Fennec Pharmaceuticals Announces Acceptance of Abstracts at the 2026 ASCO Annual Meeting
Rhea-AI Summary
Fennec Pharmaceuticals (NASDAQ: FENC) announced four abstracts evaluating PEDMARK® (sodium thiosulfate) were accepted to the 2026 ASCO Annual Meeting, May 29–June 2, 2026, in Chicago. Two items are poster presentations and two are abstract-only publications.
PEDMARK is approved for pediatric patients one month and older and carries a NCCN 2A recommendation for adolescent and young adult patients. Full abstracts will be available on the ASCO website on May 21, 2026 at 5:00 p.m. ET.
Positive
- Four abstracts accepted to ASCO 2026 (May 29–June 2)
- PEDMARK approved for pediatric patients one month and older
- NCCN 2A recommendation for adolescent and young adult patients
- Two scheduled poster presentations at ASCO (May 31, June 1)
Negative
- Two abstracts listed as abstract-only (no scheduled poster session)
News Market Reaction – FENC
In the Apr 22 session, FENC gained 2.14%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Apr 07 | Investigator study | Positive | -1.6% | New investigator-sponsored Phase I/II PEDMARK study in broader cancer populations. |
| Mar 31 | Equity inducement grants | Neutral | +6.6% | Stock option inducement grants to 24 new non-executive employees. |
| Mar 24 | FY2025 earnings | Positive | -19.2% | Strong FY2025 sales growth, equity raise, debt paydown and business update. |
| Mar 18 | Earnings date notice | Neutral | -3.7% | Announcement of timing for FY2025 and Q4 2025 financial results release. |
| Mar 16 | Patent settlement | Positive | +5.0% | Settlement with Cipla delaying generic sodium thiosulfate entry until 2033. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent history shows several positive or constructive updates (earnings growth, litigation settlement, new studies) sometimes met with negative price reactions, indicating a tendency for the stock to sell off or underreact to good news.
Over the past months, Fennec has focused on expanding PEDMARK’s clinical and commercial footprint. On Mar 16, 2026, the company settled PEDMARK patent litigation with Cipla, which restricted generic entry until Sep 1, 2033, and the stock rose about 5%. The FY2025 earnings release on Mar 24, 2026 highlighted strong revenue growth and debt elimination but coincided with a nearly 19% decline. Subsequent news on investigator‑sponsored studies (Apr 7, 2026) also saw a modest negative reaction. Today’s ASCO abstract acceptances continue the theme of building real‑world and clinical evidence around PEDMARK.
Key Terms
cisplatin-induced hearing loss medical
ototoxicity medical
american society of clinical oncology medical
asco medical
national comprehensive cancer network medical
phase 1 trial medical
randomized medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
– Data from Four Studies Spotlight Rising Clinical Interest & Urgency to Address Cisplatin-Induced Hearing Loss and Its Lasting Impact on Patients –
RESEARCH TRIANGLE PARK, N.C., April 21, 2026 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, today announced that four abstracts evaluating PEDMARK® (sodium thiosulfate injection) were accepted as part of the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting program, taking place May 29-June 2, 2026 in Chicago, IL.
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.
Poster Presentation Details:
Title: Effects of Delayed Sodium Thiosulfate on Cisplatin-Induced Ototoxicity in Pediatric and Adolescent Patients with Cancer: Results from the Japanese Children’s Cancer Group STS-J01 Study
Poster Session: Pediatric Oncology
Date and Time: June 1, 2026, 1:30 PM - 4:30 PM CT
Abstract Number: 10052
Lead Author: Eiso Hiyama, MD, professor in the Department of Pediatric Surgery at Hiroshima University Hospital in Hiroshima, Japan
Title: Randomized Phase 1 Trial of Cisplatin-Based Chemotherapy With or Without Sodium Thiosulfate for Men with Metastatic Germ Cell Tumor (GCT)
Poster Session: Genitourinary Cancer—Prostate, Testicular, and Penile
Date and Time: May 31, 2026, 9:00 AM - 12:00 PM CT
Abstract Number: TPS5131
Lead Author: Koral Shah, MD, Hematology/Oncology chief fellow, City of Hope
Abstract-Only Publication Details:
Title: Real-World Feasibility and Tolerability of PEDMARK® for Otoprotection in Young Adults Receiving Cisplatin for Solid Tumors.
Abstract Number: e24189
Lead Author: Veronica Alana Vestal, MD, Comprehensive Cancer Center of University of Puerto Rico
Title: Audiometric Outcomes for Intravenous Sodium Thiosulfate for Cisplatin-Induced Ototoxicity Prevention in Adults with Head and Neck Cancer
Abstract Number: e18110
Lead Author: James Johns, MD, Icahn School of Medicine at Mount Sinai, New York
The full abstracts will be available on the ASCO® website on May 21, 2026, at 5:00 p.m. ET.
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.1
Hearing loss from cisplatin treatment is not rare. Studies show that between 60
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.6,7 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.89
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
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
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 (≥
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, with rights to 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.
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, future commercial and regulatory milestone and royalty payments from Norgine, 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, 2025. 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.
®2026 Fennec Pharmaceuticals Inc. All rights reserved.
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
1 Rybak L. Mechanisms of Cisplatin Ototoxicity and Progress in Otoprotection. Current Opinion in Otolaryngology & Head and Neck Surgery. 2007, Vol. 15: 364-369.
2 Langer T, am Zehnhoff-Dinnesen A, Radtke S, Meitert J, Zolk O. Trends Pharmacol Sci. 2013;34(8):458-469
3 Landier W. Ototoxicity and Cancer Therapy. Cancer. June 2016 Vol. 122, No.11: 1647-1658.
4 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
5 . 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.
6 Chattaraj A et al. Cisplatin-Induced Ototoxicity: A Concise Review of the Burden, Prevention, and Interception Strategies. JCO Oncol Pract. 2023;19
7 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.
8 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
9 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.
