Biotechnology Overview: Industry Center – Yahoo Finance

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More On This Industry Summary News Leaders & Laggards Company Index Industry Browser Related Industries Diagnostic Substances Drug Delivery Drug Manufacturers - Major Drug Manufacturers - Other Drug Related Products Drugs - Generic Top Industries Auto Manufacturers - Major Biotechnology Business Software & Services Chemicals - Major Diversified Communication Equipment Conglomerates Diversified Computer Systems Diversified Investments Diversified Utilities Drug Manufacturers - Major Electric Utilities Food - Major Diversified Industrial Metals & Minerals Major Airlines Major Integrated Oil & Gas Money Center Banks Property & Casualty Insurance Semiconductor - Broad Line Telecom Services - Domestic Tobacco Products, Other Complete Industry List... In-depth Company Dossier Reports on over 7,500 publicly traded U.S. companies. Click here for your free report. Industry Market Summary Biotechnology Composite Value:918.9 Today's Change:-0.78% S&P 500: -0.29% Biotechnology News Exelixis Announces Genentech Presentation of Preliminary Phase 1B Trial Results for the Combination of Cobimetinib and Atezolizumab at ASCO 2016 Annual Meeting 14 minutes ago (Business Wire) Exelixis, Inc. today announced that its collaborator Genentech, a member of the Roche Group, will present preliminary results from a phase 1b clinical trial evaluating the safety and clinical activity of cobimetinib, an Exelixis-discovered MEK inhibitor, in combination with atezolizumab, an anti-PD-L1 antibody discovered and developed by Genentech, in patients with metastatic colorectal cancer . Stemline Therapeutics SL-401 Phase 2 BPDCN Data Delivered Via Oral Presentation at ASCO; High Response Rates Demonstrated Across All Lines As Enrollment Proceeds - (GlobeNewswire) TESARO Provides Pipeline Update at ASCO Investor Briefing - (GlobeNewswire) More News on Biotechnology: Latest News, Industry Top Performers Intraday Price Performance % Change Market Cap More Top Intraday Price Performers... Market Capitalization % Change Market Cap SHIRE [SHP.L] -0.94% $2607.6 B AMGEN [AMGN.MX] -0.52% $2216.5 B GILEAD SCIENCES [GILD.MX] -0.62% $2134.9 B SUN PHARMACEUTICALS INDUSTRIES [SUNPHARMA.NS] -1.26% $1831.4 B AMGEN-T [4332.HK] 0.00% $505.0 B More Top Companies by Market Cap... More Top Performers: by Valuation, by Growth, by Financial Strength Industry Calendar Upcoming Events Date Co Event 06/05/16 EXEL Exelixis Inc Investor/Analyst Briefing to Review Cabozantinib Data at the American Society of Clinical Oncology (ASCO) Annual Meeting 06/06/16 ARIA ARIAD Pharmaceuticals Investor and Analyst Briefing and Webcast 06/11/16 AGIO Agios Pharmaceuticals Inc Conference Call to Discuss Data from PKR Activators AG-348 and AG-519 More Upcoming Events... Recent Events Date Co Event 06/03/16 BLUE bluebird bio, Inc. coverage initiated by Cantor Fitzgerald 06/03/16 OMER Omeros Corporation coverage initiated by Cantor Fitzgerald 06/03/16 ONCE Spark Therapeutics, Inc. coverage initiated by Cantor Fitzgerald More Recent Events... Locate Industry by Company Enter Symbol: AdChoices Industry Statistics Market Capitalization: 9,619B Price / Earnings: 165.8 Price / Book: 23.4 Net Profit Margin (mrq): 19.7% Price To Free Cash Flow (mrq): -290.2 Return on Equity: 15.4% Total Debt / Equity: 105.0 Dividend Yield: 2.0% View Industry Browser Community Spotlight Most Active Boards Board Popularity CTRX PGLAF NRPH Unusually Active Boards Board Variance CTRX NRPH PDLI RSS Feeds

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Biotechnology Overview: Industry Center - Yahoo Finance

Puma Biotechnology Inc (PBYI) Pops 60% on FDA Review – Investorplace.com

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By Robert Martin, InvestorPlace Writer|May 22, 2017, 11:12 am EDT

Puma Biotechnology Inc (NASDAQ:PBYI) jolted as much as 80% higher on Monday morning on news that theU.S. Food & Drug Administration posted a seemingly positive review of Pumas breast cancer drug, neratinib, ahead of an official vote Wednesday. PBYI then settled back to just 60% gains a few hours into the trading day.

The FDA asked a few questions and raised a few concerns, notably, tolerability of neratinib in this patient population is a concern given the frequent dose interruptions, reductions, and discontinuations observed, mostly due to diarrhea.

Specifically, 95% of patients in clinical trials suffered from diarrhea, with 40% of those suffering the grade 3 form of the side effect.

However, on the whole, PBYI investors seemed pleased with what the FDA did (and didnt) ask, taking the review as an encouraging sign ahead of the companys Oncologic Drugs Advisory Committee meeting, scheduled for Wednesday.

Neratinib (PB272) is being tested for the extended adjuvant treatment of HER2-positive early stage breast cancer. The drug is meant for patients who have already received Herceptin.

The FDA preview said that the primary analysis showed an improvement with neratinib, and that despite changes made to the clinical trial, the results of sensitivity analyses appear to be generally similar to the primary analysis results, supporting an effect of neratinib.

The results are receiving a warm welcome from PBYI stock longs, who have suffered a roughly 80% decline from 2014 highs even after todays boffo gains.

The company has been a hotbed of volatility thanks to its dependence on this single candidate Puma Biotechnology is pre-revenue, and has been incurring increasingly larger net losses over the past few years. Specifically, red ink of about $55 million in 2013 has ballooned to losses of $276 million last year.

As of this writing, Robert Martin did not hold a position in any of the aforementioned securities.

Article printed from InvestorPlace Media, http://investorplace.com/2017/05/puma-biotechnology-inc-pbyi-pops-60-fda-review/.

2017 InvestorPlace Media, LLC

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Puma Biotechnology Inc (PBYI) Pops 60% on FDA Review - Investorplace.com