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.
Biotech Stock Roundup: Clovis Soars on Rubraca Data, Seattle Hit by Study Halt
Read MoreHide Full Article
Clovis and Seattle Genetics were both in the news with the companies providing pipeline updates -- while Clovis’ shares soared on positive Rubraca data, Seattle Genetics’ shares were impacted by the discontinuation of a late-stage study.
Recap of the Week’s Most Important Stories
Clovis Shoots Up on Rubraca Data: Clovis’ shares shot up 46.5% on impressive late-stage data on PARP inhibitor, Rubraca. The company said that Rubraca significantly improved progression-free survival in all ovarian cancer patient populations evaluated in the study. Clovis intends to file for Rubraca’s label expansion within the next four months for a second-line and later maintenance treatment indication for all women with platinum-sensitive ovarian cancer who have responded to their most recent platinum therapy. Rubraca had gained accelerated FDA approval in Dec 2016 for use in advanced ovarian cancer patients who have been treated with two or more chemotherapies and who have deleterious germline or somatic BRCA mutations. A broader label would boost Rubraca’s sales potential (Read more: Clovis Up Nearly 50% on Solid Data from Ovarian Cancer Study).
Year-to-date (YTD), Clovis has outperformed the Zacks-categorized Medical-Biomedical/Genetics industry with the company skyrocketing 99.6% while the industry is up 6.3%.
Seattle Hit by Study Discontinuation: Seattle Genetics saw its shares declining 4% on the discontinuation of a late-stage study on vadastuximab talirine (SGN-CD33A) in frontline older acute myeloid leukemia (AML) patients. The company took the decision based on consultations with the Independent Data Monitoring Committee (IDMC) as well as a review of unblinded data which showed a higher incidence of deaths including fatal infections in the vadastuximab talirine arm. The company has stopped patient enrolment and treatment in all studies being conducted with vadastuximab talirine including a study in frontline high risk myelodysplastic syndrome (MDS). The path forward for vadastuximab talirine will be determined following data review and consultation with the FDA (Read more: Seattle Genetics Halts Phase III Study on Leukemia Drug).
Amgen’s Xgeva under Review for Label Expansion: Amgen (AMGN - Free Report) is looking to expand the label of its blockbuster drug, Xgeva. The company wants the use of Xgeva to be allowed for multiple myeloma patients -- Xgeva is currently indicated for the prevention of fractures and other skeletal-related events in patients with bone metastases from solid tumors. The FDA expects to respond on the regulatory application by Feb 3, 2018. Label expansion into the multiple myeloma patient population will boost Xgeva sales, which came in at $1.5 billion in 2016 (Read more: Amgen's Xgeva Myeloma Label Expansion sBLA Accepted by FDA).
Celgene Presents Data on Revlimid-Rituxan Combo: Celgene announced interim results from a late-stage study evaluating Revlimid plus Roche’s Rituxan (rituximab) in patients with relapsed or refractory marginal zone lymphoma (MZL). Clinical activity was observed across indolent non-Hodgkin lymphomas, marginal zone and follicular histologies, as well as responses in poor risk patient subpopulations including early relapsing patients and patients who were refractory to multiple lines of therapy. Revlimid, Celgene’s key growth driver, has orphan drug status for the treatment of extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue.
Watch out for the usual pipeline updates and data presentations from biotech companies.
Zacks' Hidden Trades
While we share many recommendations and ideas with the public, certain moves are hidden from everyone but selected members of our portfolio services. Would you like to peek behind the curtain today and view them?
Starting now, for the next month, I invite you to follow all Zacks' private buys and sells in real time from value to momentum...from stocks under $10 to ETF to option movers...from insider trades to companies that are about to report positive earnings surprises (we've called them with 80%+ accuracy). You can even look inside portfolios so exclusive that they are normally closed to new investors.
Image: Bigstock
Biotech Stock Roundup: Clovis Soars on Rubraca Data, Seattle Hit by Study Halt
Clovis and Seattle Genetics were both in the news with the companies providing pipeline updates -- while Clovis’ shares soared on positive Rubraca data, Seattle Genetics’ shares were impacted by the discontinuation of a late-stage study.
Recap of the Week’s Most Important Stories
Clovis Shoots Up on Rubraca Data: Clovis’ shares shot up 46.5% on impressive late-stage data on PARP inhibitor, Rubraca. The company said that Rubraca significantly improved progression-free survival in all ovarian cancer patient populations evaluated in the study. Clovis intends to file for Rubraca’s label expansion within the next four months for a second-line and later maintenance treatment indication for all women with platinum-sensitive ovarian cancer who have responded to their most recent platinum therapy. Rubraca had gained accelerated FDA approval in Dec 2016 for use in advanced ovarian cancer patients who have been treated with two or more chemotherapies and who have deleterious germline or somatic BRCA mutations. A broader label would boost Rubraca’s sales potential (Read more: Clovis Up Nearly 50% on Solid Data from Ovarian Cancer Study).
Year-to-date (YTD), Clovis has outperformed the Zacks-categorized Medical-Biomedical/Genetics industry with the company skyrocketing 99.6% while the industry is up 6.3%.
Seattle Hit by Study Discontinuation: Seattle Genetics saw its shares declining 4% on the discontinuation of a late-stage study on vadastuximab talirine (SGN-CD33A) in frontline older acute myeloid leukemia (AML) patients. The company took the decision based on consultations with the Independent Data Monitoring Committee (IDMC) as well as a review of unblinded data which showed a higher incidence of deaths including fatal infections in the vadastuximab talirine arm. The company has stopped patient enrolment and treatment in all studies being conducted with vadastuximab talirine including a study in frontline high risk myelodysplastic syndrome (MDS). The path forward for vadastuximab talirine will be determined following data review and consultation with the FDA (Read more: Seattle Genetics Halts Phase III Study on Leukemia Drug).
Amgen’s Xgeva under Review for Label Expansion: Amgen (AMGN - Free Report) is looking to expand the label of its blockbuster drug, Xgeva. The company wants the use of Xgeva to be allowed for multiple myeloma patients -- Xgeva is currently indicated for the prevention of fractures and other skeletal-related events in patients with bone metastases from solid tumors. The FDA expects to respond on the regulatory application by Feb 3, 2018. Label expansion into the multiple myeloma patient population will boost Xgeva sales, which came in at $1.5 billion in 2016 (Read more: Amgen's Xgeva Myeloma Label Expansion sBLA Accepted by FDA).
Celgene Presents Data on Revlimid-Rituxan Combo: Celgene announced interim results from a late-stage study evaluating Revlimid plus Roche’s Rituxan (rituximab) in patients with relapsed or refractory marginal zone lymphoma (MZL). Clinical activity was observed across indolent non-Hodgkin lymphomas, marginal zone and follicular histologies, as well as responses in poor risk patient subpopulations including early relapsing patients and patients who were refractory to multiple lines of therapy. Revlimid, Celgene’s key growth driver, has orphan drug status for the treatment of extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue.
Celgene is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index gained 2.6% over the last four trading sessions. Among major biotech stocks, Biogen (BIIB - Free Report) was up almost 5% while Celgene was up 4.3%. Over the last six months, Vertex (VRTX - Free Report) was up 65.3% while Gilead (GILD - Free Report) was down 11.4% (See the last biotech stock roundup here: Management Changes at Biogen, Alexion, GILD Files HIV Drug).
What's Next in the Biotech World?
Watch out for the usual pipeline updates and data presentations from biotech companies.
Zacks' Hidden Trades
While we share many recommendations and ideas with the public, certain moves are hidden from everyone but selected members of our portfolio services. Would you like to peek behind the curtain today and view them?
Starting now, for the next month, I invite you to follow all Zacks' private buys and sells in real time from value to momentum...from stocks under $10 to ETF to option movers...from insider trades to companies that are about to report positive earnings surprises (we've called them with 80%+ accuracy). You can even look inside portfolios so exclusive that they are normally closed to new investors.
Click here for Zacks' secret trade>>