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Fennec Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2026-03-31 10:00
Core Insights - Fennec Pharmaceuticals announced the grant of incentive stock options to 24 new non-executive employees as part of its 2026 Equity Inducement Plan, totaling 377,500 shares [1][2] Group 1: Stock Options and Inducement Plan - The incentive stock options (ISOs) have an exercise price of $5.77 per share, equal to the closing price on March 30, 2026, and a term of ten years from the grant date [3] - One-third of the shares underlying each ISO will vest on the one-year anniversary of the grant date, with the remaining shares vesting monthly over the following 24 months, contingent on continued employment [3] Group 2: Company Overview - Fennec Pharmaceuticals is focused on combating ototoxicity in cancer patients undergoing cisplatin-based chemotherapy, with its primary product being PEDMARK, which aims to reduce the risk of platinum-induced ototoxicity [4] - PEDMARK received FDA approval in September 2022, followed by European Commission approval in June 2023 and U.K. approval in October 2023 under the brand name PEDMARQSI [4] - In March 2024, Fennec entered into an exclusive licensing agreement with Norgine Pharmaceuticals for the commercialization of PEDMARQSI in Europe, the U.K., Australia, and New Zealand, with the product already available in the U.K. and Germany [5]
Fennec Pharmaceuticals Announces Settlement Agreement Resolving PEDMARK Patent Litigation
Globenewswire· 2026-03-16 12:08
Core Insights - Fennec Pharmaceuticals has reached a settlement with Cipla regarding the litigation over Cipla's application to market a generic version of PEDMARK, with Cipla agreeing not to enter the market until September 1, 2033, or earlier under specific conditions [1] Company Overview - Fennec Pharmaceuticals is a specialty pharmaceutical company focused on reducing ototoxicity in cancer patients undergoing cisplatin-based chemotherapy [14] - PEDMARK is the first FDA-approved therapy to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients aged 1 month and older with localized, non-metastatic solid tumors [2][6] Product Details - PEDMARK is a unique formulation of sodium thiosulfate available in single-dose, ready-to-use vials for intravenous use [2] - The product has been endorsed by the National Comprehensive Cancer Network (NCCN) for the adolescent and young adult population with a 2A recommendation [3] Market Context - Approximately 500,000 patients in the U.S. are diagnosed annually with cancers treatable by platinum-based chemotherapy, with many experiencing lifelong hearing loss due to ototoxicity [4] - Prior to PEDMARK's FDA approval, there were no preventative agents for hearing loss resulting from cancer treatment, significantly impacting patients' quality of life [4] Clinical Studies - PEDMARK has been validated through two Phase 3 clinical studies, COG ACCL0431 and SIOPEL 6, demonstrating its efficacy in reducing ototoxicity [5] - The COG ACCL0431 study included various childhood cancers treated with intensive cisplatin therapy, while SIOPEL 6 focused on hepatoblastoma patients [5] Regulatory and Commercialization Status - PEDMARK received FDA approval in September 2022 and has also been approved in Europe and the U.K. under the brand name PEDMARQSI [14][15] - Fennec has entered into an exclusive licensing agreement with Norgine Pharmaceuticals for the commercialization of PEDMARQSI in Europe, the U.K., Australia, and New Zealand [15] - The product has Orphan Drug Exclusivity in the U.S. and Pediatric Use Marketing Authorization in Europe, providing significant market protection [16]
Fennec Pharmaceuticals Announces Clinical Research Collaboration with Tampa General Hospital Cancer Institute
Globenewswire· 2026-03-04 12:05
Core Insights - Fennec Pharmaceuticals is initiating a study at Tampa General Hospital to evaluate the clinical utility of sodium thiosulfate injection (PEDMARK) in reducing ototoxicity risk in adolescent and young adult (AYA) and adult patients undergoing cisplatin chemotherapy [1][2] Company Overview - Fennec Pharmaceuticals is a specialty pharmaceutical company focused on combating ototoxicity in cancer patients receiving cisplatin-based chemotherapy [18] - PEDMARK is the first FDA-approved therapy to reduce the risk of ototoxicity associated with cisplatin in pediatric patients aged one month and older with localized, non-metastatic solid tumors [6][10] - The company received FDA approval for PEDMARK in September 2022 and has since expanded its market presence with approvals in Europe and the UK [18][19] Clinical Study and Research - The study at Tampa General Hospital aims to gather real-world clinical data and audiology monitoring to inform future research and quality efforts in managing ototoxicity [2][3] - The evaluation will help demonstrate the clinical utility of PEDMARK across diverse patient populations and tumor types, enhancing understanding of its role in hearing loss protection [3] Ototoxicity Context - Cisplatin and other platinum-based chemotherapies are essential for treating solid tumors but can lead to significant hearing loss, affecting 60-90% of patients depending on treatment specifics [4][5] - Hearing loss from cisplatin treatment can severely impact quality of life, necessitating lifelong hearing aids or cochlear implants for many patients [5][8] Regulatory and Market Position - PEDMARK is recognized by the National Comprehensive Cancer Network with a 2A recommendation for use in AYA patients, indicating its importance in clinical practice [2][7] - Approximately 500,000 patients in the U.S. are diagnosed annually with cancers treatable by platinum-based chemotherapy, highlighting a substantial market opportunity for PEDMARK [7]
Fennec Pharmaceuticals Announces Investigator-Sponsored Trial to Be Conducted by City of Hope in Metastatic Testicular Germ Cell Tumors
Globenewswire· 2025-12-09 12:00
Core Insights - Fennec Pharmaceuticals is initiating a study to evaluate PEDMARK for preventing cisplatin-induced ototoxicity in adult men with stage II-III metastatic testicular germ cell tumors, reflecting a growing clinical interest in addressing hearing loss among cancer patients [1][4]. Company Overview - Fennec Pharmaceuticals is a specialty pharmaceutical company focused on reducing the risk of ototoxicity in cancer patients receiving cisplatin-based chemotherapy. The company has received FDA approval for PEDMARK in September 2022 and European Commission approval in June 2023 [24][25]. Study Details - The investigator-sponsored study by City of Hope will assess the addition of PEDMARK to standard cisplatin chemotherapy to reduce drug-induced ear damage in men with metastatic testicular germ cell tumors. The study is a Phase I trial (NCT07218913) [5][6]. Clinical Context - Cisplatin has significantly improved survival rates for patients with germ cell tumors, but it can lead to permanent hearing loss in up to 80% of survivors, impacting their quality of life [2][8]. The study aims to integrate hearing protection into comprehensive cancer care [4]. Product Information - PEDMARK (sodium thiosulfate injection) is the first FDA-approved therapy to reduce the risk of ototoxicity associated with cisplatin in pediatric patients aged one month and older with localized, non-metastatic solid tumors. It is also recommended for adolescent and young adult patients by the National Comprehensive Cancer Network [3][12]. Market Opportunity - Approximately 500,000 patients in the U.S. are diagnosed annually with cancers treatable by platinum-based chemotherapy, highlighting a significant market opportunity for PEDMARK. The incidence of ototoxicity varies between 60-90% depending on treatment specifics [13][9]. Future Collaborations - Multiple other investigator-initiated studies are under review or in advanced stages of contracting, which are expected to strengthen Fennec's clinical and commercial foundation [7].
Fennec Pharmaceuticals to Participate in Piper Sandler 37th Annual Healthcare Conference
Globenewswire· 2025-11-26 10:59
Core Insights - Fennec Pharmaceuticals Inc. will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on December 3, 2025, at 1:00 p.m. ET, available via webcast [1][2] Company Overview - Fennec Pharmaceuticals is a specialty pharmaceutical company focused on combating ototoxicity in cancer patients undergoing cisplatin-based chemotherapy [3] - The company is commercializing PEDMARK, which aims to reduce the risk of platinum-induced ototoxicity in cancer patients [3] - PEDMARK received FDA approval in September 2022, European Commission approval in June 2023, and U.K. approval in October 2023 under the brand name PEDMARQSI [3] Licensing and Commercialization - In March 2024, Fennec entered into an exclusive licensing agreement with Norgine Pharmaceuticals Ltd. for the commercialization of PEDMARQSI in Europe, U.K., Australia, and New Zealand [4] - PEDMARQSI is currently commercially available in the U.K. and Germany [4] Regulatory Status and Market Protection - PEDMARK has received Orphan Drug Exclusivity in the U.S., while PEDMARQSI has received Pediatric Use Marketing Authorization in Europe, providing eight years plus two years of data and market protection [5] - Fennec holds patents protecting PEDMARK until 2039 in both the U.S. and internationally [5]
Fennec Pharmaceuticals Announces Completion Of Full Debt Redemption
Globenewswire· 2025-11-19 12:03
Core Insights - Fennec Pharmaceuticals has successfully repurchased and redeemed all outstanding convertible notes issued to Petrichor Opportunities Fund, eliminating its debt [1][2] - The total cost for the repurchase and redemption of the Petrichor notes was approximately $21.73 million, which included principal, accrued interest, and a redemption fee [2] - Fennec is focused on the commercialization of PEDMARK, a drug aimed at reducing platinum-induced ototoxicity in cancer patients, which has received multiple regulatory approvals [3][5] Financial Summary - The aggregate repurchase and redemption price of the Petrichor notes was $21,729,455.30, comprising $19,476,655.48 in principal, $305,134.27 in accrued interest, and a $1,947,665.55 redemption fee [2] - Prior to redemption, the notes had an interest rate tied to the prime rate with a floor of 3.5% plus a margin rate of 4.5% [2] Product and Market Information - PEDMARK received FDA approval in September 2022, European Commission approval in June 2023, and U.K. approval in October 2023 under the brand name PEDMARQSI [3] - Fennec entered into an exclusive licensing agreement with Norgine Pharmaceuticals for the commercialization of PEDMARQSI in Europe, the U.K., Australia, and New Zealand [4] - PEDMARK has Orphan Drug Exclusivity in the U.S. and PEDMARQSI has received Pediatric Use Marketing Authorization in Europe, providing significant market protection [5]
Fennec Pharmaceuticals Announces Closing of Private Offering of Common Shares in Canada
Globenewswire· 2025-11-18 13:30
Core Points - Fennec Pharmaceuticals Inc. has closed a non-brokered offering of common shares in Canada at a price of US$7.50 per share, raising aggregate gross proceeds of US$5,025,000 [1][2] Group 1: Offering Details - The offering was made to prospective purchasers in Canada (excluding Quebec) under the listed issuer financing exemption, and the common shares are not subject to a hold period under Canadian securities laws [2][4] - The offering document related to this transaction can be accessed on the Company's profile at www.sedarplus.com and www.fennecpharma.com [3] Group 2: Company Overview - Fennec Pharmaceuticals is focused on combating ototoxicity in cancer patients receiving cisplatin-based chemotherapy, with its primary product being PEDMARK, which received FDA approval in September 2022 and European Commission approval in June 2023 [6][8] - PEDMARQSI, the brand name for PEDMARK in the U.K., received approval in October 2023, and the product is now commercially available in the U.K. and Germany following an exclusive licensing agreement with Norgine Pharmaceuticals Ltd. [7][8] Group 3: Regulatory and Market Position - PEDMARK has received Orphan Drug Exclusivity in the U.S., and PEDMARQSI has received Pediatric Use Marketing Authorization in Europe, providing significant market protection [8] - Fennec holds patents for PEDMARK that extend until 2039 in both the U.S. and internationally, enhancing its competitive position in the market [8]
Fennec Pharmaceuticals Announces Closing of Offering of Common Shares
Globenewswire· 2025-11-17 21:15
Core Viewpoint - Fennec Pharmaceuticals Inc. has successfully closed a public offering of 5,366,667 common shares at a price of $7.50 per share, raising approximately $40.25 million in gross proceeds before expenses [1][2]. Group 1: Offering Details - The offering included the full exercise of the underwriters' option to purchase additional shares [1]. - The net proceeds will be used to repurchase certain indebtedness and for working capital and general corporate purposes [2]. - Piper Sandler & Co. and Craig-Hallum Capital Group LLC served as joint book-running managers, with H.C. Wainwright & Co. as lead manager and Stephens Inc. as co-manager [2]. Group 2: Company Overview - Fennec Pharmaceuticals is focused on combating ototoxicity in cancer patients undergoing cisplatin-based chemotherapy, primarily through its product PEDMARK [5]. - PEDMARK received FDA approval in September 2022, followed by approvals from the European Commission in June 2023 and the U.K. in October 2023 under the name PEDMARQSI [5]. - In March 2024, Fennec entered into an exclusive licensing agreement with Norgine Pharmaceuticals Ltd. for the commercialization of PEDMARQSI in Europe, the U.K., Australia, and New Zealand [6]. Group 3: Regulatory and Market Position - PEDMARK has Orphan Drug Exclusivity in the U.S., while PEDMARQSI has received Pediatric Use Marketing Authorization in Europe, providing it with a total of ten years of market protection [7]. - Fennec holds patents for PEDMARK that extend until 2039 in both the U.S. and internationally [7].
Fennec Pharmaceuticals Announces Private Offering of Common Shares in Canada
Globenewswire· 2025-11-14 04:11
Core Viewpoint - Fennec Pharmaceuticals Inc. is initiating a non-brokered offering of common shares in Canada at a price of US$7.50 per share, aiming for gross proceeds of up to US$5,025,000, with the offering expected to close on November 17, 2025, subject to customary closing conditions [1][2]. Offering Details - The offering targets prospective purchasers in Canada (excluding Quebec) under the listed issuer financing exemption, and the shares will not be subject to a hold period under Canadian securities laws [2][4]. - There are no guarantees regarding the completion of the offering or the total gross proceeds raised [2]. Company Background - Fennec Pharmaceuticals is focused on combating ototoxicity in cancer patients undergoing cisplatin-based chemotherapy, with its product PEDMARK approved by the FDA in September 2022 and by the European Commission in June 2023 [6][8]. - The company has an exclusive licensing agreement with Norgine Pharmaceuticals Ltd. for the commercialization of PEDMARQSI in Europe, the U.K., Australia, and New Zealand, with the product already available in the U.K. and Germany [7]. Regulatory and Market Position - PEDMARK has received Orphan Drug Exclusivity in the U.S., and PEDMARQSI has Pediatric Use Marketing Authorization in Europe, providing significant market protection [8]. - Fennec holds patents for PEDMARK that extend until 2039 in both the U.S. and internationally, enhancing its competitive position in the market [8].
Fennec Pharmaceuticals Announces Pricing of Offering of Common Shares
Globenewswire· 2025-11-14 04:07
Core Viewpoint - Fennec Pharmaceuticals Inc. has announced a public offering of 4,666,667 common shares priced at $7.50 per share, aiming to raise approximately $35 million in gross proceeds before expenses [1][2] Group 1: Offering Details - The offering includes a 30-day option for underwriters to purchase an additional 700,000 common shares under the same terms [1] - The expected closing date for the offering is November 17, 2025, pending customary closing conditions [1] Group 2: Use of Proceeds - The net proceeds from the offering will be used to repurchase and redeem certain indebtedness, with any remaining funds allocated for working capital and general corporate purposes [2] Group 3: Company Background - Fennec Pharmaceuticals is focused on combating ototoxicity in cancer patients undergoing cisplatin-based chemotherapy, with its product PEDMARK approved by the FDA in September 2022 and by the European Commission in June 2023 [5][6] - The company has entered into an exclusive licensing agreement with Norgine Pharmaceuticals Ltd. for the commercialization of PEDMARQSI in Europe, the U.K., Australia, and New Zealand [6] - PEDMARK has received Orphan Drug Exclusivity in the U.S., and PEDMARQSI has received Pediatric Use Marketing Authorization in Europe, providing significant market protection [7]