Evoke Pharma to Report Fourth Quarter and Full Year 2023 Results on March 14, 2024
March 07 2024 - 4:10PM
Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical
company focused on treatments for gastrointestinal (GI) diseases
with an emphasis on Gimoti® (metoclopramide) nasal spray, today
announced that the Company is scheduled to release its fourth
quarter and full year 2023 on Thursday, March 14, 2024, after the
market closes.
Management will host a conference call and webcast with
accompanying slides on Thursday, March 14, 2024, at 4:30 p.m. ET to
discuss the results. The dial-in numbers for the conference call
are (800) 267-6316 and (203) 518-9783 for international callers.
The conference ID number is EVOKQ423.
The webcast details can be found in the events section of
Evoke’s investor relations page.
In addition, a telephonic replay of the call will be available
until March 21, 2024. The replay dial-in numbers are (888) 562-3381
for domestic callers and (402) 220-1189 for international
callers.
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, commercialized and markets 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. Visitwww.EvokePharma.com for more information.
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About Gimoti® (metoclopramide) nasal spray
GIMOTI is indicated for the relief of symptoms in adults with
acute and recurrent diabetic gastroparesis. Important Safety
InformationWARNING: 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.
Safe Harbor StatementEvoke 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: potential
future prescribing trends for GIMOTI based on Evoke’s or EVERSANA’s
marketing efforts; Evoke’s commercialization plans, including its
plans to increase awareness of and access to GIMOTI; and Evoke’s
future capital requirements. 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 drive
market demand for GIMOTI; Evoke’s ability to obtain additional
financing as needed to support its operations; the COVID-19
pandemic may continue to disrupt Evoke’s and EVERSANA’s business
operations impairing the ability to commercialize GIMOTI and
Evoke’s ability to generate 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
result in recalls or product liability claims; Evoke’s ability to
maintain intellectual property protection for GIMOTI; and other
risks and uncertainties 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 & Media Contact:Daniel
Kontoh-Boateng DKB PartnersTel:
862-213-1398dboateng@dkbpartners.net
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