Confirmed FDA acceptability of comparative exposure pharmacokinetic (PK) study design and agreement on related CMC data package elements for Gimoti™ new drug application (NDA) Partnered with Spaulding Clinical Research to complete PK study in second half of 2017 Received FDA agreement that a
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
Projected cash runway extended to first quarter 2020 SOLANA BEACH, Calif. , May 08, 2019 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced its financial results for the first quarter
Gimoti™ Prescription Drug User Fee Act (PDUFA) date is June 19, 2020 SOLANA BEACH, Calif. , May 12, 2020 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced its financial results for the
Nearly 293% growth of product sales, 235% growth of prescriptions and 87% increase in new prescribers for Gimoti ® New notice of allowance from USPTO to expand Gimoti patent estate SOLANA BEACH, Calif. , May 12, 2021 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc.
Several sales growth indicators increased over Q4, 2021: New Prescribers up 41%; Product delivered to patients up 39%; Net Revenue increased by 16%; Prescriptions written up 22% SOLANA BEACH, Calif. , May 10, 2022 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc.
Net product sales increased by 94% from Q1 2022 New cumulative prescribers up by 17% from Q4 2022 Doubled patient enrollment since Q1 2022; 127% increase SOLANA BEACH, Calif. , May 15, 2023 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily
SOLANA BEACH, Calif., March 15, 2017 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal diseases, today announced its financial results for the fourth quarter and full year ended December 31, 2016.
Successfully completed pivotal pharmacokinetic trial and finalized the proposed to-be-marketed Gimoti™ dose Announced discovery of sex-based pharmacokinetic differences for Gimoti™ Met with FDA regarding NDA women-only filing strategy and post-marketing plans 505(b)(2) NDA submission planned for
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
