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Athenex Inc (ATNX.OQ)

ATNX.OQ on NASDAQ Stock Exchange Global Select Market

14.83USD
23 Aug 2019
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Latest Key Developments (Source: Significant Developments)

Athenex Inc Announces Second Quarter 2019 Financial Results
Wednesday, 7 Aug 2019 

Aug 7 (Reuters) - Athenex Inc ::ATHENEX, INC. ANNOUNCES SECOND QUARTER 2019 FINANCIAL RESULTS, POSITIVE PHASE III RESULTS ON ORAL PACLITAXEL PLUS ENCEQUIDAR AND INCREASED PRODUCT SALES GUIDANCE.Q2 LOSS PER SHARE $0.44.Q2 EARNINGS PER SHARE ESTIMATE $-0.37 -- REFINITIV IBES DATA.COMPANY IS PREPARING TWO NDA SUBMISSIONS FOLLOWING SUCCESSFUL PHASE III STUDIES ANNOUNCED WITHIN LAST TWELVE MONTHS.POSITIVE PHASE III RESULTS OF ORAL PACLITAXEL SHOW STATISTICALLY SIGNIFICANT IMPROVEMENT IN OVERALL RESPONSE RATE IN METASTATIC BREAST CANCER.RAISING PRODUCT SALES GUIDANCE TO 30% - 35% YEAR/YEAR GROWTH IN 2019.QTRLY TOTAL REVENUE $22.2 MILLION VERSUS $11.6 MILLION.Q2 REVENUE VIEW $21.3 MILLION -- REFINITIV IBES DATA.PHASE III STUDY OF ORAL PACLITAXEL AND ENCEQUIDAR FOR METASTATIC BREAST CANCER MET PRIMARY EFFICACY ENDPOINT.  Full Article

Athenex Inc Says Study Met Primary Endpoint Showing Statistically Significant Improvement In Overall Response Rate For Oral Paclitaxel A
Wednesday, 7 Aug 2019 

Aug 7 (Reuters) - Athenex Inc ::ATHENEX INC - STUDY MET PRIMARY ENDPOINT SHOWING STATISTICALLY SIGNIFICANT IMPROVEMENT IN OVERALL RESPONSE RATE FOR ORAL PACLITAXEL A.ATHENEX INC - STUDY MET PRIMARY ENDPOINT SHOWING STATISTICALLY SIGNIFICANT IMPROVEMENT IN OVERALL RESPONSE RATE.ATHENEX INC - STRONG TREND IN PROGRESSION-FREE SURVIVAL (PFS) AND OVERALL SURVIVAL (OS) OF ORAL PACLITAXEL COMPARED TO IV PACLITAXEL.ATHENEX INC - NEUROPATHY WAS LESS FREQUENT WITH ORAL PACLITAXEL COMPARED TO IV PACLITAXEL PLAN TO REQUEST A PRE-NDA MEETING AS SOON AS POSSIBLE.ATHENEX INC - EVALUATING ORAL PACLITAXEL IN COMBINATION WITH RAMUCIRUMAB IN PATIENTS WITH GASTRIC CANCER IN AN EXPANSION PHASE OF A PHASE 1B STUDY.ATHENEX INC - TESTING COMBINATION OF ORAL PACLITAXEL WITH AN ANTI-PD1, PEMBROLIZUMAB, IN PATIENTS WITH ADVANCED SOLID MALIGNANCIES.  Full Article

Athenex Provides Update Regarding The Vasopressin Case
Friday, 2 Aug 2019 

Aug 2 (Reuters) - Athenex Inc ::ATHENEX PROVIDES AN UPDATE REGARDING THE VASOPRESSIN CASE.ATHENEX INC - A U.S. DISTRICT COURT DENIED CO'S MOTION FOR SUMMARY JUDGMENT AND GRANTING FDA'S CROSS-MOTION FOR SUMMARY JUDGMEN.ATHENEX - WILL CEASE PRODUCING AND MARKETING ITS COMPOUNDED VASOPRESSIN PRODUCT UNTIL IT IS PERMITTED TO RECOMMENCE PRODUCTION BY COURT AND FDA.ATHENEX INC - PLANS TO APPEAL RULING REGARDING VASOPRESSIN CASE AND SEEK A STAY OF RULING PENDING ITS APPEAL.  Full Article

Athenex Inc Files For Offering Of 10 Mln Shares Of Common Stock Offered By The Selling Stockholders
Tuesday, 23 Jul 2019 

July 23 (Reuters) - Athenex Inc ::ATHENEX INC FILES FOR OFFERING OF 10.0 MILLION SHARES OF COMMON STOCK OFFERED BY THE SELLING STOCKHOLDERS - SEC FILING.  Full Article

Athenex Announces Strategic Global Initiatives To Expand Clinical Operations
Friday, 28 Jun 2019 

June 28 (Reuters) - Athenex Inc ::ATHENEX ANNOUNCES STRATEGIC GLOBAL INITIATIVES TO EXPAND CLINICAL OPERATIONS.ATHENEX INC - EXPANDED ITS PRESENCE IN EUROPE AND LATIN AMERICA.ATHENEX INC - COMPANY HAS FORMED A SUBSIDIARY IN UNITED KINGDOM AND ESTABLISHED OFFICES IN MANCHESTER.ATHENEX INC - CURRENTLY CONDUCTING CLINICAL STUDIES IN UK AND INTENDS TO CONTINUE EXPANDING ITS RESEARCH AND DEVELOPMENT CAPABILITIES IN REGION.ATHENEX INC - IN LATIN AMERICA, RECENTLY ENTERED AGREEMENT TO BUY CERTAIN ASSETS OF CIDAL LIMITED IN EXCHANGE FOR SHARES OF ATHENEX COMMON STOCK.  Full Article

Athenex Says API Plant In China Has Voluntarily Suspended Production Activities
Thursday, 6 Jun 2019 

June 6 (Reuters) - Athenex Inc ::ATHENEX PROVIDES AN UPDATE ON ITS CHONGQING API PLANT.ATHENEX INC - API PLANT IN CHONGQING, CHINA HAS VOLUNTARILY SUSPENDED PRODUCTION ACTIVITIES.ATHENEX INC - VOLUNTARY TEMPORARY SUSPENSION OCCURRED LAST MONTH, AND COMPANY EXPECTS TO HAVE A RESOLUTION BY END OF Q3 OF 2019.ATHENEX INC - VOLUNTARY ACTION CAME AFTER TRAGIC ACCIDENTS AT OTHER CHEMICAL PLANTS IN SOME CHINESE PROVINCES LEADING TO PLANT INSPECTIONS.ATHENEX INC - PLANS TO CONTINUE SELLING EXISTING API INVENTORIES THROUGH AT LEAST Q3 OF THIS YEAR.ATHENEX INC - BUILD-OUT OF NEW API PLANT IN CHONGQING IS NEAR COMPLETION AND PLANT IS EXPECTED TO COMMENCE OPERATIONS IN FIRST HALF OF 2020.ATHENEX INC - RE-AFFIRMS ITS PRODUCT SALES GUIDANCE OF A 25% TO 30% INCREASE IN 2019 FROM PRODUCT SALES REVENUE OF $56.4 MILLION REPORTED IN 2018..ATHENEX INC - BELIEVES API PLANT HAS BEEN IN COMPLIANCE FROM A SAFETY AND REGULATORY PERSPECTIVE..  Full Article

Athenex Announces Xiangxue Life Sciences Receives IND Allowance From China's National Medical Products Administration
Thursday, 21 Mar 2019 

March 21 (Reuters) - Athenex Inc ::ATHENEX ANNOUNCES XIANGXUE LIFE SCIENCES RECEIVES IND ALLOWANCE FROM CHINA'S NATIONAL MEDICAL PRODUCTS ADMINISTRATION FOR CANCER IMMUNOTHERAPY DRUG CANDIDATE.ATHENEX INC - ENCOURAGING POSITIVE CLINICAL SAFETY AND EFFICACY SIGNALS WERE OBSERVED IN PRELIMINARY INVESTIGATOR-INITIATED PILOT STUDIES IN CHINA.ATHENEX INC - THIS COMPANY-SPONSORED IND ALLOWS XIANGXUE LIFE SCIENCES (XLIFESC) TO PROCEED TO NEXT STAGE OF CLINICAL STUDIES IN CHINA.  Full Article

Athenex Q4 Loss Per Share $0.41
Monday, 11 Mar 2019 

March 11 (Reuters) - Athenex Inc ::ATHENEX, INC. ANNOUNCES FOURTH QUARTER AND YEAR ENDED DECEMBER 31, 2018 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE.Q4 REVENUE ROSE 43 PERCENT TO $21.3 MILLION.Q4 REVENUE ESTIMATE $30.8 MILLION -- REFINITIV IBES DATA.Q4 LOSS PER SHARE $0.41.Q4 EARNINGS PER SHARE ESTIMATE $-0.20 -- REFINITIV IBES DATA.FORECASTING THAT PRODUCT SALES IN 2019 WILL INCREASE BY BETWEEN 25% AND 30% YEAR-OVER-YEAR FROM $56.4 MILLION IN 2018.  Full Article

Chongqing Jingdong And Athenex Announce Partnership To Develop KX2-391 In China
Thursday, 3 Jan 2019 

Jan 3 (Reuters) - Athenex Inc ::CHONGQING JINGDONG PHARMACEUTICAL AND ATHENEX ANNOUNCE A STRATEGIC PARTNERSHIP AND LICENSING AGREEMENT TO DEVELOP AND COMMERCIALIZE KX2-391 IN CHINA.ATHENEX TO RECEIVE UPFRONT AND POTENTIAL DEVELOPMENT MILESTONES, ALONG WITH TIERED ROYALTIES BASED ON NET SALES.ATHENEX IS EXPECTED TO RECEIVE AN UPFRONT PAYMENT OF AN AGGREGATE AMOUNT OF US$14.5 MILLION.ATHENEX WILL ALSO BE ELIGIBLE TO RECEIVE OTHER DEVELOPMENT MILESTONE PAYMENTS OF UP TO US$15 MILLION.IN ADDITION, AGREEMENT PROVIDES FOR TIERED ROYALTIES BASED ON ANNUAL NET SALES STARTING AT 15%.  Full Article

Athenex Announces Results Of Oraxol-Plus-Ramucirumab Phase 1B Trial In Gastric Cancer
Tuesday, 11 Dec 2018 

Dec 11 (Reuters) - Athenex Inc ::ATHENEX ANNOUNCES POSITIVE SECOND COHORT RESULTS OF ORAXOL-PLUS-RAMUCIRUMAB PHASE 1B CLINICAL TRIAL IN GASTRIC CANCER.ATHENEX INC - RESULTS INDICATED STRONG POSITIVE SIGNALS OF EFFICACY AND TREATMENT WAS WELL TOLERATED..ATHENEX INC - THERE WAS ONE SEVERE ADVERSE EVENT (SAE) OF GRADE-4 NEUTROPENIA IN ONE PATIENT WHO HAD COMPLETE RECOVERY FROM THIS EVENT..  Full Article

Endo gains on favorable FDA drug compounding decision

March 1 Endo International Plc said on Friday the U.S. health regulator has decided https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm632432.htm?utm_campaign=Compounding:%20FDA%20finalizes%20guidance%20on%20evaluating%20the%20clinical%20need%20for%20outsourcing&utm_medium=email&utm_source=Eloqua not to include blood pressure treatment vasopressin in its list of drugs that can be used in compounding, in a boost to the drugmaker that makes the only FDA-approved version of the produ