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Sesen Bio Inc

SESN.OQ

Latest Trade

0.71USD

Change

-0.01(-1.79%)

Volume

329,181

Today's Range

0.70

 - 

0.72

52 Week Range

0.70

 - 

6.04

As of on the NASDAQ ∙ Minimum 15 minute delay

Latest Developments

Sesen Bio - On Nov 17, FDA Granted Co's Request For A Type A Meeting To Discuss Recommendations Regarding CRL

Nov 18 (Reuters) - Sesen Bio Inc <SESN.O>::SESEN BIO - ON NOV 17, FDA GRANTED CO REQUEST FOR A TYPE A MEETING TO DISCUSS RECOMMENDATIONS REGARDING CRL FOR CO'S BLA FOR VICINEUMTM.SESEN BIO INC - CLINICAL TYPE A MEETING HAS BEEN SCHEDULED FOR DECEMBER 8, 2021.

Sesen Bio Reports Q3 Earnings Per Share Of $0.36

Nov 8 (Reuters) - Sesen Bio Inc <SESN.O>::SESEN BIO REPORTS THIRD QUARTER 2021 FINANCIAL RESULTS AND BUSINESS UPDATE.SESEN BIO INC - QTRLY CASH, CASH EQUIVALENTS AND RESTRICTED CASH WERE $175.3 MILLION AS OF SEP 30 VERSUS $55.4 MILLION IN DEC 30.SESEN BIO INC - Q3 EARNINGS PER SHARE $0.36.

Sesen Bio Announces Productive CMC Type A Meeting With The FDA

Nov 1 (Reuters) - Sesen Bio Inc <SESN.O>::SESEN BIO ANNOUNCES PRODUCTIVE CMC TYPE A MEETING WITH THE FDA.SESEN BIO INC - BELIEVES IT HAS A CLEAR UNDERSTANDING OF WHAT ADDITIONAL INFORMATION REGARDING CMC IS REQUIRED FOR RESUBMISSION OF BLA.SESEN BIO INC - FDA CONFIRMED THAT VICINEUM MANUFACTURED USING PROPOSED COMMERCIAL PROCESS IS COMPARABLE TO VICINEUM USED IN PRIOR CLINICAL TRIALS.SESEN BIO INC - FDA ALSO CONFIRMED THAT SESEN BIO CAN UTILIZE VICINEUM MANUFACTURED DURING PROCESS VALIDATION FOR ANY POTENTIAL FUTURE CLINICAL TRIALS.

Sesen Bio Says FDA Issued Warning Letter To Former Study Investigator In Phase 3 Trial For Vicineum

Oct 27 (Reuters) - Sesen Bio Inc <SESN.O>::SESEN BIO - ON OCT 27, FDA PUBLISHED A WARNING LETTER ISSUED TO A FORMER STUDY INVESTIGATOR IN CO'S PHASE 3 VISTA TRIAL FOR VICINEUM - SEC FILING.SESEN BIO - DISCONTINUED USE OF STUDY INVESTIGATOR OVER 4 YRS AGO WHEN CO LEARNED OF PROFESSIONAL MISCONDUCT BY INVESTIGATOR UNRELATED TO VISTA TRIAL.SESEN BIO - FDA WARNING LETTER INDICATES STUDY INVESTIGATOR DID NOT COMPLY WITH STATUTORY REQUIREMENTS REGARDING CONDUCT OF CLINICAL INVESTIGATIONS.SESEN BIO - STUDY INVESTIGATOR OPERATED A CLINICAL SITE THAT WAS PREVIOUSLY PART OF THE VISTA TRIAL, WHICH WAS CLOSED BY CO ON MAY 26, 2017.SESEN BIO - STUDY INVESTIGATOR'S MEDICAL LICENSE TEMPORARILY SUSPENDED ON MAY 29, 2017 DUE TO INACCURATE RECORDKEEPING, UNASSOCIATED WITH CO, PATIENTS IN VISTA TRIAL.SESEN BIO INC - INCLUDED CORRESPONDING PATIENT DATA FROM CLINICAL SITE IN ITS BLA SUBMISSION TO FDA.SESEN BIO - COMPANY DID NOT RECEIVE ANY WARNING LETTERS OR DISCIPLINE REVIEW LETTERS DURING THE FDA’S REVIEW OF THE BLA FOR VICINEUM.

Sesen Bio Says FDA Granted Co Request For Meeting To Discuss Issues Raised In FDA's CRL

Oct 19 (Reuters) - Sesen Bio Inc <SESN.O>::SESEN BIO INC - FDA GRANTED CO REQUEST FOR A TYPE A MEETING TO DISCUSS CHEMISTRY, MANUFACTURING AND CONTROLS ISSUES RAISED IN FDA'S CRL.SESEN BIO INC - CMC TYPE A MEETING HAS BEEN SCHEDULED FOR OCTOBER 29, 2021..SESEN BIO - TYPE A MEETING TO DISCUSS ISSUES RAISED IN CRL REGARDING BLA FOR VICINEUM FOR TREATMENT OF BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER.SESEN BIO INC - ALSO PREPARING FOR A SEPARATE TYPE A MEETING TO DISCUSS RECOMMENDATIONS SPECIFIC TO ADDITIONAL CLINICAL/STATISTICAL DATA.SESEN BIO INC - COMPANY EXPECTS CLINICAL TYPE A MEETING TO OCCUR LATER IN Q4 OF 2021..

Sesen Bio Approved Restructuring Plan

Sept 2 (Reuters) - Sesen Bio Inc <SESN.O>::SESEN BIO INC - ON AUGUST 30, APPROVED A RESTRUCTURING PLAN - SEC FILING.SESEN BIO - RESTRUCTURING PLAN INCLUDES REDUCTION IN CO'S WORKFORCE BY APPROXIMATELY 18 POSITIONS.SESEN BIO - RESTRUCTURING PLAN INCLUDES ADDITIONAL COST-SAVING INITIATIVES WHILE CO CONTINUES DEVELOPMENT OF VICINEUM.SESEN BIO - EXPECTS REDUCTIONS RELATED TO RESTRUCTURING PLAN WILL DECREASE ANNUAL CASH COSTS BY ABOUT $5.7 MILLION.SESEN BIO - CURRENTLY ESTIMATES THAT IT WILL INCUR AGGREGATE RESTRUCTURING CHARGES IN Q3 OF ABOUT $5.8 MILLION.SESEN BIO - EXECUTION OF RESTRUCTURING PLAN IS EXPECTED TO BE SUBSTANTIALLY COMPLETE BY END OF Q4 2021.SESEN BIO - INTENDS TO WORK CLOSELY WITH FDA TO UNDERSTAND NEXT STEPS FOR VICINEUM.

Sesen Bio Reports Second Quarter 2021 Financial Results And Significant Global Progress For Vicineum

Aug 9 (Reuters) - Sesen Bio Inc <SESN.O>::SESEN BIO REPORTS SECOND QUARTER 2021 FINANCIAL RESULTS AND SIGNIFICANT GLOBAL PROGRESS FOR VICINEUM™.Q2 LOSS PER SHARE $0.15.Q2 EARNINGS PER SHARE ESTIMATE $-0.06 -- REFINITIV IBES DATA.BELIEVES IT REMAINS ON TRACK FOR POTENTIAL APPROVAL IN EUROPE AND KEY MARKETS IN MENA IN 2022.BELIEVES IT REMAINS ON TRACK FOR AN FDA DECISION ON ITS BLA FOR VICINEUM BY AUGUST 18, 2021.

Sesen Bio Announces Partnership With Eczacibasi Pharmaceuticals Marketing For Commercialization Of Vicineum In Turkey

Aug 5 (Reuters) - Sesen Bio Inc <SESN.O>::SESEN BIO ANNOUNCES PARTNERSHIP WITH ECZACIBASI PHARMACEUTICALS MARKETING (EIP) FOR THE COMMERCIALIZATION OF VICINEUM™ IN TURKEY.SESEN BIO INC - ENTITLED TO RECEIVE A 30% ROYALTY ON NET SALES IN TURKEY.SESEN BIO INC - TO RECEIVE $1.5 MILLION UPFRONT AND IS ELIGIBLE FOR ADDITIONAL REGULATORY AND COMMERCIAL MILESTONE PAYMENTS.

Sesen Bio Expects Vicineum Product To Be Commercially Available In U.S. In Q4 2021

July 26 (Reuters) - Sesen Bio Inc <SESN.O>::SESEN BIO ANNOUNCES SIGNIFICANT COMMERCIAL PROGRESS AS THE COMPANY APPROACHES THE POTENTIAL APPROVAL AND LAUNCH OF VICINEUM™ IN THE US.SESEN BIO INC - PRESCRIPTION DRUG USER FEE ACT (PDUFA) DATE OF AUGUST 18, 2021 FOR VICINEUM.SESEN BIO INC - EXPECTS VICINEUM PRODUCT TO BE COMMERCIALLY AVAILABLE TO PHYSICIANS AND PATIENTS IN Q4 OF 2021.

Sesen Bio Says Co Got Notice From EMA That CHMP Has Conditionally Accepted Proprietary Brand Name Vysyneumtm For Oportuzumab Monatox In EU

April 1 (Reuters) - Sesen Bio Inc <SESN.O>::SESEN BIO - ON MAR 31, GOT NOTICE FROM EMA THAT CHMP HAS CONDITIONALLY ACCEPTED PROPRIETARY BRAND NAME VYSYNEUMTM FOR OPORTUZUMAB MONATOX IN EU.

Quote and financial data from Refinitiv. Fund performance data provided by Lipper. All quotes delayed a minimum of 15 minutes.

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