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. reports developments as a commercial-stage specialty pharmaceutical company focused on PEDMARK® (sodium thiosulfate injection), a therapy used to reduce the risk of cisplatin-induced ototoxicity in pediatric patients with localized, non-metastatic solid tumors. The company also markets the product in Europe and the United Kingdom under the PEDMARQSI® name and has disclosed a licensing arrangement for commercialization in additional non-U.S. markets.
Recurring news themes include PEDMARK product sales and financial results, commercialization updates, scientific abstracts, investigator-sponsored and real-world studies in cancer patients receiving cisplatin-based chemotherapy, product exclusivity and patent matters, and equity compensation actions under Nasdaq rules.
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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.