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Fennec Pharmaceuticals Inc. - FENC STOCK NEWS

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) is a commercial-stage biopharmaceutical company dedicated to developing innovative therapies for the treatment of cancer. Based in Research Triangle Park, North Carolina, Fennec Pharmaceuticals has a significant focus on addressing unmet medical needs in pediatric oncology.

The company’s lead product, PEDMARK, is a novel formulation of sodium thiosulfate designed to prevent cisplatin-induced hearing loss (ototoxicity) in children. Cisplatin is a chemotherapy drug that, while effective, can cause irreversible hearing damage in pediatric patients. PEDMARK has successfully completed Phase III clinical trials and received FDA approval, making it the first and only therapy indicated to reduce the risk of ototoxicity in pediatric patients aged 1 month and older with localized, non-metastatic solid tumors.

Fennec Pharmaceuticals was originally founded as Adherex Technologies Inc. in 1996 and underwent a name change to its current identity in September 2014. The company has recently announced a series of significant developments, including:

  • Hosting quarterly conference calls to discuss financial results and business outlooks.
  • Entering an exclusive licensing agreement with Norgine to commercialize PEDMARQSI® (the European branding of PEDMARK) in Europe, Australia, and New Zealand. Under this partnership, Fennec will receive up to €250 million in milestone payments and royalties.
  • Receiving EU marketing authorization for PEDMARQSI in June 2023 and UK approval in October 2023.

These strategic moves demonstrate Fennec's commitment to expanding its reach and impact in the global market. The company continues to work diligently to ensure that its life-saving therapies are accessible to as many patients as possible. The operational and financial strength of Fennec Pharmaceuticals, coupled with its pioneering product, positions the company as a significant player in the biopharmaceutical industry.

For the latest updates, investors and stakeholders can access conference call information, news releases, and financial reports on the company’s website. Fennec's investor relations team, led by CFO Robert Andrade, is available for any inquiries.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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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Fennec Pharmaceuticals reports Q3 2020 financial results, highlighting key developments on PEDMARK™, aimed at preventing platinum-induced ototoxicity in children. Following a constructive FDA meeting, the company plans to resubmit its New Drug Application without the need for additional studies. Financially, Fennec holds $33.2 million in cash and no debt. However, it posted a net loss of $6.2 million, an increase from $1.8 million the previous year, primarily due to rising R&D and G&A expenses related to commercialization efforts.

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Fennec Pharmaceuticals announced that the U.S. Patent and Trademark Office will issue U.S. Patent 10,792,363 covering anhydrous sodium thiosulfate formulations for its drug PEDMARK. This patent enhances the drug's intellectual property protection as Fennec aims to prevent platinum-induced ototoxicity in pediatric patients. PEDMARK, previously designated as an Orphan Drug, is pivotal for children undergoing platinum-based chemotherapy. The European Medicines Agency is currently evaluating its Marketing Authorization Application.

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FAQ

What is the current stock price of Fennec Pharmaceuticals (FENC)?

The current stock price of Fennec Pharmaceuticals (FENC) is $6.17 as of December 6, 2024.

What is the market cap of Fennec Pharmaceuticals (FENC)?

The market cap of Fennec Pharmaceuticals (FENC) is approximately 158.0M.

What is Fennec Pharmaceuticals Inc.?

Fennec Pharmaceuticals Inc. is a commercial-stage biopharmaceutical company focused on developing therapies for pediatric oncology, including its lead product PEDMARK.

What is PEDMARK?

PEDMARK is a novel formulation of sodium thiosulfate designed to prevent cisplatin-induced hearing loss in pediatric patients.

Where is Fennec Pharmaceuticals headquartered?

Fennec Pharmaceuticals is headquartered in Research Triangle Park, North Carolina, USA.

What recent achievements has Fennec Pharmaceuticals made?

Recent achievements include FDA approval for PEDMARK, a licensing agreement with Norgine for EU and ANZ commercialization, and hosting regular investor conference calls to discuss financial results.

How can investors get updates about Fennec Pharmaceuticals?

Investors can get updates through the company's website, where they can find news releases, financial reports, and conference call information.

Who is the CFO of Fennec Pharmaceuticals?

The CFO of Fennec Pharmaceuticals is Robert Andrade.

What was Fennec Pharmaceuticals formerly known as?

Fennec Pharmaceuticals was formerly known as Adherex Technologies Inc.

When was Fennec Pharmaceuticals founded?

Fennec Pharmaceuticals was founded in 1996.

What is the significance of PEDMARK's FDA approval?

PEDMARK's FDA approval is significant as it is the first and only approved therapy to reduce the risk of cisplatin-induced ototoxicity in pediatric patients.

What are the terms of the licensing agreement with Norgine?

The licensing agreement with Norgine includes upfront consideration of €40 million, up to €210 million in milestone payments, and double-digit tiered royalties on net sales.

Fennec Pharmaceuticals Inc.

Nasdaq:FENC

FENC Rankings

FENC Stock Data

158.01M
22.97M
16.22%
54.73%
6.8%
Biotechnology
Biological Products, (no Disgnostic Substances)
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United States of America
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