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PBYI

Puma Biotechnology

$8.71

0.24 (2.83%)

18:08
12/11/19
12/11
18:08
12/11/19
18:08

Puma Biotechnology presents Phase II results of neratinib in breast cancer

Puma Biotechnology announced that results from an ongoing Phase II clinical trial of Puma's drug neratinib are being presented at the 2019 San Antonio Breast Cancer Symposium. Neratinib was approved by the FDA in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy and is marketed in the U.S. as Nerlynx tablets. Nerlynx was granted marketing authorization by the European Commission for the extended adjuvant treatment of hormone receptor-positive HER2-positive early stage breast cancer in August 2018. The Phase II SUMMIT basket trial is a study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating HER2 or HER3 mutations. The interim efficacy summary of the breast cohort that received neratinib in combination with trastuzumab and fulvestrant showed that for the 17 efficacy evaluable patients, 9 patients - 53% - experienced a confirmed objective response, all of which were classified as partial responses, and 10 patients - 59% - experienced clinical benefit. The median duration of response has not been reached and the median progression-free survival was 9.8 months. At the time of data cut-off, five patients continued to receive treatment. The most frequently observed adverse event was diarrhea. No patient permanently discontinued neratinib due to diarrhea.

PBYI Puma Biotechnology
$8.71

0.24 (2.83%)

11/07/19
LEHM
11/07/19
NO CHANGE
Target $6
LEHM
Underweight
Puma Biotechnology price target lowered to $6 from $9 at Barclays
Barclays analyst Gena Wang lowered her price target for Puma Biotechnology to $6 from $9 and keeps an Underweight rating on the shares. Puma reported Q3 Nerlynx revenue of $53.6M, below the consensus of $59.0M, and lowered its 2019 guidance for the second time to $205M-$210M from $220M-$240M, Wang tells investors in a research note. The analyst continues to see a limited growth outlook in extended adjuvant setting as well as metastatic HER2+ breast cancer.
11/07/19
RBCM
11/07/19
NO CHANGE
Target $13
RBCM
Sector Perform
Puma Biotechnology price target lowered to $13 from $23 at RBC Capital
RBC Capital analyst Kennen MacKay lowered his price target on Puma Biotechnology to $13 and kept his Sector Perform rating after its Q3 results showed a miss on Nerlynx sales. The analyst warns that the print may reflect lower demand due to dose-reductions, also noting his lowered estimates in late-stage metastatic breast cancer where he sees greater competitive pressure from other HER2+ agents in that setting.
11/08/19
CANT
11/08/19
NO CHANGE
Target $14
CANT
Neutral
Puma Biotechnology price target lowered to $14 from $20 at Cantor Fitzgerald
Cantor Fitzgerald analyst Alethia Young lowered her price target for Puma Biotechnology to $14 from $20 saying she's more cautious on the long-term revenue outlook for Nerlynx following the company's Q3 results. The analyst reiterates a Neutral rating on the shares.
12/06/19
HCWC
12/06/19
INITIATION
Target $15
HCWC
Buy
Puma Biotechnology initiated with a Buy at H.C. Wainwright
H.C. Wainwright analyst Edward White initiated coverage of Puma Biotechnology with a Buy rating and $15 price target. The analyst believes metastatic breast cancer is a "sizeable opportunity" for the company to capitalize on with Nerlynx. He sees a "promising future" for the drug.

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