# Fennec Pharmaceuticals

Fennec Pharmaceuticals is an Asset Manager based in Research Triangle Park, United States.

## Overview

- **Organization type:** Asset Manager
- **Headquarters:** Research Triangle Park, United States
- **Region:** North America
- **Address:** Research Triangle Park, NC, United States
- **Founded:** 1996
- **Assets under management:** Undisclosed
- **Website:** fennecpharma.com

## Regulatory record

- **Reports private funds:** No

## About

Fiercely devoted to the fight against ototoxicity in pediatric cancer patients who receive cisplatin-based chemotherapy. | Fiercely dedicated to the fight against cisplatin-induced ototoxicity.

## Sectors

- Healthcare Services

## People

- Rostislav Raykov — Chief Executive Officer
- Robert Andrade — Chief Financial Officer

## Questions

### What does Fennec Pharmaceuticals actually sell?

Fennec sells Pedmark, an FDA-approved formulation of sodium thiosulfate that reduces the risk of hearing loss in children receiving cisplatin-based chemotherapy for localized solid tumors. The drug received US approval in September 2022 and remains the company's sole commercial product. No other approved therapies directly address cisplatin-induced ototoxicity in the pediatric population.

### Why does Fennec have only one drug in its pipeline?

Fennec's business model centers on a single asset, Pedmark, rather than a diversified pipeline. The company has pursued label expansion opportunities for the same molecule — such as additional pediatric indications and cisplatin-related hearing loss in other cancer types — rather than acquiring or developing unrelated compounds. This concentration reflects a deliberate bet that Pedmark's first-mover advantage in an unserved niche generates sufficient return without dilutive diversification.

### How does Fennec generate revenue outside the United States?

Fennec uses an out-licensing model for non-US territories. In 2021, the company granted Norgine exclusive rights to commercialize Pedmark in Europe, Australia, and New Zealand, with Fennec receiving milestone payments and royalties on sales. This asset-light approach reduces the capital burden of building an international sales force while retaining full US commercial operations.

### Who are Fennec's direct competitors?

Pedmark currently faces no direct approved competitors for preventing cisplatin-induced hearing loss in pediatric patients. Indirect alternatives include audiological monitoring, cochlear implants, or dose reductions in chemotherapy — none of which prevent the underlying ototoxic damage. This therapeutic moat depends on Pedmark remaining the only approved pharmacologic option, a position vulnerable to any new entrant targeting the same FDA label.

### What was Fennec's path to FDA approval?

Fennec completed two pivotal Phase 3 trials, SIOPEL 6 and COG ACCL0431, which studied sodium thiosulfate in pediatric patients receiving cisplatin. The FDA accepted the New Drug Application in 2020 and issued a Complete Response Letter later that year due to manufacturing deficiencies, not clinical data. After resolving those issues, Fennec received approval in September 2022 following a split advisory committee vote that ultimately endorsed the risk-benefit profile (per FDA records, 2022).

## Related profiles

- [HCM III Acquisition Corp.](https://altss.com/profile/hcm-iii-acquisition-corp)

---

Last updated: 2026-06-03T20:00:00.000Z

Canonical page: https://altss.com/profile/fennec-pharmaceuticals-inc

Maintained by Altss — https://altss.com — methodology: https://altss.com/methodology