Fennec Pharmaceuticals Announces Settlement Agreement Resolving PEDMARK Patent Litigation

Rhea-AI Summary

Fennec Pharmaceuticals (NASDAQ:FENC) announced a settlement with Cipla resolving PEDMARK patent litigation. The lawsuit will be dismissed and Cipla agrees not to market a generic sodium thiosulfate product until September 1, 2033, subject to earlier entry under certain circumstances. PEDMARK is FDA‑approved to reduce cisplatin‑related ototoxicity in pediatric patients ≥1 month; pivotal Phase 3 data and safety rates are summarized in prescribing information.

Positive

• Generic entry delayed to Sept 1, 2033
• Lawsuit dismissal with each party bearing its own costs
• Pivotal Phase 3 data supporting indicated use

Negative

• Settlement allows earlier generic entry under certain circumstances
• Hypernatremia observed in 12%–26% of clinical trial patients
• Hypokalemia observed in 15%–27% of clinical trial patients

Key Figures

Eligible cancer patients: 500,000 patients/year Hypersensitivity incidence: 8%–13% Hypernatremia incidence: 12%–26% +5 more

8 metrics

Eligible cancer patients 500,000 patients/year U.S. cancers annually that could be treated with platinum-based chemotherapy

Hypersensitivity incidence 8%–13% Hypersensitivity reactions in PEDMARK clinical trials

Hypernatremia incidence 12%–26% Hypernatremia cases reported in PEDMARK clinical trials

Hypokalemia incidence 15%–27% Hypokalemia cases in PEDMARK clinical trials

Severe hypokalemia 9%–27% Grade 3 or 4 hypokalemia in PEDMARK clinical trials

Cisplatin infusion limit 6 hours Safety and efficacy not established for cisplatin infusions longer than this

GFR threshold 60 mL/min/1.73m2 Renal function level triggering closer monitoring for electrolyte issues

Generic entry date September 1, 2033 Earliest date Cipla may enter U.S. market under settlement terms

Market Reality Check

Price: $7.52 Vol: Volume 86,014 is below 20...

low vol

$7.52 Last Close

Volume Volume 86,014 is below 20-day average 126,962 (relative volume 0.68x) ahead of this news. low

Technical Shares at 7.52 were trading below the 200-day MA of 8.27 before the announcement.

Peers on Argus

Pre-news, FENC screened as moving up in the momentum scanner, while key biotech ...

Pre-news, FENC screened as moving up in the momentum scanner, while key biotech peers like IMMP (-11.89%), CADL (-7.54%), and NMRA (-5.36%) were down. Mixed to negative peer moves suggest this litigation settlement is stock-specific rather than a sector-wide driver.

Historical Context

5 past events · Latest: 2026-03-04 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
2026-03-04	Clinical collaboration	Positive	+2.5%	New real-world collaboration on PEDMARK use in AYA and adult patients.
2026-02-20	Real-world data	Positive	-0.5%	Adult head & neck cancer data supporting safe integration of PEDMARK.
2025-12-26	Holder share sale	Negative	-4.9%	Southpoint sold 1,000,000 shares, cutting its ownership stake.
2025-12-09	New trial	Positive	+1.3%	City of Hope to run Phase I study in metastatic testicular cancer.
2025-12-02	Clinical results	Positive	-1.6%	Positive Phase 2/3 Japan data showing reduced hearing loss with PEDMARK.

Pattern Detected

Recent PEDMARK-focused positive news has produced a mix of aligned and contrary price reactions, with both gains and modest pullbacks following favorable updates.

Recent Company History

Over the last several months, Fennec’s news flow has centered on expanding and validating PEDMARK® across settings. On Dec 2, 2025, positive topline Phase 2/3 data from Japan showed reduced cisplatin-induced hearing loss, yet shares slipped modestly. Subsequent investigator‑sponsored adult trials and real-world data presentations in early 2026 underscored safety and hearing preservation, with mixed stock responses. A Southpoint share sale on Dec 26, 2025 coincided with a sharper decline. Today’s patent litigation settlement complements this pattern of de‑risking around PEDMARK’s franchise.

Market Pulse Summary

This announcement clarifies PEDMARK’s competitive landscape by resolving litigation and delaying a g...

Analysis

This announcement clarifies PEDMARK’s competitive landscape by resolving litigation and delaying a generic entrant until September 1, 2033, helping define the branded product’s U.S. exclusivity window. It underscores PEDMARK’s role as the only FDA‑approved therapy to reduce cisplatin‑related ototoxicity in pediatric patients, supported by two Phase 3 studies. Investors may track future real-world data, additional indications, safety findings such as electrolyte disturbances, and any new trials or partnerships as key drivers for the PEDMARK franchise.

Key Terms

ototoxicity, cisplatin, Phase 3, National Comprehensive Cancer Network, +1 more

5 terms

ototoxicity medical

"indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric"

Ototoxicity is damage to the inner ear caused by certain drugs or chemicals that can impair hearing and balance, ranging from temporary ringing to permanent hearing loss. Investors should care because ototoxic effects can limit a medical product’s marketability, trigger stricter safety testing, slow approvals, increase legal and treatment costs, and hurt sales—similar to a car defect that makes a model unsafe and forces recalls or redesigns.

cisplatin medical

"ototoxicity associated with cisplatin treatment in pediatric patients 1 month of age and older"

Cisplatin is a widely used chemotherapy drug containing platinum that kills cancer cells by binding to their DNA and preventing the cells from copying and repairing themselves. Investors pay attention to cisplatin because its patent status, clinical use, side effects, manufacturing costs and inclusion in treatment guidelines influence demand, sales and liability risk for drug makers and hospitals — think of it as a powerful tool whose availability and reputation can shift a company's revenue like a key product line.

Phase 3 medical

"across two open-label, randomized Phase 3 clinical studies, the Children’s Oncology Group"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

National Comprehensive Cancer Network medical

"recommended for the adolescent and young adult (AYA) population by the National Comprehensive Cancer Network"

A coalition of major cancer centers and experts that develops widely used, evidence-based treatment guidelines for oncology care. Its recommendations act like a trusted rulebook or roadmap for doctors, insurers and hospitals, so updates can change which therapies get prescribed, reimbursed or adopted—making it an important influence on drug uptake, clinical trial value and healthcare company prospects.

glomerular filtration rate medical

"Monitor for signs and symptoms of hypernatremia and hypokalemia more closely if the glomerular filtration rate"

Glomerular filtration rate (GFR) measures how well the kidneys filter waste from blood, expressed as the volume of blood cleared per minute; think of it like the flow rate through a coffee filter that tells you how quickly liquid is being cleaned. Investors care because GFR is a key clinical metric used to gauge patient health, determine drug dosing, qualify participants for trials, and influence regulatory decisions and market size for treatments related to kidney function.

AI-generated analysis. Not financial advice.

RESEARCH TRIANGLE PARK, N.C., March 16, 2026 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, today announces that it has entered into an agreement with Cipla Limited and Cipla USA, Inc. to settle the litigation between them regarding Cipla’s application to FDA for approval to market a generic version of Fennec’s PEDMARK® (sodium thiosulfate injection) product. See Fennec Pharmaceuticals Inc. v. Cipla Limited and Cipla USA, Inc., C.A. No. 2:23-cv-00123-JKS-MAH (D.N.J.). Under the terms of the agreement, the lawsuit will be dismissed with each party bearing their own costs, and Cipla will not enter the market with its generic sodium thiosulfate product until September 1, 2033, or earlier under certain circumstances.

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.^1,2 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.^3,4

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^Ò.

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, 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, 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.

©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 Chattaraj A et al. Cisplatin-Induced Ototoxicity: A Concise Review of the Burden, Prevention, and Interception Strategies. JCO Oncol Pract. 2023;19
² 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.
³ 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
⁴ 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 does the FENC settlement with Cipla mean for PEDMARK market exclusivity?

It delays Cipla's generic launch until September 1, 2033, preserving market exclusivity near term. According to the company, the agreement dismisses litigation and bars Cipla from entering the market until that date, except under specified earlier conditions.

Will the FENC v. Cipla lawsuit be dismissed and who pays legal costs?

Yes — the lawsuit will be dismissed with each party bearing its own costs. According to the company, the settlement resolves litigation and allocates legal expenses to each side without cost awards.

What is PEDMARK's FDA indication described by Fennec (FENC)?

PEDMARK is indicated to reduce cisplatin‑related ototoxicity in pediatric patients one month and older with localized, non‑metastatic solid tumors. According to the company, approval is supported by two Phase 3 studies and NCCN 2A recommendation for AYA patients.

What safety risks for PEDMARK did Fennec highlight that investors should note?

Clinical trials reported hypernatremia in 12%–26% and hypokalemia in 15%–27% of patients. According to the company, monitoring of serum sodium and potassium is recommended and some events reached Grade 3 or 4 severity.

Can Cipla enter the PEDMARK market before September 1, 2033 under the settlement terms?

Possibly — Cipla may enter earlier under defined circumstances in the agreement. According to the company, the settlement delays entry until 2033 but preserves specific conditions that could permit earlier market entry.