Press Releases

Date Title and Summary Additional Formats
Toggle Summary Evoke Pharma Submits Response to FDA Review Letter for Gimoti™ NDA
Meeting with FDA scheduled for March 21, 2019 SOLANA BEACH, Calif. , March 14, 2019 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that it has submitted its response to the U.S.
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Toggle Summary Evoke Pharma Reports Fourth Quarter and Full Year 2018 Financial Results and FDA Communication
Recently received multi-disciplinary review (DR) letter from U.S. Food and Drug Administration ( FDA ) for Gimoti™ 505(b)(2) New Drug Application (NDA) April 1 , 2019 Prescription Drug User Fee Act (PDUFA) date maintained Company expects to hold a conference call at a later date instead of its
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Toggle Summary Evoke Pharma Receives Preliminary FDA Communication on Gimoti™ NDA
SOLANA BEACH Calif. , March 04, 2019 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), today announced the receipt of a multi-disciplinary review (DR) letter from the U.S. Food and Drug Administration ( FDA ) in association with the Gimoti 505(b)(2) New Drug Application (NDA).
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Toggle Summary Evoke Pharma Schedules Conference Call and Webcast for Fourth Quarter and Full-Year 2018 Financial Results
SOLANA BEACH, Calif. , Feb. 27, 2019 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the Company will release financial results for the fourth quarter and full year ended
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Toggle Summary Evoke Pharma Signs Commercial and Financial Agreement for its Lead Product Gimoti™ in the U.S. with Novos Growth Partners
Novos to provide fully integrated commercial function for Evoke and non-dilutive financing for the commercialization of Gimoti, extending cash runway into 2020 Evoke will retain greater than 80% of product profits following approval SOLANA BEACH, Calif. , Jan.
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Toggle Summary Evoke Pharma Reports Third Quarter 2018 Results
April 1, 2019 PDUFA date for Gimoti™ NDA Cash runway extended through June 2019 SOLANA BEACH, Calif. , Nov. 13, 2018 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced its financial
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Toggle Summary Evoke Pharma’s Gimoti™ NDA Accepted for FDA Review
April 1, 2019 PDUFA Target Goal Date Gimoti Brand Name Conditionally Accepted SOLANA BEACH, Calif. , Aug. 16, 2018 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the Company’s
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Toggle Summary Evoke Pharma Reports Second Quarter 2018 Results and Recent Highlights
Gimoti ™ NDA submitted to FDA on June 1 st ; awaiting 74-Day FDA filing communication letter Gender-specific patents granted for Gimoti in the European Union and Mexico SOLANA BEACH, Calif. , Aug. 09, 2018 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company
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Toggle Summary Evoke Announces FDA Submission of New Drug Application for Gimoti™
Company to host a corporate update conference call today, June 4, 2018 at 4:30pm EST SOLANA BEACH, Calif. , June 04, 2018 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced the submission
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Toggle Summary Evoke Pharma Reports First Quarter 2018 Results and Highlights
The Company will hold a conference call following submission of Gimoti NDA NDA submission for Gimoti™ on track for second quarter of 2018 Announced discovery of sex-based pharmacokinetic differences for Gimoti Waiver of the PDUFA fee for Gimoti NDA granted by FDA Cash runway extended into April
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