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Mabion SA (MABP.WA)

MABP.WA on Warsaw Stock Exchange

32.25PLN
18 Sep 2020
Change (% chg)

-1.15zł (-3.44%)
Prev Close
33.40zł
Open
33.90zł
Day's High
33.90zł
Day's Low
31.50zł
Volume
30,681
Avg. Vol
80,920
52-wk High
105.20zł
52-wk Low
17.00zł

Latest Key Developments (Source: Significant Developments)

Mabion Signs Memorandum Of Understanding With Vaxine On Covax-19
Monday, 14 Sep 2020 

Sept 14 (Reuters) - Mabion SA ::SIGNS MEMORANDUM OF UNDERSTANDING ON COOPERATION WITH AUSTRALIA-BASED VAXINE.COOPERATION REGARDS POTENTIAL DEVELOPMENT, PRODUCTION AND MARKETING OF COVAX-19 PRODUCT.COVAX-19 PRODUCT MAY CONSTITUE VACCINE FOR COVID-19.UNDERSTANDING REGARDS POLAND AND EU IN PARTICULAR.PARTIES AIM TO NEGOTIATE AND CONCLUDE DEAL ON PRODUCTION OF PRODUCT BY MABION IF THEY CHOOSE SO.POTENTIAL COOPERATION WILL NOT NEGATIVELY IMPACT COMPANY'S CURRENT PROJECTS.DEVELOPMENT AND COMMERCIALISATION OF MABIONCD20 REMAINS PRIORITY.  Full Article

Mabion To Consider Filing For Registration Of MabionCD20 With FDA Sooner Than Planned
Friday, 28 Aug 2020 

Aug 28 (Reuters) - Mabion SA ::SAYS IS INFORMED BY FDA COMPANY CAN USE PART OF DATA GENERATED FOR REGISTRATION OF MABIONCD20 IN EU IN FDA REGISTRATION PROCESS.SAYS WILL CONSIDER EARLIER THAN PLANNED FILING FOR REGISTRATION WITH FDA.  Full Article

Mabion AGM Resolves To Increase Share Capital Via Issue Of Up To 55,954 V Series Shares
Monday, 15 Jun 2020 

June 15 (Reuters) - Mabion SA ::AGM RESOLVES TO INCREASE SHARE CAPITAL BY UP TO 5,595 ZLOTYS VIA ISSUE OF UP TO 55,954 V SERIES SHARES WITHOUT PRE-EMPTIVE RIGHTS AT 0.10 ZLOTY PER SHARE.  Full Article

Mabion Q1 Net Loss Widens To 19.8 Mln Zlotys
Monday, 25 May 2020 

May 25 (Reuters) - Mabion SA ::Q1 NET LOSS 19.8 MILLION ZLOTYS VERSUS LOSS OF 15.0 MILLION ZLOTYS YEAR AGO.NO REVENUE IN Q1.Q1 OPERATING LOSS 16.7 MILLION ZLOTYS VERSUS LOSS OF 14.5 MILLION ZLOTYS YEAR AGO.  Full Article

Mabion Resolves To Increase Share Capital Via Issue Of Up To 1.9 Mln U Series Shares
Monday, 18 May 2020 

May 18 (Reuters) - Mabion SA ::RESOLVES TO INCREASE SHARE CAPITAL BY UP TO 190,728 ZLOTYS VIA ISSUE OF UP TO 1.9 MILLION U SERIES SHARES WITHOUT PRE-EMPTIVE RIGHTS.  Full Article

Mabion FY Net Loss Narrows To 63.7 Mln Zlotys
Thursday, 9 Apr 2020 

April 9 (Reuters) - Mabion SA ::REPORTED ON WEDNESDAY FY NET LOSS 63.7 MILLION ZLOTYS VERSUS LOSS OF 68.9 MILLION ZLOTYS YEAR AGO.FY REVENUE 0 ZLOTYS VERSUS 0 ZLOTYS YEAR AGO.FY OPERATING LOSS 63.3 MILLION ZLOTYS VERSUS LOSS OF 64.6 MILLION ZLOTYS YEAR AGO.  Full Article

Mabion Appoints Krzysztof Kaczmarczyk To Chairman Of Supervisory Board Post
Tuesday, 17 Mar 2020 

March 16 (Reuters) - Mabion SA ::SAID ON MONDAY IT HAS APPOINTED KRZYSZTOF KACZMARCZYK TO CHAIRMAN OF SUPERVISORY BOARD POST.MACIEJ WIECZOREK HAS RESIGNED FROM CHAIRMAN OF SUPERVISORY BOARD POST.  Full Article

Mabion Assesses Possible Impact Of Coronavirus Outbreak On Staffing, R&D And Production
Tuesday, 17 Mar 2020 

March 17(Reuters) - Mabion SA ::SAID ON MONDAY THE COMPANY'S RESEARCH AND DEVELOPMENT WORKS MAY BE TEMPORARILY DELAYED DUE TO REMOTE WORK REQUIREMENTS FOR SOME POSITIONS IN RESPONSE TO CORONAVIRUS OUTBREAK.THE COMPANY CANNOT RULE OUT THAT POTENTIAL DISRUPTIONS TO INTEGRITY OF SUPPLY CHAIN FOR SOME COMPONENTS, MATERIALS, MACHINERY AND DEVICES WILL SLOW DOWN RESEARCH AND DEVELOPMENT WORKS AND PRODUCTION PROCESSES.SUCH SLOW-DOWN WOULD INCLUDE PRODUCTION OF THIRD VALIDATION SERIES OF LARGE SCALE PRODUCED MABIONCD20.THE COMPANY'S PROCESSES ARE CONCENTRATED ON MAINTAINING PROGRESS AND FINISHING WORKS ON MABIONCD20 VALIDATION AND MOVING TO NEXT RESEARCH STAGES FOR LARGE SCALE PROCESS PRODUCT.AT PRESENT VALIDATION WORKS ARE ON SCHEDULE WITHOUT DISRUPTION AND THE COMPANY HAS NO KNOWLEDGE OF DELAYS TO SUPPLIES OF COMPONENTS, MATERIALS, MACHINES OR DEVICES.THE COMPANY RECOGNISES INSTABILITY OF MARKET LIQUIDITY ON CORONAVIRUS AND POSSIBLE RESULTING LIMITATIONS TO FINANCING FOR THE COMPANY.THE COMPANY ACKNOWLEDGES BUT HAS SO FAR NOT BEEN AFFECTED BY POTENTIAL SHIFTS IN ADMINISTRATIVE PROCESSES INCLUDING MEDICINES REGULATOR APPROVALS, AS WELL AS DECISIONS ON PUBLIC FUNDING AND VAT TAX REFUNDS.  Full Article

Mabion Announces Financing Plan Following New Regulations Strategy For MabionCD20 Drug With EMA
Monday, 16 Mar 2020 

March 17 (Reuters) - Mabion SA ::SAID ON MONDAY IT HAS STARTED DISCUSSION ON COMPANY FINANCING WITH REGARD TO NEW REGULATIONS STRATEGY FOR MABIONCD20 DRUG WITH EMA.SAID IT HAS RECEIVED SUPPORTING DOCUMENTS FROM ITS SHAREHOLDERS IN WHICH THEY DECLARE TO INCREASE COMPANY'S CAPITAL BY NO LESS THAN 15 MILLION ZLOTYS IN 2020 .THE CAPITAL INCREASE WILL BE IMPLEMENTED BY ACQUISITION OF SHARES UNDER NEW ISSUE OR BY USING DEBT INSTRUMENTS.SAID HAS ACCEPTED THE SUPPORTING DOCUMENTS AND RESOLVED TO TAKE ACTIONS AIMED AT OBTAINING DEBT FINANCING, WHICH WILL ENABLE SUCCESSFUL IMPLEMENTATION OF NEW REGULATIONS STRATEGY FOR REGISTERING MABIONCD20 WITH EMA.SAID CAPITAL SUPPLY AND DEBT FINANCING SHOULD GUARANTEE APPROVAL OF THE MEDICINE FOR MARKETING IN BOTH THE EU AND THE US.SAID IT DOES NOT EXCLUDE SEEKING AND USING OTHER SOURCES OF FINANCING FOR DEVELOPMENT OF NEW PROJECTS .  Full Article

Mabion To Seek Direct EMA Approval For MabionCD20 Large Commercial Scale
Monday, 16 Mar 2020 

March 17 (Reuters) - Mabion SA ::SAID ON MONDAY IT HAS DECIDED TO MODIFY ITS REGULATIONS STRATEGY FOR MABIONCD20 DRUG WITH EMA.THE COMPANY WILL SEEK EMA APPROVAL FOR DRUG DIRECTLY IN LARGE COMMERCIAL SCALE.PREVIOUS PLANNED STRATEGY WAS TWO-STEP WITH SMALL-SCALE APPROVAL FOLLOWED BY LARGE COMMERCIAL SCALE APPROVAL.THE COMPANY WILL SUBMIT A NEW APPLICATION TO EMA FOR CONSIDERATION OF TARGET SCALE.THE COMPANY WILL MAKE SUBMISSION AFTER IT GETS VALIDATION DATA AND BIOSIMILARITY OF PRODUCT MADE DURING FULL SCALE PRODUCTION.CURRENT ANALYTICAL DATA FOR LARGE SCALE SHOWS REPEATABILITY AND HIGH DEGREE OF BIOSIMILARITY, WHICH SIGNIFICANTLY RAISES PROBABILITY OF WITHDRAWING FROM ADDITIONAL LARGER CLINICAL TRIALS.THE COMPANY HAS BEGUN THIRD PRODUCTION VALIDATION SERIES OF LARGE SCALE.MODIFIED STRATEGY IS MOST OPTIMAL PATH IN TERMS OF FINANCES AND TIME WITH REGARD TO REGISTRATION OF PRODUCT COMING FROM LARGE SCALE PROCESS AND COMMERCIALISATION OF THE DRUG IN THE EU.THE COMPANY INTENDS TO FINALISE THE REGISTRATION OF THE LARGE SCALE PROCESS PRODUCT IN JUNE 2020.CONSULTATIONS WITH EMA REPRESENTATIVES UNDER SCIENTIFIC ADVICE PROCEDURE REGARDING THE RANGE AND FORMAT OF THE NEW SUBMISSIONS ARE PLANNED FOR APRIL/MAY.DECISION REGARDING WITHDRAWAL OF APPLICATIONS DOES NOT AFFECT TIMETABLES FOR LARGE SCALE PRODUCTION VALIDATION, BRIDGING STUDIES AND WORKS TOWARDS REGISTERING THE DRUG IN THE UNITED STATES.  Full Article

BRIEF-Mabion Meets Minimum Staff Level Requirement To Stay At Lodz Special Economic Zone

* SAYS MEETS MINIMUM STAFF LEVEL REQUIREMENT TO REMAIN AT LODZ SPECIAL ECONOMIC ZONE Source text for Eikon: Further company coverage: (Gdansk Newsroom)