Seagen Inc. , along with partner Astellas Pharma Inc., announced that the European Commission (“EC”) has approved their antibody-drug conjugate ("ADC"), Padcev (enfortumab vedotin), as a monotherapy for the treatment of locally advanced/metastatic urothelial cancer in adult patients having previously received a platinum-containing chemotherapy and a PD-1/L1 inhibitor.
Following the latest nod, enfortumab vedotin became the first ADC approved in Europe for people living with urothelial cancer, the most common type of bladder cancer.
The EC’s approval was based on data from the phase III EV-301 study, which evaluated enfortumab vedotin versus chemotherapy in patients similar to those mentioned above.
Data from the study showed that treatment with enfortumab vedotin demonstrated an overall survival benefit as compared with chemotherapy.
In February 2022, the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) confirmed its previously adopted positive opinion, recommending marketing authorization to Padcev. The CHMP recommended approval of Padcev as a monotherapy for the treatment of patients similar to those mentioned above. In December 2021, the CHMP rendered a positive opinion on and recommended marketing authorization to Padcev for the given indication.
Shares of Seagen have lost 4.6% so far this year compared with the industry’s decrease of 13.9%.
In December 2019, FDA had granted accelerated approval to Padcev for the treatment of patients with advanced/metastatic urothelial cancer who had received treatment with both a checkpoint inhibitor (PD-1/PD-L1) and platinum-based chemotherapy.
In July 2021, the FDA approved two supplemental biologics license applications (sBLA) seeking label expansion for Padcev.
The first sBLA approval converts Padcev’s accelerated approval to regular approval in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. The second sBLA approval makes Padcev the first and only FDA-approved drug to treat patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and are not eligible for cisplatin.
In 2021, Padcev generated sales worth $339.9 million, reflecting an increase of 53% year over year. The nod in Europe is likely to boost sales of the drug in 2022 and beyond.
Seagen is also investigating Padcev in combination with Merck’s (MRK - Free Report) PD-L1 inhibitor, Keytruda, in several mid-stage studies in first- and second-line metastatic urothelial cancer, as well as in muscle-invasive bladder cancer.
Merck’s biggest revenue generator, Keytruda, is approved for treating several types of cancer indications. MRK is also studying the drug for yet more types of cancer indications.
Zacks Rank & Stocks to Consider
Seagen currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector are Aligos Therapeutics, Inc. (ALGS - Free Report) and Voyager Therapeutics, Inc. (VYGR - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The Zacks Consensus Estimate for Aligos Therapeutics’ loss per share has narrowed 15.1% for 2022 and 45.7% for 2023 over the past 60 days.
Earnings of ALGS surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.
Voyager Therapeutics’ loss per share estimates have narrowed 38.6% for 2022 and 29% for 2023 over the past 60 days. The VYGR stock has skyrocketed 221.8% year to date.
Earnings of Voyager Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.
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Seagen Inc. , along with partner Astellas Pharma Inc., announced that the European Commission (“EC”) has approved their antibody-drug conjugate ("ADC"), Padcev (enfortumab vedotin), as a monotherapy for the treatment of locally advanced/metastatic urothelial cancer in adult patients having previously received a platinum-containing chemotherapy and a PD-1/L1 inhibitor.
Following the latest nod, enfortumab vedotin became the first ADC approved in Europe for people living with urothelial cancer, the most common type of bladder cancer.
The EC’s approval was based on data from the phase III EV-301 study, which evaluated enfortumab vedotin versus chemotherapy in patients similar to those mentioned above.
Data from the study showed that treatment with enfortumab vedotin demonstrated an overall survival benefit as compared with chemotherapy.
In February 2022, the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) confirmed its previously adopted positive opinion, recommending marketing authorization to Padcev. The CHMP recommended approval of Padcev as a monotherapy for the treatment of patients similar to those mentioned above. In December 2021, the CHMP rendered a positive opinion on and recommended marketing authorization to Padcev for the given indication.
Shares of Seagen have lost 4.6% so far this year compared with the industry’s decrease of 13.9%.
In December 2019, FDA had granted accelerated approval to Padcev for the treatment of patients with advanced/metastatic urothelial cancer who had received treatment with both a checkpoint inhibitor (PD-1/PD-L1) and platinum-based chemotherapy.
In July 2021, the FDA approved two supplemental biologics license applications (sBLA) seeking label expansion for Padcev.
The first sBLA approval converts Padcev’s accelerated approval to regular approval in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. The second sBLA approval makes Padcev the first and only FDA-approved drug to treat patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and are not eligible for cisplatin.
In 2021, Padcev generated sales worth $339.9 million, reflecting an increase of 53% year over year. The nod in Europe is likely to boost sales of the drug in 2022 and beyond.
Seagen is also investigating Padcev in combination with Merck’s (MRK - Free Report) PD-L1 inhibitor, Keytruda, in several mid-stage studies in first- and second-line metastatic urothelial cancer, as well as in muscle-invasive bladder cancer.
Merck’s biggest revenue generator, Keytruda, is approved for treating several types of cancer indications. MRK is also studying the drug for yet more types of cancer indications.
Zacks Rank & Stocks to Consider
Seagen currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector are Aligos Therapeutics, Inc. (ALGS - Free Report) and Voyager Therapeutics, Inc. (VYGR - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The Zacks Consensus Estimate for Aligos Therapeutics’ loss per share has narrowed 15.1% for 2022 and 45.7% for 2023 over the past 60 days.
Earnings of ALGS surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.
Voyager Therapeutics’ loss per share estimates have narrowed 38.6% for 2022 and 29% for 2023 over the past 60 days. The VYGR stock has skyrocketed 221.8% year to date.
Earnings of Voyager Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.
Just Released: Zacks Top 10 Stocks for 2024
Hurry – you can still get in early on our 10 top tickers for 2024. Hand-picked by Zacks Director of Research, Sheraz Mian, this portfolio has been stunningly and consistently successful. From inception in 2012 through November, 2023, the Zacks Top 10 Stocks gained +974.1%, nearly TRIPLING the S&P 500’s +340.1%. Sheraz has combed through 4,400 companies covered by the Zacks Rank and handpicked the best 10 to buy and hold in 2024. You can still be among the first to see these just-released stocks with enormous potential.
See New Top 10 Stocks >>
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