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.
Seagen (SGEN), Astellas Submit 2 sBLAs to FDA for Urothelial Cancer
Read MoreHide Full Article
Seagen Inc. and its Japanese partner, Astellas Pharma Inc., announced the completion of submissions of two supplemental biologics license applications (sBLAs) to the FDA for Padcev (enfortumabvedotin-ejfv). One of the sBLA seeks to convert Padcev’s accelerated approval to regular approval in adult patients with locally advanced or metastatic urothelial cancer who were previously treated withplatinum-based chemotherapy and a PD-1/PD-L1 inhibitor. The second submission requests an expansion of the current label to include 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.
Shares of the company have increased 34% in the past year compared with the industry’s growth of 12.6%.
The first application is based on data from the phase III EV-301 confirmatory study (NCT03474107).The study compared Padcevwith chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated withplatinum-based chemotherapy and a PD-1/PD-L1 inhibitor. The study’s primary endpoint was the overall survival (OS) of patients treated with Padcev versus chemotherapy.
The second submission, for a label expansion in the United States, was based on results from the second cohort of EV-201 (NCT03219333). The pivotal phase II study is evaluating Padcev in patients with locally advanced or metastatic urothelial cancer who had received prior immunotherapy treatment but were not eligible for cisplatin. The study’s primary endpoint was the objective response rate.
We remind investors that in December 2019, the FDA 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. Following this nod, Padcev became the first FDA-approved drug for treating the given patient population.
Padcev is an antibody-drug conjugate (ADC) targeting Nectin-4, a cell adhesion molecule expressed in many solid tumors.
Acorda’s loss per share estimates have narrowed from $9.66 to $7.91 for 2020 over the past 60 days.
Atea’s earnings per share estimates have increased from $3.53 to $3.70 for 2021 over the past 60 days. Shares of the company have increased 174.9% in the past year.
Clearside’s loss per share estimates have narrowed from 38 cents to 28 cents for 2021 over the past 60 days. Shares of the company have increased 25.3% in the past year.
The COVID-19 outbreak has shifted consumer behavior dramatically, and a handful of high-tech companies have stepped up to keep America running. Right now, investors in these companies have a shot at serious profits. For example, Zoom jumped 108.5% in less than 4 months while most other stocks were sinking. Our research shows that 5 cutting-edge stocks could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of this decade, especially for those who get in early.
Image: Bigstock
Seagen (SGEN), Astellas Submit 2 sBLAs to FDA for Urothelial Cancer
Seagen Inc. and its Japanese partner, Astellas Pharma Inc., announced the completion of submissions of two supplemental biologics license applications (sBLAs) to the FDA for Padcev (enfortumabvedotin-ejfv). One of the sBLA seeks to convert Padcev’s accelerated approval to regular approval in adult patients with locally advanced or metastatic urothelial cancer who were previously treated withplatinum-based chemotherapy and a PD-1/PD-L1 inhibitor. The second submission requests an expansion of the current label to include 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.
Shares of the company have increased 34% in the past year compared with the industry’s growth of 12.6%.
The first application is based on data from the phase III EV-301 confirmatory study (NCT03474107).The study compared Padcevwith chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated withplatinum-based chemotherapy and a PD-1/PD-L1 inhibitor. The study’s primary endpoint was the overall survival (OS) of patients treated with Padcev versus chemotherapy.
The second submission, for a label expansion in the United States, was based on results from the second cohort of EV-201 (NCT03219333). The pivotal phase II study is evaluating Padcev in patients with locally advanced or metastatic urothelial cancer who had received prior immunotherapy treatment but were not eligible for cisplatin. The study’s primary endpoint was the objective response rate.
We remind investors that in December 2019, the FDA 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. Following this nod, Padcev became the first FDA-approved drug for treating the given patient population.
Padcev is an antibody-drug conjugate (ADC) targeting Nectin-4, a cell adhesion molecule expressed in many solid tumors.
Zacks Rank & Stocks to Consider
Seagencurrently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the healthcare sector include Acorda Therapeutics Inc. , Atea Pharmaceuticals Inc. (AVIR - Free Report) and Clearside Biomedical Inc. (CLSD - Free Report) . All carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Acorda’s loss per share estimates have narrowed from $9.66 to $7.91 for 2020 over the past 60 days.
Atea’s earnings per share estimates have increased from $3.53 to $3.70 for 2021 over the past 60 days. Shares of the company have increased 174.9% in the past year.
Clearside’s loss per share estimates have narrowed from 38 cents to 28 cents for 2021 over the past 60 days. Shares of the company have increased 25.3% in the past year.
Seagen Inc. Price
Seagen Inc. price | Seagen Inc. Quote
These Stocks Are Poised to Soar Past the Pandemic
The COVID-19 outbreak has shifted consumer behavior dramatically, and a handful of high-tech companies have stepped up to keep America running. Right now, investors in these companies have a shot at serious profits. For example, Zoom jumped 108.5% in less than 4 months while most other stocks were sinking. Our research shows that 5 cutting-edge stocks could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of this decade, especially for those who get in early.
See the 5 high-tech stocks now>>