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Puma Biotechnology Inc (PBYI.OQ)

PBYI.OQ on NASDAQ Stock Exchange Global Select Market

25.22USD
18 Jan 2019
Change (% chg)

$-0.25 (-0.98%)
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Volume
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Latest Key Developments (Source: Significant Developments)

Puma Biotechnology - District Court Of Central District Of California, Southern Division Preliminarily Approved Certain Proposed Settlements
Monday, 19 Nov 2018 08:24am EST 

Nov 19 (Reuters) - Puma Biotechnology Inc ::PUMA BIOTECHNOLOGY -ON NOV 11, DISTRICT COURT OF CENTRAL DISTRICT OF CALIFORNIA, SOUTHERN DIVISION PRELIMINARILY APPROVED CERTAIN PROPOSED SETTLEMENTS.PUMA BIOTECHNOLOGY INC - HAS AGREED TO INSTRUCT ITS INSURER TO PAY PLAINTIFFS' ATTORNEYS A TOTAL OF $1.175 MILLION, AMONG OTHERS - SEC FILING.  Full Article

Puma Biotechnology Files New Drug Submission For Nerlynx In Canada
Tuesday, 31 Jul 2018 08:30am EDT 

July 31 (Reuters) - Puma Biotechnology Inc ::PUMA BIOTECHNOLOGY FILES NEW DRUG SUBMISSION FOR NERLYNX IN CANADA.PUMA BIOTECHNOLOGY INC - NDS FOR NERLYNX HAS NOW ENTERED REVIEW PERIOD.  Full Article

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

BRIEF-Oncbiomune Announces Former Puma Biotechnology Executive And Genentech Veteran Brian Barnett, M.D., As Chief Executive Officer

* ONCBIOMUNE ANNOUNCES FORMER PUMA BIOTECHNOLOGY EXECUTIVE AND GENENTECH VETERAN BRIAN BARNETT, M.D., AS CHIEF EXECUTIVE OFFICER Source text for Eikon: Further company coverage: