Despite phase 3 data last year that demonstrated the effectiveness of Soligenix’s cutaneous T-cell lymphoma (CTCL) treatment, the FDA has halted the biotech's approval plan in its tracks. The agency has sent a refuse-to-file letter, leaving the company scrambling to decide on a path to market and its stock sinking.
Soligenix has opened patient enrolment for its Phase IIa clinical trial of SGX302 (synthetic hypericin) for the treatment of mild-to-moderate psoriasis.
Soligenix has opened patient enrolment for its Phase IIa clinical trial of SGX302 (synthetic hypericin) for the treatment of mild-to-moderate psoriasis.
Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products...
PRINCETON, N.J., Sept. 16, 2021 /PRNewswire/ -- Soligenix (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that following the validation of synthetic hypericin's biologic activity in the positive pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study in cutaneous T-cell lymphoma (CTCL), as well as positive proof-of-concept (PoC) demonstrated in a small Phase 1/2 pilot study in mild-to-moderate psoriasis patients, the Company will be expanding this novel therapy under the research name SGX302 into psoriasis, a large and underserved market with a significant unmet medical need.
PRINCETON, N.J., May 15, 2020 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the quarter ended March 31, 2020.
Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today positive preliminary top-line results for its pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial evaluating SGX301 (Synthetic Hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL). The study enrolled 169 patients randomized 2:1 to receive either SGX301 or placebo, demonstrating statistically significant treatment response (p=0.04) in the Composite Assessment of Index Lesion Score (CAILS) primary endpoint assessment at 8 weeks for Cycle 1. In addition, preliminary assessment of the open-label Cycle 2 results suggest a significantly more robust response rate after 12 weeks of SGX301 treatment. These data are expected to be announced in June 2020.
Soligenix Receives US Patent for Improved Production of Synthetic Hypericin Composition