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Form 8-K

sec.gov

8-K — Milestone Pharmaceuticals Inc.

Accession: 0001104659-26-094466

Filed: 2026-08-12

Period: 2026-08-12

CIK: 0001408443

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — tm2614433d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2614433d1_ex99-1.htm)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):

August 12, 2026

MILESTONE

PHARMACEUTICALS INC.

(Exact name of registrant as specified in its

charter)

Québec

001-38899

Not

applicable

(state or other jurisdiction of incorporation)

(Commission File Number)

(I.R.S. Employer Identification No.)

1111

Dr. Frederik-Philips Boulevard,

Suite

420

Montréal,

Québec CA

H4M

2X6

(Address of principal executive offices)

(Zip Code)

Registrant's telephone number, including area

code: (514)

336-0444

(Former

name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K

filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General

Instruction A.2. below):

¨ Written

communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting

material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement

communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement

communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b)

of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which

registered

Common

Shares

MIST

The

Nasdaq Stock Market LLC

Indicate by check mark

whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§ 230.405

of this chapter) or Rule 12b–2 of the Securities Exchange Act of 1934 (§ 240.12b–2 of this chapter).

Emerging growth company

¨

If an emerging growth

company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or

revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 2.02.

Results of Operations and Financial Condition.

On August 12, 2026, Milestone Pharmaceuticals

Inc. issued a press release announcing its financial results for the second quarter ended June 30, 2026 and other business highlights.

A copy of the press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.

The information provided in this Item 2.02, including

Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended

(the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference

in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in

such filing.

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits.

Exhibit

No.

Description

99.1

Press Release, dated August 12, 2026

104

Cover Page Interactive Data File--the cover page XBRL tags are embedded within the Inline XBRL document

SIGNATURES

Pursuant to the requirements

of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto

duly authorized.

MILESTONE PHARMACEUTICALS INC.

By:

/s/Amit Hasija

Amit Hasija

Chief Financial Officer

Dated: August 12, 2026

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2614433d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Milestone Pharmaceuticals Announces Second

Quarter 2026 Financial Results and Provides Corporate Update

Over 50%

of commercially insured lives in the U.S., representing a recent and significant increase, now have coverage for CARDAMYST®

(etripamil) nasal spray

Phase 3 registrational trial of

etripamil for atrial fibrillation with rapid ventricular rate (AFib-RVR) first clinical sites activated, advancing Milestone’s

potential, second cardiovascular indication

$170.6 million in cash, cash equivalents and short-term

investments as of June 30, 2026, provides runway into H2 2027

Company to host investor call and webcast at 8:30am

ET today

MONTREAL and CHARLOTTE,

N.C., August 12, 2026 – Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical

company focused on the development and commercialization of innovative cardiovascular medicines, today announced financial results for

the second quarter ended June 30, 2026, and provided corporate and regulatory updates.

“We continue to make steady progress on

the launch of CARDAMYST for PSVT supported by prescription growth from a widening base of new prescribers and a meaningful recent increase

in insurance coverage. We are confident that this increased coverage paired with optimized sales and marketing strategies positions us

to drive acceleration of CARDAMYST prescriptions moving forward,” said Joseph Oliveto, President and Chief Executive Officer of

Milestone Pharmaceuticals. “Separately, we have activated several sites in our Phase 3 ReVeRA-301 trial in AFib-RVR and look forward

to enrolling the first patient. AFib-RVR is one of the most common heart arrhythmias, affecting millions of Americans. The trial is evaluating

the same self-administered regimen already approved in PSVT, giving us a clear path toward extending etripamil to a larger, adjacent patient

population.”

Launch Progress for CARDAMYST

CARDAMYST®

(etripamil) nasal spray was launched for paroxysmal supraventricular tachycardia (PSVT) in mid-February 2026.

· More than 800 unique prescribers have

started patients on CARDAMYST through June 30, compared to approximately 200 at the

end of Q1.

· More than 1,500 scripts for CARDAMYST

have been filled for more than 1,300 patients with PSVT through June 30, 2026, compared

to approximately 300 scripts for 300 patients at the end of Q1.

·

Commercial

lives covered remained relatively unchanged through Q2 at approximately 25%; however, covered lives have significantly grown to approximately

50% to date as a result of recently reported formulary coverage for CARDAMYST from UnitedHealthcare and several other prominent commercial

insurers.

· CARDAMYST

has been nominated for the 2026 Prix Galien USA Awards for “Best Pharmaceutical Product.”

Regulatory and Clinical Updates

Regulatory review of the marketing

authorization application for etripamil for PSVT in Europe remains on track for a decision from the European Medicines Agency (EMA) in

the first half of 2027. The New Drug Application for etripamil for PSVT in China is currently under review by China’s National

Medical Products Administration (NMPA). Our partner, Everest Medicines, is responsible for engagement with the NMPA for the program.

Two new articles have been published in the peer-reviewed

Journal of the American College of Cardiology: Advances, supporting the efficacy, safety and emerging role of CARDAMYST for the

management of PSVT.

· Paroxysmal

Supraventricular Tachycardia Treatment: Evaluating the Evidence for Established and Newly

Approved Options, a summarization of the current acute PSVT treatment landscape, that

includes the limitations of existing management approaches and the emerging role of etripamil

nasal spray as an acute, self-administered option for outside of the healthcare setting.

· Minimal

Blood Pressure Effects of Intranasal Etripamil for Paroxysmal Supraventricular Tachycardia,

an analysis showing that intranasal etripamil has minimal blood pressure effects, with hypotension

and syncope occurring rarely across more than 1,600 clinical trial participants.

Additionally, “The

Impact of Paroxysmal Supraventricular Tachycardia on Patients’ Daily Life and Quality of Life Between Episodes,” an analysis

which demonstrates the substantial burden between PSVT episodes, PSVT patients’ quality of life and full participation in daily

activities, will be presented at the upcoming European Society of Cardiology (ESC) Congress, August 28-31, 2026.

Phase

3 registrational trial in atrial fibrillation with rapid ventricular rate (AFib-RVR) is now

open and enrolling patients. The ReVeRA-301 Phase 3 registrational trial evaluating self-administered

etripamil as a potential treatment for patients with AFib-RVR is now open, with several sites activated and evaluating patients for enrollment.

Previously announced plans to enroll the first patient in the second half of 2026 remain on track. The Company intends to follow the supplemental

New Drug Application (sNDA) regulatory approval pathway and expects to leverage the initial PSVT indication and its safety database along

with the results from the planned Phase 3 study in AFib-RVR.

Second Quarter 2026 Financial Results

As of June 30, 2026, Milestone had cash,

cash equivalents, and short-term investments of $170.6 million, compared to $106.0 million as of December 31, 2025. The Company

currently expects its cash, cash equivalents and short-term investments to be sufficient to cover operating expenses and capital expenditure

into the second half of 2027.

Product revenues were $0.6 during the three months

ended June 30, 2026. There was no product revenue during the three months ended June 30, 2025. For the six months ended June 30,

2026, product revenues were $0.8 million. There was no product revenue during the six months ended June 30, 2025.

Research and development expense for the three

months ended June 30, 2026, was $3.5 million, compared with $3.7 million for the prior year period. For the six months ended June 30,

2026, research and development expense was $6.8 million, compared with $8.6 million for the same period in 2025. The decrease was a result

of a decrease in outside service costs related to drug development and research.

Selling, general and administrative expense for

the three months ended June 30, 2026, was $22.6 million, compared with $8.9 million for the prior year period. For the six months

ended June 30, 2026, selling, general and administrative expense was $43.3 million, compared with $24.4 million for the same period

in 2025. The increase was a result of additional personnel costs, professional costs, and other operational expenses related to the launch

of CARDAMYST.

For the three months ended June 30, 2026,

net loss was $28.6 million or $0.21 per share, compared to a net loss of $13.0 million or $0.20 per share for the prior year period.

For the six months ended June 30, 2026, net loss was $54.7 million, or $0.41 per share, compared with $33.7 million, or $0.51 per

share, for the same period in 2025.

For further details on the Company’s financials,

refer to the Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the U.S. Securities and Exchange

Commission (SEC) today.

Conference Call and Webcast Details

Conference Dial-in:

1-877-407-0792

International Dial-in:

1-201-689-8263

Conference ID:

13761073

Webcast link:

click here

CallMe™ link:

https://callme.viavid.com/viavid/?callme=true&passcode=13756738&h=true&info=company-email&r=true&B=6

CallMe™: Participants can use guest dial-in

numbers above and be answered by an operator OR click the CallMe™ link for instant telephone access to the event. The CallMe™

link will be made active 15 minutes prior to scheduled start time.

A replay of the audio webcast of the call will

be available under the “Investors and Media” section of Milestone’s corporate website, www.milestonepharma.com.

About CARDAMYST

CARDAMYST®

(etripamil) nasal spray is approved by the U.S. Food and Drug Administration (FDA) for the conversion of acute symptomatic

episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. It is a novel calcium channel blocker nasal spray

designed as a self-administered rapid response therapy for patients, thereby bypassing the need for immediate medical oversight. The

product is intended to provide health care providers with a new treatment option to enable on-demand care and patient self-management.

This portable treatment may provide patients with active management and a greater sense of control over their condition. CARDAMYST is

well studied with a robust clinical trial program that includes a completed Phase 3 clinical-stage program for the treatment of PSVT.

Currently, etripamil is in Phase 2 development for treatment of PSVT in pediatric patients and Phase 3 development for control of acute

atrial fibrillation with rapid ventricular rate (AFib-RVR) in adults. For more information, please visit CARDAMYST.com.

Indication

CARDAMYST

is indicated for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.

IMPORTANT SAFETY INFORMATION FOR CARDAMYST

(etripamil)

What is CARDAMYST?

CARDAMYST

is a prescription medicine used to help restore normal sinus heart rhythm in adults who have symptoms of sudden episodes of fast heartbeat

called paroxysmal supraventricular tachycardia (PSVT).

It is not known if CARDAMYST is safe and effective

in children.

Do not use CARDAMYST if you:

· are

allergic to CARDAMYST or any of its ingredients. See the Patient Information for a complete

list of ingredients in CARDAMYST.

· have

limitations in activities due to heart failure (moderate to severe heart failure).

· have

Wolff-Parkinson-White (WPW) syndrome, Lown-Ganong-Levine syndrome, or an abnormal heart rhythm

pattern called pre-excitation (delta wave) on an electrocardiogram (ECG).

· have

sick sinus syndrome without a permanent pacemaker.

· have

second degree or higher atrioventricular (AV) block.

Before using CARDAMYST, tell your healthcare

provider about all of your medical conditions, including if you:

· have

a history of fainting.

· have

low blood pressure.

· are

pregnant or plan to become pregnant. It is not known if CARDAMYST will harm your unborn baby.

· are

breastfeeding or plan to breastfeed. It is not known if CARDAMYST passes into your breast

milk. You should stop breastfeeding for 12 hours after treatment with CARDAMYST. During this

time, pump and throw away your breast milk. Talk to your healthcare provider about the best

way to feed your baby after using CARDAMYST.

Tell your healthcare

provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of CARDAMYST?

CARDAMYST may cause serious side effects,

including:

· Fainting

due to CARDAMYST effects on blood pressure, heart rate, and electrical activity of the heart. CARDAMYST

may cause dizziness and fainting, especially in people with a history of fainting and certain

heart problems, or people with a history of fainting during an episode of PSVT. Use CARDAMYST

while sitting in a safe area where you will not fall if you become dizzy or lightheaded.

Lie down if you feel dizzy or lightheaded after using CARDAMYST. If fainting occurs after

using CARDAMYST, caregivers should place you on your back and seek medical help.

The most common side effects of CARDAMYST

include:

·

nasal discomfort

·

nasal congestion

·

runny nose

·

throat irritation

·

nosebleed

These are not all of the possible side effects for CARDAMYST.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see the full Prescribing Information

https://milestonepharma.com/etripamilprescribinginformation.pdf for

CARDAMYST.

About Milestone Pharmaceuticals

Milestone Pharmaceuticals

Inc. (Nasdaq: MIST) is an emerging commercial-stage biopharmaceutical company advancing innovative cardiovascular medicines to benefit

people living with certain heart conditions. Milestone’s lead product is CARDAMYST® (etripamil) nasal spray, a novel calcium

channel blocker, which is FDA-approved for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT)

to sinus rhythm in adults. Etripamil is also in Phase 3 development for the control of symptomatic episodic attacks associated with AFib-RVR.

https://milestonepharma.com/

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking

statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “continue,”

“could,” “demonstrate,” “designed,” “develop,” “estimate,” “expect,”

“may,” “pending,” “plan,” “potential,” “progress,” “will,” “intend”

and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended

to identify forward-looking statements. These forward-looking statements are based on Milestone’s expectations and assumptions

as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ

materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding:

the commercialization and adoption of CARDAMYST; the timing and outcomes of future interactions with U.S. and foreign regulatory

bodies, including the FDA, EMA and NMPA; the expected timing of initiation, completion, and results and data of Milestone’s ongoing

and planned clinical studies, including the Phase 3 study in AFib-RVR; Milestone’s anticipated cash runway; and other statements

not related to historical facts. Important factors that could cause actual results to differ materially from those in the forward-looking

statements include, but are not limited to whether Milestone’s future interactions with the EMA will have satisfactory outcomes;

whether and when, if at all, Milestone’s MMA for etripamil will be approved by the EMA; uncertainties related to the timing of

initiation, enrollment, completion, evaluation and results of Milestone’s clinical trials; risks and uncertainty related to the

complexity inherent in cleaning, verifying and analyzing trial data; and whether the clinical trials will validate the safety and efficacy

of etripamil for PSVT or other indications, among others, general economic, political, and market conditions, including deteriorating

market conditions due to investor concerns regarding inflation, international tariffs and conflicts, and overall fluctuations in

the financial markets in the United States and abroad, risks related to pandemics and public health emergencies, and risks

related the sufficiency of Milestone’s capital resources and its ability to raise additional capital in the current economic climate.

These and other risks are set forth in Milestone’s filings with the SEC, including in its annual report on Form 10-K for the

year ended December 31, 2025, under the caption “Risk Factors,” as such discussions may be updated from time

to time by subsequent filings Milestone may make with the SEC. Except as required by law, Milestone assumes no obligation to update

any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

# # #

Contact:

Investor Relations

Kevin Gardner, kgardner@lifesciadvisors.com

Media Relations

Rebecca Novak, rnovak@milestonepharma.com

Milestone Pharmaceuticals Inc.

Condensed Consolidated Balance Sheets (Unaudited)

(in thousands of U.S. dollars, except share

data)

June 30, 2026

December 31, 2025

Assets

Current assets

Cash and cash equivalents

$ 169,728

$ 73,046

Short-term investments

881

32,914

Accounts receivable, net

2,720

License receivable

1,546

Research and development tax credits receivable

515

316

Prepaid expenses

1,035

1,805

Inventory, net

4,722

648

Other receivables

726

1,646

Total current assets

180,327

111,921

Operating lease right-of-use assets

829

1,129

Property and equipment, net

469

511

Total assets

$ 181,625

$ 113,561

Liabilities, and Shareholders' Equity

Current liabilities

Accounts payable

$ 8,454

$ 5,645

Accrued liabilities

11,983

7,644

Operating lease liabilities

670

647

Deferred revenue

1,034

Other current liabilities

43

43

Total current liabilities

22,184

13,979

Operating lease liabilities, net of current portion

192

539

Senior secured convertible notes

59,207

57,191

Royalty financing obligation, long-term

81,763

Other long-term liabilities

61

83

Total liabilities

163,407

71,792

Shareholders’ Equity

Common shares, no par value, unlimited shares authorized, 124,497,980 shares issued and outstanding as of June 30, 2026, 106,236,344 shares issued and outstanding as of December 31, 2025

384,985

352,619

Pre-funded warrants - 16,412,925 issued and outstanding as of June 30, 2026, and 16,412,925 as of December 31, 2025

55,649

55,649

Additional paid-in capital

62,867

64,104

Accumulated deficit

(485,283 )

(430,603 )

Total shareholders’ equity

18,218

41,769

Total liabilities and shareholders’ equity

$ 181,625

$ 113,561

Milestone Pharmaceuticals Inc.

Condensed Consolidated Statements of Loss (Unaudited)

(in thousands of U.S. dollars, except share

and per share data)

Three months ended June 30,

Six months ended June 30,

2026

2025

2026

2025

Revenues

Product revenue, net

$ 559

$ —

$ 797

$ —

License and other revenue

Total revenues

559

797

Operating Expenses

Cost of product sales

32

46

Research and development, net of tax credits

3,509

3,669

6,760

8,647

Selling, general and administrative

22,648

8,862

43,284

24,407

Total operating expenses

26,189

12,531

50,090

33,054

Loss from operations

(25,630 )

(12,531 )

(49,293 )

(33,054 )

Interest income

1,741

516

3,473

1,213

Interest expense

(4,725 )

(951 )

(8,860 )

(1,886 )

Net loss and comprehensive loss

$ (28,614 )

$ (12,966 )

$ (54,680 )

$ (33,727 )

Weighted average number of shares and pre-funded warrants outstanding, basic and diluted

138,691,580

66,380,118

134,512,026

66,333,024

Net loss per share, basic and diluted

$ (0.21 )

$ (0.20 )

$ (0.41 )

$ (0.51 )

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- Definition

Two-character EDGAR code representing the state or country of incorporation.

+ References

No definition available.

+ Details

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dei_EntityIncorporationStateCountryCode

Namespace Prefix:

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Data Type:

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Period Type:

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- Definition

The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

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dei_EntityRegistrantName

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- Definition

The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

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Name:

dei_EntityTaxIdentificationNumber

Namespace Prefix:

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Data Type:

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Period Type:

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- Definition

Local phone number for entity.

+ References

No definition available.

+ Details

Name:

dei_LocalPhoneNumber

Namespace Prefix:

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Data Type:

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Balance Type:

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Period Type:

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

+ Details

Name:

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Namespace Prefix:

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Data Type:

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Balance Type:

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Period Type:

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

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Namespace Prefix:

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Data Type:

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- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

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Data Type:

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Balance Type:

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Period Type:

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- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

Name:

dei_SecurityExchangeName

Namespace Prefix:

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Data Type:

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Balance Type:

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Period Type:

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

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Namespace Prefix:

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Data Type:

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Balance Type:

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Period Type:

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- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

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Data Type:

dei:tradingSymbolItemType

Balance Type:

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Period Type:

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

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