Fennec Pharmaceuticals Inc. - FENC STOCK NEWS

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.

Fennec Pharmaceuticals has launched PEDMARK (sodium thiosulfate injection), the first FDA-approved therapy to mitigate cisplatin-induced hearing loss in pediatric patients aged one month and older with localized, non-metastatic solid tumors. This breakthrough therapy offers substantial help to patients at risk of permanent hearing loss, previously managed with cochlear implants. The company also introduced the Fennec HEARS™ program, providing financial support and care coordination. PEDMARK, which received FDA approval in September 2022, addresses a significant medical need, as approximately 60% of pediatric patients treated with cisplatin face irreversible hearing loss.

Fennec Pharmaceuticals Inc. has successfully completed a second closing of $20 million in senior secured promissory notes as part of an investment agreement with Petrichor Healthcare Capital Management. This funding followed the FDA approval of PEDMARK®, aimed at reducing cisplatin-induced ototoxicity in pediatric patients. The company may access an additional $20 million before December 31, 2023, under the agreement. PEDMARK® is the only FDA-approved therapy for preventing this type of hearing loss, offering vital protection for children undergoing chemotherapy.

Fennec Pharmaceuticals announced that the FDA has approved PEDMARK (sodium thiosulfate injection), marking it as the first and only therapy approved to reduce the risk of ototoxicity from cisplatin in pediatric patients. This approval addresses a significant unmet medical need, as cisplatin treatment often leads to severe hearing loss in children. Clinical trials showed that the incidence of hearing loss in patients receiving PEDMARK was significantly lower than in those treated with cisplatin alone (21.4% vs. 73.3% and 32.7% vs. 63%). PEDMARK is indicated for patients aged one month and older with localized, non-metastatic solid tumors.

Fennec Pharmaceuticals reported the completion of a $5 million financing milestone under an investment agreement with Petrichor Healthcare Capital Management. An additional $20 million may be provided upon FDA approval of PEDMARK, a drug aimed at preventing chemotherapy-induced hearing loss in pediatric patients. The FDA's action date for the New Drug Application is set for September 23, 2022. The funding will also help Fennec repay existing debts. The company has potential access to $20 million by the end of 2023, contingent on meeting agreement terms.