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The Zacks Analyst Blog Highlights: Verona, Squibb, Protagonist and Amgen
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For Immediate Release
Chicago, IL – March 29, 2018 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include Verona Pharma plc (VRNA - Free Report) , Squibb Company (BMY - Free Report) , Protagonist Therapeutics (PTGX - Free Report) and Amgen (AMGN - Free Report)
Here are highlights from Wednesday’s Analyst Blog:
Biotech Stock Roundup: PTGX, AMGN, AGN & More
It was a week that saw Protagonist stock crashing on news of discontinuation of a phase IIb study, Amgen’s Reptha getting a positive CHMP opinion, Verona Pharma stock rallying on positive top-line data from COPD study and the FDA accepting sBLA for Bristol-Myers’ Opdivo.
Recap of the Past Week’s Most Important Stories
Protagonist Plummets on Study Results: Shares of Protagonist Therapeutics plummeted on announcement of the discontinuation of phase IIb study — PROPEL — on its ulcerative colitis ("UC") candidate, PTG-100. The company decided to discontinue the study as a planned interim analysis of PROPEL study by an independent Data Monitoring Committee determined that the study will not be able to achieve its primary endpoint of clinical remission.
The interim analysis was done on data from first 65 patients who had completed the 12-week treatment with PTG-100. The total patient population of the study was 240. The company has notified that it will stop further treatment of patients currently in the study. Protagonist has also postponed its decision to initiate a phase II/III on PTG-100 in patients with chronic pouchitis, as it awaits full review of the interim data from the PROPEL study (Read more: Protagonist Therapeutics Stalls Ulcerative Colitis Study)
Amgen’s Repatha Gets Positive CHMP Opinion: Amgen announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) rendered a positive opinion on the company’s regulatory application seeking approval to include data from the cardiovascular outcomes study, FOURIER, on the European label of its PCSK9 inhibitor, Repatha.
The application seeks for a new indication in the Repatha label for adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels. Concurrently, the CHMP gave a positive opinion for the marketing authorization to Amgen and Allergan’s (AGN), ABP 980, a biosimilar of Roche’s oncology drug Herceptin.
The biosimilar has been recommended for approval for the treatment of the same three types of cancer — HER2-positive metastatic breast cancer, HER2-positive early breast cancer and HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction. (Read more: Amgen's Repatha Gains CHMP Nod to Include Outcomes Data)
Verona Pharma Surges on Study Results: Shares of Verona Pharma plc surged following positive top-line data from its phase IIb study evaluating pipeline candidate, RPL554. RPL554, a first-in-class, inhaled, dual inhibitor is being evaluated as a maintenance treatment for chronic obstructive pulmonary disease (“COPD”). The study met its primary endpoint as RPL554 demonstrated clinically and statistically significant improvements in lung function at all dose levels.
Additionally, secondary endpoints were also met and support the potential clinical benefits of RPL554 for the treatment of COPD. The positive results from the study support the progression of RPL554 into later stage development as an inhaled treatment for COPD patients. Verona Pharma doesn’t have any approved product in its portfolio and the successful development and commercialization of the drug will significantly boost results.
Bristol-Myers’ Opdivo sbLA Accepted by the FDA: The FDA accepted Bristol-Myers Squibb Company’s supplemental Biologics License Application (sBLA) for blockbuster drug Opdivo in combination with Yervoy for the treatment of adults with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. The agency has also granted the application priority review and set an action date of Jul 10, 2018. The combination is already approved for a variety of oncology indications.
Zacks Investment Research is under common control with affiliated entities (including a broker-dealer and an investment adviser), which may engage in transactions involving the foregoing securities for the clients of such affiliates.
Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit http://www.zacks.com/performance for information about the performance numbers displayed in this press release.
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The Zacks Analyst Blog Highlights: Verona, Squibb, Protagonist and Amgen
For Immediate Release
Chicago, IL – March 29, 2018 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include Verona Pharma plc (VRNA - Free Report) , Squibb Company (BMY - Free Report) , Protagonist Therapeutics (PTGX - Free Report) and Amgen (AMGN - Free Report)
Here are highlights from Wednesday’s Analyst Blog:
Biotech Stock Roundup: PTGX, AMGN, AGN & More
It was a week that saw Protagonist stock crashing on news of discontinuation of a phase IIb study, Amgen’s Reptha getting a positive CHMP opinion, Verona Pharma stock rallying on positive top-line data from COPD study and the FDA accepting sBLA for Bristol-Myers’ Opdivo.
Recap of the Past Week’s Most Important Stories
Protagonist Plummets on Study Results: Shares of Protagonist Therapeutics plummeted on announcement of the discontinuation of phase IIb study — PROPEL — on its ulcerative colitis ("UC") candidate, PTG-100. The company decided to discontinue the study as a planned interim analysis of PROPEL study by an independent Data Monitoring Committee determined that the study will not be able to achieve its primary endpoint of clinical remission.
The interim analysis was done on data from first 65 patients who had completed the 12-week treatment with PTG-100. The total patient population of the study was 240. The company has notified that it will stop further treatment of patients currently in the study. Protagonist has also postponed its decision to initiate a phase II/III on PTG-100 in patients with chronic pouchitis, as it awaits full review of the interim data from the PROPEL study (Read more: Protagonist Therapeutics Stalls Ulcerative Colitis Study)
Amgen’s Repatha Gets Positive CHMP Opinion: Amgen announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) rendered a positive opinion on the company’s regulatory application seeking approval to include data from the cardiovascular outcomes study, FOURIER, on the European label of its PCSK9 inhibitor, Repatha.
The application seeks for a new indication in the Repatha label for adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels. Concurrently, the CHMP gave a positive opinion for the marketing authorization to Amgen and Allergan’s (AGN), ABP 980, a biosimilar of Roche’s oncology drug Herceptin.
The biosimilar has been recommended for approval for the treatment of the same three types of cancer — HER2-positive metastatic breast cancer, HER2-positive early breast cancer and HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction. (Read more: Amgen's Repatha Gains CHMP Nod to Include Outcomes Data)
Verona Pharma Surges on Study Results: Shares of Verona Pharma plc surged following positive top-line data from its phase IIb study evaluating pipeline candidate, RPL554. RPL554, a first-in-class, inhaled, dual inhibitor is being evaluated as a maintenance treatment for chronic obstructive pulmonary disease (“COPD”). The study met its primary endpoint as RPL554 demonstrated clinically and statistically significant improvements in lung function at all dose levels.
Additionally, secondary endpoints were also met and support the potential clinical benefits of RPL554 for the treatment of COPD. The positive results from the study support the progression of RPL554 into later stage development as an inhaled treatment for COPD patients. Verona Pharma doesn’t have any approved product in its portfolio and the successful development and commercialization of the drug will significantly boost results.
Bristol-Myers’ Opdivo sbLA Accepted by the FDA: The FDA accepted Bristol-Myers Squibb Company’s supplemental Biologics License Application (sBLA) for blockbuster drug Opdivo in combination with Yervoy for the treatment of adults with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. The agency has also granted the application priority review and set an action date of Jul 10, 2018. The combination is already approved for a variety of oncology indications.
Zacks Investment Research is under common control with affiliated entities (including a broker-dealer and an investment adviser), which may engage in transactions involving the foregoing securities for the clients of such affiliates.
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Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit http://www.zacks.com/performance for information about the performance numbers displayed in this press release.