Soligenix (NASDAQ:SNGX) stock is roaring higher on Thursday thanks to some positive news from the U.S. Food and Drug Administration (FDA) today.
The run for SNGX stock has to do with the FDA’s Office of Orphan Products Development of the United States granting it orphan drug designation. This is for the active ingredient hypericin and its use in treating T-cell lymphoma.
The FDA’s decision today is an expansion on previous orphan drug designation for hypericin. That allowed it to be used in the treatment of cutaneous T-cell lymphoma.
That’s great news for SNGX shareholders as it opens the drug up to a wider market. In addition to this, it also gives it other advantages. Among them are seven-year market exclusivity after final approval, as well as financial and regulatory benefits including government grants covering clinical trials and waiving FDA user fees.
Christopher Schaber, PhD, president and CEO of Soligenix, said the following about the news sending SNGX stock higher.
“The FDA’s decision to grant and expand our hypericin orphan drug designation beyond CTCL signifies an important step for Soligenix as we continue to advance the program toward NDA filing in the first half of 2022.”
SNGX is seeing heavy trading on the FDA news today. As of this writing, some 42 million shares of the stock have changed hands. That’s a massive surge compared to the company’s daily average trading volume of about 678,000 shares.
SNGX stock was up 9% as of Thursday afternoon.
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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
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