EVOK Evoke Pharma Inc.

5.7
+0.16  (+3%)
Previous Close 5.54
Open 5.75
52 Week Low 0.73323
52 Week High 6.0628
Market Cap $148,264,199
Shares 26,011,263
Float 25,373,072
Enterprise Value $128,403,104
Volume 752,538
Av. Daily Volume 1,836,679
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Drug Pipeline

Drug Stage Notes
Gimoti - EVK-001
Diabetic gastroparesis
Approved
Approved
FDA Approval announced June 19, 2020.

Latest News

  1. SOLANA BEACH, Calif., Aug. 06, 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 second quarter ended June 30, 2020.

    "The recent FDA approval of Gimoti, the first and only outpatient treatment option that bypasses the stomach to relieve symptoms in adults with acute and recurrent diabetic gastroparesis, marked the most significant milestone in our history," said David A. Gonyer, R.Ph., President and CEO of Evoke Pharma. "We are currently focused on the commercial launch of Gimoti during the fourth quarter of 2020 with EVERSANA, our commercial partner. EVERSANA is working with us to fully implement…

    SOLANA BEACH, Calif., Aug. 06, 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 second quarter ended June 30, 2020.

    "The recent FDA approval of Gimoti, the first and only outpatient treatment option that bypasses the stomach to relieve symptoms in adults with acute and recurrent diabetic gastroparesis, marked the most significant milestone in our history," said David A. Gonyer, R.Ph., President and CEO of Evoke Pharma. "We are currently focused on the commercial launch of Gimoti during the fourth quarter of 2020 with EVERSANA, our commercial partner. EVERSANA is working with us to fully implement our strategy, while leveraging their integrated suite of commercialization capabilities. Simultaneously, we have manufactured the first commercial batch of Gimoti with our contract manufacturing partner, Patheon. We believe that we will be well prepared to launch Gimoti and look forward to providing patients with diabetic gastroparesis the only outpatient non-oral treatment option to help improve gastroparesis patients' quality of life."

    Second Quarter 2020 Financial Review

    For the second quarter of 2020, net loss was approximately $7.0 million, or $0.28 per share, compared to a net loss of approximately $2.1 million, or $0.09 per share, for the second quarter of 2019.

    Research and development expenses totaled approximately $5.8 million for the second quarter of 2020, compared to approximately $1.2 million for the second quarter of 2019. The increase during the three months ended June 30, 2020 is primarily due to recording a $5 million expense in June 2020 upon achieving a technology acquisition milestone related to FDA's approval of Gimoti.  Although the expense was recorded when incurred, the payment is not due until June 2021.  Other research and development expenses incurred primarily related to responding to requests for additional information from FDA related to the New Drug Application and preparing for future manufacturing for the commercial launch of Gimoti.

    For the second quarter of 2020, general and administrative expenses were approximately $1.2 million compared to approximately $0.9 million for the second quarter of 2019.

    Total operating expenses for the second quarter of 2020 were approximately $7.0 million, compared to total operating expenses of approximately $2.1 million for the second quarter of 2019.

    As of June 30, 2020, the Company's cash and cash equivalents were approximately $8.0 million. The Company expects that its current cash balance will be sufficient to support operations into the second quarter of 2021, without further borrowings from EVERSANA or consideration of potential future GIMOTI revenue.

    About Evoke Pharma, Inc.

    Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The Company is developing Gimoti, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women (approximately 80% of the affected patients).

    Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious digestive system symptoms. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Metoclopramide is currently available only in oral and injectable formulations and is the only drug currently approved in the United States to treat gastroparesis. Visit www.EvokePharma.com for more information.

    Safe Harbor Statement

    Evoke 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. These forward-looking statements include statements regarding: the timing of the commercial launch of GIMOTI and commercial activities to be conducted by EVERSANA; the potential of GIMOTI to provide an important new alternative to current treatment options; and Evoke's projected cash runway and potential to access the EVERSANA line of credit.  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's and EVERSANA's ability to successfully launch and drive market demand for GIMOTI and the timing thereof; Evoke's ability to obtain additional financing as needed to support its operations, including through the EVERSANA line of credit which is subject  to certain customary conditions; the COVID-19 pandemic may disrupt Evoke's and EVERSANA's business operations impairing the ability to commercialize GIMOTI and  Evoke's ability to generate any product revenue; Evoke's dependence on third parties for the manufacture of GIMOTI; Evoke is entirely dependent on the success of GIMOTI; inadequate efficacy or unexpected adverse side effects relating to GIMOTI that could delay or prevent commercialization, or that could result in recalls or product liability claims; our ability to obtain and maintain intellectual property protection for GIMOTI; and other risks detailed in Evoke's prior press releases and in the periodic reports it files with the Securities and Exchange Commission. 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.

    (Financial Statements to Follow)

    Evoke Pharma, Inc.



    Condensed Balance Sheets
        
     June 30,

    2020
     December 31,

    2019
     (Unaudited)  
    Assets   
    Current Assets:   
    Cash and cash equivalents$7,990,392  $5,663,833 
    Prepaid expenses 193,902   581,706 
    Other current assets 11,551    
    Total current assets 8,195,845   6,245,539 
    Operating lease right-of-use asset 71,211   138,538 
    Other assets    11,551 
    Total assets$8,267,056  $6,395,628 
        
    Liabilities and stockholders' equity   
    Current Liabilities:   
    Accounts payable and accrued expenses$604,832  $1,033,383 
    Accrued compensation 860,521   843,162 
    Operating lease liability 71,211   138,538 
    Paycheck protection program loan 104,168    
    Milestone payable 5,000,000    
    Total current liabilities 6,640,732   2,015,083 
        
    Long-term Liabilities:   
    Note payable 2,000,000    
        
    Total liabilities 8,640,732   2,015,083 
        
    Stockholders' equity:   
    Common stock 2,601   2,443 
    Additional paid-in capital 94,111,817   90,108,492 
    Accumulated deficit (94,488,094)  (85,730,390)
    Total stockholders' equity (deficit) (373,676)  4,380,545 
    Total liabilities and stockholders' equity$8,267,056  $6,395,628 
            



    Evoke Pharma, Inc.



    Condensed Statement of Operations

    (Unaudited)
            
     Three Months Ended

    June 30,
     Six Months Ended

    June 30,
      2020   2019   2020   2019 
    Operating expenses:       
    Research and development$5,782,094  $1,205,599  $6,245,946  $1,952,481 
    General and administrative 1,182,872   918,139   2,512,707   2,141,152 
    Total operating expenses 6,964,966   2,123,738   8,758,653   4,093,633 
    Loss from operations (6,964,966)  (2,123,738)  (8,758,653)  (4,093,633)
    Other income (expense):       
    Interest income 485   9,642   3,863   14,271 
    Interest expense (2,914)     (2,914)   
    Total other income (expense) (2,429)  9,642   949   14,271 
    Net loss$(6,967,395) $(2,114,096) $(8,757,704) $(4,079,362)
            
    Net loss per share of common stock, basic and diluted$(0.28) $(0.09) $(0.35) $(0.20)
            
    Weighted-average shares used to compute basic and diluted net loss per share 24,987,975   23,258,567   24,713,928   20,371,442 
                    

    Investor Contact:

    The Ruth Group

    Alexander Lobo

    Tel: 646-536-7037

     

    Primary Logo

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  2. SOLANA BEACH, Calif., July 15, 2020 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that it has initiated the commercial manufacturing of Gimoti™ (metoclopramide) nasal spray with its manufacturing partner, Patheon, a division of Thermo Fisher Scientific, Inc. Gimoti was approved by the U.S. Food and Drug Administration on June 19, 2020 for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. The Company plans to launch sales of Gimoti in the fourth quarter 2020 with its partner EVERSANA.

    "We have continued to accelerate the necessary pre-commercialization activities for Gimoti alongside our commercial…

    SOLANA BEACH, Calif., July 15, 2020 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that it has initiated the commercial manufacturing of Gimoti™ (metoclopramide) nasal spray with its manufacturing partner, Patheon, a division of Thermo Fisher Scientific, Inc. Gimoti was approved by the U.S. Food and Drug Administration on June 19, 2020 for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. The Company plans to launch sales of Gimoti in the fourth quarter 2020 with its partner EVERSANA.

    "We have continued to accelerate the necessary pre-commercialization activities for Gimoti alongside our commercial and manufacturing partners," said David Gonyer, R.Ph., President and CEO. "Together with Patheon, we have initiated manufacturing process for the first commercial batch of Gimoti. We expect these activities to be completed over the next several weeks and ahead of our planned launch in the fourth quarter of 2020."

    About Evoke Pharma, Inc.

    Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The Company developed GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults.

    Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious GI symptoms as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Prior to FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations and remains the only drug currently approved in the United States to treat gastroparesis. Visit www.EvokePharma.com for more information.

    Safe Harbor Statement

    Evoke 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. These forward-looking statements include statements regarding: the timing of completing the commercial manufacturing of Gimoti and other pre-commercialization activities; the timing of the commercial launch of Gimoti and commercial activities to be conducted by EVERSANA; and the size of the gastroparesis market and the potential of Gimoti to provide an important new alternative to current treatment options. 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's and Patheon's ability to successfully complete the commercial manufacturing of Gimoti; Evoke's and EVERSANA's ability to successfully launch and drive market demand for Gimoti and the timing thereof; Evoke's ability to obtain additional financing as needed to support its operations, including through its existing line of credit with EVERSANA which is subject to certain customary conditions; the COVID-19 pandemic may disrupt Evoke's, Patheon's and EVERSANA's business operations impairing the ability to manufacture or commercialize Gimoti and Evoke's ability to generate any product revenue; Evoke's dependence on third parties for the manufacture of Gimoti; Evoke is entirely dependent on the success of Gimoti; inadequate efficacy or unexpected adverse side effects relating to Gimoti that could delay or prevent commercialization, or that could result in recalls or product liability claims; our ability to obtain and maintain intellectual property protection for Gimoti; and other risks detailed in Evoke's prior press releases and in the periodic reports it files with the Securities and Exchange Commission. 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.

    Investor Contact:

    The Ruth Group

    Tram Bui

    Tel: 646-536-7035

    Primary Logo

    View Full Article Hide Full Article
  3. SOLANA BEACH, Calif., July 08, 2020 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that as of June 30, 2020 it had cash and cash equivalents of approximately $8.0 million.  Based on its current operating plan, Evoke believes that its existing cash and cash equivalents will provide sufficient cash to fund its operations into the second quarter of 2021, without consideration of the remaining $3.0 million available under its EVERSANA line of credit or potential GIMOTI revenue.

    "Following the approval of GIMOTI, the first and only nasal therapeutic to treat the symptoms of diabetic gastroparesis in adults, we have further improved…

    SOLANA BEACH, Calif., July 08, 2020 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that as of June 30, 2020 it had cash and cash equivalents of approximately $8.0 million.  Based on its current operating plan, Evoke believes that its existing cash and cash equivalents will provide sufficient cash to fund its operations into the second quarter of 2021, without consideration of the remaining $3.0 million available under its EVERSANA line of credit or potential GIMOTI revenue.

    "Following the approval of GIMOTI, the first and only nasal therapeutic to treat the symptoms of diabetic gastroparesis in adults, we have further improved our capital position in preparation for commercialization," said David Gonyer, R.Ph., President and CEO.  "We are planning to launch GIMOTI via our partner, EVERSANA, in the fourth quarter and are continuing to execute on essential pre-commercialization activities. The partnership with EVERSANA has allowed us avoid significant capital investment by leveraging their infrastructure, expertise and financial resources for this product launch."

    About Evoke Pharma, Inc.

    Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The Company developed GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults.

    Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious GI symptoms as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Prior to FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations and remains the only drug currently approved in the United States to treat gastroparesis. Visit www.EvokePharma.com for more information.

    Safe Harbor Statement

    Evoke 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. These forward-looking statements include statements regarding: the timing of the commercial launch of GIMOTI and commercial activities to be conducted by EVERSANA; the size of the gastroparesis market and the potential of GIMOTI to provide an important new alternative to current treatment options; and Evoke's projected cash runway and potential to continue to access the EVERSANA line of credit.  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's and EVERSANA's ability to successfully launch and drive market demand for GIMOTI and the timing thereof; Evoke's ability to obtain additional financing as needed to support its operations, including through the EVERSANA line of credit which is subject  to certain customary conditions; the COVID-19 pandemic may disrupt Evoke's and EVERSANA's business operations impairing the ability to commercialize GIMOTI and  Evoke's ability to generate any product revenue; Evoke's dependence on third parties for the manufacture of GIMOTI; Evoke is entirely dependent on the success of GIMOTI; inadequate efficacy or unexpected adverse side effects relating to GIMOTI that could delay or prevent commercialization, or that could result in recalls or product liability claims; our ability to obtain and maintain intellectual property protection for GIMOTI; and other risks detailed in Evoke's prior press releases and in the periodic reports it files with the Securities and Exchange Commission. 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.

    Investor Contact: 

    The Ruth Group

    Tram Bui

    Tel: 646-536-7035

    Primary Logo

    View Full Article Hide Full Article
  4. Commercial Partner EVERSANA Prepares for GIMOTI Launch
    Evoke Extends Cash Runway into 2021

    SOLANA BEACH, Calif., June 19, 2020 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for GIMOTI™ (metoclopramide) nasal spray, the first and only nasally-administered product indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.

    "We are extremely pleased to have received FDA approval to commercially market GIMOTI in the United States. This approval represents the first novel pharmaceutical treatment for gastroparesis…

    Commercial Partner EVERSANA Prepares for GIMOTI Launch

    Evoke Extends Cash Runway into 2021

    SOLANA BEACH, Calif., June 19, 2020 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for GIMOTI™ (metoclopramide) nasal spray, the first and only nasally-administered product indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.

    "We are extremely pleased to have received FDA approval to commercially market GIMOTI in the United States. This approval represents the first novel pharmaceutical treatment for gastroparesis in several decades. Many times, patients do not experience adequate relief of their gastroparesis symptoms from current treatments, representing a significant need for a new approach to therapy. We are excited to be able to offer health care providers and their patients a unique non-oral treatment option to relieve symptoms and help improve their quality of life," said David Gonyer, R.Ph., President and CEO.

    "Patients with gastroparesis suffer from characteristic symptoms such as nausea, abdominal pain, bloating, early satiety as well as vomiting which can be severe and debilitating. These patients often have erratic absorption of orally administered drugs due to delayed gastric emptying," stated Henry Parkman, MD, Stanley H. Lorber Research Endowment Fund and Chair, and Director, Gastroenterology Motility Laboratory, School of Medicine at Temple University. "Unlike oral medications, GIMOTI is administered nasally, bypassing the diseased GI track, allowing the drug to enter the bloodstream directly and therefore may provide predictable delivery of the therapy."

    "Together with our partner EVERSANA, we are now fully focused on executing our commercialization strategy for GIMOTI by leveraging EVERSANA's integrated suite of capabilities and highly experienced sales and marketing team," continued David Gonyer, R.Ph. "We anticipate initiating commercial sales in the fourth quarter of 2020." 

    The FDA approval of GIMOTI allows Evoke to access its existing $5 million line of credit from EVERSANA to support manufacturing and other aspects of GIMOTI's commercialization. As of May 31, 2020, the Company's cash and cash equivalents were approximately $4.7 million. Evoke believes, based on its current operating plan, that its cash and cash equivalents, together with the EVERSANA line of credit, will support the company's operations into 2021, without consideration of potential GIMOTI revenue.

    About GIMOTI™ (metoclopramide) nasal spray

    GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.

    Important Safety Information

    WARNING: TARDIVE DYSKINESIA

    • Metoclopramide can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. The risk of developing TD increases with duration of treatment and total cumulative dosage.
    • Discontinue GIMOTI in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after metoclopramide is stopped.
    • Avoid treatment with metoclopramide (all dosage forms and routes of administration) for longer than 12 weeks because of the increased risk of developing TD with longer-term use.

    GIMOTI is not recommended for use in:

    • Pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates.
    • Moderate or severe hepatic impairment (Child‑Pugh B or C), moderate or severe renal impairment (creatinine clearance less than 60 mL/minute), and patients concurrently using strong CYP2D6 inhibitors due to the risk of increased drug exposure and adverse reactions.

    GIMOTI is contraindicated:

    • In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide.
    • When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation).
    • In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor.
    • In patients with epilepsy. Metoclopramide may increase the frequency and severity of seizures.
    • In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm.

    Potential adverse reactions associated with metoclopramide include:  Tardive dyskinesia (TD), other extrapyramidal effects (EPS), parkinsonism symptoms, motor restlessness, neuroleptic malignant syndrome (NMS), depression, suicidal ideation and suicide, hypertension, fluid retention, hyperprolactinemia, effects on the ability to drive and operate machinery.

    Most common adverse reactions (≥5%) for GIMOTI are: dysgeusia, headache, and fatigue. 

    These are not all of the possible side effects of GIMOTI. Call your doctor for medical advice about whether you should take GIMOTI and the possible risk factors and side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

    About Evoke Pharma, Inc.

    Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The Company developed GIMOTI, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults.

    Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious GI symptoms as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Prior to FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations and remains the only drug currently approved in the United States to treat gastroparesis. Visit www.EvokePharma.com for more information.

    Safe Harbor Statement

    Evoke 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. These forward-looking statements include statements regarding: the timing of the commercial launch of GIMOTI and commercial activities to be conducted by EVERSANA; the size of the gastroparesis market and the potential of GIMOTI to provide an important new alternative to current treatment options; and Evoke's projected cash runway and potential to access the EVERSANA line of credit.  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's and EVERSANA's ability to successfully launch and drive market demand for GIMOTI and the timing thereof; Evoke's ability to obtain additional financing as needed to support its operations, including through the EVERSANA line of credit which is subject to certain customary conditions; the COVID-19 pandemic may disrupt Evoke's and EVERSANA's business operations impairing the ability to commercialize GIMOTI and Evoke's ability to generate any product revenue; Evoke's dependence on third parties for the manufacture of GIMOTI; Evoke is entirely dependent on the success of GIMOTI; inadequate efficacy or unexpected adverse side effects relating to GIMOTI that could delay or prevent commercialization, or that could result in recalls or product liability claims; our ability to obtain and maintain intellectual property protection for GIMOTI; and other risks detailed in Evoke's prior press releases and in the periodic reports it files with the Securities and Exchange Commission. 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.

    Investor Contact:

    The Ruth Group

    Tram Bui

    Tel: 646-536-7035

    Primary Logo

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  5. SOLANA BEACH, Calif., May 20, 2020 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proprietary brand name, "Gimoti," for the Company's nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis as resubmitted in the 505(b)(2) New Drug Application (NDA).

    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…

    SOLANA BEACH, Calif., May 20, 2020 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proprietary brand name, "Gimoti," for the Company's nasal spray product candidate for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis as resubmitted in the 505(b)(2) New Drug Application (NDA).

    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.

    "Receipt of conditional proprietary brand name approval further supports our commercialization strategy," said Dave Gonyer, R.Ph., President and CEO. "Gimoti's nasal spray delivery is designed to facilitate drug absorption by allowing Gimoti to bypass the dysfunctional GI track in patients with this disease. We continue to believe Gimoti, if approved, will provide an important new product that has the potential to help treat patients suffering from gastroparesis."

    About Evoke Pharma, Inc.

    Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The Company is developing Gimoti, a nasal spray formulation of metoclopramide, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women.

    Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which the stomach takes too long to empty its contents resulting in serious GI symptoms as well as other systemic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. Metoclopramide is currently available only in oral and injectable formulations and is the only drug currently approved in the United States to treat gastroparesis. Visit www.EvokePharma.com for more information.

    Safe Harbor Statement

    Evoke 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. These forward-looking statements include statements regarding: whether conditional proprietary brand name approval will support Evoke's commercialization strategy, if Gimoti is approved; and potential FDA approval of the Gimoti NDA.  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: the FDA may not approve the Gimoti NDA or give final approval of the Gimoti brand name; the potential for the FDA to delay the PDUFA target goal date due to the FDA's internal resource constraints or other reasons; FDA may not agree with Evoke's conclusion of the results from the manufacturing testing or the root cause analysis Evoke provided to address the deficiencies raised in the Complete Response Letter (CRL) regarding Gimoti; the FDA may require Evoke to conduct additional studies; the inherent risks of clinical development and regulatory approval of Gimoti; Evoke's dependence on third parties for the manufacture of Gimoti and analysis of the manufacturing data; Evoke is entirely dependent on the success of Gimoti; Evoke will require substantial additional funding to continue its operations into the second quarter of 2020, and may be unable to raise capital or obtain funds when needed, including to fund ongoing operations; Evoke could face significant additional costs due to litigation or other events; and other risks detailed in Evoke's prior press releases and in the periodic reports it files with the Securities and Exchange Commission. 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.

    Investor Contact:
    The Ruth Group
    Tram Bui
    Tel: 646-536-7035

     

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