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The Zacks Analyst Blog Highlights: Amgen, Alexion, Regeneron, Allergan and Savara
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For Immediate Release
Chicago, IL – June 20, 2019 – 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: Amgen (AMGN - Free Report) , Alexion , Regeneron (REGN - Free Report) , Allergan and Savara (SVRA - Free Report) .
Here are highlights from Wednesday’s Analyst Blog:
Biotech Stock Roundup: AMGN, ALXN, REGN and More
It was a busy week for the biotech sector. The FDA approved Amgen’s biosimilar for a leading breast cancer drug, Herceptin. Meanwhile, Alexion’s Ultomiris was approved in Japan. Regeneron presented positive data on an investigational bispecific monoclonal antibody for lymphoma.
Recap of the Week’s Top Stories:
Amgen Gets Approval for Biosimilar Kanjinti: Amgen and its biosimilar collaboration partner, Allergan announced that the FDA has approved Kanjinti (trastuzumab-anns), their biosimilar of Roche’s blockbuster breast cancer drug, Herceptin. The biosimilar was approved for all approved indications of the reference drug, Herceptin — HER2 overexpressing adjuvant and metastatic breast cancer, and HER2 overexpressing metastatic gastric cancer or gastroesophageal junction adenocarcinoma.
Amgen has a collaboration agreement with Allergan for the worldwide development and commercialization of four oncology antibody biosimilars. Kanjinti is the second drug to receive FDA approval under this agreement.
In addition, Amgen announced five-year overall survival (OS) analysis from the single-arm, phase II BLAST study on leukemia drug, BLINCYTO. The study evaluated Blincyto in patients with minimal residual disease (MRD)-positive acute lymphoblastic leukemia (ALL). Results from the study showed a median OS of 36.5 months for Blincyto-treated patients with a median follow-up of 59.8 months. More than half of the patients who achieved a complete MRD response following the first cycle of Blincyto treatment were alive at five years.
Regeneron Presents Positive Data on Lymphoma Candidate: Regeneron announced positive early-stage data for pipeline candidate, REGN1979. The data will be presented at the 24th Congress of the European Hematology Association (EHA). REGN1979, an investigational bispecific monoclonal antibody, is being evaluated in patients with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL). The data also includes patients with R/R diffuse large B-cell lymphoma (DLBCL), who had progressed after CAR-T therapy. The primary objective was to assess the safety, tolerability and dose-limiting toxicities of the candidate. High response rates observed with REGN1979 in both relapsed or refractory diffuse large B-cell lymphoma and follicular lymphoma were encouraging. Moreover, two patients, who failed CAR-T therapy and received REGN1979 80 mg, achieved complete response.
The R/R follicular lymphoma (FL) grades 1 to 3a treatment arm showed an overall response rate of 93% (13 of 14 patients) in patients, who received doses of 5 mg or more, with a complete response rate of 71% (10 of 14 patients). In DLBCL patients treated with REGN1979 80 mg to 160 mg, an overall response rate of 57% was observed. In R/R DLBCL patients, whose disease progressed after CD-19 directed CAR-T therapy, two out of four achieved a complete response. The company will initiate a phase II program later in the month for a potential registration, and proactively evaluate active REGN1979 doses in indolent and aggressive non-Hodgkin lymphoma.
Alexion’s Ultomiris Gets Approval in Japan: Alexion announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Ultomiris (ravulizumab), the first and only long-acting C5 complement inhibitor administered every eight weeks, for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). The drug is already approved in the United States. The approval was based on comprehensive results from two phase III studies, which included 441 patients who had either never been treated with a complement inhibitor before, or who had been stable on Alexion’s lead drug Soliris. Results showed that the efficacy of Ultomiris administered every eight weeks was non-inferior to the efficacy of SOLIRIS administered every two weeks on all 11 endpoints.
Earlier, Alexion announced positive, long-term data from the extension of the phase III study on Ultomiris and Soliris in complement inhibitor-naïve, adult patients with PNH. The data demonstrated that Ultomiris administered every eight weeks provided consistent efficacy and safety through 52 weeks, with no cases of breakthrough hemolysis associated with incomplete C5 complement inhibition. The data was presented at the Annual Congress of the European Hematology Association. Ultomirus was studied in the largest-ever phase III program in PNH.
Savara Crashes on Late-Stage Study Failure: Savara crashed after it announced that its lead pipeline candidate, Molgradex, failed to meet the primary endpoint in the pivotal phase III study — IMPALA — evaluating it in autoimmune alveolar pulmonary proteinosis (aPAP), a rare lung disorder. The IMPALA study evaluated Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), in patients with aPAP compared to placebo for improvement in alveolar-arterial oxygen gradient (A-aDO2) as its primary endpoint. The study evaluated two dose administrations — once daily continuous administration of and once daily in seven-day intermittent cycles — of 300 µg Molgradex over 24 weeks. Data from the study demonstrated average improvement of 12.1 mmHg in patients who were administered Molgradex once daily continuously compared with an improvement of 8.8 mmHg for placebo. However, the treatment difference of 4.6 mmHg failed to meet the primary endpoint.
Molgradex also failed to achieve improvement of statistical significance in two key secondary endpoints – the six-minute walk distance (6MWD) and requirement for whole lung lavage (“WLL”).
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: Amgen, Alexion, Regeneron, Allergan and Savara
For Immediate Release
Chicago, IL – June 20, 2019 – 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: Amgen (AMGN - Free Report) , Alexion , Regeneron (REGN - Free Report) , Allergan and Savara (SVRA - Free Report) .
Here are highlights from Wednesday’s Analyst Blog:
Biotech Stock Roundup: AMGN, ALXN, REGN and More
It was a busy week for the biotech sector. The FDA approved Amgen’s biosimilar for a leading breast cancer drug, Herceptin. Meanwhile, Alexion’s Ultomiris was approved in Japan. Regeneron presented positive data on an investigational bispecific monoclonal antibody for lymphoma.
Recap of the Week’s Top Stories:
Amgen Gets Approval for Biosimilar Kanjinti: Amgen and its biosimilar collaboration partner, Allergan announced that the FDA has approved Kanjinti (trastuzumab-anns), their biosimilar of Roche’s blockbuster breast cancer drug, Herceptin. The biosimilar was approved for all approved indications of the reference drug, Herceptin — HER2 overexpressing adjuvant and metastatic breast cancer, and HER2 overexpressing metastatic gastric cancer or gastroesophageal junction adenocarcinoma.
Amgen has a collaboration agreement with Allergan for the worldwide development and commercialization of four oncology antibody biosimilars. Kanjinti is the second drug to receive FDA approval under this agreement.
In addition, Amgen announced five-year overall survival (OS) analysis from the single-arm, phase II BLAST study on leukemia drug, BLINCYTO. The study evaluated Blincyto in patients with minimal residual disease (MRD)-positive acute lymphoblastic leukemia (ALL). Results from the study showed a median OS of 36.5 months for Blincyto-treated patients with a median follow-up of 59.8 months. More than half of the patients who achieved a complete MRD response following the first cycle of Blincyto treatment were alive at five years.
Amgen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
Regeneron Presents Positive Data on Lymphoma Candidate: Regeneron announced positive early-stage data for pipeline candidate, REGN1979. The data will be presented at the 24th Congress of the European Hematology Association (EHA). REGN1979, an investigational bispecific monoclonal antibody, is being evaluated in patients with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL). The data also includes patients with R/R diffuse large B-cell lymphoma (DLBCL), who had progressed after CAR-T therapy. The primary objective was to assess the safety, tolerability and dose-limiting toxicities of the candidate. High response rates observed with REGN1979 in both relapsed or refractory diffuse large B-cell lymphoma and follicular lymphoma were encouraging. Moreover, two patients, who failed CAR-T therapy and received REGN1979 80 mg, achieved complete response.
The R/R follicular lymphoma (FL) grades 1 to 3a treatment arm showed an overall response rate of 93% (13 of 14 patients) in patients, who received doses of 5 mg or more, with a complete response rate of 71% (10 of 14 patients). In DLBCL patients treated with REGN1979 80 mg to 160 mg, an overall response rate of 57% was observed. In R/R DLBCL patients, whose disease progressed after CD-19 directed CAR-T therapy, two out of four achieved a complete response. The company will initiate a phase II program later in the month for a potential registration, and proactively evaluate active REGN1979 doses in indolent and aggressive non-Hodgkin lymphoma.
Alexion’s Ultomiris Gets Approval in Japan: Alexion announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Ultomiris (ravulizumab), the first and only long-acting C5 complement inhibitor administered every eight weeks, for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). The drug is already approved in the United States. The approval was based on comprehensive results from two phase III studies, which included 441 patients who had either never been treated with a complement inhibitor before, or who had been stable on Alexion’s lead drug Soliris. Results showed that the efficacy of Ultomiris administered every eight weeks was non-inferior to the efficacy of SOLIRIS administered every two weeks on all 11 endpoints.
Earlier, Alexion announced positive, long-term data from the extension of the phase III study on Ultomiris and Soliris in complement inhibitor-naïve, adult patients with PNH. The data demonstrated that Ultomiris administered every eight weeks provided consistent efficacy and safety through 52 weeks, with no cases of breakthrough hemolysis associated with incomplete C5 complement inhibition. The data was presented at the Annual Congress of the European Hematology Association. Ultomirus was studied in the largest-ever phase III program in PNH.
Savara Crashes on Late-Stage Study Failure: Savara crashed after it announced that its lead pipeline candidate, Molgradex, failed to meet the primary endpoint in the pivotal phase III study — IMPALA — evaluating it in autoimmune alveolar pulmonary proteinosis (aPAP), a rare lung disorder. The IMPALA study evaluated Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), in patients with aPAP compared to placebo for improvement in alveolar-arterial oxygen gradient (A-aDO2) as its primary endpoint. The study evaluated two dose administrations — once daily continuous administration of and once daily in seven-day intermittent cycles — of 300 µg Molgradex over 24 weeks. Data from the study demonstrated average improvement of 12.1 mmHg in patients who were administered Molgradex once daily continuously compared with an improvement of 8.8 mmHg for placebo. However, the treatment difference of 4.6 mmHg failed to meet the primary endpoint.
Molgradex also failed to achieve improvement of statistical significance in two key secondary endpoints – the six-minute walk distance (6MWD) and requirement for whole lung lavage (“WLL”).
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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.