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Novartis Announces Positive Results on Migraine Candidate
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Novartis AG (NVS - Free Report) announced positive results from the phase IIIb study, LIBERTY, which assessed the efficacy and safety of erenumab (AMG 334) 140mg in patients with episodic migraine who had experienced two to four previous preventive treatment failures, due to lack of efficacy or intolerable side effects.
The study met its primary endpoint, with significantly more patients taking erenumab experiencing at least a 50% reduction from baseline in their monthly migraine days as compared to placebo. The trial met all secondary endpoints including reduction of monthly migraine days, lowering in days needing acute (rescue) medication, improvement in scores on the Migraine Physical Function Impact Diary (MPFID) tool, and 75% and 100% responder rates (number of patients experiencing at least a 75% or 100% reduction in monthly migraine days compared to placebo.) The safety data are consistent with previous studies of erenumab to date, showing a placebo-like safety profile.
Novartis will present full data at an upcoming scientific meeting.
Novartis' stock has rallied 3.2% in the last six months compared with the industry's 10.% gain.
Erenumab, an investigational fully human monoclonal antibody is designed to selectively block the calcitonin gene-related peptide (CGRP) receptor, which plays a critical role in migraine activation. The candidate is being developed by Novartis in collaboration with Amgen, Inc. (AMGN - Free Report) .
The candidate is the first investigational therapy targeting the CGRP pathway to have received Food and Drug Administration and European Medicines Agency (EMA) regulatory filing acceptance.
Upon approval, Novartis and Amgen will co-commercialize erenumab in the United States. Amgen has exclusive commercialization rights to the drug in Japan and Novartis has exclusive rights to commercialize in the rest of the world.
Novartis has a strong oncology portfolio of drugs like Afinitor, Exjade, Jakavi, Zykadia, Tasigna, Jadenu, and Kisqali. The recent approval of Kymriah for acute lymphoblastic leukemia is a major boost for Novartis given the potential in the CAR-T therapy space. New products like Cosentyx and Entresto are expected to boost the top line. Cosentyx has been strong and the company has grabbed market shares from rivals like AbbVie, Inc.'s (ABBV - Free Report) Humira and Amgen’s Enbrel.
Zacks Rank & Key Pick
Novartis currently carries a Zacks Rank #3 (Hold).
Exelixis’ earnings per share estimates have moved up from 72 cents to 73 cents for 2018 over the last 60 days. The company delivered a positive earnings surprise in the last four quarters, with an average beat of 572.92%.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
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Novartis Announces Positive Results on Migraine Candidate
Novartis AG (NVS - Free Report) announced positive results from the phase IIIb study, LIBERTY, which assessed the efficacy and safety of erenumab (AMG 334) 140mg in patients with episodic migraine who had experienced two to four previous preventive treatment failures, due to lack of efficacy or intolerable side effects.
The study met its primary endpoint, with significantly more patients taking erenumab experiencing at least a 50% reduction from baseline in their monthly migraine days as compared to placebo. The trial met all secondary endpoints including reduction of monthly migraine days, lowering in days needing acute (rescue) medication, improvement in scores on the Migraine Physical Function Impact Diary (MPFID) tool, and 75% and 100% responder rates (number of patients experiencing at least a 75% or 100% reduction in monthly migraine days compared to placebo.) The safety data are consistent with previous studies of erenumab to date, showing a placebo-like safety profile.
Novartis will present full data at an upcoming scientific meeting.
Novartis' stock has rallied 3.2% in the last six months compared with the industry's 10.% gain.
Erenumab, an investigational fully human monoclonal antibody is designed to selectively block the calcitonin gene-related peptide (CGRP) receptor, which plays a critical role in migraine activation. The candidate is being developed by Novartis in collaboration with Amgen, Inc. (AMGN - Free Report) .
The candidate is the first investigational therapy targeting the CGRP pathway to have received Food and Drug Administration and European Medicines Agency (EMA) regulatory filing acceptance.
Upon approval, Novartis and Amgen will co-commercialize erenumab in the United States. Amgen has exclusive commercialization rights to the drug in Japan and Novartis has exclusive rights to commercialize in the rest of the world.
Novartis has a strong oncology portfolio of drugs like Afinitor, Exjade, Jakavi, Zykadia, Tasigna, Jadenu, and Kisqali. The recent approval of Kymriah for acute lymphoblastic leukemia is a major boost for Novartis given the potential in the CAR-T therapy space. New products like Cosentyx and Entresto are expected to boost the top line. Cosentyx has been strong and the company has grabbed market shares from rivals like AbbVie, Inc.'s (ABBV - Free Report) Humira and Amgen’s Enbrel.
Zacks Rank & Key Pick
Novartis currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the healthcare sector is Exelixis, Inc. (EXEL - Free Report) with a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Exelixis’ earnings per share estimates have moved up from 72 cents to 73 cents for 2018 over the last 60 days. The company delivered a positive earnings surprise in the last four quarters, with an average beat of 572.92%.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
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