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Pharma Stock Roundup: Merck's Keytruda Shines in Study, Priority Review for Kymriah Label Expansion
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This week, companies like Novartis (NVS - Free Report) , Merck (MRK - Free Report) and Johnson & Johnson (JNJ - Free Report) were in the news. While Merck provided data on Keytruda, Novartis was in the news for gaining priority review status for the label expansion of its CAR-T therapy, Kymriah.
Recap of the Week’s Most Important Stories
Merck’s Keytruda Shines in 1st Line Lung Cancer Study: Merck scored a win this week with its anti-PD-1 therapy, Keytruda (in combination with Alimta (pemetrexed) and cisplatin or carboplatin) meeting the primary endpoints of overall survival (“OS”) and progression-free survival (“PFS”) in a late-stage study for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (“NSCLC”). The interim analysis conducted by an independent Data Monitoring Committee showed that the Keytruda combination resulted in significantly longer OS and PFS compared to Alimta plus platinum chemotherapy alone (Read more: Merck Strong on Confirmatory Phase III Lung Cancer Study).
Priority Review for Label Expansion of Novartis’s Kymriah: Novartis, the first company to gain FDA approval for a CAR-T therapy, Kymriah, said that the agency has granted priority review to the company’s regulatory application seeking to expand the label of the product. Novartis is looking to get Kymriah approved for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (“DLBCL”) who are ineligible for or relapse after autologous stem cell transplant (“ASCT”).
Kymriah also got accelerated assessment status from the European Medicines Agency (“EMA”) for the treatment of children and young adults with r/r B-cell acute lymphoblastic leukemia (“ALL”) and for adult patients with r/r DLBCL who are ineligible for ASCT (Read more: Novartis sBLA for CAR-T Therapy Kymriah Accepted by FDA).
Unfavorable IPR Decision for J&J: J&J suffered a setback this week with the U.S. Patent & Trademark Office (“PTO”) issuing a final written decision in an inter partes review (“IPR”) related to the sole unexpired patent listed as covering the company’s prostate cancer therapy, Zytiga (abiraterone acetate), in the FDA’s Orange Book. Generic drug company Argentum Pharmaceuticals had challenged all claims of the patent, which is due to expire on Aug 24, 2027.
J&J issued a statement regarding the PTO’s decision and said that it is evaluating its options for a rehearing and/or an appeal to the Court of Appeals for the Federal Circuit. Zytiga brought in sales of about $1.8 billion during the first nine months of 2017.
Novartis’s Sandoz in Global Partnership with Biocon for Biosimilars: Sandoz, a Novartis division, is entering into a global partnership with Biocon for the development, manufacture and commercialization of multiple biosimilars in immunology and oncology.
The companies will share responsibility for end-to-end development, manufacturing and global regulatory approvals for a number of products, and will have a cost and profit share arrangement while commercialization responsibilities will be divided.
This partnership will allow both companies to address the next wave of biosimilar opportunities globally. Sandoz and Biocon both have had some success in the biosimilar space. Sandoz’s portfolio includes five biosimilars marketed in various countries across the world. The company is currently seeking FDA approval for its biosimilar version of AbbVie’s blockbuster immunology drug, Humira. The regulatory application for the biosimilar was recently accepted for review by the FDA.
Pfizer-Gilead in Clinical Trial Collaboration: Pfizer (PFE - Free Report) has entered into a clinical trial collaboration with Kite, a Gilead (GILD - Free Report) company, under which the safety and efficacy of Kite’s CAR-T cell therapy, Yescarta (axicabtagene ciloleucel), will be evaluated in combination with Pfizer’s utomilumab, a fully humanized 4-1BB agonist monoclonal antibody, in patients with refractory large B-cell lymphoma. A phase I/II study is expected to commence this year. Pfizer is a Zacks Rank #2 (Buy) stock - you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. The company’s stock is up 16.7% over the last one year, compared to the 22.9% rally of the industry it belongs to.
Watch out for the usual pipeline and regulatory updates as well as J&J’s fourth quarter earnings announcement on January 23.
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Pharma Stock Roundup: Merck's Keytruda Shines in Study, Priority Review for Kymriah Label Expansion
This week, companies like Novartis (NVS - Free Report) , Merck (MRK - Free Report) and Johnson & Johnson (JNJ - Free Report) were in the news. While Merck provided data on Keytruda, Novartis was in the news for gaining priority review status for the label expansion of its CAR-T therapy, Kymriah.
Recap of the Week’s Most Important Stories
Merck’s Keytruda Shines in 1st Line Lung Cancer Study: Merck scored a win this week with its anti-PD-1 therapy, Keytruda (in combination with Alimta (pemetrexed) and cisplatin or carboplatin) meeting the primary endpoints of overall survival (“OS”) and progression-free survival (“PFS”) in a late-stage study for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (“NSCLC”). The interim analysis conducted by an independent Data Monitoring Committee showed that the Keytruda combination resulted in significantly longer OS and PFS compared to Alimta plus platinum chemotherapy alone (Read more: Merck Strong on Confirmatory Phase III Lung Cancer Study).
Priority Review for Label Expansion of Novartis’s Kymriah: Novartis, the first company to gain FDA approval for a CAR-T therapy, Kymriah, said that the agency has granted priority review to the company’s regulatory application seeking to expand the label of the product. Novartis is looking to get Kymriah approved for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (“DLBCL”) who are ineligible for or relapse after autologous stem cell transplant (“ASCT”).
Kymriah also got accelerated assessment status from the European Medicines Agency (“EMA”) for the treatment of children and young adults with r/r B-cell acute lymphoblastic leukemia (“ALL”) and for adult patients with r/r DLBCL who are ineligible for ASCT (Read more: Novartis sBLA for CAR-T Therapy Kymriah Accepted by FDA).
Unfavorable IPR Decision for J&J: J&J suffered a setback this week with the U.S. Patent & Trademark Office (“PTO”) issuing a final written decision in an inter partes review (“IPR”) related to the sole unexpired patent listed as covering the company’s prostate cancer therapy, Zytiga (abiraterone acetate), in the FDA’s Orange Book. Generic drug company Argentum Pharmaceuticals had challenged all claims of the patent, which is due to expire on Aug 24, 2027.
J&J issued a statement regarding the PTO’s decision and said that it is evaluating its options for a rehearing and/or an appeal to the Court of Appeals for the Federal Circuit. Zytiga brought in sales of about $1.8 billion during the first nine months of 2017.
Novartis’s Sandoz in Global Partnership with Biocon for Biosimilars: Sandoz, a Novartis division, is entering into a global partnership with Biocon for the development, manufacture and commercialization of multiple biosimilars in immunology and oncology.
The companies will share responsibility for end-to-end development, manufacturing and global regulatory approvals for a number of products, and will have a cost and profit share arrangement while commercialization responsibilities will be divided.
This partnership will allow both companies to address the next wave of biosimilar opportunities globally. Sandoz and Biocon both have had some success in the biosimilar space. Sandoz’s portfolio includes five biosimilars marketed in various countries across the world. The company is currently seeking FDA approval for its biosimilar version of AbbVie’s blockbuster immunology drug, Humira. The regulatory application for the biosimilar was recently accepted for review by the FDA.
Pfizer-Gilead in Clinical Trial Collaboration: Pfizer (PFE - Free Report) has entered into a clinical trial collaboration with Kite, a Gilead (GILD - Free Report) company, under which the safety and efficacy of Kite’s CAR-T cell therapy, Yescarta (axicabtagene ciloleucel), will be evaluated in combination with Pfizer’s utomilumab, a fully humanized 4-1BB agonist monoclonal antibody, in patients with refractory large B-cell lymphoma. A phase I/II study is expected to commence this year. Pfizer is a Zacks Rank #2 (Buy) stock - you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. The company’s stock is up 16.7% over the last one year, compared to the 22.9% rally of the industry it belongs to.
Performance
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
The NYSE ARCA Pharmaceutical Index was up 1.5% over the last four trading sessions. Among major stocks, Merck was up 6.1% while Bristol-Myers Squibb (BMY - Free Report) declined 1%. Over the last six months, Bristol-Myers was up 14.4% while GlaxoSmithKline (GSK - Free Report) declined 7.7% (See the last pharma stock roundup here: Novo Nordisk Reveals Bid to Acquire Ablynx, Pfizer & Others at Healthcare Conference).
What's Next in the Pharma World?
Watch out for the usual pipeline and regulatory updates as well as J&J’s fourth quarter earnings announcement on January 23.
Will You Make a Fortune on the Shift to Electric Cars?
Here's another stock idea to consider. Much like petroleum 150 years ago, lithium power may soon shake the world, creating millionaires and reshaping geo-politics. Soon electric vehicles (EVs) may be cheaper than gas guzzlers. Some are already reaching 265 miles on a single charge.
With battery prices plummeting and charging stations set to multiply, one company stands out as the #1 stock to buy according to Zacks research.
It's not the one you think.
See This Ticker Free >>