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 (FENC) delivers innovative therapies targeting cisplatin-induced hearing loss in pediatric cancer patients. This news hub provides investors and healthcare professionals with essential updates on clinical advancements, regulatory milestones, and strategic partnerships.
Access timely reports on PEDMARK® development progress, including FDA communications and international commercialization efforts through European licensing agreements. Our curated news collection ensures you stay informed about pivotal Phase III trial outcomes and market expansion initiatives without promotional bias.
Key updates include earnings announcements, research publications, manufacturing developments, and conference participation details. All content undergoes rigorous verification to maintain compliance with financial disclosure standards and medical reporting best practices.
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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.
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