Welcome to our dedicated page for Fennec Pharmaceuticals news (Ticker: FENC), a resource for investors and traders seeking the latest updates and insights on Fennec Pharmaceuticals stock.
Fennec Pharmaceuticals Inc. (NASDAQ: FENC) is a commercial-stage biopharmaceutical company dedicated to developing innovative therapies for the treatment of cancer. Based in Research Triangle Park, North Carolina, Fennec Pharmaceuticals has a significant focus on addressing unmet medical needs in pediatric oncology.
The company’s lead product, PEDMARK, is a novel formulation of sodium thiosulfate designed to prevent cisplatin-induced hearing loss (ototoxicity) in children. Cisplatin is a chemotherapy drug that, while effective, can cause irreversible hearing damage in pediatric patients. PEDMARK has successfully completed Phase III clinical trials and received FDA approval, making it the first and only therapy indicated to reduce the risk of ototoxicity in pediatric patients aged 1 month and older with localized, non-metastatic solid tumors.
Fennec Pharmaceuticals was originally founded as Adherex Technologies Inc. in 1996 and underwent a name change to its current identity in September 2014. The company has recently announced a series of significant developments, including:
- Hosting quarterly conference calls to discuss financial results and business outlooks.
- Entering an exclusive licensing agreement with Norgine to commercialize PEDMARQSI® (the European branding of PEDMARK) in Europe, Australia, and New Zealand. Under this partnership, Fennec will receive up to €250 million in milestone payments and royalties.
- Receiving EU marketing authorization for PEDMARQSI in June 2023 and UK approval in October 2023.
These strategic moves demonstrate Fennec's commitment to expanding its reach and impact in the global market. The company continues to work diligently to ensure that its life-saving therapies are accessible to as many patients as possible. The operational and financial strength of Fennec Pharmaceuticals, coupled with its pioneering product, positions the company as a significant player in the biopharmaceutical industry.
For the latest updates, investors and stakeholders can access conference call information, news releases, and financial reports on the company’s website. Fennec's investor relations team, led by CFO Robert Andrade, is available for any inquiries.
Fennec Pharmaceuticals announced a significant milestone with the positive opinion from the CHMP for Pedmarqsi™ (sodium thiosulfate), aimed at reducing the risk of cisplatin-induced hearing loss in pediatric patients diagnosed with localized, non-metastatic solid tumors. This potential approval marks Pedmarqsi as the first therapy in the EU targeting this critical unmet need, following its FDA approval in the U.S. in September 2022. Clinical trials demonstrated a significant reduction in hearing loss incidences with Pedmarqsi alongside cisplatin. The European Commission's ratification is anticipated by early June 2023, which could benefit approximately 5,000 eligible children annually.
Fennec Pharmaceuticals reported its fiscal year 2022 results, highlighting FDA approval of PEDMARK® in September 2022 as a significant milestone. The company reported net product sales of $1.54 million and a gross profit of $1.4 million. Cash and cash equivalents increased to approximately $23.8 million, sufficient to fund planned activities for 2023. However, Fennec posted a net loss of $23.7 million for the year, up from $17.3 million in 2021, reflecting rising operational costs. Looking forward, Fennec aims to expand the prescriber base and utilization of PEDMARK® while navigating increased expenses due to headcount growth and marketing efforts.
Fennec Pharmaceuticals has announced that the FDA granted Orphan Drug Exclusivity for PEDMARK® (sodium thiosulfate injection), aimed at reducing the risk of cisplatin-related ototoxicity in pediatric patients with localized, non-metastatic solid tumors. This exclusivity provides seven years of market protection, commencing from its approval date on September 20, 2022. Furthermore, PEDMARK® is supported by three U.S. patents extending its protection until 2039. The drug stands as the sole FDA-approved option for this indication, backed by clinical studies demonstrating its efficacy. This exclusivity positions Fennec to potentially capitalize on a market of over 10,000 children annually receiving cisplatin treatment.
Fennec Pharmaceuticals Inc. (NASDAQ: FENC) announced that the National Comprehensive Cancer Network has updated its guidelines to include PEDMARK as a key therapy for reducing ototoxicity caused by cisplatin in pediatric patients with localized, non-metastatic solid tumors. Following its FDA approval in September 2022, PEDMARK offers a critical mitigation strategy for hearing loss, which affects up to 90% of children undergoing cisplatin treatment. The update highlights the growing recognition of the need to preserve hearing in young patients, as permanent hearing loss can significantly impact learning and development.
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