemotherapy.
Pfizer’s stock has declined 47.3% so far this year against an increase of 3.9% for the industry.
Image Source: Zacks Investment Research
Pfizer’s acquisition of Seagen closed on Dec 14. Pfizer had offered to buy cancer drugmaker Seagen for approximately $43 billion in March. Seagen’s acquisition has strengthened Pfizer’s portfolio of cancer drugs by adding a class of ADCs. Seagen is a pioneer in ADC technology. Seagen currently markets four cancer drugs — Adcetris, Padcev, Tukysa and Tivdak. Pfizer expects the acquisition to double the size of its early-stage oncology pipeline over the long term. In 2024, Pfizer expects revenues of $3.1 billion from Seagen.
Estimates for Novo Nordisk’s 2023 earnings per share have increased from $2.57 to $2.61 over the past 60 days. Estimates for 2024 have jumped from $2.99 per share to $3.10 over the same timeframe. NVO’s stock has surged 46.3% year to date.
Earnings of Novo Nordisk beat estimates in two of the last four quarters, missed in one and matched estimates in one, delivering an earnings surprise of 0.58% on average.
Estimates for Puma Biotech’s 2023 earnings per share have increased from 67 cents to 72 cents over the past 60 days. Estimates for 2024 have jumped from 56 cents per share to 64 cents over the same timeframe. PBYI’s stock has declined 6.7% year to date.
Earnings of Puma Biotech beat estimates in three of the last four quarters and missed in one, delivering an earnings surprise of 76.55% on average.
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Pfizer (PFE) Stock Rises on FDA Nod for Expanded Use of Padcev
Pfizer’s (PFE - Free Report) shares were up around 1.6% on Monday after the FDA approved the expanded use of Padcev, an antibody-drug conjugate (ADC) added from its recently closed acquisition of Seagen.
The FDA approved Padcev in combination with Merck’s (MRK - Free Report) Keytruda for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC). This marked the first approval for a combination of an ADC product plus PD-L1 inhibitor for the treatment of advanced bladder cancer, offering an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC, for years.
Antibody-drug conjugates are considered a disruptive innovation in the pharmaceutical industry as these are expected to enable better treatment of cancer by harnessing the targeting power of antibodies to deliver cytotoxic molecule drugs to tumors. These are poised to replace chemotherapy in many tumor types.
The approval was based on data from the phase III EV-302 (also known as KEYNOTE-A39) study. Data from the study showed that Padcev plus Keytruda nearly doubled the median overall survival (OS) and median progression-free survival (PFS) in the abovementioned advanced bladder cancer patient group compared to platinum-containing chemotherapy. Treatment with the combination led to a 53% reduction in the risk of death (OS) and a 55% reduction in the risk of cancer progression or death (PFS). Pfizer believes the survival benefit seen in the study shows the potential of Padcev plus Keytruda for the first-line treatment of patients with la/mUC.
At present, Padcev, in combination with Keytruda, is approved, on an accelerated basis, for treating la/mUC in adult patients who are not eligible to receive cisplatin-containing chemotherapy. The EV-302 study was the confirmatory study for converting this accelerated approval to full approval. With the latest approval, Padcev in combination with Keytruda is eligible for expanded use in patients with la/mUC who are eligible to receive cisplatin chemotherapy.
Pfizer’s stock has declined 47.3% so far this year against an increase of 3.9% for the industry.
Image Source: Zacks Investment Research
Pfizer’s acquisition of Seagen closed on Dec 14. Pfizer had offered to buy cancer drugmaker Seagen for approximately $43 billion in March. Seagen’s acquisition has strengthened Pfizer’s portfolio of cancer drugs by adding a class of ADCs. Seagen is a pioneer in ADC technology. Seagen currently markets four cancer drugs — Adcetris, Padcev, Tukysa and Tivdak. Pfizer expects the acquisition to double the size of its early-stage oncology pipeline over the long term. In 2024, Pfizer expects revenues of $3.1 billion from Seagen.
Zacks Rank & Stocks to Consider
Pfizer currently has a Zacks Rank #3 (Hold).
Some better-ranked drug/biotech companies worth considering are Novo Nordisk (NVO - Free Report) and Puma Biotech (PBYI - Free Report) , sporting a Zacks Rank #1 (Strong Buy) each currently. You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for Novo Nordisk’s 2023 earnings per share have increased from $2.57 to $2.61 over the past 60 days. Estimates for 2024 have jumped from $2.99 per share to $3.10 over the same timeframe. NVO’s stock has surged 46.3% year to date.
Earnings of Novo Nordisk beat estimates in two of the last four quarters, missed in one and matched estimates in one, delivering an earnings surprise of 0.58% on average.
Estimates for Puma Biotech’s 2023 earnings per share have increased from 67 cents to 72 cents over the past 60 days. Estimates for 2024 have jumped from 56 cents per share to 64 cents over the same timeframe. PBYI’s stock has declined 6.7% year to date.
Earnings of Puma Biotech beat estimates in three of the last four quarters and missed in one, delivering an earnings surprise of 76.55% on average.