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 (NASDAQ:FENC) announced a significant investment agreement with Petrichor Healthcare Capital Management, potentially worth up to $45 million. The deal consists of $5 million in senior secured promissory notes and an additional $20 million contingent on FDA approval of PEDMARK™ by September 30, 2022. This funding aims to support the commercialization of PEDMARK™, which seeks to mitigate ototoxicity in pediatric cancer patients undergoing chemotherapy. The notes bear a five-year term with interest tied to the US Prime Rate plus 4.5%.
Fennec Pharmaceuticals Inc. (NASDAQ:FENC) announced the successful election of its director nominees at the Annual General Meeting held on June 14, 2022, in New York. All nominees received a strong majority of votes, with Dr. Khalid Islam receiving 99.59% in favor. Additionally, shareholders voted overwhelmingly (99.23%) to appoint Haskell & White LLP as auditors and approved the executive compensation package with 99.03% support. The meeting reflects strong shareholder confidence in the company's leadership and governance.
Fennec Pharmaceuticals Inc. (NASDAQ:FENC) announced its participation in several upcoming investor conferences, including the H.C. Wainwright Global Investment Conference on May 24, the Craig-Hallum Institutional Investor Conference on June 1, and the JMP Securities Life Sciences Conference on June 15. The focus of the company is on PEDMARK™, a formulation aimed at preventing platinum-induced ototoxicity in pediatric patients, with significant implications for children undergoing chemotherapy. The Marketing Authorization Application for PEDMARK is under review by the European Medicines Agency.
Fennec Pharmaceuticals Inc. reported its Q1 2022 financial results, highlighting a net loss of $3.7 million, a decrease from $4.7 million in Q1 2021. Cash and cash equivalents stand at approximately $18.3 million, down from $21.1 million at year-end 2021, primarily due to ongoing costs related to the resubmission of the NDA for PEDMARK™. R&D expenses fell to $1.4 million from $2.4 million year-over-year, reflecting a shift towards pre-commercialization efforts. The FDA's PDUFA target action date for PEDMARK™ is set for September 23, 2022, potentially marking a significant milestone if approved.
Fennec Pharmaceuticals announced that its resubmitted New Drug Application (NDA) for PEDMARK, aimed at preventing platinum-induced ototoxicity in pediatric patients, has been accepted by the FDA. The PDUFA action date is set for September 23, 2022. This development is significant as PEDMARK has received Breakthrough Therapy and Fast Track Designation, indicating its potential to transform treatment for children at risk of hearing loss from chemotherapy. The company continues its efforts to facilitate the FDA's review process.
Fennec Pharmaceuticals (NASDAQ: FENC) will participate in the 2022 Maxim Group Virtual Growth Conference from March 28-30, 2022. CFO Robert Andrade will engage in a fireside chat on March 28 at 4:00 p.m. ET. The conference will cover key discussions on Fennec's developments, including PEDMARK™, aimed at preventing platinum-induced ototoxicity in children undergoing chemotherapy. PEDMARK has garnered Breakthrough Therapy and Fast Track Designations from the FDA and is currently under evaluation by the European Medicines Agency for marketing authorization.
Fennec Pharmaceuticals has resubmitted its New Drug Application (NDA) for PEDMARK™, aimed at preventing platinum-induced ototoxicity in pediatric cancer patients. The FDA's feedback during the process was appreciated, and the company is committed to making PEDMARK™ available for those affected. With over 10,000 children potentially receiving platinum-based chemotherapy annually in the U.S. and Europe, the need for an effective preventive agent is vital. The application is also under review by the European Medicines Agency, highlighting the global importance of PEDMARK™.
Fennec Pharmaceuticals (NASDAQ:FENC) announced a planned resubmission of the New Drug Application (NDA) for PEDMARK™ in Q1 2022. The company reported a net loss of $17.3 million for 2021 ($0.67 per share), a slight improvement from $18.1 million in 2020. Cash and cash equivalents stood at $21.1 million as of December 31, 2021, down from $30.3 million the previous year. Research and Development expenditures were $5 million, with General and Administrative expenses totaling $12.2 million, both showing minor fluctuations compared to 2020.
Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX:FRX) announced the resignation of Chief Commercial Officer Shubh Goel, effective late February 2022. The company's CEO, Rosty Raykov, expressed gratitude for Goel's contributions while emphasizing the commitment to commercialize PEDMARK™, a sodium thiosulfate formulation designed to prevent platinum-induced ototoxicity in children receiving chemotherapy. PEDMARK™ has received FDA Breakthrough Therapy and Fast Track Designations, and its Marketing Authorization Application is under review by the European Medicines Agency.
Fennec Pharmaceuticals announced on Nov. 30, 2021, that it received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for PEDMARK™, intended to prevent ototoxicity in pediatric patients undergoing cisplatin chemotherapy. The CRL cited manufacturing deficiencies that must be resolved before approval. Fennec plans to request a Type A meeting with the FDA to discuss the issues and the NDA resubmission process. Currently, the company has approximately $24 million in cash and equivalents as of September 30, 2021.
FAQ
What is the current stock price of Fennec Pharmaceuticals (FENC)?
What is the market cap of Fennec Pharmaceuticals (FENC)?
