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PBYI

Puma Biotechnology

$95.70

-0.35 (-0.36%)

04:55
01/12/18
01/12
04:55
01/12/18
04:55

Puma Biotechnology says CHMP to discuss neratinib on January 23

Puma Biotechnology announced last night that it met with Europe's Committee for Medicinal Products for Human Use Scientific Advisory Group on Oncology. SAG was asked to provide an opinion on the clinical relevance of the five-year absolute treatment difference in invasive disease free survival seen in the Phase III ExteNET trial and on the risk of gastrointestinal toxicity with neratinib and its acceptability in the proposed patient population in the company's Marketing Authorization Application for neratinib, Puma said. Based on the feedback from SAG and the rapporteurs, the company intends to modify the summary of product characteristics, sometimes referred to as the European product label, in its MAA for neratinib to further refine the intended population to patients at a high risk of disease recurrence. Puma noted that CHMP will be conducting an oral hearing to discuss the MAA for neratinib on January 23, and that it has been invited to present the risk benefit profile of neratinib in the identified population at this meeting.

PBYI Puma Biotechnology
$95.70

-0.35 (-0.36%)

11/10/17
FBCO
11/10/17
NO CHANGE
Target $142
FBCO
Outperform
Puma Biotechnology launch meeting high expectations, says Credit Suisse
Credit Suisse analyst Alethia Young raised her price target for Puma Biotechnology shares to $142 from $136 saying she believes the Nerlynx launch is living up to high expectations. The analyst keeps an Outperform rating on Puma following the Q3 results.
12/14/17
SBSH
12/14/17
NO CHANGE
Target $164
SBSH
Buy
Citi sees positive CHMP opinion for Puma's neratinib
Citi analyst Yigal Nochomovitz says his analysis of drugs evaluated during European Medicines Agency Scientific Advisory Group meetings in oncology provides "unusually strong evidence" that Puma Biotechnology's neratinib is likely to receive a positive Committee for Medicinal Products for Human Use opinion. Puma yesterday announced that the EMA requested a Scientific Advisory Group provide an opinion on the clinical aspects of neratinib on January 11, 2018. The analyst identified 14 instances where the EMA convened a SAG in oncology, with 86% receiving a positive CHMP opinion. Further, 100% of tyrosine kinase inhibitors in the examples Nochomovitz identified received a positive CHMP opinion. He believes this reinforces his positive view on neratinib. The analyst has a Buy rating on Puma Biotechnology with a $164 price target.
12/18/17
LEER
12/18/17
NO CHANGE
LEER
Puma Biotechnology, Clovis top picks in biotech for 2018 at Leerink
Leerink analyst Michael Schmidt expects oncology to remain an attractive area within Biotech in 2018. Key product launches, a rich set of pivotal trial results, and pending regulatory decisions among stocks he covers make 2018 a catalyst-rich year, particularly in the first half of 2018, the analyst contends. Puma Biotechnology (PBYI) and Clovis (CLVS) are Schmidt's top-picks with Incyte (INCY) as a close third. Additionally, he sees ImmunoGen (IMGN) and Karyopharm (KPTI) as attractive emerging small-caps for 2018.
01/03/18
SBSH
01/03/18
NO CHANGE
Target $164
SBSH
Buy
Puma Biotechnology sold off on FDA database comments, says Citi
Citi analyst Yigal Nochomovitz attributes the 5% pullback yesterday in shares of Puma Biotechnology to a competing research firm highlighting that the FDA's Adverse Event Reporting System shows 137 adverse events and four deaths among patients receiving Nerlynx. The FAERS has "substantial limitations which FDA has publically acknowledged," Nochomovitz tells investors in a research note titled "Alert: Word to the Wise on Using FDA's Adverse Event Reporting." The analyst believes the FAERS data by themselves are not an indicator of the safety profile of a drug. He keeps a Buy rating on Puma with a $164 price target.

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