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Puma Biotechnology Inc (PBYI.OQ)

PBYI.OQ on NASDAQ Stock Exchange Global Select Market

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15 Feb 2019
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Latest Key Developments (Source: Significant Developments)

Puma Biotechnology To Receive Payments Up To $7.2 Mln From License Agreement With Knight Therapeutics
Friday, 11 Jan 2019 

Jan 11 (Reuters) - Puma Biotechnology Inc::PUMA BIOTECHNOLOGY AND KNIGHT THERAPEUTICS ENTER INTO EXCLUSIVE LICENSE AGREEMENT TO COMMERCIALIZE NERLYNX® (NERATINIB) IN CANADA.PUMA BIOTECHNOLOGY INC - PUMA WILL RECEIVE UPFRONT AND MILESTONE PAYMENTS UP TO $7.2 MILLION USD THROUGHOUT TERM OF THIS AGREEMENT.PUMA BIOTECHNOLOGY INC - KNIGHT WILL BE RESPONSIBLE FOR ALL COMMERCIAL ACTIVITIES AND FUTURE REGULATORY SUBMISSIONS FOR NERLYNX IN CANADA.  Full Article

Knight Therapeutics Enters License Agreement With Puma Biotechnology To Commercialize Nerlynx In Canada
Friday, 11 Jan 2019 

Jan 11 (Reuters) - Knight Therapeutics Inc ::KNIGHT THERAPEUTICS INC - ENTERED INTO LICENSE AGREEMENT WITH PUMA BIOTECHNOLOGY GRANTING CO EXCLUSIVE RIGHT TO COMMERCIALIZE NERLYNX IN CANADA.  Full Article

Puma Biotechnology Announces Top Line Results Of Phase III NALA Trial Of Neratinib
Tuesday, 18 Dec 2018 

Dec 17 (Reuters) - Puma Biotechnology Inc ::PUMA BIOTECHNOLOGY ANNOUNCES TOP LINE RESULTS OF THE PHASE III NALA TRIAL OF NERATINIB IN PATIENTS WITH HER2-POSITIVE METASTATIC BREAST CANCER.PUMA BIOTECHNOLOGY INC - SAFETY PROFILE OF NERATINIB IN PHASE III NALA STUDY WAS CONSISTENT WITH PREVIOUS CLINICAL TRIALS OF NERATINIB.PUMA BIOTECHNOLOGY - CO-PRIMARY ENDPOINTS OF TRIAL ARE CENTRALLY CONFIRMED PROGRESSION FREE SURVIVAL (PFS) AND OVERALL SURVIVAL (OS).  Full Article

Puma Biotechnology Q3 Adjusted Non-GAAP Earnings Per Share $0.16
Friday, 2 Nov 2018 

Puma Biotechnology Inc ::PUMA BIOTECHNOLOGY REPORTS THIRD QUARTER 2018 FINANCIAL RESULTS.Q3 ADJUSTED NON-GAAP EARNINGS PER SHARE $0.16.Q3 REVENUE $62.6 MILLION VERSUS I/B/E/S VIEW $57.9 MILLION.Q3 EARNINGS PER SHARE VIEW $-0.97 -- THOMSON REUTERS I/B/E/S.Q3 LOSS PER SHARE $0.37.NET CASH USED IN OPERATING ACTIVITIES FOR Q3 OF 2018 WAS $7.3 MILLION.AT SEPTEMBER 30, 2018, PUMA HAD CASH AND CASH EQUIVALENTS OF $68.3 MILLION AND MARKETABLE SECURITIES OF $59.7 MILLION.EXPECT NERLYNX TO BE COMMERCIALLY AVAILABLE TO PATIENTS IN EUROPE IN 2019.EXPECT NERLYNX LAUNCH IN GERMANY DURING FIRST HALF OF 2019.EXPECT NERLYNX LAUNCH THROUGHOUT EUROPE IN SECOND HALF OF 2019.  Full Article

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

In rare class action trial, jury finds Puma Biotech liable for fraud – but Puma claims victory

On Monday, after eight days of trial and nearly four days of deliberation, a federal jury in Santa Ana, California found the pharmaceutical company Puma Biotechnology and its CEO, Alan Auerbach, liable for securities fraud for a statement Auerbach made on a call with stock analysts in July 2014. The jury said Auerbach knowingly misrepresented clinical trial results on the disease-free survival rate of breast cancer patients treated with the drug neratinib, which is intended to preven