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Biotech Stock Roundup: Inotek Plunges on Pipeline Setback, Kite Files IND for Study Initiation
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It was a relatively slow week for the biotech sector though companies like Inotek and OPKO (OPK - Free Report) made it to the headlines due to pipeline setbacks.
Recap of the Week’s Most Important Stories
Inotek Shares Hit by Disappointing Data: Inotek’s shares plunged 71.3% on news that the company’s lead pipeline candidate failed to achieve the primary endpoint in a late-stage study. Trabodenoson failed to show superiority to placebo at all 12 time points in the study conducted for the treatment of primary open-angle glaucoma (POAG) or ocular hypertension (OHT). Although the company said that some secondary endpoints were achieved with the 6% dose doing better than placebo, questions remain about the viability of trabodenoson as a monotherapy. The company will arrive at a decision regarding the monotherapy program once more data is available later this quarter. Meanwhile, trabodenoson is being evaluated in combination with Xalatan (latanoprost) in a mid-stage study with results expected in mid-17. Over the past one year, Inotek has underperformed the Zacks-categorized Medical-Biomedical/Genetics industry with the company declining 45.1% compared to the industry decline of 24.7%.
OPKO Drug Fails in Late-Stage Study: OPKO also announced some disappointing news on the pipeline front with the company saying that growth hormone deficiency (GHD) product, hGH-CTP, failed to meet the primary endpoint in a late-stage study in adults. However, the company said that it has identified one or two outliers which could have affected the primary outcome. OPKO is, therefore, carrying out a further analysis of the study population. Meanwhile, a pivotal phase III study is being conducted on hGH-CTP in pre-pubertal growth hormone deficient children. hGH-CTP is being developed under a collaboration agreement with Pfizer.
Kite Seeks FDA Nod for Phase I Study Initiation: Immuno-oncology focused Kite is seeking permission from the FDA to start a phase I study on KITE-718, which is designed to express TCRs that target MAGE A3 and MAGE A6 -- MAGE A3/A6 are often found in common tumors like bladder, esophageal, head and neck, lung and ovarian cancers. We note that Kite is currently seeking FDA approval for its CAR-T candidate, KTE-C19, for the treatment of patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant (ASCT). The company initiated a rolling BLA filing in Dec 2016 with the submission expected to complete by the end of the first quarter of 2017. Kite 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
The NASDAQ Biotechnology Index declined slightly (0.4%) over the last four trading days. Among major biotech stocks, Amgen (AMGN - Free Report) gained 1.6% while Alexion declined 2.7%. Over the last six months, Biogen (BIIB - Free Report) was up 20.5% while Vertex (VRTX - Free Report) lost 13.4%. Vertex has underperformed the Zacks-categorized Medical-Biomedical/Genetics industry over the past one year with shares declining 40.1% during this period (See the last biotech stock roundup here: FDA Nod for Biogen/Ionis Drug, Seattle Genetics Hit by Clinical Hold).
What's Next in the Biotech World?
Stay tuned to the 35th annual J.P. Morgan Healthcare Conference where several companies will be present providing pipeline updates, preliminary results as well as 2017 guidance.
Where Do Zacks' Investment Ideas Come From?
You are welcome to download the full, up-to-the-minute list of 220 Zacks Rank #1 "Strong Buy" stocks free of charge. There is no better place to start your own stock search. Plus you can access the full list of must-avoid Zacks Rank #5 "Strong Sells" and other private research. See the stocks free >>
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Biotech Stock Roundup: Inotek Plunges on Pipeline Setback, Kite Files IND for Study Initiation
It was a relatively slow week for the biotech sector though companies like Inotek and OPKO (OPK - Free Report) made it to the headlines due to pipeline setbacks.
Recap of the Week’s Most Important Stories
Inotek Shares Hit by Disappointing Data: Inotek’s shares plunged 71.3% on news that the company’s lead pipeline candidate failed to achieve the primary endpoint in a late-stage study. Trabodenoson failed to show superiority to placebo at all 12 time points in the study conducted for the treatment of primary open-angle glaucoma (POAG) or ocular hypertension (OHT). Although the company said that some secondary endpoints were achieved with the 6% dose doing better than placebo, questions remain about the viability of trabodenoson as a monotherapy. The company will arrive at a decision regarding the monotherapy program once more data is available later this quarter. Meanwhile, trabodenoson is being evaluated in combination with Xalatan (latanoprost) in a mid-stage study with results expected in mid-17. Over the past one year, Inotek has underperformed the Zacks-categorized Medical-Biomedical/Genetics industry with the company declining 45.1% compared to the industry decline of 24.7%.
OPKO Drug Fails in Late-Stage Study: OPKO also announced some disappointing news on the pipeline front with the company saying that growth hormone deficiency (GHD) product, hGH-CTP, failed to meet the primary endpoint in a late-stage study in adults. However, the company said that it has identified one or two outliers which could have affected the primary outcome. OPKO is, therefore, carrying out a further analysis of the study population. Meanwhile, a pivotal phase III study is being conducted on hGH-CTP in pre-pubertal growth hormone deficient children. hGH-CTP is being developed under a collaboration agreement with Pfizer.
Kite Seeks FDA Nod for Phase I Study Initiation: Immuno-oncology focused Kite is seeking permission from the FDA to start a phase I study on KITE-718, which is designed to express TCRs that target MAGE A3 and MAGE A6 -- MAGE A3/A6 are often found in common tumors like bladder, esophageal, head and neck, lung and ovarian cancers. We note that Kite is currently seeking FDA approval for its CAR-T candidate, KTE-C19, for the treatment of patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant (ASCT). The company initiated a rolling BLA filing in Dec 2016 with the submission expected to complete by the end of the first quarter of 2017. Kite 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 declined slightly (0.4%) over the last four trading days. Among major biotech stocks, Amgen (AMGN - Free Report) gained 1.6% while Alexion declined 2.7%. Over the last six months, Biogen (BIIB - Free Report) was up 20.5% while Vertex (VRTX - Free Report) lost 13.4%. Vertex has underperformed the Zacks-categorized Medical-Biomedical/Genetics industry over the past one year with shares declining 40.1% during this period (See the last biotech stock roundup here: FDA Nod for Biogen/Ionis Drug, Seattle Genetics Hit by Clinical Hold).
What's Next in the Biotech World?
Stay tuned to the 35th annual J.P. Morgan Healthcare Conference where several companies will be present providing pipeline updates, preliminary results as well as 2017 guidance.
Where Do Zacks' Investment Ideas Come From?
You are welcome to download the full, up-to-the-minute list of 220 Zacks Rank #1 "Strong Buy" stocks free of charge. There is no better place to start your own stock search. Plus you can access the full list of must-avoid Zacks Rank #5 "Strong Sells" and other private research. See the stocks free >>