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.
Fennec Pharmaceuticals announced it anticipates receiving a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for PEDMARK after the PDUFA target date of November 27, 2021. The CRL is due to identified deficiencies during a pre-approval inspection of the drug product manufacturer’s facility. The company plans to address these issues and seek a Type A meeting with the FDA to discuss the necessary steps for resubmission. PEDMARK aims to prevent ototoxicity in pediatric patients undergoing platinum-based chemotherapy.
Fennec Pharmaceuticals (NASDAQ:FENC) reported third-quarter financial results for 2021, highlighting a net loss of $4.2 million, or $0.16 per share, an improvement from a $6.2 million loss in Q3 2020. The company had approximately $24.3 million in cash as of September 30, 2021. Their NDA application for PEDMARK™, aimed at preventing cisplatin-induced hearing loss in children, is under FDA review with a target action date set for November 27, 2021. R&D expenses decreased to $1.2 million, while G&A expenses fell by $1.6 million due to timing related to NDA approval.
Fennec Pharmaceuticals announced participation in three virtual investor conferences in September 2021. These include the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, Oppenheimer Fall Healthcare Life Sciences & MedTech Summit from September 20-23, and the Cantor Virtual Global Healthcare Conference from September 27-30. The company focuses on its product PEDMARK™, designed to prevent platinum-induced ototoxicity in pediatric cancer patients, which is pivotal as over 10,000 children annually risk hearing loss from treatments.
Fennec Pharmaceuticals reported its Q2 2021 financial results, highlighting a net loss of $4 million ($0.15 per share), improved from a $4.8 million loss in Q2 2020. The company has $27.3 million in cash and equivalents, down from $30.3 million at the end of 2020, due to R&D and administrative expenses. Fennec is focused on its PEDMARK™ therapy for preventing cisplatin-induced hearing loss in children, with a crucial FDA PDUFA action date set for November 27, 2021. R&D expenses decreased to $800,000 from $1.1 million, reflecting a shift towards essential launch preparations.
On June 29, 2021, Fennec Pharmaceuticals announced the election of its management's proposed board nominees at the Annual General Meeting in Irvine, California. The results show strong shareholder support, with Dr. Khalid Islam receiving 99.05% approval and other nominees like Adrian Haigh and Chris A. Rallis also garnering over 97% support. Furthermore, 99.88% of shareholders approved the appointment of Haskell & White LLP as auditors, and 97.48% voted in favor of executive compensation. This indicates significant confidence from shareholders in the company's direction.
Fennec Pharmaceuticals (NASDAQ:FENC; TSX:FRX) has announced an amendment to its debt facility with Bridge Bank, increasing the total amount from $18 million to $20 million. This facility includes three term loans, with $5 million available upon closing and $7.5 million contingent on FDA approval of PEDMARKTM. The funds will support the company’s working capital and commercialization activities for PEDMARK, which aims to prevent platinum-induced ototoxicity in pediatric patients. The FDA has set a PDUFA date for the NDA of PEDMARK on November 27, 2021.
Fennec Pharmaceuticals announced that the FDA has accepted its NDA resubmission for PEDMARK™ to prevent cisplatin-induced ototoxicity in pediatric patients with localized, non-metastatic solid tumors. The PDUFA action date is set for November 27, 2021. If approved, PEDMARK™ would be the first therapy for this indication. The drug has received Fast Track and Breakthrough Therapy Designations. The previous CRL cited manufacturing deficiencies but raised no safety or efficacy concerns, indicating no need for additional clinical data.
Fennec Pharmaceuticals Inc. has resubmitted its New Drug Application (NDA) to the FDA for PEDMARK™, a therapy aimed at preventing cisplatin-induced hearing loss in children aged 1 month to < 18 years. The resubmission follows FDA's Type A meeting feedback and focuses on resolving manufacturing facility issues, with no additional clinical data required. If approved, PEDMARK would be the first therapy to address this serious side effect of chemotherapy. The drug has received Breakthrough Therapy and Fast Track Designation from the FDA.
Fennec Pharmaceuticals (NASDAQ:FENC) is moving forward with plans to finalize and resubmit its New Drug Application for PEDMARK to the FDA by Q2 2021. The company reported Q1 2021 financial results, showing cash reserves of approximately $27 million and no outstanding debt. R&D expenses increased to $2.4 million, reflecting heightened development activities, while general and administrative costs remained stable at $2.5 million. The net loss for the quarter was $4.7 million, or $0.18 per share, slightly up from a loss of $3.8 million in Q1 2020.
Fennec Pharmaceuticals (NASDAQ:FENC) is advancing its New Drug Application (NDA) resubmission for PEDMARK™, a treatment for preventing platinum-induced ototoxicity in children, targeting Q2 2021. The company has $30 million in cash and no debt, with a net loss of $18.1 million ($0.76 per share) for 2020. R&D expenses fell to $5.1 million, while G&A costs rose to $13 million due to commercialization efforts. Despite a net increase in cash from a $32 million equity financing, Fennec sees ongoing losses but confirms financial stability for planned activities in 2021.
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