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 (PBYI) Expands Study Cohort for Lead Candidate PB272
Read MoreHide Full Article
Puma Biotechnology, Inc. (PBYI - Free Report) has expanded the fourth cohort of the phase II SUMMIT study evaluating its lead candidate PB272 (neratinib) as a single agent in patients with solid tumors who have an activating HER2 mutation (basket study). The expanded cohort includes patients with metastatic cervical cancer and whose tumors have a HER2 mutation.
Puma Biotech’s share price has declined 36.7% in the past one year compared with Zacks classified Medical-Biomedical and Genetics industry’s fall of 13.6%.
Coming back to the release, the open-label, multicenter, multi-histology, international SUMMIT basket study is being conducted to evaluate the safety and efficacy of PB272 administered daily to patients who have solid tumors with activating ERBB mutations, including EGFR, HER2 and HER3. The cohorts included in the basket study for the patients receiving neratinib monotherapy are hormone receptor-negative breast cancer, biliary tract cancers, endometrial cancer, gastric/esophageal cancer, ovarian cancer and all other solid tumors with a HER2 mutation. The cohorts receiving combination treatment, on the other hand, include hormone receptor-positive breast cancer and bladder cancer.
According to the press release issued by Puma Biotech, the cervical cancer patients initially entered the study in the “other solid tumors with a HER2 mutation” cohort, and due to the preliminary activity witnessed in the study, the company expanded a separate cervical cancer cohort following the protocol of the study.
Therefore, the expanded HER2-mutant cervical cancer cohort will now enroll a total of 18 patients. Meanwhile, the company expects to present full data from the SUMMIT study at a medical meeting this year.
Puma Biotech has made significant progress with PB272 in both the U.S. and the EU. While the European Medicines Agency has validated the company’s marketing authorization application for PB272 for the extended adjuvant treatment of HER2-positive early-stage breast cancer, the FDA has accepted the new drug application for the candidate for the extended adjuvant treatment of patients with early-stage HER2-overexpressed/amplified breast cancer, who have been previously treated with Herceptin-based adjuvant therapy.
Puma Biotech currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector, include Kamada Ltd. , Epizyme, Inc. and Arena Pharmaceuticals, Inc. . While Kamada and Epizyme sport a Zacks Rank #1 (Strong Buy), Arena carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Kamada’s earnings estimates for 2017 were up 66.7% over the last 60 days. The company posted a positive earnings surprise in two of the four trailing quarters, with an average beat of 31.25%. Its share price was up 40% in the past one year.
Arena’s loss estimates narrowed 2.86% and 3.03% in 2016 and 2017 respectively over last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters, with an average beat of 11.43%. Its share price was up 4.2% in the past one year.
Epizyme’s loss estimates narrowed 3% and 2.36% in 2016 and 2017 respectively over last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters, with an average beat of 11.43%. Its share price was up 18.6% in the past one year.
Zacks' Top Investment Ideas for Long-Term Profit
How would you like to see our best recommendations to help you find today’s most promising long-term stocks? Starting now, you can look inside our portfolios featuring stocks under $10, income stocks, value investments and more. These picks, which have double and triple-digit profit potential, are rarely available to the public. But you can see them now. Click here >>
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Puma (PBYI) Expands Study Cohort for Lead Candidate PB272
Puma Biotechnology, Inc. (PBYI - Free Report) has expanded the fourth cohort of the phase II SUMMIT study evaluating its lead candidate PB272 (neratinib) as a single agent in patients with solid tumors who have an activating HER2 mutation (basket study). The expanded cohort includes patients with metastatic cervical cancer and whose tumors have a HER2 mutation.
Puma Biotech’s share price has declined 36.7% in the past one year compared with Zacks classified Medical-Biomedical and Genetics industry’s fall of 13.6%.
Coming back to the release, the open-label, multicenter, multi-histology, international SUMMIT basket study is being conducted to evaluate the safety and efficacy of PB272 administered daily to patients who have solid tumors with activating ERBB mutations, including EGFR, HER2 and HER3. The cohorts included in the basket study for the patients receiving neratinib monotherapy are hormone receptor-negative breast cancer, biliary tract cancers, endometrial cancer, gastric/esophageal cancer, ovarian cancer and all other solid tumors with a HER2 mutation. The cohorts receiving combination treatment, on the other hand, include hormone receptor-positive breast cancer and bladder cancer.
According to the press release issued by Puma Biotech, the cervical cancer patients initially entered the study in the “other solid tumors with a HER2 mutation” cohort, and due to the preliminary activity witnessed in the study, the company expanded a separate cervical cancer cohort following the protocol of the study.
Therefore, the expanded HER2-mutant cervical cancer cohort will now enroll a total of 18 patients. Meanwhile, the company expects to present full data from the SUMMIT study at a medical meeting this year.
Puma Biotech has made significant progress with PB272 in both the U.S. and the EU. While the European Medicines Agency has validated the company’s marketing authorization application for PB272 for the extended adjuvant treatment of HER2-positive early-stage breast cancer, the FDA has accepted the new drug application for the candidate for the extended adjuvant treatment of patients with early-stage HER2-overexpressed/amplified breast cancer, who have been previously treated with Herceptin-based adjuvant therapy.
Puma Biotechnology Inc Price
Puma Biotechnology Inc Price | Puma Biotechnology Inc Quote
Zacks Rank & Key Picks
Puma Biotech currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector, include Kamada Ltd. , Epizyme, Inc. and Arena Pharmaceuticals, Inc. . While Kamada and Epizyme sport a Zacks Rank #1 (Strong Buy), Arena carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Kamada’s earnings estimates for 2017 were up 66.7% over the last 60 days. The company posted a positive earnings surprise in two of the four trailing quarters, with an average beat of 31.25%. Its share price was up 40% in the past one year.
Arena’s loss estimates narrowed 2.86% and 3.03% in 2016 and 2017 respectively over last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters, with an average beat of 11.43%. Its share price was up 4.2% in the past one year.
Epizyme’s loss estimates narrowed 3% and 2.36% in 2016 and 2017 respectively over last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters, with an average beat of 11.43%. Its share price was up 18.6% in the past one year.
Zacks' Top Investment Ideas for Long-Term Profit
How would you like to see our best recommendations to help you find today’s most promising long-term stocks? Starting now, you can look inside our portfolios featuring stocks under $10, income stocks, value investments and more. These picks, which have double and triple-digit profit potential, are rarely available to the public. But you can see them now. Click here >>