On August 3, 2026 TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics) reported its financial results for the second quarter of 2026, along with recent company developments and provided an update on 2026 financial guidance.

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Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, stated, "The second quarter of 2026 was another strong quarter for TG Therapeutics. BRIUMVI delivered another outstanding commercial quarter, exceeding our expectations once again and putting us on track to exit 2026 at an approximately $1 billion annualized U.S. BRIUMVI revenue run rate.

Mr. Weiss continued, "Beyond our commercial performance, we continued to expand the long-term opportunity for BRIUMVI with positive Phase 3 ENHANCE results supporting a simplified initiation regimen, encouraging progress in our subcutaneous BRIUMVI program, advancement into myasthenia gravis and schizophrenia, and continued momentum across our azer-cel cell therapy platform. As BRIUMVI continues to grow, it is becoming the foundation of a broader company focused on advancing innovative therapies for immune-mediated diseases. The progress we made this quarter reinforces our confidence in our strategy and our ability to create long-term value for both patients and shareholders."

Recent Highlights & Developments

BRIUMVI (ublituximab-xiiy) Commercialization

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BRIUMVI U.S. net product revenue of $227.7 million for the second quarter 2026, representing approximately a 64% increase over the same period last year

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Total global revenue of $240.3 million for the second quarter 2026

Subcutaneous BRIUMVI

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Announced positive pharmacokinetic (PK), pharmacodynamic (PD), safety, and tolerability data from a Phase 1 clinical trial evaluating a subcutaneous formulation of ublituximab (the active agent in BRIUMVI) as compared to IV BRIUMVI

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Subcutaneous BRIUMVI demonstrated mean bioavailability of greater than 60% relative to IV administration in the Phase 1 trial

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PK modeling and simulation informed by the Phase 1 bioavailability data support the quarterly subcutaneous dosing regimen that is being evaluated in the fully enrolled Phase 3 trial

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Top-line Phase 3 data is expected year-end 2026 or early 2027

Positive Topline Phase 3 ENHANCE Data

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Announced positive topline results from the Phase 3 ENHANCE trial, a randomized, double-blind study evaluating a consolidated single infusion regimen for initiation of BRIUMVI in adults with RMS

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The ENHANCE trial met its primary endpoint, demonstrating bioequivalent drug exposure between the currently approved BRIUMVI initiation infusion dosing regimen of 150 mg on Day 1 and 450 mg on Day 15 and a consolidated single 600 mg infusion on Day 1, eliminating the need for a Day 15 infusion.

BRIUMVI in Myasthenia Gravis

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Announced positive topline phase 1 data for subcutaneous BRIUMVI in patients with myasthenia gravis (MG)

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Initiated a potentially registration-directed randomized phase 2 clinical trial evaluating IV BRIUMVI as a maintenance therapy following induction with efgartigimod in adult patients with MG

BRIUMVI in Schizophrenia

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Initiated a Phase 2 clinical trial evaluating BRIUMVI in adults with treatment-resistant schizophrenia

2026 Financial Guidance Update

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Raises full year 2026 target total global revenue to approximately $950 million

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Raises full year 2026 target BRIUMVI U.S. net product revenue to approximately $890 – $905 million

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Full year 2026 target operating expense, defined as R&D and SG&A, of approximately $350 – $400 million excluding non-cash compensation, in addition to approximately $100 million in expenses associated with the subcutaneous BRIUMVI manufacturing costs and secondary manufacturer start-up costs

2026 Remaining Development Pipeline Anticipated Milestones

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Present full results from the Phase 3 ENHANCE trial combining Day 1 and Day 15 doses of IV BRIUMVI

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Present preliminary Phase 1 azer-cel data in Progressive MS in the second half of 2026

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Announce topline Phase 3 data for subcutaneous BRIUMVI year-end 2026/first quarter 2027

Financial Results for Second Quarter 2026

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Product Revenue, net: Product revenue, net was $235.8 million and $437.1 million for the three and six months ended June 30, 2026, respectively, compared to $138.8 million and $258.5 million for the three and six months ended June 30, 2025, respectively. Product revenue, net consists primarily of net product sales of BRIUMVI in the United States, which totaled $227.7 million and $422.5 million during the three and six months ended June 30, 2026. Also included in product revenue, net for the three and six months ended June 30, 2026 are sales of BRIUMVI to our ex-U.S. licensing partner, Neuraxpharm, of $8.1 million and $14.6 million, respectively.

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License, milestone, royalty and other revenue: License, milestone, royalty and other revenue was approximately $4.5 million and $8.1 million for the three and six months ended June 30, 2026, respectively, compared to approximately $2.3 million and $3.5 million for the three and six months ended June 30, 2025. License, milestone, royalty and other revenue for the three and six months ended June 30, 2026 is predominantly comprised of $3.6 million and $6.3 million, respectively, of royalty revenue recognized under the Commercialization Agreement with Neuraxpharm, and $0.9 million and $1.8 million, respectively, of consideration received for development and regulatory activities performed on behalf of Neuraxpharm in accordance with the Commercialization Agreement.

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R&D Expenses: Total research and development (R&D) expense was approximately $95.3 million and $143.7 million for the three and six months ended June 30, 2026, compared to $31.8 million and $78.1 million for the three and six months ended June 30, 2025. During the three and six months ended June 30, 2026 we incurred approximately $54.6 million and $58.8 million, respectively related to subcutaneous manufacturing and secondary manufacturer expenses. The period over period increase in R&D was also attributable to higher clinical trial-related expenses associated with our development pipeline during the period

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SG&A Expenses: Total selling, general and administrative (SG&A) expense was approximately $82.1 million and $170.3 million for the three and six months ended June 30, 2026, compared to $55.6 million and $105.9 million for the three and six months ended June 30, 2025. The increase in selling, general and administrative costs during the three and six months ended June 30, 2026 was primarily due to an increase in marketing and media spend, and personnel costs associated with the commercialization of BRIUMVI.

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Net income: Net income was $7.8 million and $27.6 million for the three and six months ended June 30, 2026, respectively, compared to net income of $28.2 million and $33.2 million for the three and six months ended June 30, 2025.

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Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $612.3 million as of June 30, 2026. We anticipate that our cash, cash equivalents and investment securities as of June 30, 2026, combined with the projected revenues from BRIUMVI, will be sufficient to fund our business based on our current operating plan.

CONFERENCE CALL INFORMATION
The Company will host a conference call today, August 3, 2026, at 8:30 AM ET, to discuss the Company’s financial results from second quarter of 2026.

To participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source An audio recording of the conference call will also be available for a period of 30 days after the call.

ABOUT BRIUMVI (ublituximab-xiiy) 150 mg/6 mL Injection for IV
BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.

BRIUMVI is indicated in the U.S. for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease and in several countries outside of the U.S. for the treatment of adult patients with RMS with active disease defined by clinical or imaging features.

A list of authorized specialty distributors can be found at www.briumvi.com.

(Press release, TG Therapeutics, AUG 3, 2026, View Source [SID1234669612])

On August 3, 2026 Lantern Pharma Inc. (Nasdaq: LTRN), a clinical-stage AI-driven precision oncology company, reported the formal creation of Open-Medicine AI (OMAI) and the execution of commercial licensing agreements between OMAI and Lantern Pharma. The agreements, which have received Lantern Pharma Board approval, are consistent with the framework outlined in Lantern’s most recent registered direct financing and establish the commercial operating structure for the multi-agentic AI co-scientist platform previously launched as withZeta.ai.

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OMAI will continue to advance the multi-agentic architecture, first proven in oncology and rare cancer research, while expanding its application across broader disease areas. The formation of the entity and the licensing arrangements position OMAI for independent growth, while expanding value creation opportunities and preserving strategic alignment with Lantern Pharma’s clinical programs and shareholders.

AI Centers of Excellence in Dallas, Texas and Bengaluru, India

In the first quarter of 2026, Lantern established and staffed an AI Center of Excellence in Bengaluru, India. This center will serve as a core operational hub accelerating the development, refinement, and scaling of the Open-Medicine platform. The Bengaluru team will bring additional specialized talent to the existing team in Dallas (where Lantern is also headquartered). Both sites will focus on functional enhancements in multi-agent systems, computational biology modeling, knowledge engineering, and large-scale scientific curation — furthering Open-Medicine’s ability to deliver production-grade capabilities to researchers and institutions worldwide.

Market Need and Competitive Landscape

The global market for AI-enabled drug discovery and development tools is projected to exceed $10 billion by 2030, with oncology representing the largest therapeutic segment and compound annual growth rates above 30 percent. The underlying need is structural: traditional drug development remains slow, expensive, and poorly suited to the hundreds of rare and complex diseases that lack commercial scale under conventional models. Knowledge remains fragmented across literature, clinical trial databases, institutional archives, and individual expertise, while experimental iteration continues to consume months or years and hundreds of thousands to millions of dollars per cycle.

At the same time, major general-purpose AI companies — including Anthropic and OpenAI — have publicly signaled or begun developing platforms and tools aimed at scientific discovery and drug development. Their entrance validates the long-term importance of AI co-scientists while also highlighting the differentiation required for durable impact. While general models excel at broad reasoning and language, domain-specific multi-agentic systems grounded in curated ontologies, domain-specific computational tools, and disease-area expertise are required to deliver the precision, auditability, and scientific rigor demanded by drug development.

OMAI is uniquely positioned for differentiated value creation at this intersection. Built from the ground up for oncology and rare disease research and drug-development, the platform combines specialized agent roles, recursive investigation modes, living knowledge graphs, and production tools (including blood-brain barrier prediction, multi-omic analytics via ZetaOmics, and generative chemistry capabilities). Its architecture is designed not merely to retrieve information but to generate, stress-test, and harden insights in a manner that mirrors how expert scientific teams actually work – iteratively, collaboratively and focused on actionable results.

Platform Foundation and Expansion Path

OMAI inherits the full multi-agentic system originally commercialized as withZeta.ai, including:

● Coordinated specialist agents spanning medicinal chemistry, computational biology, clinical trial strategy, biomarkers & translational science, clinical oncology, and general research.
● Three research modes (Explorer, Investigator, Reporter) that support rapid exploration through deep multi-source investigation to structured reporting.
● Proprietary rare-cancer knowledge bases and ontologies covering hundreds of disease entities, biomarkers, clinical trials, and literature.
● Expanding computational layers, including ZetaOmics for multi-omic analysis and continued development of parallel swarm intelligence capabilities.

While rare cancers remain a core component, OMAI’s roadmap includes systematic expansion into additional high-need disease areas – especially in collaboration with leading academic and commercial leaders – that experience the same challenges of fragmented knowledge, high failure costs, limited traditional investment and urgency of patient and disease management needs.

"Open-Medicine AI is built to change how medicines are discovered and developed globally, and as a separate company, to pursue dedicated funding and a valuation path distinct from Lantern’s clinical activity and operations." – Panna Sharma, CEO & President of Lantern Pharma

(Press release, Lantern Pharma, AUG 3, 2026, View Source [SID1234669611])

On August 3, 2026 Keros therapeutics presented its corporate presentation.

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(Presentation, Keros Therapeutics, AUG 3, 2026, View Source [SID1234669610])

On August 3, 2026 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported financial results for the second quarter of 2026 (2Q26) and raised revenue guidance for 2026.

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"Our second quarter results highlight strong execution and momentum across the business, delivering 16% year-over-year total revenue growth and driving a considerable increase to our full-year revenue guidance," said Renee Gala, president and chief executive officer of Jazz Pharmaceuticals. "We remain focused on long-term growth as we prepare to launch Ziihera in HER2+ 1L GEA, advance the zanidatamab and Epidiolex clinical programs, and expand our pipeline through targeted corporate development and internal research and development. The combination of commercial execution, portfolio expansion and our strong financial foundation positions Jazz to deliver meaningful innovation for patients and substantial value for shareholders."

Recent Key Highlights

•Highest ever total quarterly revenues of $1.2 billion with 16% year-over-year (YoY) growth.
•Generated GAAP / non-GAAP1 adjusted earnings per share (EPS) of $2.78 / $5.71 with $824 million in cash from operations in the first half of 2026.
•U.S. Food and Drug Administration (FDA) granted Priority Review and set Prescription Drug User Fee Act (PDUFA) target action date of August 25, 2026 for supplemental Biologics License Application (sBLA) for zanidatamab containing combinations in first-line (1L) gastroesophageal adenocarcinoma (GEA).
•Results from Phase 3 HERIZON-GEA-01 published in The New England Journal of Medicine; additional subgroup analyses presented in an oral presentation at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting showing improved clinical outcomes with zanidatamab-containing combinations regardless of PD-L1 expression, including in PD-L1-negative patients.
•FDA granted Breakthrough Therapy designation (BTD) for zanidatamab in adults with previously treated locally advanced, unresectable, or metastatic HER2-positive colorectal cancer (CRC).
•Following strong 1H26 commercial execution, the company raised its 2026 revenue guidance range to $4.60 – $4.75 billion, reflecting anticipated double-digit YoY revenue growth from both Xywav and the combined epilepsy and oncology franchises.

Business Updates

Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:
•Xywav net product sales increased 13% YoY to $471 million in 2Q26.
•Robust new patient growth, with approximately 525 net patient adds in 2Q26. There were approximately 17,125 active patients exiting the quarter, comprised of approximately 11,275 narcolepsy patients and approximately 5,850 idiopathic hypersomnia (IH) patients.
•Continued physician and patient demand for the differentiated benefits of low-sodium Xywav.

Epidiolex/Epidyolex (cannabidiol):
•Epidiolex/Epidyolex net product sales increased 16% YoY to $292 million in 2Q26, driven by continued strong demand.
•Expanded Epidiolex development program to reach more patients with the following clinical trials: Phase 3 trial in developmental and epileptic encephalopathy (DEE), Phase 2/3 trial in juvenile myoclonic epilepsy (JME) and Phase 3b/4 trial in adult Lennox-Gastaut syndrome (LGS).
•Submitted New Drug Application (NDA) for cannabidiol capsule formulation to broaden utilization of cannabidiol in currently approved indications and increase flexibility for patients.

Ziihera (zanidatamab-hrii):
•Ziihera net product sales in biliary tract cancer (BTC) were $15 million in 2Q26.
•Prepared to launch zanidatamab in HER2+ 1L GEA (PDUFA date of August 25, 2026).
•Top-line results from the second interim overall survival (OS) analysis for the HERIZON-GEA-01 trial doublet regimen are expected in 3Q26.

Modeyso (dordaviprone):
•Modeyso net product sales were $48 million in 2Q26 with more than 600 patients having received Modeyso from product launch in August 2025 through the end of the second quarter of 2026.
•Anticipate the OS interim analysis for the event-driven Phase 3 ACTION trial in 1H27, based on current pace of event accrual.

Zepzelca (lurbinectedin):
•Zepzelca net product sales increased 42% YoY to $106 million in 2Q26, driven by continued uptake of the Zepzelca and atezolizumab combination in the 1L maintenance ES-SCLC setting, partially offset by a decline in second-line use.
•Based on the results from the LAGOON trial of Zepzelca in second-line metastatic SCLC, and in alignment with FDA, in 3Q26, we will submit for FDA’s review and subsequent action a labeling supplement to remove the second-line indication. The first-line maintenance indication will not be affected.

Corporate Development:
•Announced a preclinical research collaboration with AbCellera Biologics Inc. (AbCellera), to develop next-generation T-cell engaging multispecific antibodies for multiple gastrointestinal (GI) cancers and other solid tumors.
•The company continues to actively evaluate additional value-enhancing corporate development.

Financial Highlights
Three Months Ended
June 30, Six Months Ended
June 30,
(In millions, except per share amounts) 2026 2025 2026 2025
Total revenues $ 1,208.3 $ 1,045.7 $ 2,277.2 $ 1,943.5
GAAP net income (loss) $ 192.8 $ (718.5) $ 485.9 $ (811.0)
Non-GAAP adjusted net income (loss) $ 396.4 $ (504.8) $ 815.9 $ (399.6)
GAAP earnings (loss) per share $ 2.78 $ (11.74) $ 7.17 $ (13.28)
Non-GAAP adjusted earnings (loss) per share $ 5.71 $ (8.25) $ 12.04 $ (6.54)

GAAP and non-GAAP adjusted net income in 2Q26 includes acquired in-process research and development (IPR&D) expense of $77.0 million, relating to upfront payments made in connection with our collaboration and license agreement with AbCellera and asset purchase agreement to acquire remaining rights for JZP898 from Werewolf Therapeutics, Inc. (Werewolf). This impacted our GAAP and non-GAAP adjusted results by $65.4 million (net of tax of $11.6 million) or $0.94 per share.
GAAP and non-GAAP adjusted net loss in 2Q25 includes acquired IPR&D expense of $905.4 million representing the value allocated to Modeyso in the Chimerix Acquisition, which impacted our results by $14.78 per share and $14.75 per share on a GAAP and non-GAAP adjusted basis, respectively.
Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.
Total Revenues
Three Months Ended
June 30, Six Months Ended
June 30,
(In millions) 2026 2025 2026 2025
Xywav $ 471.2 $ 415.3 $ 879.4 $ 760.1
Xyrem 30.5 35.4 61.7 72.6
Sleep 501.7 450.7 941.1 832.7
Epidiolex/Epidyolex 292.1 251.7 541.9 469.4
Epilepsy 292.1 251.7 541.9 469.4
Zepzelca 105.8 74.5 206.8 137.5
Rylaze/Enrylaze 99.5 100.7 203.2 194.9
Defitelio/defibrotide 62.0 48.1 109.4 88.8
Modeyso 48.2 0.5 89.6 0.5
Vyxeos 31.4 44.9 58.0 74.4
Ziihera 15.4 6.0 28.7 8.0
Oncology 362.3 274.7 695.7 504.1
Other — 8.5 2.7 18.8
Product sales, net 1,156.1 985.6 2,181.4 1,825.0
High-sodium oxybate AG royalty revenue 42.2 54.1 78.5 103.0
Other royalty and contract revenues 10.0 6.0 17.3 15.5
Total revenues $ 1,208.3 $ 1,045.7 $ 2,277.2 $ 1,943.5

Total revenues increased 16% in 2Q26 YoY primarily due to higher Xywav, Epidiolex/Epidyolex and Zepzelca net product sales and the inclusion of Modeyso net product sales, following FDA approval in August 2025.

Operating Expenses and Income Tax Expense (Benefit)
Three Months Ended
June 30, Six Months Ended
June 30,
(In millions, except percentages) 2026 2025 2026 2025
GAAP:
Cost of product sales $ 116.4 $ 116.3 $ 250.5 $ 220.9
Gross margin on total revenues 90.4% 88.9% 89.0% 88.6%
Selling, general and administrative $ 389.2 $ 358.4 $ 741.9 $ 872.4
% of total revenues 32.2% 34.3% 32.6% 44.9%
Research and development $ 207.5 $ 189.9 $ 403.5 $ 370.6
% of total revenues 17.2% 18.2% 17.7% 19.1%
Acquired in-process research and development $ 77.0 $ 905.4 $ 77.0 $ 905.4
Gain on sale of priority review voucher $ — $ — $ (122.8) $ —
Income tax expense (benefit) $ 18.1 $ (17.2) $ 24.2 $ (35.0)
Effective tax rate 8.6% 2.3% 4.7% 4.1%

Three Months Ended
June 30, Six Months Ended
June 30,
(In millions, except percentages) 2026 2025 2026 2025
Non-GAAP adjusted:
Cost of product sales $ 95.1 $ 76.3 $ 185.1 $ 146.0
Gross margin on total revenues 92.1% 92.7% 91.9% 92.5%
Selling, general and administrative $ 343.2 $ 310.3 $ 651.7 $ 782.6
% of total revenues 28.4% 29.7% 28.6% 40.3%
Research and development $ 184.9 $ 167.0 $ 357.2 $ 326.7
% of total revenues 15.3% 16.0% 15.7% 16.8%
Acquired in-process research and development $ 77.0 $ 905.4 $ 77.0 $ 905.4
Income tax expense $ 74.4 $ 42.2 $ 115.6 $ 78.7
Effective tax rate 15.8% (9.1)% 12.4% (24.6)%

Changes in operating expenses and income tax expense (benefit) in 2Q26 over the prior year period are primarily due to the following:
•Cost of product sales, on a GAAP and non-GAAP adjusted basis, increased in 2Q26, primarily due to higher royalty expenses, driven by higher revenues of Modeyso and Zepzelca, offset on a GAAP basis, by lower acquisition accounting inventory fair value step up expense.
•Selling, general and administrative (SG&A) expenses, on a GAAP and non-GAAP adjusted basis, increased in 2Q26, primarily due to higher marketing investment and compensation-related expenses in support of our commercial portfolio.
•Research and development (R&D) expenses, on a GAAP and non-GAAP adjusted basis, increased in 2Q26, driven by higher clinical studies costs, primarily related to zanidatamab.
•Acquired IPR&D, on a GAAP and non-GAAP adjusted basis, in 2Q26 comprised the upfront payments to AbCellera and Werewolf.
•Income tax expense, on a GAAP and non-GAAP adjusted basis, in 2Q26 reflects changes in the geographic mix of income and expenses compared to 2Q25.

(Press release, Jazz Pharmaceuticals, AUG 3, 2026, View Source [SID1234669609])

On August 3, 2026 Handa Pharmaceuticals, Inc. ("Handa") (TSE:6620) reported that the U.S. Food and Drug Administration ("FDA") has granted tentative approval to OMCAZIO (cabozantinib) capsules, a novel alternate-salt formulation of cabozantinib developed by Handa’s U.S. subsidiary, Handa Oncology, LLC (the "Company").

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OMCAZIO (cabozantinib) capsules are indicated for the treatment of:

adult patients with advanced renal cell carcinoma (RCC);
adult patients with advanced RCC, in combination with nivolumab, as a first-line treatment;
adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib;
adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (epNET).
OMCAZIO was developed under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. In bioavailability / bioequivalence studies, OMCAZIO was shown to be bioequivalent to CABOMETYX[1] at a lower dose, and demonstrated no clinically significant food effect, and improved absorption of cabozantinib.

Because OMCAZIO is bioequivalent to CABOMETYX at a lower dose, the OMCAZIO label includes the following recommendations for converting patients between the two products:

CABOMETYX tablets dosage OMCAZIO capsules dosage
60 mg once daily 34.5 mg once daily
40 mg once daily 23 mg once daily
20 mg once daily 11.5 mg once daily
"Tentative approval marks an important regulatory milestone for Handa. We developed OMCAZIO with the goal of providing an alternative oral cabozantinib formulation that may offer greater flexibility for patients and healthcare providers," said Bill Liu, Chairman and CEO of Handa. "We are continuing our commercial readiness activities and look forward to making OMCAZIO available to patients following FDA final approval."

A tentative approval indicates that FDA has determined that an application meets the agency’s standards for safety, effectiveness and manufacturing quality.

Cabozantinib is one of the commonly used oral targeted therapies in oncology. According to Exelixis, Inc., U.S. net product revenues for CABOMETYX were approximately $2.11 billion in 2025.[2]

IMPORTANT SAFETY INFORMATION

BOXED WARNING: RISK OF SERIOUS ADVERSE REACTIONS OR REDUCED EFFECTIVENESS DUE TO MEDICATION ERRORS
OMCAZIO is not substitutable on a mg-to-mg basis with other cabozantinib products. Inappropriate substitution or incorrect conversion of OMCAZIO capsules for another cabozantinib product can increase the risk of serious adverse reactions. Confirm that the intended cabozantinib product at the intended dosage and strength is being prescribed and dispensed.

WARNINGS AND PRECAUTIONS

Risk of Serious Adverse Reactions or Reduced Effectiveness Due to Medication Errors: Cabozantinib is available in multiple dosage forms and strengths. OMCAZIO is not substitutable on a mg-to-mg basis with other cabozantinib products. Confirm that the intended cabozantinib product is being prescribed and dispensed.
Hemorrhage: Do not administer OMCAZIO if recent history of hemorrhage.
Perforations and Fistulas: Monitor for symptoms. Discontinue OMCAZIO for Grade 4 events.
Thromboembolic Events: Discontinue OMCAZIO for myocardial infarction or serious venous or arterial thromboembolic events.
Hypertension and Hypertensive Crisis: Monitor blood pressure regularly. Interrupt OMCAZIO for hypertension not adequately controlled with anti-hypertensive therapy. Discontinue OMCAZIO for hypertensive crisis or severe hypertension that cannot be controlled.
Cardiac Failure: Monitor for signs and symptoms of cardiac failure throughout treatment.
Diarrhea: May be severe. Interrupt OMCAZIO until diarrhea resolves or improve to ≤Grade 1, then resume at reduced dose. Recommend standard antidiarrheal treatments.
Palmar-Plantar Erythrodysesthesia (PPE): Interrupt OMCAZIO treatment until PPE resolves or improves to Grade 1.
Hepatotoxicity: When used with nivolumab, higher frequencies of Grade 3 and 4 ALT and AST elevation may occur than with OMCAZIO alone. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider withholding OMCAZIO and/or nivolumab, initiating corticosteroid therapy, and/or permanently discontinuing the combination for severe or life-threatening hepatotoxicity.
Adrenal Insufficiency: When used in combination with nivolumab, primary or secondary adrenal insufficiency may occur. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold OMCAZIO and/or nivolumab depending on severity.
Proteinuria: Monitor urine protein. Interrupt OMCAZIO until proteinuria resolves to ≤Grade 1, resume OMCAZIO at a reduced dose. Discontinue for nephrotic syndrome.
Osteonecrosis of the jaw (ONJ): Withhold OMCAZIO for at least 3 weeks prior to invasive dental procedures and for development of ONJ.
Impaired Wound Healing: Withhold OMCAZIO for at least 3 weeks before elective surgery. Do not administer for at least 2 weeks following major surgery and adequate wound healing. The safety of resumption of OMCAZIO after resolution of wound healing complications has not been established.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue OMCAZIO.
Thyroid Dysfunction: Monitor thyroid function before and during treatment with OMCAZIO.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS

The most common adverse reactions (≥20%) include:

OMCAZIO as a single agent: diarrhea, fatigue, palmar plantar erythrodysesthesia (PPE), decreased appetite, hypertension, nausea, vomiting, decreased weight, and constipation.
OMCAZIO in combination with nivolumab: diarrhea, fatigue, hepatotoxicity, PPE, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough, and upper respiratory tract infection.
DRUG INTERACTIONS

Strong CYP3A inhibitors: Reduce the OMCAZIO dosage if coadministration cannot be avoided.
Strong or moderate CYP3A inducers: Increase the OMCAZIO dosage if coadministration cannot be avoided.
CONTRAINDICATION

None.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed.
Pediatric Use: Monitor open growth plates in adolescent patients. Consider interrupting or discontinuing OMCAZIO if abnormalities occur.
About OMCAZIO

OMCAZIO is a novel alternate-salt capsule formulation of cabozantinib, a tyrosine kinase inhibitor. The formulation is engineered to improve absorption and can be administered with or without food. OMCAZIO has received tentative approval from the FDA and is not yet available for commercial distribution in the United States.

(Press release, Handa Oncology, AUG 3, 2026, View Source [SID1234669607])