PRINCETON, N.J. - Soligenix, Inc. (NASDAQ:SNGX), a biopharmaceutical company, has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for SuVax™, a vaccine candidate targeting the Sudan ebolavirus (SUDV). The designation, announced today, provides the company with seven years of market exclusivity upon potential FDA approval.
Orphan drug status is granted to treatments for rare diseases affecting fewer than 200,000 people in the U.S. This status offers Soligenix various incentives, including tax credits, FDA fee waivers, and eligibility for grants to support clinical trials.
SuVax™ is a protein subunit vaccine composed of the recombinantly expressed SUDV glycoprotein, intended for both prevention and post-exposure prophylaxis against SUDV infection. The vaccine leverages a novel adjuvant and a thermostabilization process, allowing it to remain stable at high temperatures, which is crucial for use in regions with limited refrigeration capabilities.
Dr. Oreola Donini, Chief Scientific Officer at Soligenix, highlighted the vaccine's potential, noting its 100% protection rate in non-human primate studies and its specific targeting of SUDV, a type of ebolavirus without current treatment or vaccine options. SuVax™ has shown stability for at least two years at temperatures up to 40 degrees Celsius (104 degrees Fahrenheit).
The vaccine's development is in collaboration with Dr. Axel Lehrer at the University of Hawai'i at Mānoa and includes a robust protein manufacturing process and a novel adjuvant, both independently tested in clinical studies. SuVax™ could also be part of a multivalent vaccine, potentially combined with antigens against other viruses like Marburg marburgvirus (MARV).
SUDV is the second-most common cause of human ebolavirus infection, with high mortality rates and limited treatment options. The latest outbreak was recorded in Uganda from August to October 2022. The FDA's orphan drug designation marks a significant milestone for Soligenix as it advances its vaccine program.
This development is part of Soligenix's broader portfolio, which includes treatments for rare diseases and a public health solutions segment focusing on vaccines for biodefense threats and emerging infectious diseases. The company's efforts have been supported by government funding from agencies such as the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).
The information in this article is based on a press release statement from Soligenix.
InvestingPro Insights
In light of Soligenix, Inc.'s (NASDAQ:SNGX) recent orphan drug designation for its Sudan ebolavirus vaccine candidate, SuVax™, investors may find the following InvestingPro Data and Tips particularly relevant:
The company's market capitalization stands at 4.87 million USD, reflecting a small-cap stock that could offer growth potential but also comes with a higher risk profile. The stock's Price / Book ratio for the last twelve months as of Q4 2023 is 1.93, which suggests that the market values the company at nearly twice its book value. This valuation metric can be insightful for investors comparing the market's valuation of the company to its actual net asset value.
Despite the promising news, Soligenix's financial performance presents challenges. The company's revenue for the last twelve months as of Q4 2023 was 0.84 million USD, with a notable decline in revenue growth of -11.55% during the same period. This could be a point of concern for investors looking for companies with strong and consistent revenue growth. Additionally, the gross profit margin was reported at -365.15%, indicating that the company is currently not generating a profit on its sales, which is a critical factor for long-term sustainability.
For those considering an investment in Soligenix, two InvestingPro Tips could be particularly instructive. Firstly, the company holds more cash than debt on its balance sheet, which is a positive sign of financial stability. Secondly, the Relative Strength Index (RSI) suggests the stock is in oversold territory, which might indicate a potential buying opportunity for contrarian investors or those looking for a rebound.
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