Gimoti™ Prescription Drug User Fee Act (PDUFA) date is June 19, 2020 SOLANA BEACH, Calif., May 12, 2020 -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical.

Evoke Pharma, Inc. (EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that it has resubmitted its 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Gimoti™, the company’s nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis. The NDA for Gimoti was resubmitted based on feedback received during the Type A meeting with FDA in July 2019.

EVERSANA to commercialize and distribute Gimoti in the U.S. SOLANA BEACH, Calif. and CHICAGO, Jan. 23, 2020 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, and EVERSANA™, an independent provider of global commercial services to the life science industry, today announced a collaboration to utilize EVERSANA’s integrated suite of outsourced services to commercialize and distribute Gimoti™ in the United States (U.S.). Gimoti is Evoke’s nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis.

Evoke Pharma, Inc. (EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that it has completed manufacturing commercial scale batches of its product candidate Gimoti (metoclopramide nasal spray) with its partner Thermo Fisher Scientific, a leading global contract development and manufacturing organization that specializes in the preparation, fill and finish of nasal spray products. Evoke plans to collect Chemistry, Manufacturing and Controls (CMC) data from these registration batches, which were requested in the complete response letter (CRL) from the U.S. Food and Drug Administration (FDA).

SOLANA BEACH, Calif., March 12, 2020 -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today.

Evoke Pharma, Inc. (EVOK), a specialty pharmaceutical company focused on the development of drugs to treat gastrointestinal (GI) disorders and diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s resubmission of its 505(b)(2) New Drug Application (NDA) for Gimoti™, the Company’s nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis.

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Trailing twelve-month data shows us that Evoke Pharma, Inc.'s (NASDAQ:EVOK) earnings loss has accumulated to -US$7.4m...

Evoke Pharma, Inc. (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. 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. “We have been working diligently to prepare the meeting package required at the time a type A meeting request is submitted to FDA.

Evoke Pharma, Inc. (EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that on November 12, 2019, it received notification from the Listing Qualifications Department of the Nasdaq Stock Market indicating that the Company has been granted an additional 180-day grace period to regain compliance with the minimum $1.00 bid price per share requirement of Nasdaq’s Marketplace Rule 5550(a)(2). In accordance with the rule, the Company was eligible for the additional compliance period because it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement.

SOLANA BEACH, Calif., Aug. 08, 2019 -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today.

The name Gimoti (pronounced “jye-MOH-tee”) was developed in compliance with FDA’s Guidance for Industry, Contents of a Complete Submission for the Evaluation of Proprietary Names. Based on the development program, which included research with physicians and pharmacists, as well as an international name assessment, the Company believes Gimoti is a proprietary name with strong marketing potential that is also consistent with FDA’s goal of preventing medication errors and potential harm to the public by ensuring that only appropriate proprietary names are approved for use.

A look at the shareholders of Evoke Pharma, Inc. (NASDAQ:EVOK) can tell us which group is most powerful. Institutions...

The FDA receives Evoke Pharma's (EVOK) refiling of new drug application for its pipeline candidate Gimoti, which is being developed to treat diabetic gastroparesis.

Zynerba (ZYNE) announces positive top-line results from the BELIEVE 1 study evaluating the efficacy and safety of Zygel in a heterogeneous group of rare and ultra-rare epilepsies.

Evoke Pharma, Inc. (EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that on November 29, 2019, it received notification from the Listing Qualifications Department of the Nasdaq Stock Market that the Company has regained compliance with the minimum bid price requirement under Nasdaq’s Marketplace Rule 5550(a)(2) for continued listing on the Nasdaq Capital Market. Accordingly, Nasdaq considers the matter closed. Gastroparesis is a debilitating, episodic condition that disproportionately affects adult women and is characterized by slow or delayed gastric emptying of the stomach’s contents after meals, often resulting in flares of symptoms that include nausea, vomiting, abdominal pain and bloating.

Foamix (FOMX) enrolls first patient in phase II study on its topical combination foam, FCD105, for the treatment of moderate-to-severe acne vulgaris.

SOLANA BEACH, Calif., Nov. 07, 2019 -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today.

After wallowing in penny stock territory until mid-July, the stock has broken the downtrend seen since early March and is experiencing some upward momentum. The company bought the rights to the investigational asset from Questcor Pharma in 2007 by paying $650,000 upfront and an additional $500,000 in May 2014 as a milestone payment. It is being evaluated as a treatment option for relieving symptoms in adult women with acute and recurrent diabetic gastroparesis.

Evoke Pharma, Inc. (EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance for the Gimoti™ trademark. Gimoti is Evoke’s nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis. The U.S. Food and Drug Administration (FDA) is currently reviewing the New Drug Application (NDA) for Gimoti and has set a target goal date under the Prescription Drug User Fee Act (PDUFA) of June 19, 2020.