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Puma Biotechnology Inc (PBYI.OQ)

PBYI.OQ on NASDAQ Stock Exchange Global Select Market

52.00USD
20 Jul 2018
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$-0.45 (-0.86%)
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Latest Key Developments (Source: Significant Developments)

Puma Biotechnology And Pint Pharma Enter Licensing Agreement To Commercialize Nerlynx In Latin America
Tuesday, 3 Apr 2018 08:45am EDT 

April 3 (Reuters) - Puma Biotechnology Inc ::PUMA BIOTECHNOLOGY AND PINT PHARMA ENTER INTO EXCLUSIVE LICENSING AGREEMENT TO COMMERCIALIZE NERLYNX® (NERATINIB) IN LATIN AMERICA.‍PUMA WILL RECEIVE AN UPFRONT PAYMENT AS WELL AS POTENTIAL REGULATORY AND COMMERCIAL MILESTONE PAYMENTS TOTALING UP TO $34.5 MILLION​.DIGIT ROYALTIES ON NERLYNX SALES IN LATIN AMERICA.DEAL FOR PINT PHARMA TO COMMERCIALIZE NERLYNX IN ARGENTINA, BRAZIL, CHILE, COLOMBIA, MEXICO AND REST OF LATIN AMERICA​.PINT PHARMA WILL BE RESPONSIBLE FOR COMMERCIALIZING NERLYNX IN LATIN AMERICA.  Full Article

Puma Biotechnology ‍Nerlynx Included As Recommended Treatment Option In NCCN Clinical Practice Guidelines
Monday, 2 Apr 2018 08:45am EDT 

April 2 (Reuters) - Puma Biotechnology Inc ::‍NERLYNX INCLUDED AS RECOMMENDED TREATMENT OPTION IN NCCN CLINICAL PRACTICE GUIDELINES IN ONCOLOGY CENTRAL NERVOUS SYSTEM CANCERS.NCCN GUIDELINES INCLUDE NERLYNX IN COMBINATION WITH CAPECITABINE/ PACLITAXEL AS TREATMENT OPTIONS WITH BREAST CANCER BRAIN METASTASES​.  Full Article

Puma Biotechnology Requests EMA To Re-Examine the Negative Opinion Issued By CHMP For MAA For Neratinib
Thursday, 8 Mar 2018 06:39am EST 

March 8 (Reuters) - Puma Biotechnology Inc ::PUMA BIOTECHNOLOGY SAYS ‍GIVEN WRITTEN NOTICE TO EMA TO REQUEST RE-EXAMINATION OF NEGATIVE OPINION ISSUED BY CHMP IN FEB 2018 FOR MAA FOR NERATINIB.  Full Article

Puma Biotechnology Inc Files For Non Timely 10-K - SEC Filing‍​
Thursday, 1 Mar 2018 05:13pm EST 

March 1 (Reuters) - Puma Biotechnology Inc ::PUMA BIOTECHNOLOGY INC FILES FOR NON TIMELY 10-K - SEC FILING‍​.  Full Article

Puma Biotechnology Q4 Loss Per Share $1.71
Thursday, 1 Mar 2018 04:05pm EST 

March 1 (Reuters) - Puma Biotechnology Inc ::PUMA BIOTECHNOLOGY REPORTS FOURTH QUARTER AND FULL YEAR 2017 FINANCIAL RESULTS.Q4 ADJUSTED NON-GAAP LOSS PER SHARE $1.03.Q4 LOSS PER SHARE $1.71.IS NOT IN A POSITION TO FILE ITS FORM 10-K FOR FY ENDED DEC 31, 2017​ WITHIN PRESCRIBED TIME PERIOD.  Full Article

EMA Recommends Against Approval Of Puma Biotechnology's Breast Cancer Drug Neratinib‍​
Friday, 23 Feb 2018 06:30am EST 

Feb 23 (Reuters) - EU Medicines Agency::EU MEDICINES AGENCY RECOMMENDATIONS FOR FEBRUARY 2018.EU MEDICINES AGENCY RECOMMENDATIONS FOR FEBRUARY 2018 BREAST CANCER DRUG NERATINIB.EU MEDICINES AGENCY RECOMMENDS APPROVAL OF PFIZER'S MYLOTARG FOR TREATMENT OF ACUTE MYELOID LEUKAEMIA‍​‍​‍​.  Full Article

Puma Biotechnology And Canbridge Life Sciences Enter Into Exclusive Licensing Agreement
Thursday, 1 Feb 2018 04:15pm EST 

Feb 1 (Reuters) - Puma Biotechnology Inc ::PUMA BIOTECHNOLOGY AND CANBRIDGE LIFE SCIENCES ENTER INTO EXCLUSIVE LICENSING AGREEMENT TO COMMERCIALIZE NERLYNX® (NERATINIB) IN GREATER CHINA.PUMA BIOTECHNOLOGY - CANBRIDGE WILL DEVELOP AND COMMERCIALIZE NERLYNX (NERATINIB) IN MAINLAND CHINA, TAIWAN, HONG KONG, AND MACAU.PUMA BIOTECHNOLOGY SAYS WILL RECEIVE UPFRONT PAYMENT OF $30 MILLION.PUMA BIOTECHNOLOGY - CO TO GET UPFRONT PAYMENT OF $30 MILLION AND POTENTIAL MILESTONE PAYMENTS TOTALING UP TO $40 MILLION.PUMA BIOTECHNOLOGY - TO GET SIGNIFICANT DOUBLE-DIGIT ROYALTIES ON NERLYNX SALES IN GREATER CHINA AND POTENTIAL MILESTONE PAYMENTS.  Full Article

Puma Biotechnology Says EMA's CHMP Has Communicated A Negative Trend Vote For Its Breast Cancer Treatment, Neratinib
Tuesday, 23 Jan 2018 04:15pm EST 

Jan 23 (Reuters) - Puma Biotechnology Inc ::PUMA BIOTECHNOLOGY ANNOUNCES RESULTS OF CHMP ORAL EXPLANATION FOR NERATINIB FOR EXTENDED ADJUVANT TREATMENT OF HER2-POSITIVE EARLY STAGE BREAST CANCER.PUMA BIOTECHNOLOGY - CHMP USE OF EMA COMMUNICATED NEGATIVE TREND VOTE AFTER MEETING WITH CO TO DISCUSS MAA FOR NERATINIB​.PUMA BIOTECHNOLOGY - NEGATIVE TREND VOTE MEANS IT IS UNLIKELY CHMP WILL PROVIDE POSITIVE OPINION RELATED TO MAA AT FORMAL DECISION VOTE IN FEB. 2018.PUMA BIOTECHNOLOGY - NEGATIVE TREND VOTE ALSO MEANS ADDITIONAL STEPS WOULD NEED TO BE TAKEN TO GAIN MARKETING APPROVAL IN EUROPE.PUMA BIOTECHNOLOGY - CHMP INDICATED BENEFIT RISK ASSESSMENT NEGATIVE AS STUDY RESULTS BASED ON EVIDENCE FROM SINGLE PIVOTAL TRIAL, AMONG OTHER THINGS.PUMA BIOTECH -CHMP INDICATED BENEFIT RISK ASSESSMENT ALSO NEGATIVE AS 2- & 5-YEAR IDFS BENEFITS OBSERVED TO-DATE MAY LACK SUFFICIENT CLINICAL RELEVANCE.  Full Article

Puma Biotechnology Announces Positive Outcome Of European Opposition Proceedings
Monday, 11 Dec 2017 08:45am EST 

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 09:15am EST 

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 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.