On April 7, 2026 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, reported that Arthur Sands, M.D., Ph.D., president and chief executive officer of Nurix, will participate in a fireside chat at the 25th Annual Needham Virtual Healthcare Conference in April.

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Needham Virtual Healthcare Conference
Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix
Monday, April 13, 2026, at 1:30 – 2:10 p.m. ET
The fireside chat will be webcast live and may be viewed via a link in the Investors section of the Nurix website. The archived webcast will be available for 30 days after the event.

(Press release, Nurix Therapeutics, APR 7, 2026, View Source [SID1234664210])

On April 7, 2026 NovaBridge Biosciences (Nasdaq: NBP) ("NovaBridge" or the "Company"), a global biotechnology platform company committed to accelerating access to innovative medicines, reported financial results for the full year ended December 31, 2025, and highlighted recent pipeline progress and business updates for its two lead investigational programs, givastomig (Phase 2, directed to gastric cancer), and VIS-101 (Phase 2, targeting wet age-related macular degeneration, or wet AMD).

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"2025 was a consequential year for NovaBridge, with our successful transformation to a global biotech platform. The accelerated momentum that we have experienced over the last quarter – marked by compelling proof-of-concept data for our two potential class-leading, blockbuster product candidates, givastomig and VIS-101 — serves as strong validation of our strategy," said Fu Wei, Executive Chairman of the Board of NovaBridge. "With the expansion of NovaBridge’s Board of Directors and the executive leadership team of both NovaBridge and our Visara subsidiary, I believe we have the experience to execute on our 2026 milestones and the next phase of growth. We remain steadfast in our commitment to bring innovative medicines to the global community and create value for our investors."

"Compelling clinical results from the last quarter have reinforced the class-leading potential for givastomig and VIS-101 and meaningfully de-risked their clinical paths forward. For givastomig, the FDA confirmed potential eligibility for an Accelerated Approval pathway at a productive Type B meeting, following robust potential best-in-class Phase 1b efficacy and favorable overall tolerability results. At the same time, VIS-101 continues to advance in wet AMD following its successful Phase 2a readout showing rapid, robust, durable and potential best-in-class responses," said Sean Fu, PhD, MBA, Chief Executive Officer of NovaBridge. "We are building on these outstanding achievements to initiate next-stage studies for both programs this year, bringing them one step closer to commercialization and to patients in need."

Pipeline Overview and Potential Upcoming Milestones

NovaBridge’s late-stage potential class-leading pipeline is led by givastomig for the treatment of gastric cancer, and VIS-101 for the care of wet AMD:

Givastomig Update

Givastomig, a bispecific CLDN18.2 X 4-1BB antibody targeting Claudin 18.2-positive (CLDN 18.2+) tumor cells, is being developed for the treatment of first line (1L) metastatic gastric cancer. Currently, there are approximately 180,000 patients diagnosed with 1L gastric cancer in the US/EU5 and Japan, among which, approximately 105,0002,3 cases are Her2-/CLDN18.2 positive.

NovaBridge reported positive Phase 1b dose expansion data in January 2026 demonstrating:

•
Robust efficacy, with 75% objective response rate (n=52 evaluable subjects, 50/50 at 8 mg/kg or 12 mg/kg)
•
Responses observed across a range of PD-L1 and CLDN18.2 expression levels
•
Durable responses with 16.9-month median progression free survival (n=53 evaluable subjects, 50/50 at 8 mg/kg or 12 mg/kg)
•
Good overall tolerability in combination with immunochemotherapy, without dose dependent toxicity
Givastomig has broad potential in gastric cancer and other CLDN18.2+ tumors such as pancreatic ductal adenocarcinoma and biliary tract cancer.

In March 2026, NovaBridge reported givastomig’s potential eligibility for an Accelerated Approval Pathway in 1L Her2-, CLDN18.2+, PD-L1+ patients with gastroesophageal carcinoma.

Upcoming Givastomig Milestones:

•
2026: Medical meeting presentation of Phase 1b combination gastric cancer data
•
YE 2026: Potential to begin Accelerated Approval Pathway Phase 3 study as early as YE 2026
VIS-101 Update and Upcoming Milestones

VIS-101, a dual purpose-designed VEGF-A X ANG-2 inhibitor, is being developed for wet AMD, estimated to affect more than 20 million people globally4.

Visara reported positive Phase 2a data in February 2026 demonstrating:

•
Good safety and tolerability
•
Rapid, robust and durable treatment responses
o
Mean BCVA >10 ETDRS letters
o
Mean CST 100 – 150 um
o
Potentially best-in-class durability with:
▪
~two thirds of patients retreatment free at four months
▪
~half of patients retreatment free at six months
VIS-101 has broad potential in retinal vascular diseases including wet AMD, diabetic macular edema (DME) and retinal vein occlusion (RVO), which, together, affect more than 57 million people globally4.

Upcoming VIS-101 Milestones:

•
H2 2026: Initiate Phase 2b program in wet-AMD
•
2027: Initiate global Phase 3 program
2025 Selected Corporate Development Highlights:

Executive Appointments:

•
Emmett T. Cunningham, Jr., MD, PhD, MPH, Vice-Chairman of the NovaBridge Board of Directors, and Founder and Executive Chairman, Visara
•
Kyler Lei, MSc, Chief Financial Officer of NovaBridge
•
Expansion of the NovaBridge Board of Directors, with the appointments of Robert Lenz, MD, PhD; Xin Liu, MEng, MFin; Sean Cao, PhD, MBA; Emmett T. Cunningham, Jr., MD, PhD, MPH; and Ian Woo, MA, MBA, with:
o
Appointments of Dr. Lenz (Chairman), Dr. Cunningham, and Dr. Cao to the NovaBridge Research and Development Committee
o
Appointment of Ken Takeshita, MD to the NovaBridge Scientific Advisory Board

•
Buildout of the Visara Executive Team with the appointment of Cadmus Rich, MD, MBA, as Chief Medical Officer, and formation of the:
o
Visara Scientific Advisory Board, with the appointment of Carlos Quezada-Ruiz, MD, FASRS (Chairman)
Strategic Business Development Transactions:

•
NovaBridge: Strategic transformation to a global biotech platform to advance high-value therapeutic assets through its "hub-and-spoke" model
•
Bridge Health: Acquisition of rights and patent filings related to multiple bispecific antibodies and antibody drug conjugates, based on the parental antibody used in givastomig-related antibodies
•
Visara, Inc: Formation of NovaBridge’s first "spoke", executed through a series of collaborative agreements, including completion of a Series A Financing and partnerships with AskGene and Everest Medicines, related to worldwide rights for VIS-101 outside of Greater China and certain other countries in Asia
Full Year 2025 Financial Results

Cash Position

As of December 31, 2025, the Company had cash, cash equivalents, and short-term investments of $210.8 million. The Company’s current cash position is expected to support operations through 2028.

Shares Outstanding

As of December 31, 2025, the Company had 265,377,891 ordinary shares issued and outstanding, representing the equivalent of 115,381,692 ADSs, assuming the conversion of all ordinary shares into ADSs.

Research & Development Expenses

Research and development (R&D) expenses were $62.9 million for the year ended December 31, 2025, compared to $21.8 million for the year ended December 31, 2024, an increase of $41.1 million primarily attributable to the recognition of in-process R&D (IPR&D) expenses related to the acquisition of VIS-101 through the Visara transaction and the Bridge Health asset acquisition, partially offset by reimbursements recognized under an existing collaboration agreement with ABL Bio Inc. (ABL Bio) and lower employee benefit and compensation expenses resulting from a lower headcount.

Administrative Expenses

Administrative expenses were $31.4 million for the year ended December 31, 2025, compared to $29.7 million for the year ended December 31, 2024, an increase of $1.7 million. The increase was primarily attributable to a higher employee share-based compensation expense related to the market and service-based awards, as well as an increased professional service expenses in the current period, partially offset by lower legal expenses and reduced employee benefit and compensation expenses resulting from a lower headcount. The employee share-based compensation expense during the year ended December 31, 2024 included forfeitures in connection with the divestiture of our Greater China assets and business operations.

Interest Income

Interest income was $7.6 million for the year ended December 31, 2025, compared to $7.5 million for the year ended December 31, 2024. The increase was primarily attributable to slightly higher average investable cash balances.

Other Income (Expenses), Net

Other expenses, net were $1.7 million for the year ended December 31, 2025, compared to $4.7 million for the year ended December 31, 2024. The change was primarily attributable to the settlement of repurchase obligations associated with the TJ Biopharma redemptions in the prior period, smaller impacts from foreign exchange losses recognized in 2025, and recognition of an accumulated gain associated with the available-for-sale-debt securities, partially offset by the changes in the fair value and extinguishment of put-right liabilities, as well as fair value changes in our equity securities.

Equity in Loss of Affiliates

Equity in loss of affiliates was zero for the year ended December 31, 2025, compared to $1.0 million for the year ended December 31, 2024. The decrease was driven by no further recognition of allocated losses from our unconsolidated investee, as the investee no longer qualified for equity method accounting

Net Loss from Continuing Operations

Net loss from continuing operations was $88.3 million for the year ended December 31, 2025, compared to $49.7 million for the year ended December 31, 2024. Net loss per share from continuing operations attributable to ordinary shareholders was $(0.21) for the year ended December 31, 2025 compared to $(0.27) for the year ended December 31, 2024.

Gain (Loss) from Discontinued Operations

Net loss from discontinued operations was zero for the year ended December 31, 2025, compared to a net gain of $27.5 million for the year ended December 31, 2024.

Net Loss Attributable to Redeemable Noncontrolling Interests

Net loss attributable to redeemable Noncontrolling Interests ("NCI") was $42.1 million for the year ended December 31, 2025, compared to $0.0 million for the year ended December 31, 2024. The loss represents the allocation of the operating losses incurred by our subsidiary Visara for the year ended December 31, 2025 to noncontrolling interests based on the liquidation preferences associated with the Series A Subscription Agreement. The allocation reduced the carrying value of the redeemable NCI to zero in our consolidated balance sheets as of December 31, 2025. There was no noncontrolling interest for the year ended December 31, 2024.

Net Loss attributable to NovaBridge

Net loss attributable to NovaBridge was $46.3 million for the year ended December 31, 2025, compared to $22.2 million for the year ended December 31, 2024. Net loss per share attributable to ordinary shareholders was $(0.21) for the year ended December 31, 2025 compared to $(0.12) for the year ended December 31, 2024.

About Givastomig

Givastomig (TJ033721 / ABL111) is a bispecific CLDN 18.2 X 4-1BB antibody targeting Claudin 18.2 (CLDN18.2)-positive (CLDN 18.2+) tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for potential treatment of gastric cancer and other Claudin 18.2+ gastrointestinal malignancies. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of the proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents.

Givastomig is being jointly developed through a global partnership with ABL Bio, in which NovaBridge is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.

About VIS-101

VIS-101 (also known as ASKG712 or AM712), purpose-designed to be best-in-class, is a dual VEGF-A X ANG-2 inhibitor in development for the treatment of retinal vascular diseases, such as wet age-related macular degeneration (wet AMD), diabetic macular edema (DME) and retinal vein occlusion (RVO), which, together, affect more than 57 million people globally4. VIS-101’s bispecific, tetravalent design format provides more binding sites and increased VEGF-A and ANG-2 affinity, for rapid, robust and class-leading durable responses. VIS-101 has completed initial safety and dose-escalation studies in both the US and China and a randomized, dose-ranging 2a study in China (NCT05456828). VIS-101 is expected to advance to a dose-determining Phase 2b study in 2026, with initiation of the global Phase 3 program in 2027.

NovaBridge is the majority shareholder of Visara, and Visara controls global rights to VIS-101 outside of greater China and certain countries in Asia.

(Press release, NovaBridge Biosciences, APR 7, 2026, View Source [SID1234664209])

On April 7, 2026 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), reported it has released the next segment on its CEO Corner, a platform featuring Walter Klemp, Chief Executive Officer.

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In this segment, Mr. Klemp highlights the differentiated safety profile of Annamycin, emphasizing its lack of cardiotoxicity which is a significant limitation associated with traditional anthracyclines such as doxorubicin. Annamycin was specifically designed to avoid cardiac damage, and has demonstrated this advantage across preclinical and clinical studies. This non-cardiotoxic profile could expand treatment options for patients with relapsed or refractory acute myeloid leukemia (AML) and advanced solid tumors, particularly those previously treated with anthracyclines or with existing cardiac risk factors. Mr. Klemp also notes the potential benefits for physicians in enabling more flexible treatment strategies, as well as the favorable regulatory and commercial implications of a differentiated safety profile. As the Company advances its MIRACLE Study, he underscores that Annamycin’s unique design may position it as a promising new option in oncology, with the potential to reshape the use of anthracyclines in modern cancer care.

Access the CEO Corner on the Company’s website.

(Press release, Moleculin, APR 7, 2026, View Source [SID1234664208])

On April 7, 2026 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported an update on new patent claims based on FLAMINGO-01 statistically significant open label immune response and recurrence rate data.

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Statistically significant immune response and recurrence rate data is the basis for new claims recently filed that GLSI-100 clinically benefits non-HLA-A*02 patients, which the Company believes increases the market for GLSI-100 by an additional 100% to 88,000 new patients per year in the US and Europe.
The claims also show a favorable comparison to the blinded HLA-A*02 arms of FLAMINGO-01, without any unblinding.
The invention is solely owned by the Company. If the patent claims are granted, following successful patent prosecution, the patent could provide patent protection through 2045.
The Company plans to expand its immune response analysis of GP2 specific T cells by sequencing the DNA of a patient’s T cells at baseline and after treatment with GP2. The T cell sequences can be compared to the immune response changes over time.

CEO Snehal Patel commented, "We believe that these patent claims, based on statistically significant data, support the enrollment of patients independent of HLA type. In the US, we have already started to enroll both HLA-A*02 and non-HLA-A*02 patients in the same randomized arms in FLAMINGO-01, based on the FDA’s recent review of such protocol changes. The Company will have the option to pursue approval for both HLA-A*02 and non-HLA-A*02 patients using the increased statistical power of a combined analysis of the two patient groups together with the potential to double the market for GP2 to up to $10 billion in revenue per year."

About FLAMINGO-01 Open Label Phase III Data

More than 1,000 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:

80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.
About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

(Press release, Greenwich LifeSciences, APR 7, 2026, View Source [SID1234664206])

On April 7, 2026 Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, reported the initiation of an investigator-sponsored study by University of Arizona Cancer Center to evaluate use of PEDMARK (sodium thiosulfate injection) in adolescent and young adult (AYA) and adult patients with head and neck and testicular cancers receiving cisplatin.

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PEDMARK is currently approved for pediatric patients one month of age and older with localized, non-metastatic solid tumors, and is also recognized by the National Comprehensive Cancer Network with a 2A recommendation for use in adolescent and young adult patients.

Fennec recently announced the initiation of two other institution-led clinical studies:

● In March 2026, Fennec announced that Tampa General Hospital (TGH) Cancer Institute is initiating a study evaluating the real-world clinical utility of PEDMARK in reducing the risk of ototoxicity in AYA and adult cancer patients receiving cisplatin-based treatment. Additional investigator-initiated studies supporting the use of PEDMARK in additional tumor types and patient populations, including AYA cancer, have been submitted to Fennec and are currently under review.
● In December 2025, Fennec announced that City of Hope, a U.S. cancer research and treatment organization, is evaluating PEDMARK for the prevention of cisplatin-induced ototoxicity (CIO) in adult men with stage II-III metastatic testicular germ cell tumors.

Additional investigator-initiated studies supporting the use of PEDMARK have been submitted to Fennec and are currently under review.

"At Fennec, we are committed to supporting independent research efforts, which help build real-world evidence and expand understanding of how PEDMARK may benefit patients beyond the populations studied in our pivotal trials," said Pierre S. Sayad, PhD, M.S., chief medical officer of Fennec Pharmaceuticals. "Within the last few months, we have announced the initiation of three new studies with leading and highly respected academic and community oncology centers. We believe that data and insights generated through these studies – and others to come – will help support broader clinical adoption of PEDMARK to prevent ototoxicity, or permanent hearing loss, in AYA and adult cancer patients receiving cisplatin-based treatment. We look forward to continued dialogue with regulatory authorities regarding the potential pathways for PEDMARK label expansion as our growing body of evidence-based data matures."

University of Arizona Study Details:

University of Arizona Cancer Center: Tucson, Arizona

Principal Investigator: Lisa Davis / Alejandro Recio-Boiles

Title:

Phase I/II Open-Label Trial of Intravenous Sodium Thiosulfate (PEDMARK) as Otoprotectant in Adults Receiving Cisplatin Chemotherapy

Overview:

Phase I/II study to determine the efficacy of intravenous sodium thiosulfate to reduce hearing impairment caused by cisplatin as determined from prior hazard ratio (HR) risk reduction compared to historical control data and determine the systemic elimination of unbound cisplatin up to 6 hours after infusion.

About Cisplatin-Induced Ototoxicity

Cisplatin and other platinum-based chemotherapies are widely used to treat solid tumors and have been vital in improving survival rates. Unfortunately, these life-saving treatments often result in permanent, irreversible hearing loss, also known as ototoxicity.i

Hearing loss from cisplatin treatment is not rare. Studies show that between 60-90% of patients treated with cisplatin may develop hearing loss, depending upon the dose and duration of chemotherapyii. Many of those treated with cisplatin will require lifelong hearing aids or cochlear implants, which can be helpful for some, but do not reverse the hearing loss and can be costly over time.iii Treatment-induced hearing loss can reduce quality of survivorship as it impacts many aspects of life, such as speech and language skills, academic performance, social-emotional development, career potential and the ability to live independently.iv,v While audiologic monitoring is recommended to help manage ototoxicity, it is currently underutilized in certain cancer patient populations.

PEDMARK (sodium thiosulfate injection)

PEDMARK is the first and only U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients 1 month of age and older with localized, non-metastatic, solid tumors. It is a unique formulation of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in pediatric patients. PEDMARK is also the first and only therapeutic agent with proven efficacy and safety data with an established dosing regimen, across two open-label, randomized Phase 3 clinical studies, the Children’s Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6.

Additionally, PEDMARK is recommended for the adolescent and young adult (AYA) population by the National Comprehensive Cancer Network, or NCCN, with a 2A endorsement.

Approximately 500,000 patients in the U.S. are diagnosed annually with cancers that could be treated with a platinum-based chemotherapy.vi,vii The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of those treated will require lifelong hearing aids. Until the FDA approval of PEDMARK, there were no preventative agents for this hearing loss. Patients with hearing loss resulting from cancer treatment have a statistically significant worse quality of life compared with peers who have no hearing loss.viiiix

PEDMARK has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, COG ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, medulloblastoma, and other solid tumors. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

Indications and Usage

PEDMARK (sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

Limitations of Use

The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.

Important Safety Information

PEDMARK is contraindicated in patients with history of a severe hypersensitivity to sodium thiosulfate or any of its components.

Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate care if a hypersensitivity reaction occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration of PEDMARK. PEDMARK may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions, including anaphylactic symptoms and life-threatening or severe asthma episodes. Sulfite sensitivity is seen more frequently in people with asthma.

PEDMARK is not indicated for use in pediatric patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers.

Hypernatremia occurred in 12% to 26% of patients in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3 or 4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Withhold PEDMARK in patients with baseline serum sodium greater than 145 mmol/L.

Monitor for signs and symptoms of hypernatremia and hypokalemia more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73m2.

Administer antiemetics prior to each PEDMARK administration. Provide additional antiemetics and supportive care as appropriate.

The most common adverse reactions (≥25% with difference between arms of >5% compared to cisplatin alone) in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia.

Please see full Prescribing Information for PEDMARK at: www.PEDMARK.com.

(Press release, Fennec Pharmaceuticals, APR 7, 2026, View Source [SID1234664205])