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Evoke Pharma Inc (EVOK.OQ)

EVOK.OQ on NASDAQ Stock Exchange Capital Market

4.92USD
18 Sep 2020
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Latest Key Developments (Source: Significant Developments)

Evoke Pharma Enters Sales And Distribution Agreement With Eversana Life Science Services
Thursday, 3 Sep 2020 

Sept 2 (Reuters) - Evoke Pharma Inc ::EVOKE PHARMA INC - ENTERED SALES AND DISTRIBUTION AGREEMENT WITH EVERSANA LIFE SCIENCE SERVICES.EVOKE PHARMA INC - EVERSANA SHALL EXCLUSIVELY PURCHASE ALL OF ITS REQUIREMENTS FOR GIMOTI(TM) (METOCLOPRAMIDE) NASAL SPRAY.EVOKE PHARMA INC - EVERSANA WILL ALSO PROVIDE CERTAIN ORDER TO CASH, CHARGEBACK PROCESSING, GOVERNMENT PRICE REPORTING, AND LOGISTICS SERVICES.  Full Article

Evoke Pharma Enters Commercialization Agreement With EVERSANA Life Sciences For Gimoti
Thursday, 23 Jan 2020 

Jan 23 (Reuters) - Evoke Pharma Inc ::EVOKE PHARMA ENTERS COMMERCIALIZATION AGREEMENT WITH EVERSANA LIFE SCIENCES FOR GIMOTI.EVOKE PHARMA INC - EVERSANA TO PROVIDE $5 MILLION REVOLVING CREDIT FACILITY UPON FDA APPROVAL.EVOKE PHARMA INC - EVERSANA TO COMMERCIALIZE AND DISTRIBUTE GIMOTI IN U.S..EVOKE PHARMA INC - WILL RECORD SALES FOR GIMOTI TO EVERSANA'S THIRD PARTY LOGISTICS DIVISION AND RETAIN MORE THAN 80% OF PRODUCT PROFITS.EVOKE PHARMA INC - EVOKE AND NOVOS GROWTH PARTNERS HAVE MUTUALLY AGREED TO TERMINATE COMMERCIALIZATION AGREEMENT DATED JANUARY 5, 2019.EVOKE PHARMA INC - CO MAINTAINS OWNERSHIP OF GIMOTI NDA, ALL LEGAL, REGULATORY, AND MANUFACTURING RESPONSIBILITIES.  Full Article

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

BRIEF-Evoke Pharma Extends Cash Runway To 2Q 2021

* EVOKE PHARMA INC - AS OF JUNE 30, 2020 IT HAD CASH AND CASH EQUIVALENTS OF ABOUT $8.0 MILLION Source text for Eikon: Further company coverage: