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April 7, 2014
13:36 EDTPBYIPuma presents 'positive' PB272 Phase II data from I-SPY 2 trial
Puma Biotechnology announced the presentation of "positive" results from the Phase II clinical trial of Puma's investigational drug PB272 for the neoadjuvant treatment of breast cancer, or I-SPY 2 trial, in an oral presentation. The presentation entitled “Neratinib plus Standard Neoadjuvant Therapy for High-Risk Breast Cancer: Efficacy Results from the I-SPY 2 TRIAL” was presented today at the session entitled “Clinical Trials Symposium: Biomarker Driven Clinical Trials.” The I-SPY 2 TRIAL is a randomized Phase II clinical trial for women with newly diagnosed Stage 2 or higher breast cancer that addresses whether adding investigational drugs to standard chemotherapy in the neoadjuvant setting is better than standard chemotherapy. The primary endpoint is pathological complete response in the breast and the lymph nodes at the time of surgery. The goal of the trial is to match investigational regimens with patient subsets on the basis of molecular characteristics that benefit from the regimen. The trial enrolled patients who had a high risk of relapse using up-front tumor profiling.
News For PBYI From The Last 14 Days
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September 4, 2015
09:42 EDTPBYIBattleground: Will this $5 biotech stock go to $22 or $1.50?
In the last two days, analysts have issued widely divergent opinions and price targets on Keryx Biopharmaceuticals, a small-cap biotech company focused on the treatment of renal diseases. CITI SAYS SELL: Citi analyst Yigal Nochomovitz started shares of Keryx yesterday with a Sell rating and $1.50 price target. Nochomovitz expects the Auryxia launch and long-term sales trends to "materially underperform" consensus expectations. Auryxia is a phosphate binder used for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis. Nochomovitz estimates Auryxia has peak U.S. sales potential of $57M, well below the consensus estimate of $485M. BREAN SAYS BUY: Brean Capital analyst Jonathan Aschoff told investors this morning that he views the recent selloff in shares of Keryx as overdone. The bearish assessment of Auryxia's ultimate market potential is premature, Aschoff contends. Auryxia "finally achieved" a majority of insurance coverage in early August, which will facilitate prescription writing, the analyst argues. He also believes Keryx's 50% salesforce increase should make a "noticeable impact" on revenue. Aschoff reiterated a Buy rating on the stock with a $22 price target. WHAT'S NOTABLE: Along with yesterday's note on Keryx, Nochomovitz expanded Citi's coverage of the Biotech space by initiating seven other small- and mid-cap names. Chimerix (CMRX) is Nochomovitz's top pick with a Buy rating and $80 price target. Other stocks to which he assigned Buy ratings include Ophthotech (OPHT), Relypsa (RLYP) and ZS Pharma (ZSPH). In addition to placing a Sell rating on Keryx, Nochomovitz started Ultragenyx (RARE) with a sell and an $87 price target. He rounded out his coverage with Neutral ratings on Medivation (MDVN) and Puma Biotechnology (PBYI). PRICE ACTION: In early trading, Keryx shares fell 40c, or 7,9%, to $4.66, which comes on top of the 16% decline the stock suffered yesterday. Over the last three months, Keryx shares have fallen more than 50%.
September 3, 2015
10:04 EDTPBYIOn The Fly: Analyst Initiation Summary
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08:15 EDTPBYIChimerix rallies, Keryx falls after Citi expands Biotech coverage
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06:40 EDTPBYIPuma Biotechnology initiated with a Buy at Citi
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August 27, 2015
10:00 EDTPBYIOn The Fly: Analyst Initiation Summary
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06:29 EDTPBYIPuma Biotechnology initiated with an Overweight at JPMorgan
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