FENC Stock Overview
Fennec Pharmaceuticals Inc. operates as a biopharmaceutical company.
Fennec Pharmaceuticals Inc. Competitors
Price History & Performance
|Historical stock prices|
|Current Share Price||US$7.46|
|52 Week High||US$10.08|
|52 Week Low||US$3.82|
|1 Month Change||6.88%|
|3 Month Change||33.69%|
|1 Year Change||-19.61%|
|3 Year Change||70.71%|
|5 Year Change||-35.13%|
|Change since IPO||-93.42%|
Recent News & Updates
Fennec wins FDA approval of Pedmark for chemotherapy-induced ototoxicity in children
The FDA has approved Fennec Pharmaceuticals (NASDAQ:FENC) Pedmark (sodium thiosulfate) as a treatment for platinum chemotherapy-induced ototoxicity (ear toxicity) in children. The approval follows two Complete Response Letters from the agency, which accepted a refiled New Drug Application in April. Pedmark is now the first approved treatment designed to prevent ototoxicity in children receiving platinum-based chemotherapy. In August, Seeking Alpha contributor Bhavneesh Sharma said he was a buyer of Fennec (FENC) ahead of the FDA's September PDUFA date for Pedmark.
Buying Fennec Pharma Ahead Of September PDUFA For Pedmark
PDUFA for Pedmark (sodium thiosulfate) in treating platinum chemotherapy-induced cytotoxicity (ear toxicity) in children is scheduled on September 23. The company resolved the issues raised in the second CRL within 3 months and announced the NDA acceptance in April this year. Targeting $10 or >40% upside in 4 weeks timeframe. Fennec Pharma (FENC) is based in Durham, NC. This article will focus on an upcoming catalyst for the company's stock: PDUFA for Pedmark (sodium thiosulfate) in treating platinum chemotherapy-induced cytotoxicity (ear toxicity) in children 1 month to <18 years age on September 23 this year. Cisplatin and other platinum chemotherapy agents are widely used as first-line treatments for various pediatric solid cancers like CNS, neuroblastoma, hepatoblastoma, osteosarcoma, etc. However, these compounds cause bilateral, progressive, irreversible, dose-dependent, neurosensory hearing loss. The mechanism of cytotoxicity is the production of reactive oxygen species in target tissues in the inner ear. The average incidence of cytotoxicity with cisplatin is over 60%. The only treatment for ototoxicity due to these agents is hearing aids or inner ear implants. Currently, no treatment is available to prevent ototoxicity in children receiving platinum-based chemotherapy. Pedmark is a small molecule, unique formulation of sodium thiosulfate. It is administered 6 hours after the completion of cisplatin infusion. It acts by inhibiting oxidative stress, which is the mechanism behind platinum-induced ototoxicity. Pedmark has shown clinical efficacy in preventing platinum-induced ototoxicity in two randomized studies: COG ACCL0431 and SIOPEL 6. The results of the pivotal SIOPEL study were published in the prestigious New England Journal of Medicine. In this study, Pedmark showed a 48% reduction in the risk of hearing loss due to platinum compounds, p=0.002 (see below). It has been awarded Fast Track and Breakthrough designation by the FDA. Prior FDA approval submissions for Pedmark were given CRL twice in 2020 and 2021 due to deficiencies with the drug product manufacturer. The company resolved the issues raised in the second CRL within 3 months and announced the NDA acceptance in April this year. The PDUFA is scheduled for September 23 this year. Cash reserves are expected as $20M after the recent $5M capital raise from Petrichor Health Capital. The company can raise another $20M from Petrichor after Pedmark's FDA approval. At the current operating cash use rate, this is enough to keep the company funded for 1 year. The target market is approx. 3000 children with this ototoxicity in the U.S. every year. At a conservative price estimate of $60,000 per patient (similar to a cochlear implant), this could be a $180M/year revenue opportunity just in the U.S. Pharma companies trade at an average enterprise/peak sales of 4. In comparison, the current enterprise value of the company is just $163M. The average sell-side analyst price target on the stock is $14 (118% upside).
|FENC||US Biotechs||US Market|
Return vs Industry: FENC exceeded the US Biotechs industry which returned -27.4% over the past year.
Return vs Market: FENC exceeded the US Market which returned -22.1% over the past year.
|FENC Average Weekly Movement||8.8%|
|Biotechs Industry Average Movement||11.1%|
|Market Average Movement||6.9%|
|10% most volatile stocks in US Market||15.8%|
|10% least volatile stocks in US Market||2.8%|
Stable Share Price: FENC is not significantly more volatile than the rest of US stocks over the past 3 months, typically moving +/- 9% a week.
Volatility Over Time: FENC's weekly volatility (9%) has been stable over the past year.
About the Company
Fennec Pharmaceuticals Inc. operates as a biopharmaceutical company. Its product candidate in the clinical stage of development is PEDMARK, a formulation of sodium thiosulfate for the prevention of platinum-induced ototoxicity in pediatric cancer patients. The company was formerly known as Adherex Technologies Inc. and changed its name to Fennec Pharmaceuticals Inc. in September 2014.
Fennec Pharmaceuticals Inc. Fundamentals Summary
|FENC fundamental statistics|
Is FENC overvalued?See Fair Value and valuation analysis
Earnings & Revenue
|FENC income statement (TTM)|
|Cost of Revenue||US$0|
Last Reported Earnings
Jun 30, 2022
Next Earnings Date
|Earnings per share (EPS)||-0.67|
|Net Profit Margin||0.00%|
How did FENC perform over the long term?See historical performance and comparison