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Poxel SA (POXEL.PA)

POXEL.PA on Paris Stock Exchange

8.15EUR
19 Sep 2019
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Latest Key Developments (Source: Significant Developments)

Poxel Initiates Phase 1B MAD Trial For Nash Drug Candidate
Tuesday, 17 Sep 2019 

Sept 17 (Reuters) - Poxel SA ::POXEL INITIATES PHASE 1B MULTIPLE ASCENDING DOSE (MAD) TRIAL FOR NASH DRUG CANDIDATE, PXL065.PHASE 1B MAD TRIAL IS DESIGNED TO EVALUATE SAFETY, TOLERABILITY AND PHARMACOKINETICS (PK) AND SUPPORT DOSE SELECTION FOR A PIVOTAL STUDY; TOPLINE RESULTS EXPECTED IN Q4 2019.RESULTS FROM PHASE 1A SINGLE ASCENDING DOSE (SAD) STUDY OF PXL065 TO BE PRESENTED AT AMERICAN ASSOCIATION FOR STUDY OF LIVER DISEASES (AASLD) ANNUAL MEETING, NOVEMBER 8-12, 2019 IN BOSTON, MA.POXEL WILL MEET WITH U.S. FOOD AND DRUG ADMINISTRATION (FDA) IN EARLY Q4 2019 TO DISCUSS REGISTRATION PROGRAM AND 505(B)(2) REGULATORY PATHWAY.  Full Article

Poxel H1 Net Result Swings to Loss Of 5.8 Million Euros
Monday, 26 Aug 2019 

Aug 26 (Reuters) - POXEL SA ::POXEL REPORTS FINANCIAL RESULTS FOR FIRST HALF 2019 AND PROVIDES CORPORATE UPDATE.H1 POXEL REPORTED REVENUES OF EUR 23.2 MILLION FOR FIRST HALF OF 2019, AS COMPARED WITH EUR 37.5 MILLION DURING SAME PERIOD IN 2018.H1 NET INCOME LOSS EUR 5.8 MILLION VERSUS PROFIT EUR 7.3 MILLION YEAR AGO.H1 OPERATING LOSS EUR 5.9 MILLION VERSUS PROFIT EUR 6.4 MILLION YEAR AGO.AS OF JUNE 30, 2019, CASH AND CASH EQUIVALENTS WERE EUR 49.8 MILLION (USD 56.7 MILLION), AS COMPARED TO EUR 66.7 MILLION (USD 76.4 MILLION) AS OF DECEMBER 31, 2018.POSITIVE PHASE 3 TOP-LINE RESULTS WERE REPORTED FOR IMEGLIMIN TIMES 1 AND TIMES 3 16-WEEK PORTION OF TRIAL FOR TREATMENT OF TYPE 2 DIABETES IN JAPAN.RESULTS FROM TIMES 2 AND TIMES 3 36-WEEK OPEN LABEL PORTION OF TRIAL ARE EXPECTED AROUND END OF 2019.POSITIVE TOP-LINE RESULTS WERE REPORTED FROM IMEGLIMIN METAVANT TRIAL IN PATIENTS WITH TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE (CKD) STAGES 3B/4.A PHASE 2A PROGRAM FOR PXL770 WAS INITIATED FOR TREATMENT OF NASH; PK/PD RESULTS ARE EXPECTED IN Q4 2019 AND PHASE 2A EFFICACY AND SAFETY RESULTS ARE EXPECTED IN Q2 2020.POXEL WILL MEET WITH U.S. FDA IN Q4 2019 TO DISCUSS NEXT STEPS FOR PXL065, INCLUDING A REGISTRATION PROGRAM AND USE OF ACTOS(Ò) DATA FOR A 505(B)(2) REGISTRATION PATHWAY.  Full Article

Poxel Q1 Revenue Down At EUR 14.9 Million
Monday, 8 Apr 2019 

April 8 (Reuters) - Poxel SA ::POXEL ANNOUNCES FIRST QUARTER 2019 FINANCIAL UPDATE.Q1 REVENUE EUR 14.9 MILLION VERSUS EUR 18.3 MILLION YEAR AGO.THIS YEAR WILL BE VERY IMPORTANT FOR POXEL-CEO.Q1 CASH AND CASH EQUIVALENTS EUR 59.0 MILLION VERSUS EUR 66.7 MILLION IN Q4 2018.THERE WILL BE SEVERAL SIGNIFICANT MILESTONES THAT HAVE POTENTIAL FOR SUBSTANTIAL VALUE CREATION-CEO.WE PLAN TO INITIATE A PIVOTAL PHASE 2 PROGRAM IN BIOPSY-PROVEN NASH PATIENTS IN THE FOURTH QUARTER OR EARLY 2020.FOR PXL065, DURING Q2 2019, PLANS TO INITIATE THE PHASE 1B MULTIPLE ASCENDING DOSE STUDY, RESULTS EXPECTED DURING Q3 2019.  Full Article

Poxel FY Operating Result Turns To Profit Of 12.5 Million Euros
Thursday, 21 Mar 2019 

March 21 (Reuters) - POXEL SA ::POXEL REPORTS FINANCIAL RESULTS FOR FULL YEAR 2018 AND PROVIDES CORPORATE UPDATE.FY TURNOVER EUR 74.6 MILLION VERSUS EUR 5.3 MILLION YEAR AGO.NET RESULT FOR FINANCIAL PERIOD ENDING DECEMBER 31, 2018 WAS A NET INCOME OF EUR 13.5 MILLION.AS OF DECEMBER 31, 2018, CASH AND CASH EQUIVALENTS WERE EUR 66.7 MILLION (USD 76.4 MILLION), AS COMPARED TO EUR 53.4 MILLION (USD 64.1 MILLION) AS OF DECEMBER 31, 2017..FY OPERATING GAIN EUR 12.5 MILLION VERSUS LOSS OF EUR 21.9 MILLION YEAR AGO.  Full Article

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