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.
AstraZeneca/Merck's Lynparza Gets FDA Nod for Label Expansion
Read MoreHide Full Article
AstraZeneca, plc (AZN - Free Report) and partner Merck & Co., Inc. (MRK - Free Report) announced that the FDA has approved a new tablet formulation for ovarian cancer drug, Lynparza while also broadening its U.S. label.
AstraZeneca’s shares are up 11.5% so far this year, comparing unfavorably with an increase of 13.7% for the industry.
The FDA has approved expansion of Lynparza’s (tablets) label to include maintenance treatment of patients suffering from platinum-sensitive recurrent ovarian cancer regardless of BRCA-mutation status.
Meanwhile, the FDA also approved a new tablet formulation (2 tablets twice daily) of the PARP inhibitor as opposed to capsules (8 capsules twice daily), which should improve patient convenience.
Lynparza’s accelerated approval for BRCA-mutated ovarian cancer beyond the third-line setting was also converted to a regular approval. We remind investors that Lynparza was first approved by the FDA on an accelerated approval basis in Dec 2014, as a capsule formulation.
The label expansion strengthens Lynparza’s position in the PARP inhibitor market where competition has become fierce with Clovis Oncology, Inc.’s Rubraca, launched in Dec 2016, and Tesaro, Inc.’s Zejula (niraparib), available from Apr 2017. Shares of both these small biotechs were down on Thursday following the news.
Lynparza is also being evaluated in different studies for a range of tumor types including breast, prostate and pancreatic cancers as well as earlier-line settings for ovarian cancer.
AstraZeneca announced an oncology collaboration with Merck last month to commercialize and develop Lynparza, both as monotherapy and in combination studies for multiple cancer types. The companies will share development and marketing costs equally and also the profits from Lynparza.
Tech stocks have been a major force behind the market’s record highs, but picking the best ones to buy can be tough. There’s a simple way to invest in the success of the entire sector. Zacks has just released a Special Report revealing one thing tech companies literally cannot function without. More importantly, it reveals 4 top stocks set to skyrocket on increasing demand for these devices. I encourage you to get the report now – before the next wave of innovations really takes off.
Image: Bigstock
AstraZeneca/Merck's Lynparza Gets FDA Nod for Label Expansion
AstraZeneca, plc (AZN - Free Report) and partner Merck & Co., Inc. (MRK - Free Report) announced that the FDA has approved a new tablet formulation for ovarian cancer drug, Lynparza while also broadening its U.S. label.
AstraZeneca’s shares are up 11.5% so far this year, comparing unfavorably with an increase of 13.7% for the industry.
The FDA has approved expansion of Lynparza’s (tablets) label to include maintenance treatment of patients suffering from platinum-sensitive recurrent ovarian cancer regardless of BRCA-mutation status.
Meanwhile, the FDA also approved a new tablet formulation (2 tablets twice daily) of the PARP inhibitor as opposed to capsules (8 capsules twice daily), which should improve patient convenience.
Lynparza’s accelerated approval for BRCA-mutated ovarian cancer beyond the third-line setting was also converted to a regular approval. We remind investors that Lynparza was first approved by the FDA on an accelerated approval basis in Dec 2014, as a capsule formulation.
The label expansion strengthens Lynparza’s position in the PARP inhibitor market where competition has become fierce with Clovis Oncology, Inc.’s Rubraca, launched in Dec 2016, and Tesaro, Inc.’s Zejula (niraparib), available from Apr 2017. Shares of both these small biotechs were down on Thursday following the news.
Lynparza is also being evaluated in different studies for a range of tumor types including breast, prostate and pancreatic cancers as well as earlier-line settings for ovarian cancer.
AstraZeneca announced an oncology collaboration with Merck last month to commercialize and develop Lynparza, both as monotherapy and in combination studies for multiple cancer types. The companies will share development and marketing costs equally and also the profits from Lynparza.
AstraZeneca carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
4 Surprising Tech Stocks to Keep an Eye on
Tech stocks have been a major force behind the market’s record highs, but picking the best ones to buy can be tough. There’s a simple way to invest in the success of the entire sector. Zacks has just released a Special Report revealing one thing tech companies literally cannot function without. More importantly, it reveals 4 top stocks set to skyrocket on increasing demand for these devices. I encourage you to get the report now – before the next wave of innovations really takes off.
See Stocks Now>>