Soligenix (NASDAQ:SNGX) jumped 11% following the grant of the orphan drug designation from the FDA for its active product candidate hypericin in T-cell lymphoma treatment. The grant expands the company’s prior orphan drug designation for the active ingredient that permitted its uses in cutaneous T-Cell lymphoma treatment.
For Soligenix shareholders, this is great news as the designation grant will open up hypericin for a broader market. Besides broader market access, it also offers other benefits such as seven-year exclusivity in the market following final approval and regulatory and financial benefits that include grants that cover clinical trials and waiver of FDA user fees.
CEO Christopher Schaber said that the grant and decision to expand hypericin’s orphan drug status beyond CTCL is a massive step for the company as it advances the program ahead of NDA filing in 1H 2022. The stock traded heavily on the news, with around 42 million shares exchanging hands, a massive surge relative to the daily average volume of 678,000 shares. Therefore, in the coming months, SNGX is worth watching.
On Thursday, SNGX stock jumped 10.50% at $1.16 with more than 55.21 million shares, compared to its average volume of 681K shares. The stock has moved within a range of $1.1000 – 1.2300 after opening the trade at $1.18.