Form 8-K

8-K — Citius Pharmaceuticals, Inc.

Accession: 0001213900-26-037524

Filed: 2026-03-31

Period: 2026-03-31

CIK: 0001506251

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — ea0284323-8k_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)

March 31, 2026

Citius Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

Nevada

(State or other jurisdiction of incorporation)

001-38174

27-3425913

(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, $0.001 par value

CTXR

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 8.01 Other Events.

On March 31, 2026, Citius Oncology, Inc. (Nasdaq:

CTOR), our majority-owned subsidiary, issued a press release announcing a commercial update on the U.S. launch of LYMPHIR™ (denileukin

diftitox-cxdl). A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

Description

99.1

Press release, dated March 31, 2026.

104

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

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.

Date: March 31, 2026

CITIUS PHARMACEUTICALS, INC.

By:

/s/ Leonard Mazur

Leonard Mazur

Chairman and Chief Executive Officer

EX-99.1 — PRESS RELEASE, DATED MARCH 31, 2026

EX-99.1

Filename: ea028432301ex99-1.htm · Sequence: 2

Exhibit 99.1

Citius Oncology Provides Commercial Update on

LYMPHIR™ Launch Highlighting Early Adoption and Expanding Clinical Development

Broad institutional uptake among leading cancer

centers and payer coverage supports early prescribing momentum and clinical integration

CRANFORD, N.J., March 31, 2026 –

Citius Oncology, Inc. (“Citius Oncology”) (Nasdaq: CTOR), an oncology-focused biopharmaceutical company and majority-owned

subsidiary of Citius Pharmaceuticals, Inc. (“Citius Pharma”) (Nasdaq: CTXR), today provided a commercial update on the U.S.

launch of LYMPHIR™ (denileukin diftitox-cxdl) for the treatment of cutaneous T-cell lymphoma (CTCL), highlighting continued adoption

across leading oncology centers, broad payer coverage progress, and advancing investigator-led clinical studies.

“We are encouraged by the early commercial

indicators for LYMPHIR, including the pace of formulary adoption, breadth of payer coverage, and increasing repeat orders from leading

oncology centers,” said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharma. “As our commercial organization

continues to scale and institutions complete formulary inclusion, we expect continued expansion in prescribing activity, including into

community settings. Together with further clinical validation through ongoing investigator-led studies, these trends support LYMPHIR’s

potential not only for continued integration in the CTCL treatment landscape, but also its potential as a part of a combination immunotherapy

regimen in other cancers.”

Key Early Launch Metrics:

● Sequential growth in orders from target institutions

since launch, with initial accounts already placing repeat orders, indicating early prescribing continuity;

● Strong institutional uptake, with 83% of target

accounts having added or actively progressing LYMPHIR through formulary review;

● Broad and expanding market access with ~135 health

plans, representing ~80% of covered lives, secured and reimbursement systems established;

● No reported reimbursement denials or prior authorization

barriers;

● Increasing demand for in-services and clinical

education;

● Initial penetration into community infusion centers

underway with patients beginning to transition from larger cancer centers; and,

● Commercial buildout proceeding, with field team

onboarding in the coming month and broader field expansion in progress with our contracted sales organization.

Commercial Execution Advancing with Expanding

Market Access and Field Deployment

Commercial execution continues to advance with

the onboarding of field teams, targeted deployment of medical education and digital campaigns, attendance at major medical meetings and

increasing interaction with physicians, pharmacy stakeholders, and community centers to support the finalization of order sets and initiate

patient treatment, which typically precedes broader patient start acceleration following formulary inclusion.

Commercial supply remains well positioned to support

anticipated U.S. demand, and international expansion is underway through executed distribution agreements across Europe and the Middle

East.

Clinical Development Expands Through Leading

Academic Collaborations

In parallel, Citius Oncology is advancing LYMPHIR’s

clinical development through collaborations with leading academic centers to further evaluate its potential across broader oncology settings.

At the University of Minnesota, an investigator-sponsored study is evaluating LYMPHIR prior to CAR-T therapy in relapsed/refractory diffuse

large B-cell lymphoma, with positive

topline data presented at the ASTCT 2026 Annual Meeting and additional analyses underway. At UPMC, a Phase I study evaluating LYMPHIR

in combination with pembrolizumab in solid tumors has been completed, with positive

topline results submitted for presentation at an upcoming oncology conference. Discussions are ongoing regarding next-stage development.

These efforts support a broader strategy to evaluate LYMPHIR as a potential combination therapy across immuno-oncology settings.

Together, these commercial and clinical developments support a disciplined

launch trajectory and provide a solid foundation for continued adoption of LYMPHIR.

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.

After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin

diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a

direct cytocidal action on IL-2R-expressing tumors.

In 2021, denileukin diftitox received regulatory

approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius

acquired an exclusive license with rights to develop and commercialize denileukin diftitox in all markets except for India, Japan and

certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) 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 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.

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 are: our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; risks relating

to the results of research and development activities, including those from our existing and any new pipeline assets; 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;

the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; early-stage clinical data may not

be predictive of results from larger or later-stage studies; our ability to maintain Nasdaq’s continued listing standards; our ability

to secure strategic partnerships and expand international access to LYMPHIR; our ability to use the latest technology to support our commercialization

efforts for LYMPHIR; physician and patient acceptance of LYMPHIR in a competitive treatment landscape; 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; post-marketing requirements and ongoing regulatory compliance related

to LYMPHIR; the ability of LYMPHIR and our product candidates to impact the quality of life of our target patient populations; our ability

to procure cGMP commercial-scale supply; our ability to obtain, perform under and maintain financing and strategic agreements and relationships;

market and other conditions; 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. These risks have been and may be

further impacted by any future public health risks. 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 to reflect any change in our expectations

or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

LYMPHIR™ (denileukin diftitox-cxdl)

INDICATION

LYMPHIR is an IL2-receptor-directed cytotoxin

indicated for the treatment of adult patients with r/r Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic

therapy.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: CAPILLARY LEAK SYNDROME

Capillary leak syndrome (CLS), including life-threatening

or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold

LYMPHIR until CLS resolves, or permanently discontinue based on severity.

WARNINGS AND PRECAUTIONS

Capillary Leak Syndrome

LYMPHIR can cause capillary leak syndrome (CLS),

including life-threatening or fatal reactions. CLS was defined in the clinical trials as the occurrence of at least 2 of the following

symptoms at any time during LYMPHIR therapy: hypotension, edema, and serum albumin <3 g/dL. These symptoms were not required to occur

simultaneously to be characterized as capillary leak syndrome.

As defined, CLS occurred in 27% of patients in

the pooled population across 3 clinical trials, including 8% with Grade 3. There was one (0.8%) fatal occurrence of CLS. Of the patients

with CLS, 22% had recurrence. The majority of CLS events (81%) occurred within the first 2 cycles of treatment. The median time to onset

from Cycle 1, Day 1 was 6.5 days (range: 1 to 77), the median duration of CLS was 14 days (range: 2 to 40), and 75% of patients had resolution.

The most common symptoms included edema, hypoalbuminemia, and hypotension. Pleural effusion, pericardial effusion, and dehydration also

occurred.

Regularly assess patients for weight gain, new

onset or worsening of edema, dyspnea, and hypotension (including orthostatic changes). Monitor serum albumin levels prior to the initiation

of each cycle of therapy and more often as clinically indicated.

Withhold, reduce dose, or permanently discontinue based on severity.

If LYMPHIR is withheld, resume LYMPHIR following resolution of CLS and when serum albumin is greater than or equal to 3 g/dL.

Visual Impairment

LYMPHIR can cause serious visual impairment, including changes in visual

acuity and color vision. In the pooled population across 3 clinical trials, visual impairment occurred in 9%, with Grade 1 in 8% and Grade

2 in 1%. The most commonly reported symptom was blurred vision. Of the patients with visual impairment, 67% had resolution of their visual

impairment.

Perform baseline ophthalmic examination and monitor as clinically indicated.

If patients experience symptoms of visual impairment, such as changes in visual acuity, changes in color vision, or blurred vision, refer

for ophthalmologic evaluation.

Withhold LYMPHIR until visual impairment resolves or permanently discontinue

based on severity.

Infusion-Related Reactions

LYMPHIR can cause serious infusion-related reactions. Infusion-related

reactions were reported in 69% of patients in the pooled population across 3 clinical trials of patients who received LYMPHIR, with Grade

3 infusion-related reactions in 3.4%. Eighty-three percent of infusion-related reactions occurred in Cycles 1 and 2. The most common symptoms

included nausea, fatigue, chills, musculoskeletal pain, vomiting, fever, and arthralgia.

Premedicate patients for the first three cycles prior to starting a

LYMPHIR infusion. Monitor patients frequently during infusion. For Grade 2 or higher infusion reactions, premedicate at least 30 minutes

prior to each subsequent infusion with a systemic steroid for at least 3 cycles.

Interrupt or discontinue LYMPHIR based on severity. Institute appropriate

medical management.

Hepatotoxicity

LYMPHIR can cause hepatotoxicity. In the pooled safety population,

elevated ALT occurred in 70% of patients, with Grade 3 ALT occurring in 22%; elevated AST occurred in 64% of patients, with Grade 3 AST

elevation occurring in 9%. For Grade 3 events, median time to onset was 8 days (range: 1 to 15 days); median time to resolution was 15

days (range: 7 to 50 days); all cases of Grade 3 ALT or AST elevations resolved. Elevated total bilirubin occurred in 5% of patients,

with Grade 3 occurring in 0.9%.

Monitor liver enzymes and bilirubin at baseline and during treatment

as clinically indicated. Withhold, reduce dose, or permanently discontinue LYMPHIR based on severity.

Embryo-Fetal Toxicity

Based on its mechanism of action, LYMPHIR can cause fetal harm when

administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to the initiation of LYMPHIR.

Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during

treatment and for 7 days following the last dose of LYMPHIR.

ADVERSE REACTIONS

The most common adverse reactions (≥20%), including laboratory abnormalities,

are increased transaminases, albumin decreased, nausea, edema, hemoglobin decreased, fatigue, musculoskeletal pain, rash, chills, constipation,

pyrexia, and capillary leak syndrome.

USE IN SPECIFIC POPULATIONS

Pregnancy

Risk Summary

Based on its mechanism of action, LYMPHIR can cause fetal harm when

administered to a pregnant woman. There are no available data on the use of LYMPHIR in pregnant women to evaluate for a drug-associated

risk. No animal reproductive and developmental toxicity studies have been conducted with denileukin diftitox.

Denileukin diftitox-cxdl causes depletion of regulatory T lymphocytes

(Treg), immune activation, and capillary leak syndrome, compromising pregnancy maintenance. Advise pregnant women of the potential risk

to a fetus.

In the U.S. general population, the estimated background risk of major

birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively.

Lactation

Risk Summary

No data are available regarding the presence of denileukin diftitox-cxdl

in human milk, the effects on the breastfed child, or on milk production. Because of the potential for serious adverse reactions in breastfed

children, advise women not to breastfeed during treatment with LYMPHIR and for 7 days after the last dose.

Females and Males of Reproductive Potential

Based on its mechanism of action, LYMPHIR can cause fetal harm when

administered to a pregnant woman.

Pregnancy Testing

Verify the pregnancy status of females of reproductive potential prior

to initiating LYMPHIR.

Contraception

Females

Advise females of reproductive potential to use effective contraception

during treatment with LYMPHIR and for 7 days after the last dose.

Infertility

Males

Based on findings in rats, male fertility may be compromised by treatment

with LYMPHIR. The reversibility of the effect on fertility is unknown.

Pediatric Use

Safety and effectiveness of LYMPHIR in pediatric patients have not

been established.

Geriatric Use

Of the 69 patients with Stage I-III r/r CTCL who received LYMPHIR,

34 patients (49%) were 65 years of age and older and 10 patients (14%) were 75 years of age and older. Clinical studies of LYMPHIR did

not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult

patients.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to Citius Oncology at 1-844-459-6744.

Please read Important Safety Information and full

Prescribing Information, including Boxed WARNING, for LYMPHIR.

Investor Contact:

Ilanit Allen

ir@citiuspharma.com

908-967-6677 x113

Media Contact:

STiR-communications

Greg Salsburg

Greg@STiR-communications.com

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Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- 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

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration