Edition:
India

Evoke Pharma Inc (EVOK.OQ)

EVOK.OQ on NASDAQ Stock Exchange Capital Market

0.97USD
1:30am IST
Change (% chg)

$0.02 (+1.61%)
Prev Close
$0.95
Open
$0.99
Day's High
$0.99
Day's Low
$0.95
Volume
9,161
Avg. Vol
98,387
52-wk High
$3.40
52-wk Low
$0.50

Latest Key Developments (Source: Significant Developments)

Evoke Pharma Reports Q2 Loss Per Share $0.09
Thursday, 8 Aug 2019 

Aug 8 (Reuters) - Evoke Pharma Inc ::EVOKE PHARMA TO RESUBMIT GIMOTI™ NDA BASED ON FDA MEETING MINUTES AND ANNOUNCES SECOND QUARTER 2019 FINANCIAL RESULTS.Q2 LOSS PER SHARE $0.09.INTENDS TO RESUBMIT ITS NEW DRUG APPLICATION FOR GIMOTI IN Q4 OF 2019.  Full Article

FDA rejects EVOK's Gimoti
Tuesday, 2 Apr 2019 

April 2 (Reuters) - Evoke Pharma Inc ::EVOKE PHARMA RECEIVES COMPLETE RESPONSE LETTER AND RECOMMENDATIONS TO ADDRESS DEFICIENCIES FROM FDA FOR GIMOTI™ NDA.EVOKE PHARMA INC - AGENCY DID NOT REQUEST ANY NEW CLINICAL DATA AND DID NOT RAISE ANY SAFETY CONCERNS..EVOKE PHARMA INC - CRL STATES THAT FDA HAS DETERMINED IT CANNOT APPROVE NDA IN ITS PRESENT FORM.EVOKE PHARMA INC - ISSUES ARE RELATED TO CLINICAL PHARMACOLOGY AND PRODUCT QUALITY/DEVICE QUALITY..EVOKE PHARMA INC - CRL PROVIDES RECOMMENDATIONS TO ADDRESS TWO REMAINING APPROVABILITY ISSUES IN AN NDA RESUBMISSION.EVOKE PHARMA INC - FDA STATED OVERALL LOWER MEAN C(MAX) WAS DRIVEN BY DATA FROM THESE FEW SUBJECTS.EVOKE PHARMA - CLINICAL PHARMACOLOGY ISSUE SPECIFIC TO LOW C(MAX) IN SUBJECTS REPRESENTING LESS THAN 5% OF TOTAL ADMINISTERED GIMOTI DOSES IN PK STUDY.EVOKE PHARMA INC - FDA REQUESTED DATA FROM PREVIOUSLY PLANNED REGISTRATION BATCHES OF COMMERCIAL PRODUCT TO BE MANUFACTURED BY CO.EVOKE PHARMA - DATA REQUESTED BY FDA TO PROVIDE MORE SUPPORT FOR PROPOSED ACCEPTANCE CRITERIA FOR DROPLET SIZE DISTRIBUTION AFTER ACTUATION OF SPRAYER DEVICE.  Full Article

Evoke Pharma Q4 Loss Per Share $0.10
Wednesday, 6 Mar 2019 

March 6 (Reuters) - Evoke Pharma Inc ::EVOKE PHARMA REPORTS FOURTH QUARTER AND FULL YEAR 2018 FINANCIAL RESULTS AND FDA COMMUNICATION.Q4 LOSS PER SHARE $0.10.Q4 EARNINGS PER SHARE ESTIMATE $-0.07 -- REFINITIV IBES DATA.AS OF DECEMBER 31, 2018, COMPANY'S CASH AND CASH EQUIVALENTS WERE APPROXIMATELY $5.3 MILLION.  Full Article

Evoke Pharma Receives Preliminary FDA Communication On Gimoti NDA
Monday, 4 Mar 2019 

March 4 (Reuters) - Evoke Pharma Inc ::EVOKE PHARMA RECEIVES PRELIMINARY FDA COMMUNICATION ON GIMOTI NDA.EVOKE PHARMA INC - COMPANY PLANS TO RESPOND TO DEFICIENCIES RAISED IN DR LETTER TO ALLOW TIME FOR POTENTIAL FDA REVIEW PRIOR TO PDUFA DATE.EVOKE PHARMA INC - LETTER DESCRIBED CONCERNS IN THREE SECTIONS OF NDA.EVOKE PHARMA INC - COMPANY PLANS TO RESPOND TO DEFICIENCIES RAISED IN DR LETTER TO ALLOW TIME FOR POTENTIAL FDA REVIEW PRIOR TO PDUFA DATE.EVOKE PHARMA INC - THE CONCERNS IN THREE SECTIONS OF NDA ARE CHEMISTRY, CLINICAL AND CLINICAL PHARMACOLOGY.  Full Article

NGP Agreed To Provide Credit Up To $5 Mln To Evoke Pharma After NDA Approval Of Gimoti
Monday, 7 Jan 2019 

Jan 7 (Reuters) - Evoke Pharma Inc ::EVOKE PHARMA INC - NGP HAS AGREED TO PROVIDE A LINE OF CREDIT OF UP TO $5.0 MILLION TO COMPANY FOLLOWING NDA APPROVAL OF GIMOTI.EVOKE PHARMA INC - NGP WILL RECEIVE A LOW SINGLE DIGIT PERCENTAGE ON NET SALES OF GIMOTI IN LIEU OF ANY INTEREST ON LINE OF CREDIT.  Full Article

Evoke Pharma Signs Agreement For Gimoti In The U.S. With Novos Growth Partners
Monday, 7 Jan 2019 

Jan 7 (Reuters) - Evoke Pharma Inc ::EVOKE PHARMA SIGNS COMMERCIAL AND FINANCIAL AGREEMENT FOR ITS LEAD PRODUCT GIMOTI™ IN THE U.S. WITH NOVOS GROWTH PARTNERS.EVOKE PHARMA INC - EVOKE WILL RETAIN GREATER THAN 80% OF PRODUCT PROFITS FOLLOWING APPROVAL.EVOKE PHARMA INC - EVOKE MAINTAINS OWNERSHIP OF GIMOTI NEW DRUG APPLICATION.EVOKE PHARMA INC - EVOKE WILL MAINTAIN LEGAL, REGULATORY, AND MANUFACTURING RESPONSIBILITIES.EVOKE PHARMA INC - EVOKE WILL ALSO RETAIN A CONTRACT SALES ORGANIZATION, WHICH WOULD BE MANAGED BY NGP AND WHO WILL FINANCE WORKING CAPITAL FOR LAUNCH.EVOKE PHARMA INC - EVOKE WILL RECORD SALES FOR GIMOTI AND RETAIN MORE THAN 80% OF PRODUCT PROFITS.EVOKE PHARMA - NGP TO RECEIVE A PERCENTAGE OF PRODUCT PROFITS IN MID TO HIGH TEENS AS SERVICE FEE ONCE GIMOTI NET SALES SURPASS COMMERCIALIZATION COSTS.EVOKE PHARMA INC - TERM OF AGREEMENT IS FIVE YEARS.EVOKE PHARMA INC - GIMOTI IS EXPECTED TO BE LAUNCHED IN UNITED STATES DURING 2019, IF APPROVED BY FDA.EVOKE PHARMA INC - AS OF DECEMBER 31, 2018, EVOKE HAD APPROXIMATELY $5.3 MILLION IN CASH.EVOKE PHARMA INC - U.S. FDA HAS SET A TARGET GOAL DATE UNDER PHARMACEUTICAL DRUG USER FEE ACT OF APRIL 1, 2019.  Full Article

Evoke Announces FDA Submission Of New Drug Application For Gimoti™
Monday, 4 Jun 2018 

June 4 (Reuters) - Evoke Pharma Inc ::EVOKE ANNOUNCES FDA SUBMISSION OF NEW DRUG APPLICATION FOR GIMOTI™.EVOKE PHARMA INC - EXPECTS TO RECEIVE NOTIFICATION FROM FDA FILING WAS ACCEPTED FOR SUBSTANTIVE REVIEW IN EARLY AUGUST 2018.  Full Article

Evoke Pharma Posts Loss Of $0.13 Per Share in Q1
Monday, 14 May 2018 

May 14 (Reuters) - Evoke Pharma Inc ::EVOKE PHARMA REPORTS FIRST QUARTER 2018 RESULTS AND HIGHLIGHTS.Q1 LOSS PER SHARE $0.13.Q1 EARNINGS PER SHARE VIEW $-0.19 -- THOMSON REUTERS I/B/E/S.NDA SUBMISSION FOR GIMOT ON TRACK FOR Q2 OF 2018.INCLUDED IN NET LOSS FOR Q1 WAS A GAIN OF ABOUT $433,000 DUE TO CHANGE IN FAIR VALUE OF WARRANT LIABILITY.  Full Article

Evoke Announces Agreement With Mallinckrodt To Amend Milestone Payments
Monday, 26 Mar 2018 

March 26 (Reuters) - Evoke Pharma Inc ::EVOKE ANNOUNCES AGREEMENT WITH MALLINCKRODT TO AMEND MILESTONE PAYMENTS.‍HAS AMENDED CO'S AGREEMENT WITH MALLINCKRODT, ARD INC. TO DEFER DEVELOPMENT AND APPROVAL MILESTONE PAYMENTS FOR GIMOTI​.AMENDED AGREEMENT DEFERS AMOUNT AND TIMING OF TWO MILESTONE PAYMENTS​.‍AMENDED AGREEMENT DEFERS AMOUNT AND TIMING OF TWO MILESTONE PAYMENTS DUE UPON U.S. FDA ACCEPTANCE FOR REVIEW OF NEW DRUG APPLICATION​.EVOKE PHARMA - HAVE IMPROVED CASH RUNWAY TO JANUARY OF NEXT YEAR AND REMAIN ON TRACK TO SUBMIT GIMOTI NDA NEXT QUARTER.  Full Article

Evoke Pharma reports Q3 loss per share $0.34
Wednesday, 15 Nov 2017 

Nov 14 (Reuters) - Evoke Pharma Inc ::Evoke Pharma reports third quarter 2017 results and highlights.Q3 loss per share $0.34.Q3 earnings per share view $-0.20 -- Thomson Reuters I/B/E/S.  Full Article