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Novartis (NVS) Zykadia Positive in Phase III ASCEND-4 Study
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Novartis AG (NVS - Free Report) announced positive top-line data from a phase III study (ASCEND-4) on its oncology drug, Zykadia, for the treatment of patients with advanced anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC). We expect investors to react positively to the news.
The randomized, open label study evaluated the safety and efficacy of Zykadia, in comparison to standard chemotherapy, in previously untreated adult patients with stage IIIB or IV ALK+ NSCLC.
Results from the study showed significant improvement in progression-free survival (PFS), compared to standard chemotherapy, including maintenance, thereby meeting the primary endpoint. The study also demonstrated clinically meaningful results across key secondary efficacy measures that included the objective response rate and duration of response. The company stated that it will the share the data with regulatory authorities in the upcoming months.
Novartis expects to present full data from the study, including detailed efficacy and safety results, at a future medical congress.
Note that Zykadia is approved in the U.S. for the treatment of patients with ALK+ metastatic NSCLC, who have progressed on or are intolerant to Pfizer Inc.’s (PFE - Free Report) Xalkori. In the EU, Zykadia is approved for the treatment of adults with ALK+ advanced NSCLC, previously treated with Xalkori.
Zykadia raked in sales of $48 million in the first six months of 2016, up 41.2% from the year-ago period. Currently, the drug is approved in over 55 countries.
A successful label expansion of the drug should boost the company’s top-line growth, going forward.
Lung cancer is estimated to affect over 1.8 million individuals each year. Out of this, approximately 2–7% of cases have the ALK gene rearrangement.
The lung cancer market is highly crowded with drugs like Opdivo, Keytruda, Tarceva, Xalkori and Taxotere among others.
Novartis currently carries a Zacks Rank #3 (Hold).
Pacira Pharmaceuticals is a specialty pharmaceutical company. In the trailing four quarters, the company has recorded an average positive earnings surprise of 35.83%.
Anika Therapeutics, which specializes in orthopedic medicines, has seen its earnings estimates for 2016 increase 12.64% over the past 60 days. The company has posted an average positive earnings surprise of 42.19% over the last four quarters.
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Novartis (NVS) Zykadia Positive in Phase III ASCEND-4 Study
Novartis AG (NVS - Free Report) announced positive top-line data from a phase III study (ASCEND-4) on its oncology drug, Zykadia, for the treatment of patients with advanced anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC). We expect investors to react positively to the news.
The randomized, open label study evaluated the safety and efficacy of Zykadia, in comparison to standard chemotherapy, in previously untreated adult patients with stage IIIB or IV ALK+ NSCLC.
Results from the study showed significant improvement in progression-free survival (PFS), compared to standard chemotherapy, including maintenance, thereby meeting the primary endpoint. The study also demonstrated clinically meaningful results across key secondary efficacy measures that included the objective response rate and duration of response. The company stated that it will the share the data with regulatory authorities in the upcoming months.
Novartis expects to present full data from the study, including detailed efficacy and safety results, at a future medical congress.
NOVARTIS AG-ADR Price
NOVARTIS AG-ADR Price | NOVARTIS AG-ADR Quote
Note that Zykadia is approved in the U.S. for the treatment of patients with ALK+ metastatic NSCLC, who have progressed on or are intolerant to Pfizer Inc.’s (PFE - Free Report) Xalkori. In the EU, Zykadia is approved for the treatment of adults with ALK+ advanced NSCLC, previously treated with Xalkori.
Zykadia raked in sales of $48 million in the first six months of 2016, up 41.2% from the year-ago period. Currently, the drug is approved in over 55 countries.
A successful label expansion of the drug should boost the company’s top-line growth, going forward.
Lung cancer is estimated to affect over 1.8 million individuals each year. Out of this, approximately 2–7% of cases have the ALK gene rearrangement.
The lung cancer market is highly crowded with drugs like Opdivo, Keytruda, Tarceva, Xalkori and Taxotere among others.
Novartis currently carries a Zacks Rank #3 (Hold).
Stocks to Consider
A couple of better-ranked stocks in the health care sector include Pacira Pharmaceuticals, Inc. (PCRX - Free Report) and Anika Therapeutics, Inc. (ANIK - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.
Pacira Pharmaceuticals is a specialty pharmaceutical company. In the trailing four quarters, the company has recorded an average positive earnings surprise of 35.83%.
Anika Therapeutics, which specializes in orthopedic medicines, has seen its earnings estimates for 2016 increase 12.64% over the past 60 days. The company has posted an average positive earnings surprise of 42.19% over the last four quarters.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>