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PBYI

Puma Biotechnology

$38.05

1.35 (3.68%)

16:47
03/01/17
03/01
16:47
03/01/17
16:47

Puma Biotechnology to modify summary of product characteristics in MAA

Puma Biotechnology announced that based on its recent meeting with the Rapporteur, Co-Rapporteur and review team members, as well as the European Medicines Agency, the company plans to modify the summary of product characteristics, sometimes referred to as the European product label, in its Marketing Authorisation Application to restrict the intended population to patients initiating neratinib treatment within one year after completion of adjuvant trastuzumab therapy. The proposed SmPC will continue to include both hormone receptor positive and hormone receptor negative patients. Puma recently conducted a meeting with the Rapporteur, Co-rapporteur and members of the review team as well as EMA to discuss the responses to the 120-day list of questions received in connection with the Company's MAA for neratinib that was submitted in the summer of 2016. The initially proposed indication was for the "extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab based therapy." During this meeting it was discussed that neratinib would likely be sequenced immediately after adjuvant trastuzumab and more benefit was observed in the subgroup of patients who received neratinib within 1 year from prior trastuzumab completion when compared with those patients receiving neratinib after 1 year from the completion of prior trastuzumab treatment. In addition, data from the pivotal adjuvant trastuzumab trials suggest that patients are at higher risk of recurrence closer to completion of adjuvant trastuzumab, and the risk of recurrence may decrease over time. Based on this meeting, Puma will be revising the proposed SmPC in its MAA for neratinib to restrict the intended population to those patients initiating neratinib treatment within one year after completion of adjuvant trastuzumab therapy. The Committee for Medicinal Products for Human Use is continuing to review Puma's MAA and has not yet made a final decision to recommend approval of the drug for the updated or any other indication and there is no guarantee when, if ever, the MAA will be approved. The tables below, based on the interim 5 year analysis announced in July 2016, show results for the invasive disease free survival of the initially proposed intent to treat population and the intent to treat population in the subgroup of patients who initiated neratinib treatment within one year after completion of adjuvant trastuzumab therapy.

  • 21

    Jul

PBYI Puma Biotechnology
$38.05

1.35 (3.68%)

11/14/16
JPMS
11/14/16
NO CHANGE
JPMS
Puma Biotechnology selloff today an overreaction, says JPMorgan
JPMorgan analyst Cory Kasimov views the selloff today in shares of Puma Biotechnology as an overreaction. The diarrhea rates included in abstract posted today are worse than the last update, but the rates are equivalent to a median number of around 1 episode per patient in the first cycle of treatment, Kasimov tells investors in an intraday research note. He continues to consider neratinib an approvable drug based on currently available data.
11/14/16
STFL
11/14/16
NO CHANGE
Target $88
STFL
Buy
Stifel calls Puma selloff overdone, but concerned by management comments
Stifel analyst Thomas Shrader views the intraday selloff in Puma Biotechnology shares as an overreaction, but he calls management's comments last week "an issue." At a conference last week, management said, "In December, we showed the interim results of this and as you can see the grade 3 diarrhea ranged from 13% to 18%. And also, all of the things that would be involved in tolerability, like stopping the drug, reducing the drug, or discontinuing were all brought down as well. Here, you can see the diarrhea over time in the control study." Shrader believes today's abstract was likely embargoed, but he still finds last week's comments "strange." Nonetheless, the analyst feels neratinib's Grade 3 diarrhea rate is manageable and he notes that Grade 4 diarrhea events were zero in all arms of the trial. Shrader has a Buy rating on Puma with an $88 price target.
01/03/17
SBSH
01/03/17
NO CHANGE
Target $88
SBSH
Buy
Citi finds 'bullish' Youtube videos for Puma cancer drug
Two new "Key Opinion Leader" videos expressing continued optimism on Puma Biotechnology's breast cancer drug neratinib posted on Youtube within the last several weeks, Citi analyst Yigal Nochomovitz tells investors in a research note. Similar to two videos posted in August, the new videos have received very little online attention with 25-30 views, the analyst contends. Nochomovitz believes Key Opinion Leader interest in neratinib continues to accelerate. The analyst notes a doctor in one of the videos said the chances of getting "significant diarrhea go way, way down" after a month. He keeps a Buy rating on Puma shares with an $88 price target. The stock closed Friday up 15c to $30.70.
02/01/17
SBSH
02/01/17
NO CHANGE
Target $88
SBSH
Buy
Citi sees Puma doubling if Roche study is negative
Citi analyst Yigal Nochomovitz believes shares of Puma Biotechnology (PBYI) could rally 100% or more if Roche (RHHBY) reports a negative Phase III Aphinity study readout of Perjeta in the adjuvant treatment of HER2-positive early breast cancer. The analyst, which notes Roche slides today point to a data readout in late February or early March, sees maximum downside for Puma shares of 30% should Aphinity succeed. A selloff would be a "very good opportunity to buy the dip" as despite the controversy around neratinib's benefit/risk profile, neratinib should be approved by the FDA for extended adjuvant, Nochomovitz tells investors in a research note. The FDA action date for neratinib is in July. The analyst adds that recent stock sales by Puma management were in the context of tax obligations required for vesting of restricted stock units. Management's net ownership in the company has actually increased with the vesting of a tranche of restricted stock, Nochomovitz writes. He has a Buy rating on Puma with an $88 price target. The stock is unchanged at $32.40 in morning trading.

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