Fennec Pharmaceuticals

What Fennec Pharmaceuticals does

Fennec Pharmaceuticals Inc. is a U.S.-incorporated, publicly traded (NASDAQ: FENC; TSX: FRX) specialty pharmaceutical company headquartered in Research Triangle Park, North Carolina, with a singular commercial focus on reducing ototoxicity (irreversible hearing loss) caused by cisplatin-based chemotherapy in cancer patients. The company's core product is PEDMARK® (sodium thiosulfate injection), the first and only FDA-approved therapy indicated to reduce the risk of cisplatin-induced ototoxicity in pediatric patients aged one month and older with localized, non-metastatic solid tumors; the same active ingredient is marketed as PEDMARQSI® in the European Union and United Kingdom following EC authorization in June 2023 and UK MHRA approval in October 2023. PEDMARK is delivered as a single-dose, ready-to-use intravenous vial administered approximately six hours after cisplatin dosing, and is supported by two Phase 3 studies (COG ACCL0431 and SIOPEL 6) showing hearing-loss incidence reductions from 56–67% (cisplatin alone) to 29–35% (cisplatin + PEDMARK).

Fennec generates revenue primarily through direct net product sales of PEDMARK in the United States, where it maintains a field sales organization targeting academic medical centers, large community oncology practices, and hospital systems, supplemented by the Fennec HEARS® patient services hub to support prescribing, access, and adherence. Ex-U.S. commercialization of PEDMARQSI is executed via an exclusive licensing partnership with Norgine Pharmaceuticals covering Europe, the UK, Australia, and New Zealand, under which Fennec received a €40 million upfront payment in March 2024 and is eligible for up to €210 million in additional commercial and regulatory milestones plus tiered royalties up to the mid-twenties on net sales. International expansion is being pursued through an investigator-initiated Japanese Phase 2/3 study (STS-J01), with positive topline results reported in December 2025 and plans for registration and licensing in Japan.

Fennec's commercial momentum is visible in its financial trajectory: FY2025 net product sales reached $44.6 million (50% YoY growth from $29.6 million in FY2024), and Q1 2026 net product sales of $15.1 million represented 73% YoY growth. Following a November 2025 underwritten public offering of $40.25 million at $7.50 per share (plus a concurrent $5.025 million Canadian private placement), Fennec fully redeemed all outstanding Petrichor convertible notes, leaving the company debt-free with $40.1 million in cash and cash equivalents as of March 31, 2026. The company's competitive position is protected by a multi-layered regulatory moat — FDA Orphan Drug Exclusivity, EU Pediatric Use Marketing Authorization (8+2 years), U.S. and international patents through 2039, and a March 2026 patent litigation settlement with Cipla that delays potential generic entry until at least September 1, 2033. Clinical research collaborations with City of Hope, Tampa General Hospital/USF Health, and the University of Arizona Cancer Center are generating evidence to support label expansion into adolescent, young adult, and adult populations beyond the current pediatric indication.

Name

Fennec Pharmaceuticals

Legal name

Fennec Pharmaceuticals Inc.

Website

https://fennecpharma.com

Company type

Public

Founded year

2009

Operating status

Operating

Headcount range

11–50 employees

Short description

Fennec Pharmaceuticals is a U.S. specialty pharmaceutical company that develops and commercializes PEDMARK, the first and only FDA-approved therapy to reduce cisplatin-induced hearing loss in pediatric cancer patients, selling through a direct U.S. field sales force and an ex-U.S. licensing partnership with Norgine Pharmaceuticals.

Ownership category

akta.pro rank

Product category

Specialty Pharmaceuticals (Pediatric Oncology / Chemoprotection)

NAICS

Pharmaceutical Preparation Manufacturing (325412), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Neurology & CNS Specialty Pharmaceuticals (HLAIACAC)

Keywords

• Specialty pharmaceuticals
• Otoprotective therapy
• Pediatric oncology drugs
• Cisplatin ototoxicity
• Chemoprotective agents

Headquarters

HQ city

Durham

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D, Supply Chain

Revenue model

1. PEDMARK Product Sales: Direct net product sales of PEDMARK in the United States, generating $44.6 million in 2025 (50% year-over-year growth). Revenue from selling PEDMARK to hospitals and oncology practices treating pediatric cancer patients receiving cisplatin.
2. Licensing Royalties from Norgine: Receives €40 million upfront payment plus up to €210 million in commercial and regulatory milestones, and double-digit tiered royalties up to mid-twenties on net sales of PEDMARQSI in Europe, Australia and New Zealand.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels4 records

Core offering

Fennec Pharmaceuticals develops and commercializes PEDMARK (sodium thiosulfate injection), the first and only FDA-approved therapy to reduce the risk of ototoxicity (hearing loss) in pediatric cancer patients 1 month of age and older receiving cisplatin-based chemotherapy for localized, non-metastatic solid tumors. Internationally, the product is marketed as PEDMARQSI in the EU and UK under an exclusive licensing agreement with Norgine Pharmaceuticals. The company also operates Fennec HEARS, a patient services hub that supports access, enrollment, and ongoing utilization of PEDMARK.

Product overview

Fennec Pharmaceuticals is a specialty pharmaceutical company with a single commercial product: PEDMARK® (sodium thiosulfate injection), the first and only FDA-approved therapy to reduce the risk of ototoxicity (hearing loss) in pediatric cancer patients receiving cisplatin-based chemotherapy. Internationally, the same product is marketed as PEDMARQSI® in Europe and the UK under an exclusive licensing agreement with Norgine Pharmaceuticals. The company also operates Fennec HEARS®, a patient services program supporting PEDMARK® utilization. The portfolio is focused on addressing cisplatin-induced ototoxicity in cancer patients, with ongoing clinical research expanding into adolescent, young adult, and adult populations beyond the initial pediatric indication.

Differentiator

Problem solved

Functional benefit

Brands

• Fennec HEARS: Patient services hub providing support for patients prescribed PEDMARK
• PEDMARK
• PEDMARQSI

Products and services

• PEDMARK (sodium thiosulfate injection) PEDMARK is the first and only FDA-approved therapy to reduce the risk of ototoxicity (hearing loss) associated with cisplatin chemotherapy in pediatric patients aged 1 month 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 administration, given approximately six hours after cisplatin dosing without interfering with antitumor efficacy. It is sold in the United States directly to pediatric oncology hospitals, academic medical centers, and large community oncology practices.
• PEDMARQSI (sodium thiosulfate injection) PEDMARQSI is the international (EU and UK) brand name for sodium thiosulfate injection, the same active ingredient and formulation as PEDMARK. It is approved in the European Union (June 2023) and United Kingdom (October 2023) for reducing the risk of cisplatin-induced ototoxicity in pediatric patients and is commercialized in Europe, the UK, Australia, and New Zealand exclusively by Norgine Pharmaceuticals under a licensing agreement.
• Fennec HEARS Patient Services Hub Fennec HEARS is a comprehensive patient services hub that supports PEDMARK utilization by providing patient enrollment assistance, access support, insurance navigation, and ongoing patient management services. It is targeted at pediatric oncology patients, their families, and the healthcare providers prescribing PEDMARK.

Quantifiable outcome

• Hearing loss reduced from 56-63% to 16-24% in pediatric patients receiving PEDMARK vs cisplatin alone (Japanese STS-J01 study, 27 patients)
• +3 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature1 record

Partnerships

Four partnerships are on record, tiered core.

• University of Arizona Cancer CentercoreStrategic or Co-development Partner · 7 April 2026Investigator-sponsored study evaluating use of PEDMARK in AYA and adult patients with head and neck and testicular cancers receiving cisplatin. Study aims to assess efficacy of sodium thiosulfate to reduce cisplatin-induced hearing impairment.
• Tampa General Hospital Cancer InstitutecoreStrategic or Co-development Partner · 4 March 2026Clinical research collaboration to conduct real-world evaluation study of PEDMARK in reducing risk of ototoxicity in adolescent, young adult, and adult cancer patients receiving cisplatin chemotherapy. Collaboration includes USF Health Morsani College of Medicine.
• City of HopecoreStrategic or Co-development Partner · 9 December 2025Investigator-sponsored trial evaluating PEDMARK to prevent cisplatin-induced ototoxicity in adult men with metastatic testicular germ cell tumors. Study assesses whether adding PEDMARK to standard chemotherapy reduces hearing loss.
• Norgine Pharmaceuticals Ltd.coreChannel Partner/ Reseller/ Distributor · 17 March 2024Exclusive licensing agreement for commercialization of PEDMARQSI in Europe, UK, Australia, and New Zealand. Fennec received €40 million upfront and is eligible for up to €210 million in additional commercial and regulatory milestones, plus double-digit tiered royalties up to mid-twenties on net sales. Norgine is responsible for all commercialization activities and holds all marketing authorizations in licensed territories.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Recordati Rare Diseases: Diversified specialty pharmaceutical group with a rare disease and oncology supportive care franchise. Comparable in commercial focus on rare/oncology indications and reliance on hospital/specialty distribution channels.
• CASI Pharmaceuticals: Small-cap specialty pharmaceutical company commercializing oncology and supportive-care products, primarily through in-licensing from China. Comparable size and business model as a small public specialty pharma with a focused oncology product portfolio.
• Heron Therapeutics: Specialty pharmaceutical company focused on oncology supportive care and pain management, with products like SUSTOL and CINVANTI. Comparable business model as a single-product (or limited-portfolio) specialty pharma commercializing through hospital/oncology channels.
• Jazz Pharmaceuticals: Global specialty biopharmaceutical company with significant oncology franchise, including products acquired from Gentium (defibrotide). Relevant as a broader specialty pharma that built franchise through targeted oncology and supportive care assets.

Others

• Ligand Pharmaceuticals: Biopharmaceutical company that captures royalty and milestone streams from approved drugs through licensing arrangements. Comparable as a royalty-driven specialty pharma with revenue streams tied to partner commercialization efforts.
• Norgine Pharmaceuticals: European specialty pharmaceutical company and Fennec's exclusive licensing partner for PEDMARQSI. Norgine is not a direct competitor but a critical distribution and commercialization partner for Fennec's European and Asia-Pacific territories.

Emerging players

• Sound Pharmaceuticals: Privately-held clinical-stage biopharmaceutical company developing ebselen (SPI-1005) for the prevention and treatment of sensorineural hearing loss, including cisplatin-induced ototoxicity. Directly comparable to Fennec in target indication (cisplatin otoprotection), though PEDMARK is approved and SPI-1005 is still in development.
• Otonomy: Clinical-stage biopharmaceutical company developing therapeutics for otology (ear-related) disorders. Comparable technology/category focus on hearing-related conditions, though Otonomy targets inner ear delivery rather than systemic cisplatin otoprotection.
• Auris Medical: Clinical-stage company developing therapeutics for hearing loss and tinnitus. Comparable in therapeutic focus area (hearing-related indications), though Auris targets noise-induced and idiopathic hearing loss rather than ototoxicity.

Direct peers

• Helsinn Group: Privately-held specialty pharma focused on cancer supportive care and dermatology, with a global licensing-led business model similar to Fennec's structure. Comparable in operating model, focus on oncology supportive care, and reliance on out-licensing partnerships for international commercialization.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/FennecPharma
• LinkedInlinkedin.com/company/fennec-pharmaceuticals-inc
• Instagraminstagram.com/fennec_official

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Funding overview

Funding rounds9 records

Investors2 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Fennec Pharmaceuticals