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Poxel SA (POXEL.PA)

POXEL.PA on Paris Stock Exchange

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Latest Key Developments (Source: Significant Developments)

Poxel Announces Initiation Of Part 2 Of Phase 1A Study For Pxl065, Which Is Being Developed For Treatment Of Nash
Monday, 26 Nov 2018 

Nov 26 (Reuters) - POXEL SA ::POXEL ANNOUNCES INITIATION OF PART 2 OF PHASE 1A STUDY FOR PXL065, WHICH IS BEING DEVELOPED FOR THE TREATMENT OF NASH.PXL065 DATA TO DATE SUGGEST POTENTIAL FOR A FAVORABLE PROFILE FOR TREATMENT OF NASH."WE LOOK FORWARD TO ADVANCING BOTH OF OUR PROGRAMS FOR TREATMENT OF NASH INTO PROOF-OF-CONCEPT STUDIES IN 2019.".2ND PART OF PHASE 1A STUDY WILL ENROLL 6 HEALTHY SUBJECTS PER GROUP, WITH PRIMARY OBJECTIVE TO ASSESS SAFETY AND TOLERABILITY AND A SECONDARY OBJECTIVE TO ASSESS DOSE PROPORTIONALITY.PIOGLITAZONE, A DRUG APPROVED FOR TREATMENT OF TYPE 2 DIABETES HAS DEMONSTRATED THERAPEUTIC EFFICACY FOR NASH, EVEN IN PATIENTS WITH ADVANCED FIBROSIS.THIS PHASE 1A TRIAL, WHICH WAS DISCUSSED WITH U.S. FDA IN PRE-INVESTIGATIONAL NEW DRUG APPLICATION (IND) MEETING, WAS DESIGNED TO INCLUDE 2 SINGLE ORAL DOSES AND POTENTIALLY UP TO THREE ADDITIONAL DOSES OF PXL065.  Full Article

Poxel Presents Data For PXL770 And PXL065 For The Treatment of NASH
Monday, 12 Nov 2018 

Nov 12 (Reuters) - POXEL SA ::POXEL PRESENTS PROMISING DATA FOR PXL770 AND PXL065 FOR THE TREATMENT OF NASH AT THE AMERICAN ASSOCIATION FOR THE STUDY OF LIVER DISEASES MEETING.PXL770 WAS SHOWN TO HAVE A BENEFICIAL EFFECT ON BOTH ADIPOSE TISSUE AND LIVER THROUGH DIRECT ACTIVATION OF AMPK IN A DIO-NASH MODEL.PXL065 DATA SUGGESTS POTENTIAL FOR SIMILAR EFFICACY WITH A REDUCED SIDE EFFECT PROFILE FROM PIOGLITAZONE FOR NASH.PXL770 WAS SHOWN TO HAVE A BENEFICIAL EFFECT ON LIVER AND AT METABOLISM IN A DIO-NASH MOUSE MODEL.PHASE 1 STUDY INDICATED PXL065 WAS SAFE AND WELL-TOLERATED. NO ADVERSE EFFECTS WERE REPORTED.PXL770 APPEARS TO BE A PROMISING DRUG CANDIDATE FOR TREATMENT OF NASH.PHASE 1 STUDY INDICATED PXL065 WAS SAFE AND WELL-TOLERATED.  Full Article

Poxel Announces Completion Of Patient Enrollment For Times 2 Trial In Phase 3 Registration Program For Imeglimin In Japan
Monday, 8 Oct 2018 

Oct 8 (Reuters) - Poxel SA ::ANNOUNCES COMPLETION OF PATIENT ENROLLMENT FOR TIMES 2 TRIAL IN PHASE 3 REGISTRATION PROGRAM FOR IMEGLIMIN, AN INVESTIGATIONAL THERAPEUTIC AGENT FOR TYPE 2 DIABETES, IN JAPAN.PHASE 3 TIMES 1, TIMES 2 AND TIMES 3 TRIALS FOR IMEGLIMIN ARE NOW FULLY ENROLLED WITH OVER 1,100 PATIENTS.PHASE 3 TIMES DATA RESULTS ARE ON TRACK FOR 2019.JAPANESE NEW DRUG APPLICATION SUBMISSION FOR IMEGLIMIN TARGETED IN 2020.  Full Article

Poxel Signs Acquisition Agreement With Deuterx For Drx-065
Thursday, 30 Aug 2018 

Aug 30 (Reuters) - Poxel SA ::POXEL EXPANDS METABOLIC PIPELINE THROUGH STRATEGIC ACQUISITION AGREEMENT WITH DEUTERX FOR DRX-065, A NOVEL CLINICAL STAGE DRUG CANDIDATE FOR NASH, AND OTHER PROGRAMS.POXEL EXPANDS METABOLIC PIPELINE THROUGH STRATEGIC ACQUISITION AGREEMENT WITH DEUTERX FOR DRX-065, A NOVEL CLINICAL STAGE DRUG CANDIDATE FOR NASH, AND OTHER PROGRAMS.POXEL ACQUIRES EXCLUSIVE, WORLDWIDE OWNERSHIP TO DRX-065 (DEUTERIUM-STABILIZED R-PIOGLITAZONE),.ADDITIONAL PROGRAMS, INCLUDING DEUTERATED DRUG CANDIDATES FOR METABOLIC, SPECIALTY AND RARE DISEASES, ALSO ACQUIRED FROM DEUTERX.SAYS ILL PAY DEUTERX AN UPFRONT PAYMENT COMPOSED OF EUR 6.8 MILLION (USD 8 MILLION) IN CASH PLUS 1.29 MILLION IN NEW ORDINARY SHARES OF POXEL COMMON STOCK.POXEL PLANS TO ADVANCE PXL770 AND DRX-065, INTO PROOF-OF-CONCEPT STUDIES FOR TREATMENT OF NASH IN 2019.SAYS GAINS EXCLUSIVE, WORLDWIDE OWNERSHIP TO ADDITIONAL PROGRAMS.  Full Article

Poxel Announces Favorable Results For PXl770 Phase 1B Multiple Ascending Dose Trial And Drug-Drug Interaction Study
Wednesday, 18 Jul 2018 

July 18 (Reuters) - POXEL SA ::ANNOUNCES FAVORABLE RESULTS FOR PXL770 PHASE 1B MULTIPLE ASCENDING DOSE TRIAL AND DRUG-DRUG INTERACTION STUDY.PXL770 IS ADVANCING INTO A PHASE 2A PROOF-OF-CONCEPT PROGRAM FOR NASH.DURING H2 2018, PREPARATION FOR PHASE 2A PROGRAM FOR PXL770 WILL INCLUDE FILING INVESTIGATIONAL NEW DRUG APPLICATION WITH U.S. FDA.  Full Article

Poxel H1 Revenue Up At At 19.2 Million Euros
Tuesday, 10 Jul 2018 

July 10 (Reuters) - POXEL SA ::AS OF JUNE 30, 2018, CASH AND CASH EQUIVALENTS WERE EUR 94.4 MILLION (USD 110.1 MILLION).FOR U.S. AND EUROPE, WE ARE WORKING CLOSELY WITH ROIVANT SCIENCES ON PHASE 3-RELATED ACTIVITIES WITH GOAL TO INITIATE PHASE 3 PROGRAM IN 2019 - CEO.REVENUES OF EUR 19.2 MILLION FOR H1 2018 COMPARED WITH NO REVENUES YEAR AGO.WE ARE ON TRACK FOR DATA READOUT IN 2019, BEGINNING WITH TIMES 1 EFFICACY STUDY READOUT DURING Q2 OF 2019 - CEO.  Full Article

Poxel Announces Completion Of Patient Enrollment For Times 1 Trial
Tuesday, 3 Jul 2018 

July 3 (Reuters) - Poxel SA ::POXEL ANNOUNCES COMPLETION OF PATIENT ENROLLMENT FOR TIMES 1 TRIAL IN THE PHASE 3 REGISTRATION PROGRAM FOR IMEGLIMIN, AN INVESTIGATIONAL THERAPEUTIC AGENT FOR TYPE 2 DIABETES, IN JAPAN.PHASE 3 TIMES 1 DATA READOUT IS ON TRACK FOR Q2 OF 2019.JAPANESE NEW DRUG APPLICATION SUBMISSION FOR IMEGLIMIN TARGETED IN 2020.  Full Article

Poxel: Q4 Revenues At 5.2 Million Euros ‍​
Monday, 22 Jan 2018 

Jan 22 (Reuters) - POXEL SA ::AS OF DECEMBER 31, 2017, CASH AND CASH EQUIVALENTS WERE €53.4 MILLION ($64.1 MILLION).‍​.Q4 REVENUES OF €5.2 MILLION‍​.THE CASH BURN RATE DURING THE FOURTH QUARTER WAS IN LINE WITH THE COMPANY’S EXPECTATIONS.‍​.  Full Article

Poxel And Sumitomo Dainippon Pharma Announce Initiation Of Phase 3 Program For Imeglimin In Japan
Wednesday, 27 Dec 2017 

Dec 27 (Reuters) - POXEL SA ::POXEL AND SUMITOMO DAINIPPON PHARMA <<<4506.T>>> ANNOUNCE INITIATION OF PHASE 3 PROGRAM FOR IMEGLIMIN, AN INVESTIGATIONAL THERAPEUTIC AGENT FOR TYPE 2 DIABETES, IN JAPAN.JAPANESE NEW DRUG APPLICATION SUBMISSION FOR IMEGLIMIN TARGETED IN 2020.  Full Article

Poxel and Sumitomo Dainippon Pharma in partnership to develop and sell Imeglimin in Asia
Monday, 30 Oct 2017 

Oct 30 (Reuters) - POXEL SA ::SUMITOMO DAINIPPON PHARMA AND POXEL ANNOUNCE STRATEGIC PARTNERSHIP FOR DEVELOPMENT AND COMMERCIALIZATION OF IMEGLIMIN, AN INVESTIGATIONAL THERAPEUTIC AGENT FOR TYPE 2 DIABETES, IN JAPAN, CHINA AND ELEVEN OTHER ASIAN COUNTRIES.‍POXEL AND SUMITOMO DAINIPPON PHARMA TO JOINTLY DEVELOP IMEGLIMIN FOR TREATMENT OF TYPE 2 DIABETES IN JAPAN,​.‍SUMITOMO DAINIPPON PHARMA ASSUMES PHASE 3 AND COMMERCIALIZATION COSTS​.‍POXEL RECEIVES AN UPFRONT PAYMENT OF ¥4.75 BILLION (APPROXIMATELY EUR 36 MILLION, $42 MILLION)​.‍SUMITOMO DAINIPPON PHARMA SOLELY RESPONSIBLE FOR IMEGLIMIN IN CHINA, SOUTH KOREA, TAIWAN AND 9 OTHER SOUTHEAST ASIAN COUNTRIES​.‍PHASE 3 PROGRAM FOR IMEGLIMIN IN JAPAN ON TRACK TO BE INITIATED IN Q4 OF CY 2017​.‍RECEIVES FUTURE POTENTIAL DEVELOPMENT MILESTONE PAYMENTS AND SALES-BASED PAYMENTS OF UP TO ¥29.25 BILLION​.  Full Article