Thursday, September 25, 2014 4:26:11 PM
Puma Biotechnology: Legacy Wyeth Study Provides The Back Story On Neratinib - Adjuvant Approval Appears Unlikely
Sep. 24, 2014 7:45 AM ET | 8 comments | About: Puma Biotechnology, Inc. (PBYI) Subscribers to SA PRO had an early look at this article. Learn more about PRO »
Disclosure: The author has no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. (More...)
Summary
Based in part on data from a legacy Phase II study run by Wyeth in Herceptin pre-treated and naive patients, Neratinib unlikely to see approval in adjuvant HER2+ breast cancer.
~80% and 100% of Herceptin failures, including adjuvant stage patients, had progressed on Neratinib at 48 weeks and 96 weeks, raising doubts on Neratinib's efficacy over the long term.
FDA unlikely to approve Neratinib on 2 years follow-up data. NDA filing will more than likely require 5-8 years of follow-up.
In a 5-8 years follow-up of Neratinib in adjuvant disease, difference in disease-free survival between patients on Neratinib and patients on placebo unlikely to be statistically significant.
Updating Price Target to $49.22/share to account for greater uncertainty associated with adjuvant Neratinib and to incorporate multiple expansion due to rally in biotech stocks. Reiterate Sell Rating.
Full article on following link:
http://seekingalpha.com/article/2517175-puma-biotechnology-legacy-wyeth-study-provides-the-back-story-on-neratinib-adjuvant-approval-appears-unlikely
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