Fennec Pharmaceuticals Announces Positive Topline Results From Investigator-Initiated Clinical Study of PEDMARK® in Japan to Reduce Cisplatin-Induced Hearing Loss

Rhea-AI Summary

Fennec Pharmaceuticals (NASDAQ: FENC) reported positive topline results from the investigator‑initiated Phase 2/3 STS-J01 study of PEDMARK® in Japan to reduce cisplatin‑induced hearing loss in pediatric and AYA patients.

The primary cohort (n=27, ages 3–18) met its endpoint: hearing loss rates were 24% (ASHA) and 16% (Brock) with PEDMARK®, versus historically reported cisplatin‑only rates of 56% (ASHA) and 63% (Brock). Pharmacokinetics showed no reduction in cisplatin exposure and tumor response rate was approximately 95%. PEDMARK® was well tolerated; no adverse events were attributed to the drug. Fennec plans to pursue registration in Japan and explore partnering or licensing opportunities.

Positive

• Hearing loss 24% (ASHA) vs historical 56% with cisplatin
• Hearing loss 16% (Brock) vs historical 63% with cisplatin
• Approximate 95% overall tumor response rate
• Pharmacokinetics showed no reduction in cisplatin exposure

Negative

• Primary cohort size limited to 27 evaluable patients
• Full results pending scientific presentation and peer‑review publication

News Market Reaction

-1.55%

3 alerts

-1.55% News Effect

-$3M Valuation Impact

$217M Market Cap

0.7x Rel. Volume

On the day this news was published, FENC declined 1.55%, reflecting a mild negative market reaction. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $3M from the company's valuation, bringing the market cap to $217M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Primary cohort size: 27 patients Exploratory cohorts: 6 patients Hearing loss (ASHA): 24% +5 more

8 metrics

Primary cohort size 27 patients Phase 2/3 STS-J01 primary cohort, ages 3–18 years

Exploratory cohorts 6 patients Additional exploratory cohorts in STS-J01 study

Hearing loss (ASHA) 24% PEDMARK-treated evaluable patients vs cisplatin-only 56% in ACCL0431

Hearing loss (Brock) 16% PEDMARK-treated evaluable patients vs cisplatin-only 63% in SIOPEL-6

Subgroup hearing loss (ASHA) 19% Patients aged 7–18 years in STS-J01

Subgroup hearing loss (Brock) 14.3% Patients aged 7–18 years in STS-J01

Tumor response rate ≈95% Overall clinical response rate indicating no loss of cisplatin efficacy

Adverse events reported More than 200 Treatment-emergent events, none attributed to PEDMARK

Market Reality Check

Price: $7.59 Vol: Volume 60,400 is about 70...

low vol

$7.59 Last Close

Volume Volume 60,400 is about 70% below the 20-day average 200,006 ahead of this release. low

Technical Price $7.49 is trading below the 200-day MA $7.77 prior to the news.

Peers on Argus

Peers showed mixed moves: IMMP +5.2%, CADL +13.11%, AVIR +1.27%, while VNDA -2.5...

Peers showed mixed moves: IMMP +5.2%, CADL +13.11%, AVIR +1.27%, while VNDA -2.51% and NMRA -0.96%, indicating stock-specific factors for FENC.

Common Catalyst Some peers, such as IMMP, also reported clinical trial updates, but reactions varied.

Historical Context

5 past events · Latest: Dec 09 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 09	Clinical trial update	Positive	+1.3%	City of Hope Phase I trial of PEDMARK in metastatic testicular cancer.
Dec 02	Clinical trial results	Positive	-1.6%	Positive Phase 2/3 STS-J01 results for PEDMARK in Japan.
Nov 26	Conference participation	Neutral	-0.8%	Planned fireside chat at Piper Sandler healthcare conference.
Nov 19	Debt redemption	Positive	-6.5%	Completion of full redemption of Petrichor convertible notes.
Nov 18	Equity financing	Negative	+0.0%	Closing of Canadian private offering of common shares at $7.50.

Pattern Detected

Recent positive and de-risking events, including this clinical update and debt redemption, have not consistently translated into sustained price strength, with several showing negative or muted next-day reactions.

Recent Company History

Over the last few weeks, Fennec has reported several material developments. On Nov 13–18, 2025, it executed equity offerings totaling over $5,025,000 and an underwritten deal to help repurchase Petrichor convertible notes, later confirming full debt redemption with a payment of $21,729,455.30. A Q3 2025 10-Q detailed modest PEDMARK sales and a net loss. The company then announced completion of debt redemption, conference participation, and two PEDMARK-focused clinical updates, including this Japanese Phase 2/3 ototoxicity study and a City of Hope trial, highlighting ongoing clinical and commercial positioning steps.

Market Pulse Summary

This announcement highlighted positive topline Phase 2/3 data from Japan, with PEDMARK cutting heari...

Analysis

This announcement highlighted positive topline Phase 2/3 data from Japan, with PEDMARK cutting hearing loss to 24% (ASHA) and 16% (Brock) versus historical cisplatin-only rates of 56% and 63%, while maintaining an overall tumor response rate near 95%. The study also reported over 200 adverse events with none attributed to PEDMARK, supporting tolerability. In context of recent financings and debt redemption, investors may watch future Japanese registration steps and any partnering outcomes.

Key Terms

cisplatin-induced ototoxicity, pharmacokinetic analyses, antitumor activity, American Speech-Language-Hearing Association (ASHA), +2 more

6 terms

cisplatin-induced ototoxicity medical

"evaluating PEDMARK® (sodium thiosulfate injection) for the reduction of cisplatin-induced ototoxicity"

Cisplatin-induced ototoxicity is hearing loss or ringing in the ears caused by the chemotherapy drug cisplatin damaging the inner ear. Investors should care because this side effect can limit how the drug is used, increase costs for monitoring, treatment or legal claims, and create demand for protective therapies or devices—similar to how a car model with a known safety issue can change sales, recalls, and aftermarket repair markets.

pharmacokinetic analyses medical

"Additionally, pharmacokinetic analyses demonstrated no reduction in cisplatin exposure"

Pharmacokinetic analyses study how a drug moves through the body—how it is taken in, distributed to tissues, broken down and eliminated—measuring things like how quickly and how long the compound stays at effective levels. For investors, these results act like a route-and-timing map for a medicine: they shape dosing, safety and effectiveness expectations, regulatory approval chances and market potential, so strong pharmacokinetics reduce development risk and uncertainty.

antitumor activity medical

"no evidence of adverse interaction or attenuation of antitumor activity"

Antitumor activity describes a drug, treatment, or compound’s ability to slow, shrink, or stop the growth of tumors in laboratory tests or clinical studies; think of it like how well a weed killer reduces or eliminates unwanted plants. For investors, reported antitumor activity signals the potential effectiveness and commercial value of a therapy, influences regulatory and trial progress, and helps gauge the risk and timeline for possible revenue or further development.

American Speech-Language-Hearing Association (ASHA) medical

"hearing loss (ototoxicity) as assessed by the American Speech-Language-Hearing Association (ASHA) criteria"

American Speech-Language-Hearing Association (ASHA) is the U.S. professional organization that certifies and represents speech-language pathologists and audiologists, sets clinical standards, publishes research and issues guidance on diagnosis and treatment. Investors pay attention because ASHA’s guidelines, certification rules and advocacy can shape demand, reimbursement and purchasing decisions for hearing and speech products and services—like a trusted seal that affects market access and customer trust.

Brock grade medical

"hearing loss (ototoxicity) as assessed by the American Speech-Language-Hearing Association (ASHA) criteria and Brock grade scaling"

Brock grade is a clinical risk score used to estimate the chance that a lung nodule is cancerous by combining simple factors like nodule size, patient age, and smoking history into a single number. For investors, it matters because this score guides medical decisions, testing pathways, and market adoption of imaging tools or diagnostic tests—think of it as a traffic light or checklist that helps doctors decide whether further treatment or monitoring is needed.

treatment-emergent adverse events medical

"Across more than 200 treatment-emergent adverse events reported, none were attributed"

Events or symptoms that either appear for the first time or get worse after a patient starts a treatment; think of new or intensified side effects that show up once medicine or a medical device is used. Investors watch these closely because they affect whether a therapy can gain regulatory approval, be prescribed widely, or face legal and commercial setbacks—similar to how early customer complaints can sink a new product’s prospects.

AI-generated analysis. Not financial advice.

– Study, Which Enrolled 27 Patients, Met Primary Endpoint with a Significant Reduction in Hearing Loss in 3-18 Year Old Patients who Received PEDMARK^® when Compared with Historically Reported Rates of Hearing Loss in Patients Receiving Cisplatin Alone (16-24% versus 56-63%, Respectively) –

– PEDMARK^® Showed No Interference with Cisplatin Antitumor Activity as Evidenced by an Approximate 95% Clinical Response Rate –

– The Company Plans to Pursue Registration and is Exploring Partnering or Licensing Opportunities for PEDMARK^® in Japan Based Upon These Results –

RESEARCH TRIANGLE PARK, N.C., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, today announced positive topline results from the investigator-initiated Phase 2/3 STS-J01 clinical trial evaluating PEDMARK^® (sodium thiosulfate injection) for the reduction of cisplatin-induced ototoxicity in pediatric and adolescent and young adult (AYA) patients with non-metastatic solid tumors in Japan. 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.

The study, which enrolled 27 patients in the primary cohort (patients aged 3-18 years) and 6 in exploratory cohorts and examined the addition of PEDMARK^® administered six hours after cisplatin. The primary endpoint of the study was met and the data showed that 24% and 16% of evaluable patients who were treated with PEDMARK^® experienced hearing loss (ototoxicity) as assessed by the American Speech-Language-Hearing Association (ASHA) criteria and Brock grade scaling, respectively. These rates compare favorably to the cisplatin-only arms of PEDMARK^®’s pivotal Phase 3 trials, where 56% of children developed clinically significant hearing loss using ASHA criteria (ACCL0431) and 63% developed hearing impairment defined as Brock Grade ≥1 (SIOPEL-6). Further, the study demonstrated that among the largest subgroup of patients aged 7–18 years, hearing loss occurred in only 19% (ASHA) and 14.3% (Brock).

Additionally, pharmacokinetic analyses demonstrated no reduction in cisplatin exposure, and there was no evidence of adverse interaction or attenuation of antitumor activity. The overall tumor response rate of approximately 95% confirms that PEDMARK^® does not interfere with the antitumor activity of cisplatin.

“The STS‑J01 findings add compelling support to the global clinical evidence base for PEDMARK^®,” said Pierre S. Sayad, PhD, M.S., chief medical officer of Fennec Pharmaceuticals. “Seeing such low rates of hearing loss in a real‑world, investigator‑initiated setting in Japan reinforces the consistency and magnitude of PEDMARK^®’s protective effect, which has now been demonstrated across multiple continents, tumor types and clinical settings. Importantly, the high tumor response rate and the pharmacokinetic data show that PEDMARK^® does not interfere with how cisplatin works; by six hours, the active platinum is already bound and inactive. This is a critical and highly reassuring finding for physicians, families and regulators alike.”   

PEDMARK^® was well-tolerated in the study. Across more than 200 treatment-emergent adverse events reported, none were attributed to PEDMARK^®.

“For decades in Japan, we have witnessed the profound and lifelong burden of cisplatin‑induced hearing loss among the children and young adults,” said Eiso Hiyama, M.D., lead investigator and professor in the Department of Pediatric Surgery at Hiroshima University Hospital in Hiroshima, Japan. “These encouraging results from the first large-scale pediatric and adolescent and young adults (AYA) trial in Japan demonstrate that PEDMARK^® can protect hearing without compromising cisplatin’s efficacy or introducing any concerning side effects. As a clinician, and with the current unmet medical need of cancer patients in Japan, these findings give me confidence in the effectiveness and safety of PEDMARK^® which may offer patients the chance for both survival and preserved quality of life.”

Fennec intends to pursue registration in Japan and will also explore partnering or licensing opportunities for PEDMARK^®. Full results from the study will be shared in a future scientific presentation and submitted for publication in a peer-reviewed journal.

About the STS-J01 Study
STS-J01 is a Phase 2/3, investigator-initiated, open-label, single-arm clinical trial designed to evaluate PEDMARK for the prevention of cisplatin-induced ototoxicity. The study enrolled 33 patients in two cohorts: 27 children ages 3-18 years (primary cohort), 6 infants ≥1 month to <3 years (exploratory cohort), all with localized-stage solid tumors, including neuroblastoma, hepatoblastoma, germ cell tumors, bone and soft tissue sarcomas, medulloblastoma, and atypical teratoid rhabdoid tumors. Patients received PEDMARK intravenously six hours after cisplatin infusion, with dosing adjusted by body weight. The primary endpoint was the incidence of hearing impairment at the end of treatment in the 3- to 18-year-old cohort, assessed according to American Speech-Language-Hearing Association (ASHA) criteria. Secondary endpoints included safety, antitumor efficacy, pharmacokinetics, and incidence of hearing loss as measured by Brock grading. Exploratory measures included longitudinal audiometric follow-up and validation of surrogate hearing tests.

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.^viii,ix

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.

About Fennec Pharmaceuticals
Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company committed to the fight against ototoxicity in cancer patients who receive cisplatin-based chemotherapy. Fennec is focused on the commercialization of PEDMARK^® to reduce the risk of platinum-induced ototoxicity in cancer patients. PEDMARK received FDA approval in September 2022 and European Commission approval in June 2023 and United Kingdom (U.K.) approval in October 2023 under the brand name PEDMARQSI.

In March 2024, Fennec entered into an exclusive licensing agreement under which Norgine Pharmaceuticals Ltd., a leading European specialist pharmaceutical company, will commercialize PEDMARQSI^® in Europe, U.K., Australia and New Zealand. PEDMARQSI is now commercially available in the U.K. and Germany.

PEDMARK has received Orphan Drug Exclusivity in the U.S. and PEDMARQSI has received Pediatric Use Marketing Authorization in Europe which includes eight years plus two years of data and market protection. Further, Fennec has patents providing protection for PEDMARK until 2039 in both the U.S. and internationally.

For more information, please visit www.fennecpharma.com and follow on LinkedIn.

Forward Looking Statements
Except for historical information described in this press release, all other statements are forward-looking. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include statements about our business strategy, timeline and other goals, plans and prospects, including our commercialization plans respecting PEDMARK^®/PEDMARQSI^®, the market opportunity for and market impact of PEDMARK^®/ PEDMARQSI^®, its potential impact on patients and anticipated benefits associated with its use, and future commercial and regulatory milestones, and potential access to further funding after the date of this release. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including the risks and uncertainties that regulatory and guideline developments may change, scientific data and/or manufacturing capabilities may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, unforeseen global instability, including political instability, or instability from an outbreak of pandemic or contagious disease, such as the novel coronavirus (COVID-19), or surrounding the duration and severity of an outbreak, protection offered by the Company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company’s products will not be as large as expected, the Company’s products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, our ability to obtain necessary capital when needed on acceptable terms or at all, the Company may not meet its future capital requirements in different countries and municipalities, and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2024. Fennec disclaims any obligation to update these forward-looking statements except as required by law.

For a more detailed discussion of related risk factors, please refer to our public filings available at www.sec.gov and www.sedar.com.

PEDMARK^® PEDMARQSI^® and Fennec^® are registered trademarks of Fennec Pharmaceuticals Inc.

©2025 Fennec Pharmaceuticals Inc. All rights reserved. FEN-1604-v1

For further information, please contact:

Investors:
Robert Andrade
Chief Financial Officer
Fennec Pharmaceuticals Inc.
+1 919-246-5299

Corporate and Media:
Lindsay Rocco
Elixir Health Public Relations
+1 862-596-1304
lrocco@elixirhealthpr.com

_________________

_{ⁱ Rybak L. Mechanisms of Cisplatin Ototoxicity and Progress in Otoprotection. Current Opinion in Otolaryngology & Head and Neck Surgery. 2007, Vol. 15: 364-369.
ⁱⁱ Langer T, am Zehnhoff-Dinnesen A, Radtke S, Meitert J, Zolk O. Trends Pharmacol Sci. 2013;34(8):458-469
ⁱⁱⁱ Landier W. Ototoxicity and Cancer Therapy. Cancer. June 2016 Vol. 122, No.11: 1647-1658.
^iv Clemens E, van den Heuvel-Eibrink MM, Mulder RL, et al. Recommendations for ototoxicity surveillance for childhood, adolescent, and young adult cancer survivors: a report from the International Late Effects of Childhood Cancer Guideline Harmonization Group in collaboration with the PanCare Consortium. Lancet Oncol. 2019;20(1):e29-e41
^v Bass JK, Knight KR, Yock TI, Chang KW, Cipkala D, Grewal SS. Evaluation and management of hearing loss in survivors of childhood and adolescent cancers: a report from the children’s oncology group. Pediatr Blood Cancer. 2016;63(7):1152-1162.
^vi Chattaraj A et al. Cisplatin-Induced Ototoxicity: A Concise Review of the Burden, Prevention, and Interception Strategies. JCO Oncol Pract. 2023;19
^vii Freyer DR et al. Effects of sodium thiosulfate versus observation on development of cisplatin-induced hearing loss in children with cancer (ACCL0431): a multicentre, randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2017;18(1):63-74.
^viii Rajput K, Edwards L, Brock P, Abiodun A, Simpkin P, Al-Malky G. Ototoxicity-induced hearing loss and quality of life in survivors of paediatric cancer. Int J Pediatr Otorhinolaryngol. 2020;138:110401. doi:10.1016/j.ijporl.2020.110401
^ix Bass JK, Knight KR, Yock TI, Chang KW, Cipkala D, Grewal SS. Evaluation and management of hearing loss in survivors of childhood and adolescent cancers: a report from the children’s oncology group. Pediatr Blood Cancer. 2016;63(7):1152-1162.}

FAQ

What were the PEDMARK® hearing loss rates in the STS-J01 trial reported Dec 2, 2025 for FENC?

In the primary cohort (ages 3–18), hearing loss was 24% (ASHA) and 16% (Brock).

How do FENC’s STS-J01 PEDMARK® results compare to historical cisplatin rates?

Reported PEDMARK® rates of 24% (ASHA) and 16% (Brock) compare with historical cisplatin‑only rates of 56% (ASHA) and 63% (Brock).

Did PEDMARK® affect cisplatin anticancer activity in FENC’s Japan study?

No; pharmacokinetic data showed no reduction in cisplatin exposure and tumor response was ~95%.

What is Fennec’s regulatory plan for PEDMARK® in Japan after the Dec 2, 2025 results?

Fennec intends to pursue registration in Japan and explore partnering or licensing opportunities.

How large was the STS-J01 primary cohort in the PEDMARK® Japan study for FENC?

The primary cohort enrolled 27 patients aged 3–18 years.