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.
Puma & Medison Team Up to Commercialize Nerlynx in Israel
Read MoreHide Full Article
Puma Biotechnology, Inc. (PBYI - Free Report) and Medison Pharma Ltd — Israel's leading commercial partner for innovative pharmaceuticals — entered into an exclusive agreement to commercialize Puma’sbreast cancer drug Nerlynx (neratinib) in Israel.
Nerlynx received an FDA approval in July 2017 for the extended adjuvant treatment of patients with early-stage HER2 over expressed/amplified breast cancer, who have been previously treated with Roche's (RHHBY - Free Report) Herceptin-based adjuvant therapy. Notably, Nerlynx is the first anti-HER2 treatment to be approved by an extended adjuvant therapy for the indication. It is marketed in the United States in the form of tablets. It is currently not approved for commercialization outside of the United States.
Per the deal, Medison will be responsible for the necessary regulatory approval of Nerlynx in Israel and once approved for commercializing it in Israel. The company plans to file for a marketing authorization for Nerlynx with the Ministry of Health of Israel, and expects to receive regulatory approval during the first half of 2019. On the other hand, Puma will receive upfront and milestone payments and double digit royalties on Nerlynx sales in the region.
However, Puma’s shares have significantly outperformed the industry over a year. The stock has rallied 102.9% compared with the industry’s 7.9% growth.
However, we remind investors that recently, the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency met with Puma to convey that the former will most probably vote against the approval of neratinib at the formal CHMP decision vote scheduled next month. According to CHMP, the benefit risk assessment is unfavorable because the study results are based on evidence from a single pivotal trial.
The company might need to take additional steps to get approval in Europe.
XOMA’s loss per share estimates have narrowed from 99 cents to 42 cents for 2018 in the last 60 days. The company delivered a positive earnings surprise in one of the last four quarters, with an average beat of 47.92%. Share price of the company has skyrocketed 678.3% over a year.
Exelixis’ earnings per share estimates have moved up from 72 cents to 77 cents for 2018 over the last 60 days. The company delivered a positive earnings surprise in the last four quarters, with an average of 572.92%. Share price of the company has surged 68.4% over a year.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
Image: Bigstock
Puma & Medison Team Up to Commercialize Nerlynx in Israel
Puma Biotechnology, Inc. (PBYI - Free Report) and Medison Pharma Ltd — Israel's leading commercial partner for innovative pharmaceuticals — entered into an exclusive agreement to commercialize Puma’sbreast cancer drug Nerlynx (neratinib) in Israel.
Nerlynx received an FDA approval in July 2017 for the extended adjuvant treatment of patients with early-stage HER2 over expressed/amplified breast cancer, who have been previously treated with Roche's (RHHBY - Free Report) Herceptin-based adjuvant therapy. Notably, Nerlynx is the first anti-HER2 treatment to be approved by an extended adjuvant therapy for the indication. It is marketed in the United States in the form of tablets. It is currently not approved for commercialization outside of the United States.
Per the deal, Medison will be responsible for the necessary regulatory approval of Nerlynx in Israel and once approved for commercializing it in Israel. The company plans to file for a marketing authorization for Nerlynx with the Ministry of Health of Israel, and expects to receive regulatory approval during the first half of 2019. On the other hand, Puma will receive upfront and milestone payments and double digit royalties on Nerlynx sales in the region.
However, Puma’s shares have significantly outperformed the industry over a year. The stock has rallied 102.9% compared with the industry’s 7.9% growth.
However, we remind investors that recently, the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency met with Puma to convey that the former will most probably vote against the approval of neratinib at the formal CHMP decision vote scheduled next month. According to CHMP, the benefit risk assessment is unfavorable because the study results are based on evidence from a single pivotal trial.
The company might need to take additional steps to get approval in Europe.
Puma Biotechnology Inc Price
Puma Biotechnology Inc Price | Puma Biotechnology Inc Quote
Zacks Rank & Key Picks
Puma carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the health care space are XOMA Corporation (XOMA - Free Report) and Exelixis, Inc. (EXEL - Free Report) . While XOMA sports a Zacks Rank #1 (Strong Buy), Exelixis carries a Zacks Rank #2 (Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.
XOMA’s loss per share estimates have narrowed from 99 cents to 42 cents for 2018 in the last 60 days. The company delivered a positive earnings surprise in one of the last four quarters, with an average beat of 47.92%. Share price of the company has skyrocketed 678.3% over a year.
Exelixis’ earnings per share estimates have moved up from 72 cents to 77 cents for 2018 over the last 60 days. The company delivered a positive earnings surprise in the last four quarters, with an average of 572.92%. Share price of the company has surged 68.4% over a year.
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>