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The biotech sector was in focus with regular pipeline updates. The key stories include bigwig Gilead Sciences (GILD - Free Report) getting approval for its HIV drug Biktarvy in Europe and Puma Biotechnology (PBYI - Free Report) soaring on positive CHMP recommendation, while Merrimack plunged on the failure of its phase II study in pancreatic cancer.
Recap of Important Stories
Gilead’s Biktarvy Gets EC Approval: Gilead announced that the European Commission has granted Marketing Authorization to HIV combination therapy Biktarvy (bictegravir 50mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg; BIC/FTC/TAF). Biktarvy is approved as a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase class, emtricitabine or tenofovir.
The approval was supported by positive data from four ongoing phase III studies, namely Studies 1489 and 1490 in treatment-naïve HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults. With this approval, BIC/FTC/TAF becomes Gilead’s third FTC/TAF-based STR approved in the European Union in three years. BIC/FTC/TAF met its primary objective at 48 weeks in all four studies.The regimen was earlier approved by the FDA in February 2018. The approval in Europe will further strengthen the company’s HIV franchise. (Read more: Gilead's Biktarvy Gets EC Nod for HIV- 1 Infection)
Merrimack Plunges on Study Failure: Shares of Merrimack plunged after the company reported disappointing results from the phase II study in front-line metastatic pancreatic cancer. The phase II trial, CARRIE, evaluated the addition of MM-141 to standard-of-care treatment in patients with previously untreated metastatic pancreatic cancer and high serum levels of free Insulin-like Growth Factor-1 (IGF-1). The primary endpoint of the study was progression-free survival, while secondary endpoints included objective response rate, disease control rate, duration of response, and overall survival and safety.
Merrimack reported that the study did not meet its primary or secondary efficacy endpoints in patients, who received MM-141 in combination with nab-paclitaxel and Gemzar, compared with nab-paclitaxel and Gemzar alone. Subsequently, Merrimack has terminated the development of MM-141. With the sale of Onivyde, the company was back to being a development-stage biopharmaceutical company and was banking on its three pipeline candidates to boost its growth prospects. Hence, the failure of the CARRIE study came as a huge disappointment for its investors, given the limited number of candidates in the pipeline. Consequently, the company now plans to focus on the other two candidates in its pipeline, MM-121 and MM-310. (Read more: Merrimack Crashes as Phase II Pancreatic Cancer Study Fails)
Amgen's Presents Encouraging Data on Repatha: Amgen (AMGN - Free Report) announced encouraging data from the phase III study, BANTING, which showed that its PCSK9 inhibitor, Repatha, significantly reduced bad cholesterol in patients, with type II diabetes and hypercholesterolemia, who have already undergone moderate/high-intensity statin therapy. The study evaluated monthly subcutaneous administration of a 420 mg dose of Repatha over a period of 12 weeks in patients with type II diabetes and hypercholesterolemia or mixed dyslipidemia, who are on optimized background statin therapy. The results from the study showed that the addition of Repatha to background statin therapy significantly reduced low-density lipoprotein cholesterol (LDL-C) and non-high density lipoprotein cholesterol (non-HDL-C).
Data from the BANTING study also revealed that 84.5% of patients in the Repatha arm achieved LDL-C levels of less than 70 mg/dL, which is the recommended level by the American College of Clinical Endocrinologists for patients with type II diabetes compared with 15.4% of patients in placebo arm at week 12. (Read more: Amgen's Repatha Reduces Bad Cholestrol in Type II Diabetes)
Puma Biotechnology Soars on Positive CHMP Opinion: Shares of Puma Biotechnology soared after the company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive trend vote, recommending the approval of the Marketing Authorisation Application (MAA) for breast cancer drug, Nerlynx (neratinib). The MAA is seeking approval of the drug as extended adjuvant treatment of early-stage HER2-positive hormone receptor positive breast cancer. The news boosted investor sentiment as the CHMP had adopted a negative opinion on the MAA in February 2018. The positive opinion from the CHMP indicates an imminent tentative approval. The drug was approved by the FDA in July 2017 for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy.
Incyte Announces Positive Results on Jakafi for GVHD: Incyte (INCY - Free Report) announced that the phase II trial, REACH1, evaluating lead drug Jakafi in combination with corticosteroids for the treatment of patients with steroid-refractory acute graft-versus-host disease (GVHD), met its primary endpoint. The data from the study showed that Jakafi demonstrated an overall response rate (ORR) of 55% at day 28.
Moreover, the number of patients showing a response at any point of time, during the study, was 73%. Propelled by positive data from the REACH 1 study, Incyte now plans to file a Supplemental New Drug Application (sNDA) with the FDA, for the label expansion of Jakafi, for the treatment of steroid-refractory acute GVHD, during the third quarter of 2018. A potential label expansion for GVHD should further boost sales. (Read more: Incyte Announces Positive Results on Jakafi for GVHD)
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index lost 2.02% over the last five trading sessions. Among the major biotech stocks, Alexion gained 0.43%. Over the past six months, Celgene has lost 26.80% while Amgen has gained 6.43%. (See the last biotech stock roundup here: Biotech Stock Roundup: SRPT & SLDB Soar on Positive Data, ANIK & ZIOP Crash)
What's Next in Biotech?
Stay tuned for regulatory updates and pipeline development news.
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
Biotech Stock Roundup: PBYI Soars, MACK Crashes, GILD's Biktarvy Gets EC Nod
The biotech sector was in focus with regular pipeline updates. The key stories include bigwig Gilead Sciences (GILD - Free Report) getting approval for its HIV drug Biktarvy in Europe and Puma Biotechnology (PBYI - Free Report) soaring on positive CHMP recommendation, while Merrimack plunged on the failure of its phase II study in pancreatic cancer.
Recap of Important Stories
Gilead’s Biktarvy Gets EC Approval: Gilead announced that the European Commission has granted Marketing Authorization to HIV combination therapy Biktarvy (bictegravir 50mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg; BIC/FTC/TAF). Biktarvy is approved as a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase class, emtricitabine or tenofovir.
The approval was supported by positive data from four ongoing phase III studies, namely Studies 1489 and 1490 in treatment-naïve HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults. With this approval, BIC/FTC/TAF becomes Gilead’s third FTC/TAF-based STR approved in the European Union in three years. BIC/FTC/TAF met its primary objective at 48 weeks in all four studies.The regimen was earlier approved by the FDA in February 2018. The approval in Europe will further strengthen the company’s HIV franchise. (Read more: Gilead's Biktarvy Gets EC Nod for HIV- 1 Infection)
Merrimack Plunges on Study Failure: Shares of Merrimack plunged after the company reported disappointing results from the phase II study in front-line metastatic pancreatic cancer. The phase II trial, CARRIE, evaluated the addition of MM-141 to standard-of-care treatment in patients with previously untreated metastatic pancreatic cancer and high serum levels of free Insulin-like Growth Factor-1 (IGF-1). The primary endpoint of the study was progression-free survival, while secondary endpoints included objective response rate, disease control rate, duration of response, and overall survival and safety.
Merrimack reported that the study did not meet its primary or secondary efficacy endpoints in patients, who received MM-141 in combination with nab-paclitaxel and Gemzar, compared with nab-paclitaxel and Gemzar alone. Subsequently, Merrimack has terminated the development of MM-141. With the sale of Onivyde, the company was back to being a development-stage biopharmaceutical company and was banking on its three pipeline candidates to boost its growth prospects. Hence, the failure of the CARRIE study came as a huge disappointment for its investors, given the limited number of candidates in the pipeline. Consequently, the company now plans to focus on the other two candidates in its pipeline, MM-121 and MM-310. (Read more: Merrimack Crashes as Phase II Pancreatic Cancer Study Fails)
Amgen's Presents Encouraging Data on Repatha: Amgen (AMGN - Free Report) announced encouraging data from the phase III study, BANTING, which showed that its PCSK9 inhibitor, Repatha, significantly reduced bad cholesterol in patients, with type II diabetes and hypercholesterolemia, who have already undergone moderate/high-intensity statin therapy. The study evaluated monthly subcutaneous administration of a 420 mg dose of Repatha over a period of 12 weeks in patients with type II diabetes and hypercholesterolemia or mixed dyslipidemia, who are on optimized background statin therapy. The results from the study showed that the addition of Repatha to background statin therapy significantly reduced low-density lipoprotein cholesterol (LDL-C) and non-high density lipoprotein cholesterol (non-HDL-C).
Data from the BANTING study also revealed that 84.5% of patients in the Repatha arm achieved LDL-C levels of less than 70 mg/dL, which is the recommended level by the American College of Clinical Endocrinologists for patients with type II diabetes compared with 15.4% of patients in placebo arm at week 12. (Read more: Amgen's Repatha Reduces Bad Cholestrol in Type II Diabetes)
Amgen carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Puma Biotechnology Soars on Positive CHMP Opinion: Shares of Puma Biotechnology soared after the company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive trend vote, recommending the approval of the Marketing Authorisation Application (MAA) for breast cancer drug, Nerlynx (neratinib). The MAA is seeking approval of the drug as extended adjuvant treatment of early-stage HER2-positive hormone receptor positive breast cancer. The news boosted investor sentiment as the CHMP had adopted a negative opinion on the MAA in February 2018. The positive opinion from the CHMP indicates an imminent tentative approval. The drug was approved by the FDA in July 2017 for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy.
Incyte Announces Positive Results on Jakafi for GVHD: Incyte (INCY - Free Report) announced that the phase II trial, REACH1, evaluating lead drug Jakafi in combination with corticosteroids for the treatment of patients with steroid-refractory acute graft-versus-host disease (GVHD), met its primary endpoint. The data from the study showed that Jakafi demonstrated an overall response rate (ORR) of 55% at day 28.
Moreover, the number of patients showing a response at any point of time, during the study, was 73%. Propelled by positive data from the REACH 1 study, Incyte now plans to file a Supplemental New Drug Application (sNDA) with the FDA, for the label expansion of Jakafi, for the treatment of steroid-refractory acute GVHD, during the third quarter of 2018. A potential label expansion for GVHD should further boost sales. (Read more: Incyte Announces Positive Results on Jakafi for GVHD)
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index lost 2.02% over the last five trading sessions. Among the major biotech stocks, Alexion gained 0.43%. Over the past six months, Celgene has lost 26.80% while Amgen has gained 6.43%. (See the last biotech stock roundup here: Biotech Stock Roundup: SRPT & SLDB Soar on Positive Data, ANIK & ZIOP Crash)
What's Next in Biotech?
Stay tuned for regulatory updates and pipeline development news.
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 >>