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Puma Biotechnology Inc (PBYI.OQ)

PBYI.OQ on NASDAQ Stock Exchange Global Select Market

53.70USD
13 Jul 2018
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Latest Key Developments (Source: Significant Developments)

Puma Biotechnology Announces Results Of CHMP Reexamination Of MAA For Neratinib
Tuesday, 26 Jun 2018 

June 26 (Reuters) - Puma Biotechnology Inc ::PUMA BIOTECHNOLOGY ANNOUNCES RESULTS OF CHMP REEXAMINATION OF MAA FOR NERATINIB FOR EXTENDED ADJUVANT TREATMENT OF HER2-POSITIVE EARLY STAGE BREAST CANCER.PUMA BIOTECHNOLOGY - EUROPEAN MEDICINES AGENCY HAS ADOPTED A POSITIVE TREND VOTE RECOMMENDING APPROVAL OF MAA FOR NERATINIB.PUMA BIOTECHNOLOGY - DECISION FOLLOWS REEXAMINATION OF NEGATIVE OPINION ANNOUNCED BY CHMP AT FORMAL MEETING WITH CO TO DISCUSS MAA ON FEB 23, 2018.  Full Article

Puma Biotechnology Announces Positive Outcome Of European Opposition Proceedings
Monday, 11 Dec 2017 

Dec 11 (Reuters) - Puma Biotechnology Inc ::PUMA BIOTECHNOLOGY ANNOUNCES POSITIVE OUTCOME OF EUROPEAN OPPOSITION PROCEEDINGS.PUMA BIOTECHNOLOGY - EUROPEAN PATENT OFFICE HAS UPHELD CLAIMS IN PUMA'S LICENSED EUROPEAN PATENT, EP 2416774, WHICH WERE BEING OPPOSED BY HEXAL AG.  Full Article

PUMA BIOTECHNOLOGY, SPECIALISED THERAPEUTICS ASIA AGREE TO COMMERCIALIZE NERLYNX IN SOUTH EAST ASIA
Wednesday, 22 Nov 2017 

Nov 22 (Reuters) - Puma Biotechnology Inc ::PUMA BIOTECHNOLOGY AND SPECIALISED THERAPEUTICS ASIA ENTER INTO EXCLUSIVE LICENSING AGREEMENT TO COMMERCIALIZE NERLYNX® (NERATINIB) IN AUSTRALIA, NEW ZEALAND AND SOUTH EAST ASIA.PUMA BIOTECHNOLOGY INC - ‍PUMA WILL RECEIVE UPFRONT AND MILESTONE PAYMENTS OF UP TO $4.5 MILLION THROUGHOUT TERM OF THE AGREEMENT​.PUMA BIOTECHNOLOGY-SPECIALISED THERAPEUTICS RESPONSIBLE FOR SEEKING REGULATORY APPROVALS, FOR COMMERCIALIZING NERLYNX IN SOUTH EAST ASIAN COUNTRIES.PUMA BIOTECHNOLOGY INC - ‍EXPECT TO HAVE REGULATORY APPROVAL FOR NERLYNX IN AUSTRALIA BY Q2 OF 2019​.  Full Article

Puma Biotechnology reports Q3 adj. loss per share $1.36
Friday, 10 Nov 2017 

Nov 9 (Reuters) - Puma Biotechnology Inc :Puma Biotechnology reports third quarter 2017 financial results.Q3 adjusted non-GAAP loss per share $1.36.Q3 earnings per share view $-2.58 -- Thomson Reuters I/B/E/S.Q3 loss per share $2.07.  Full Article

Puma Biotechnology secures $100 mln term loan from Silicon Valley Bank and Oxford Finance
Friday, 3 Nov 2017 

Nov 2 (Reuters) - Puma Biotechnology Inc :Puma Biotechnology secures $100 million term loan from Silicon Valley Bank and Oxford Finance.Puma Biotechnology - ‍proceeds from financing will be used to continue to support Nerlynx commercial activities, ongoing research with neratinib ​.  Full Article

Puma Biotechnology's marketing authorization application for neratinib validated by EMA
Tuesday, 23 Aug 2016 

Puma Biotechnology Inc :Marketing authorization application for neratinib has been validated by European Medicines Agency.  Full Article

Puma Biotechnology Q2 adjusted non-gaap loss per share $1.17
Wednesday, 10 Aug 2016 

Puma Biotechnology Inc : Q2 adjusted non-gaap loss per share $1.17 . Q2 loss per share $2.05 . Puma biotechnology reports second quarter 2016 financial results . Q2 earnings per share view $-2.18 -- Thomson Reuters I/B/E/S .Puma biotechnology inc says look forward to continuing our development of neratinib in second half of 2016 and beyond.  Full Article

Puma Biotech gets EU panel nod for breast cancer drug

Puma Biotechnology Inc  on Friday won a key recommendation from a European Medicines Agency panel on its lead breast cancer drug, five months after the regulator recommended against approving it.