Evoke pharma, inc. (nasdaq evok) files an 8-k other events – market exclusive data recovery illustrator

On march 5, 2018, evoke pharma, inc. (the “company”) announced that the U.S. Food and drug administration (FDA)granted the company’s request for a small business waiver of the prescription drug user fee act (PDUFA) fee of approximately $2.4 million for its 505(b)(2) new drug application (NDA) for gimoti™, the company’s nasal delivery of metoclopramide for the treatment of symptoms associated with gastroparesis in women. The company remains on track to file the gimoti NDA in the second quarter of 2018.

The company cautions you that statements included in this report that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions.Clinical trial


these statements are based on the company’s current beliefs and expectations. These forward-looking statements include statements regarding: the company’s plans to pursue approval of gimoti in adult women with diabetic gastroparesis; the company’s belief that the sex-based PK differences are important to gastroparesis treatment; the company’s plans with respect to the content of the NDA submission, including a proposed post-marketing risk management strategy and safety trial; and the timing of the NDA submission. The inclusion of forward-looking statements should not be regarded as a representation by the company that any of its plans will be achieved.Clinical trial actual results may differ from those set forth in this report due to the risks and uncertainties inherent in the company’s business, including, without limitation: the FDA may disagree that the existing safety database and efficacy data is sufficient to allow an NDA submission and approval, including risks associated with C max falling below the bioequivalence range in the comparative exposure PK trial and the proposed duration of use for gimoti being shorter as compared to the maximum approved dosing duration for the referenced listed drug, reglan tablets, and the available safety database supporting such duration; the FDA may not agree with the company’s interpretation of the results of clinical trials of gimoti; the FDA may require additional evidence of sex-based PK differences of gimoti before making a final decision on gimoti; risks associated with the size, cost and duration of a post-marketing safety trials; later developments with the FDA that may be inconsistent with the already completed pre-NDA meetings; the inherent risks of clinical development of gimoti; evoke is entirely dependent on the success of gimoti, and the company cannot be certain that it will be able to submit an NDA for gimoti or obtain regulatory approval for or successfully commercialize gimoti; the company will require substantial additional funding to conduct any new trials required by the FDA, and may be unable to raise capital when needed, including to fund ongoing operations; the company may not be able to obtain, maintain and enforce intellectual property rights; and other risks detailed in the company’s prior periodic reports it files with the securities and exchange commission.Forward-looking statements you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the company undertakes no obligation to revise or update this report to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the private securities litigation reform act of 1995.

Evoke pharma, inc. Is a specialty pharmaceutical company. The company is focused primarily on the development of drugs to treat gastrointestinal (GI) disorders and diseases. The company is developing EVK-001, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in women.Phase clinical trial EVK-001 is a formulation of metoclopramide drug, designed to provide systemic delivery of metoclopramide through intranasal administration. The company has evaluated EVK-001 in a multicenter, randomized, double-blind, placebo-controlled parallel group, dose-ranging phase iib clinical trial. The company has commenced a phase III clinical trial of EVK-001 in female patients with symptoms associated with acute and recurrent diabetic gastroparesis. The phase III clinical trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy, safety and population pharmacokinetics of EVK-001 in adult females.Phase clinical trial

ABOUT usmarket exclusive offers the latest financial news and analysis for selected US stocks and securities. We are an investor driven research platform where new investment ideas from a exclusively selected group of seasoned investment analysts and qualified members from various disciplines are able to deliver their investment thesis’ across various industries and sectors. Our burgeoning team is comprised of individuals with strong backgrounds from various disciplines and businesses. Our goal is to provide an exclusive forum for contributors and users to leverage the knowledge base in order to make smarter investing decisions.

At market exclusive, we believe that quality information from experienced well seasoned contributors provide our members with an edge that allows them to make wise investment choices.Forward-looking statements

Market exclusive is not a registered investment broker/dealer. The content on this site is for informational purposes only. Additionally, the content on this site does not represent the views of market exclusive and is solely a representation of the authors who publish them. Before investing in any security you should do your own due diligence and consult with a registered broker or financial advisor.

On march 21, 2018, evoke pharma, inc. (“evoke” or the “company”) entered into an amendment to asset purchase agreement (the “amendment”) with mallinckrodt ARD inc. (formerly known as questcor pharmaceuticals, inc.) (“mallinckrodt”) to amend certain terms of the asset purchase agreement, dated as of june 1, 2007 (as subsequently amended, the “asset purchase agreement”).Phase clinical trial to the amendment, mallinckrodt has agreed to modify the two milestone payments, namely the $1.5 million payments due upon acceptance of the new drug application (“NDA”) for gimoti and the $3.0 million due upon approval of the gimoti NDA by the food and drug administration (“FDA”), to a single $5.0 million milestone payment due one year after FDA approval, if any, of the gimoti NDA.

As a result of the amendment, evoke believes that its existing cash and cash equivalents will be sufficient to fund its operations into january 2019.

The foregoing summary of the material terms of the amendment does not purport to be complete and is qualified in its entirety by reference to the amendment, a copy of which will be filed with the securities and exchange commission by evoke on its quarterly report on form 10-Q for the period ending march 31, 2018.Forward-looking statements

The company cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negatives of these terms or other similar expressions. These statements are based on the company’s current beliefs and expectations.Forward-looking statements these forward-looking statements include statements regarding: anticipated timing to submit an NDA for gimoti; the potential timing of FDA approval, if any, of the NDA for gimoti; and evoke’s projected cash runway. The inclusion of forward-looking statements should not be regarded as a representation by evoke that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in evoke’s business, including, without limitation: evoke may spend its available cash faster than it anticipates; the FDA may disagree that the existing safety database is sufficient to allow an NDA submission and approval; risks associated with FDA review of the final results from the comparative exposure pharmacokinetic (PK) trial, including the FDA may not agree with evoke’s interpretation of such results; later developments with the FDA that may be inconsistent with the already completed pre-NDA meetings and most recent correspondence; the inherent risks of clinical development of gimoti; evoke is entirely dependent on the success of gimoti, and evoke cannot be certain that it will be able to submit an NDA for gimoti or obtain regulatory approval for or successfully commercialize gimoti; evoke will require substantial additional funding to conduct any new safety trials required by the FDA, and may be unable to raise capital when needed, including to fund ongoing operations; and other risks detailed in evoke’s prior press releases and in the periodic reports it files with the securities and exchange commission.Clinical trial you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and evoke undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the private securities litigation reform act of 1995.

Evoke pharma, inc. Is a specialty pharmaceutical company. The company is focused primarily on the development of drugs to treat gastrointestinal (GI) disorders and diseases. The company is developing EVK-001, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in women.Clinical trial EVK-001 is a formulation of metoclopramide drug, designed to provide systemic delivery of metoclopramide through intranasal administration. The company has evaluated EVK-001 in a multicenter, randomized, double-blind, placebo-controlled parallel group, dose-ranging phase iib clinical trial. The company has commenced a phase III clinical trial of EVK-001 in female patients with symptoms associated with acute and recurrent diabetic gastroparesis. The phase III clinical trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy, safety and population pharmacokinetics of EVK-001 in adult females.Forward-looking statements

ABOUT usmarket exclusive offers the latest financial news and analysis for selected US stocks and securities. We are an investor driven research platform where new investment ideas from a exclusively selected group of seasoned investment analysts and qualified members from various disciplines are able to deliver their investment thesis’ across various industries and sectors. Our burgeoning team is comprised of individuals with strong backgrounds from various disciplines and businesses. Our goal is to provide an exclusive forum for contributors and users to leverage the knowledge base in order to make smarter investing decisions.

At market exclusive, we believe that quality information from experienced well seasoned contributors provide our members with an edge that allows them to make wise investment choices.Phase clinical trial

Market exclusive is not a registered investment broker/dealer. The content on this site is for informational purposes only. Additionally, the content on this site does not represent the views of market exclusive and is solely a representation of the authors who publish them. Before investing in any security you should do your own due diligence and consult with a registered broker or financial advisor.

banner