Blog Exposure – CHMP Recommended Against Approval of Puma Biotech’s Neratinib for Extended Adjuvant Treatment of HER2-Positive Breast Cancer

Stock Monitor: BioMarin Pharma Post Earnings Reporting

LONDON, UK / ACCESSWIRE / February 27, 2018 / Active-Investors.com has just released a free research report on Puma Biotechnology, Inc. (NASDAQ: PBYI) (“Puma Biotech”). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=PBYI as the Company’s latest news hit the wire. On February 23, 2018, the Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the refusal of the Marketing Authorisation Application (MAA) for the Company’s neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer. Register today and get access to over 1,000 Free Research Reports by joining our site below:

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Active-Investors.com is currently working on the research report for BioMarin Pharmaceutical Inc. (NASDAQ: BMRN), which also belongs to the Healthcare sector as the Company Puma Biotechnology. Do not miss out and become a member today for free to access this upcoming report at:

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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Puma Biotech most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

www.active-investors.com/registration-sg/?symbol=PBYI

The Company may request a re-examination of the opinion. A letter of intent to seek re-examination should be submitted within 15 days of acknowledgement of receipt of the final opinion package. Puma Biotech plans to submit this request in accordance with this timeline.

Puma Biotech Announced Results of CHMP Oral Explanation for Neratinib

On January 23, 2018, the Company announced that the CHMP had communicated a negative trend vote after meeting with the Company to discuss the MAA for neratinib. A negative trend vote meant it was unlikely that CHMP would provide a positive opinion related to the Company’s MAA at the formal CHMP meeting and that additional steps would need to be taken to gain marketing approval in Europe. CHMP’s opinion was based on the results from both the Phase-III ExteNET trial in extended adjuvant early stage HER2-positive breast cancer and the Phase-II CONTROL trial in extended adjuvant early stage HER2-positive breast cancer.

CHMP Approved Drug for Treatment of HER2-Positive Early Stage Breast Cancer

In June 2017, CHMP adopted a positive opinion recommending approval of Novartis’s Kisqali® (ribociclib) in combination with an aromatase inhibitor for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer as initial endocrine-based therapy.

In September 2017, CHMP adopted a positive opinion recommending granting a marketing authorization for the biosimilar medicinal product of Samsung Bioepis’ trastuzumab (Ontruzant), intended for the treatment of early and metastatic breast cancer, and metastatic gastric cancer. Ontruzant is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer.

About HER2-Positive Breast Cancer

HER2-positive breast cancer is a breast cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. Approximately 20% to 25% of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death.

About NERLYNX® (Neratinib)

NERLYNX® is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early-stage HER2 overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy. The most common adverse reactions of the tablets include diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased, and urinary tract infection.

About Puma Biotechnology, Inc.

Founded in 2010 and headquartered in Los Angeles, California, Puma Biotech is a biopharmaceutical company with a focus on in-licensing innovative drug candidates that are undergoing or have already completed initial clinical testing for the treatment of various forms of cancer and then seek to further develop these drug candidates for commercial use.

Stock Performance Snapshot

February 26, 2018 – At Monday’s closing bell, Puma Biotech’s stock slightly declined 0.51%, ending the trading session at $67.90.

Volume traded for the day: 712.38 thousand shares.

Stock performance in the past twelve-month period – up 87.57%

After yesterday’s close, Puma Biotech’s market cap was at $2.47 billion.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 1.0% at the end of the session.

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