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Form 8-K

sec.gov

8-K — CITIUS ONCOLOGY, INC.

Accession: 0001213900-26-090182

Filed: 2026-08-14

Period: 2026-08-14

CIK: 0001851484

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — ea0302226-8k_citius.htm (Primary)

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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 14, 2026

Citius Oncology, Inc.

(Exact name of registrant as specified in its charter)

Delaware

(State or other jurisdiction of incorporation)

001-41534

99-4362660

(Commission File Number)

(IRS Employer

Identification No.)

11 Commerce Drive, 1st Floor, Cranford, NJ

07016

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including

area code (908) 967-6677

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:

☐ 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 Stock

CTOR

The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth

company 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 14, 2026, Citius Oncology, Inc. issued

a press release announcing our results of operations for the third quarter of fiscal 2026. A copy of the press release is furnished as

Exhibit 99.1 to this report and is incorporated herein by reference.

The information in this

Item 2.02 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of

1934 (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 or the Exchange Act, except as expressly set forth by specific reference in such

a filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

Description

99.1

Press release, dated August 14, 2026.

104

Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL).

1

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.

CITIUS ONCOLOGY, INC.

Date: August 14, 2026

/s/ Leonard Mazur

Leonard Mazur

Chairman and Chief Executive Officer

2

EX-99.1 — PRESS RELEASE, DATED AUGUST 14, 2026

EX-99.1

Filename: ea030222601ex99-1.htm · Sequence: 2

Exhibit 99.1

Citius

Oncology, Inc. Reports Fiscal Third Quarter 2026 Financial Results and Provides Business Update

$7.1

million in revenue for the first nine months of fiscal 2026 as the LYMPHIR® launch progresses

Strong

institutional demand drives growth in total vials ordered and number of institutions ordering

LYMPHIR

ordered by 44 institutions since launch

CRANFORD,

N.J., August 14, 2026 /PRNewswire/ -- Citius Oncology, Inc. (“Citius Oncology” or the “Company”) (Nasdaq:

CTOR), an oncology-focused biopharmaceutical company and majority-owned subsidiary of Citius Pharmaceuticals, Inc. (“Citius Pharma”)

(Nasdaq: CTXR), today reported financial results for the fiscal third quarter ended June 30, 2026, and provided a business update.

“Institutional

demand (LYMPHIR vials ordered by prescribing centers from wholesalers) is accelerating. Institutional vial orders grew 31% sequentially,

from 708 in the quarter ended March 31, 2026 to 926 in the quarter ended June 30, 2026. In July, institutions ordered 383 vials from

wholesalers, the largest order month to date, reflecting a 25% increase over the prior quarter’s monthly average order. Currently,

44 institutions have prescribed and ordered LYMPHIR,” said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology.

“We

expect continued institutional demand to drive new wholesaler orders. The Company recognizes revenue when wholesaler orders are fulfilled.

Consequently, net revenue for any period reflects actual wholesaler orders fulfilled. In July, we began to see growth in institutional

demand translate into increased wholesale orders and associated revenue. The positive trajectory of formulary approvals, institutional

adoption, and unit demand gives us confidence in a robust remainder of the fiscal year,” added Mazur.

“We

generated initial momentum with a lean internal team, maintaining healthy product margins and securing broad market access. In August,

our full 29-person-strong commercial and medical affairs organizations expanded to nationwide coverage. The teams are now positioned

to accelerate commercial execution and support broader adoption by leveraging the comprehensive, scalable infrastructure already established

for LYMPHIR, including patient hub services, marketing and reimbursement support. Citius Oncology is now well positioned to broaden engagement

with treatment centers, targeting formulary inclusion at 100 priority institutions by year-end and first-in-class support for health

care providers. At the same time, we continue to advance LYMPHIR’s longer-term value proposition through investigator-initiated

studies exploring its potential in combination regimens beyond CTCL,” added Mazur.

“Overall,

the launch is moving in the right direction: more institutions are ordering LYMPHIR, vial demand is increasing, and our commercial footprint

is expanding. We believe the underlying increasing demand trends provide a strong basis for the remainder of fiscal 2026,” concluded

Mazur.

Fiscal

Third Quarter 2026 Business Highlights and Subsequent Developments

● Secured

prescriptions and orders from 44 institutions for LYMPHIR® (denileukin diftitox-cxdl), including academic oncology centers, leading

National Comprehensive Cancer Network (NCCN) institutions, and community infusion centers;

● Increased

the number of new ordering institutions by 80% in the quarter ended June 30, 2026, compared to the quarter ended March 31, 2026;

● Grew

the number of vials ordered by institutions from wholesalers by 31% in the quarter ended June 30, 2026, compared to the quarter ended

March 31, 2026, with 383 institutional vials ordered in July 2026, the largest vial order month to date;

● Secured

near-universal payer coverage, with no reimbursement denials or prior authorization barriers reported to date;

● Expanded

the commercial organization by 21 additional field-based professionals and added eight medical science liaisons, executed by the Company’s

exclusive commercialization partner, EVERSANA;

● Engaged

U.S. and international CTCL key opinion leaders at the Sixth World Congress of Cutaneous Lymphomas in Montreal through scientific exchange

and educational initiatives;

● Advanced

two investigator-initiated Phase 1 studies of LYMPHIR in combination settings:

○ Phase

1 data for LYMPHIR with pembrolizumab in recurrent or refractory gynecologic cancers presented at the 2026 American Society of Clinical

Oncology (ASCO) Annual Meeting, demonstrating:

- 20.5

months of median progression-free survival among 48% of efficacy-evaluable patients achieving clinical benefit (10 of 21),

- Responses

observed in patients previously treated with immune checkpoint inhibitors, including a 24% objective response rate (ORR) overall, and

33% ORR in patients with relapsed or refractory endometrial cancer; and,

○ Phase

1 data for LYMPHIR administered prior to CAR-T therapy in high-risk relapsed or refractory diffuse large B-cell lymphoma (DLBCL) presented

at 2026 ASTCT® & CIBMTR® Tandem Meetings, demonstrating:

- 86%

ORR, including 57% complete response (CR) and 29% partial response (PR),

- LYMPHIR

was well-tolerated with no dose-limiting toxicities observed; and,

● Appointed

Jonathan Peri, Ph.D., J.D., as an independent director on August 10, 2026, bringing three decades of leadership experience across law,

financial services and corporate governance.

2

Fiscal

Third Quarter 2026 Financial Highlights and Subsequent Developments

● Cash

and cash equivalents of $16.6 million as of June 30, 2026;

● Received

approximately $9.7 million in net proceeds from the exercise of certain warrants and funded $10.0 million under the first tranche of

a senior secured term loan facility of up to $25.0 million;

● Revenues

of $1.5 million for the three months ended June 30, 2026, compared to no revenue for the three months ended June 30, 2025; and $7.1 million

for the nine months ended June 30, 2026, compared to no revenue for the nine months ended June 30, 2025;

● Gross

profit of $1.0 million for the three months ended June 30, 2026, and $5.5 million for the nine months ended June 30, 2026;

● Research

and development (R&D) expenses of $0.2 million for the three months ended June 30, 2026, compared to $0.9 million for the prior-year

quarter; and $2.3 million for the nine months ended June 30, 2026, compared to $5.3 million for the prior-year period;

● General

and administrative (G&A) expenses of $4.2 million for the three months ended June 30, 2026, compared to $1.9 million for the prior-year

quarter, reflecting the expansion of the commercial organization; nine-month G&A of $30.7 million included a $19.7 million one-time

CMO contract cancellation charge recognized in the second fiscal quarter in connection with a notice of termination; and,

● Net

loss of $8.9 million, or $(0.08) per share, for the three months ended June 30, 2026, compared to $5.4 million, or $(0.08) per share,

for the prior-year quarter; and $41.1 million, or $(0.42) per share, for the nine months ended June 30, 2026, compared to $19.8 million,

or $(0.28) per share, for the prior-year period.

About

LYMPHIR™ (denileukin diftitox-cxdl)

LYMPHIR

is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after

at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria

toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have

entered cells to inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl has demonstrated the ability to deplete

immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.

LYMPHIR was approved by the FDA and subsequently launched in the U.S. in December 2025.

About

Citius Oncology, Inc.

Citius

Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In December 2025, Citius

Oncology launched LYMPHIR, approved by the FDA for the treatment of adults with relapsed or refractory Stage I–III CTCL who had

had at least one prior systemic therapy. Management estimates the initial CTCL market for LYMPHIR currently exceeds $400 million, is

growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex

technology, trade secrets, and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further

support Citius Oncology’s competitive positioning. For more information, please visit www.citiusonc.com.

3

About

Citius Pharmaceuticals, Inc.

Citius

Pharmaceuticals, Inc. (Nasdaq: CTXR) is a biopharmaceutical company dedicated to the development and commercialization of first-in-class

critical care products. Citius Pharma owns approximately 62% of Citius Oncology. In December 2025, Citius Oncology launched LYMPHIR,

a targeted immunotherapy for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior

systemic therapy. Citius Pharma’s late-stage pipeline also includes Mino-Lok®, a catheter lock solution to salvage catheters

in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids.

A pivotal Phase 3 trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints

of its Phase 3 trial. Citius Pharma is actively engaged with the FDA to outline next steps for both programs. For more information, please

visit www.citiuspharma.com.

Forward-Looking

Statements

This

press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and

Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future

events impacting Citius Oncology. You can identify these statements by the fact that they use words such as “will,” “anticipate,”

“estimate,” “expect,” “plan,” “should,” and “may” and other words and terms

of similar meaning or use of future dates. Forward-looking statements are based on management’s current expectations and are subject

to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors

that could cause actual results to differ materially from those currently anticipated include: our need for substantial additional funds

and our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our ability to successfully

commercialize LYMPHIR and establish a sustainable revenue stream; our ability to regain compliance with Nasdaq’s continued listing

standards; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; physician and patient

acceptance of LYMPHIR in a competitive treatment landscape; our ability to obtain, perform under, and maintain third party agreements

and relationships, including obtaining a new bulk drug substance supplier; our reliance on third-party logistics providers, distributors,

and specialty pharmacies to support commercial operations; our ability to educate providers and payers, secure adequate reimbursement,

and maintain uninterrupted product supply; our ability to secure and maintain strategic partnerships and expand international access

to LYMPHIR; risks relating to the results of research and development activities; our ability to procure cGMP commercial-scale supply;

risks related to our growth strategy; patent and intellectual property matters; government regulation; as well as other risks described

in our Securities and Exchange Commission (“SEC”) filings. Accordingly, these forward-looking statements do not constitute

guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding

our business are described in detail in our SEC filings, which are available on the SEC’s website at www.sec.gov, including in

Citius Oncology’s Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025. These

forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly

any updates or revisions to any forward-looking statements contained herein, except as required by law.

Contacts

Investor

Contact:

Ilanit Allen

ir@citiuspharma.com

908-967-6677 x113

Media

Contact: STiR-communications

Greg Salsburg

greg@stir-communications.com

Financial Tables Follow –

4

CITIUS

ONCOLOGY, INC.

CONDENSED

CONSOLIDATED BALANCE SHEETS

(Unaudited)

June 30,

2026

September 30,

2025

Current Assets:

Cash and cash equivalents

$ 16,563,705

$         3,924,908

Accounts receivable, net of allowances

686,235

Inventory

22,625,945

22,286,693

Prepaid expenses

2,831,280

1,331,280

Total Current Assets

42,707,165

27,542,881

Other Assets:

In-process research and development, net of accumulated amortization

69,385,938

73,400,000

Total Assets

$ 112,093,103

$ 100,942,881

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current Liabilities:

Accounts payable

$ 7,315,516

$ 13,234,684

License payable

15,650,000

22,650,000

Accrued expenses

25,836,120

4,093,124

Due to related party

9,985,558

9,513,771

Total Current Liabilities

58,787,194

49,491,579

Notes payable, net of deferred financing costs

6,410,161

Deferred tax liability

2,710,643

2,784,960

Note payable to related party

3,800,111

3,800,111

Total Liabilities

71,708,109

56,076,650

Stockholders’ Equity:

Preferred stock - $0.0001 par value; 10,000,000 shares authorized: no shares issued and outstanding

Common stock - $0.0001 par value; 400,000,000 shares authorized at June 30, 2026 and September 30, 2025; 105,758,982 and 83,513,442 shares issued and outstanding at June 30, 2026 and September 30, 2025, respectively

10,576

8,351

Additional paid-in capital

145,481,984

108,897,836

Accumulated deficit

(105,107,566 )

(64,039,956 )

Total Stockholders’ Equity

40,384,994

44,866,231

Total Liabilities and Stockholders’ Equity

$ 112,093,103

$ 100,942,881

5

CITIUS

ONCOLOGY, INC.

CONDENSED

CONSOLIDATED STATEMENTS OF OPERATIONS

FOR

THE THREE AND Nine months Ended June 30, 2026 and 2025 (Unaudited)

Three Months Ended

Nine Months Ended

June 30,

June 30,

June 30,

June 30,

2026

2025

2026

2025

Revenues

$ 1,493,788

$ —

$ 7,105,197

$ —

Cost of revenues

(491,843 )

(1,609,929 )

Gross Profit

1,001,945

5,495,268

Operating Expenses

Research and development

218,496

938,277

2,316,202

5,342,198

Amortization of in-process research and development

1,720,312

4,014,062

General and administrative

4,219,163

1,881,447

30,704,141

7,446,753

Stock-based compensation – general and administrative

3,560,791

2,125,237

11,043,551

6,022,287

Total Operating Expenses

9,718,762

4,944,961

48,077,956

18,811,238

Operating Loss

(8,716,817 )

(4,944,961 )

(42,582,688 )

(18,811,238 )

Other Income (Expense)

Interest income

96,848

168,857

Gain on sale of New Jersey net operating losses

1,762,000

Amortization of deferred financing costs

(179,492 )

(179,492 )

Interest expense

(231,732 )

(160,755 )

(310,604 )

(160,755 )

Total Other Income (Expense), Net

(314,376 )

(160,755 )

1,440,761

(160,755 )

Loss before Income Taxes

(9,031,193 )

(5,105,716 )

(41,141,927 )

(18,971,993 )

Income tax expense (benefit)

(107,347 )

264,240

(74,317 )

792,720

Net Loss

$ (8,923,846 )

$ (5,369,956 )

$ (41,067,610 )

$ (19,764,713 )

Net Loss Per Share - Basic and Diluted

$ (0.08 )

$ (0.08 )

$ (0.42 )

$ (0.28 )

Weighted Average Common Shares Outstanding

Basic and diluted (includes pre-funded warrants from the December 2025 offering)

107,890,452

71,552,402

98,413,989

71,552,402

6

CITIUS

ONCOLOGY, INC.

Condensed

Consolidated STATEMENTS OF CASH FLOWS

FOR

THE Nine months Ended June 30, 2026 and 2025

(Unaudited)

2026

2025

Cash Flows From Operating Activities:

Net loss

$ (41,067,610 )

$ (19,764,713 )

Adjustments to reconcile net loss to net cash used in operating activities:

Stock-based compensation expense

11,043,551

6,022,287

Amortization of in-process research and development

4,014,062

-

Amortization of deferred financing costs

179,492

-

Deferred income tax expense

(74,317 )

792,720

Changes in operating assets and liabilities:

Accounts receivable, net of allowances

(686,235 )

-

Inventory

(339,252 )

(8,940,201 )

Prepaid expenses

(1,500,000 )

1,600,000

Accounts payable

(5,919,168 )

4,955,797

Accrued expenses

19,980,496

8,458,554

Due to related party

471,787

6,875,556

Net Cash (Used In) Provided By Operating Activities

(13,897,194 )

-

Cash Flows From Investing Activities

License payments

(7,000,000 )

-

Net Cash Used In Investing Activities

(7,000,000 )

-

Cash Flows From Financing Activities

Net proceeds from notes payable

9,635,000

-

Net proceeds from exercise of warrants and pre-funded warrants

9,730,818

-

Deferred Financing Costs

(892,551 )

Net proceeds from issuance of common stock

15,062,724

-

Net Cash Provided by Financing Activities

33,535,991

-

Net Change in Cash and Cash Equivalents

12,638,797

-

Cash and Cash Equivalents – Beginning of Period

3,924,908

112

Cash and Cash Equivalents – End of Period

$ 16,563,705

$ 112

Supplemental Disclosures of Cash Flow Information and Non-cash Transactions:

Interest Paid

$ 212,794

$ -

Warrants issued for loan agreement included in deferred financing costs

$ 749,280

$ -

Deferred financing costs included in accrued expenses

$ 1,762,500

$ -

7

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

-Publisher SEC

-Name Securities Act

-Number 7A

-Section B

-Subsection 2

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- Definition

Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

+ References

No definition available.

+ Details

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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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- 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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- 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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Namespace Prefix:

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- Definition

Local phone number for entity.

+ References

No definition available.

+ Details

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Namespace Prefix:

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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

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Namespace Prefix:

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Data 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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- 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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- 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

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Name:

dei_SecurityExchangeName

Namespace Prefix:

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Data 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:

dei_SolicitingMaterial

Namespace Prefix:

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Data Type:

xbrli:booleanItemType

Balance Type:

na

Period Type:

duration

X

- 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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X

- 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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