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; TSX: FRX) is a specialty pharmaceutical company focused on reducing cisplatin-induced ototoxicity in cancer patients through its therapy PEDMARK®. The FENC news feed on Stock Titan aggregates company announcements, clinical updates, capital markets activity and regulatory developments that shape the outlook for this ototoxicity-focused business.
Investors and healthcare observers can review news about regulatory and commercial milestones for PEDMARK® in the United States and PEDMARQSI® in Europe and the U.K., as well as licensing developments with Norgine Pharmaceuticals Ltd. Updates on investigator-initiated and investigator-sponsored trials, including studies in Japan and at institutions such as City of Hope, provide insight into how PEDMARK® is being evaluated across different tumor types, age groups and geographies.
The Fennec news stream also covers financing transactions and balance sheet actions, such as underwritten public offerings of common shares, non-brokered offerings in Canada, and the use of proceeds to repurchase and redeem senior secured floating rate convertible notes issued to Petrichor Opportunities Fund I LP and Petrichor Opportunities Fund I Intermediate LP. These items help investors understand how the company funds commercialization and clinical collaborations while managing its capital structure.
Additional releases may highlight participation in healthcare conferences, changes in institutional shareholdings, and other corporate communications. By following this page, readers can access an organized view of Fennec’s official disclosures, from clinical data readouts and commercialization updates to securities offerings and debt redemptions, all in one place.
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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.
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.
Fennec Pharmaceuticals (NASDAQ:FENC) reported a significant milestone with the FDA's approval of PEDMARK®, the first therapy approved to reduce ototoxicity risk from cisplatin in pediatric patients. Following its October 2022 U.S. launch, the company secured $25 million in funding to support commercialization efforts. Financially, Fennec reported a net loss of $8.1 million for Q3 2022, compared to $4.2 million in Q3 2021. While R&D expenses decreased, G&A expenses surged by $4.1 million, reflecting the costs of building commercial infrastructure.