Evoke Pharma Requests Type A FDA Meeting to Plan for Resubmission of Gimoti™ NDA
Evoke Pharma, Inc. (EVOK)
Last evoke pharma, inc. earnings: 11/7 08:30 am
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Source: GlobeNewswire
SOLANA BEACH, Calif., June 27, 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 a type A meeting request and meeting package to the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter (CRL) dated April 1, 2019 regarding Evoke’s New Drug Application (NDA) for Gimoti™ for the relief of symptoms associated with acute and recurrent diabetic gastroparesis. The purpose of the meeting is to discuss and gain clarity on the approvability issues relating to clinical pharmacology and product quality/device quality described in the CRL. During the meeting, Evoke plans to discuss the Company’s strategy to address these issues as well as any other matters pertaining to the steps required for the resubmission of the Gimoti NDA. No safety concerns were raised and no additional clinical data were requested in the CRL. “We have bee
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News
- Evoke Pharma, Inc. (NASDAQ: EVOK) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
- Evoke Pharma, Inc. (NASDAQ: EVOK) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
- Evoke Pharma to Host Virtual Key Opinion Leader (KOL) Webinar on the Evolving Landscape of Gastroparesis: GIMOTI, Hospitalizations, and GLP-1 MedicationsGlobeNewswire
- Evoke Pharma, Inc. (NASDAQ: EVOK) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
- Evoke Pharma, Inc. (NASDAQ: EVOK) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
EVOK
Sec Filings
- 4/10/24 - Form ARS
- 4/10/24 - Form DEFA14A
- 4/10/24 - Form DEF
- EVOK's page on the SEC website