Soligenix stock rallies 400% on positive HyBryte trial results

Soligenix Inc (NASDAQ: SGNX) reported positive interim data from a trial of its HyBryte therapy on Tuesday. 

HyBryte is the biopharmaceutical firm’s treatment for early-stage cutaneous T-cell lymphoma. 

Soligenix stock rallied a whopping 400% following the interim results today. 

Here’s why it matters for Soligenix stock

Soligenix has so far enrolled six patients in the aforementioned clinical study. Three of them met the minimum threshold for the treatment to be called a success within eighteen weeks. 

The Nasdaq-listed firm is committed to signing up a total of 50 patients eventually to the ongoing trial. Christopher J. Schaber – the chief executive of SNGX said in a press release today:

Following the FLASH study which demonstrated safety and efficacy of shorter courses of HyBryte therapy, we’re pleased to see that continuing treatment for longer time periods is resulting in improved outcomes for patients.

Despite today’s rally, Soligenix stock is still down significantly versus the start of 2024. 

SGNX says another patient is showing improvement

Soligenix also confirmed today that two out of the three study participants who are yet to achieve treatment success are in early stages of the therapy only. 

The third one, it added, showed significant improvement following eighteen weeks of treatment but is yet to meet the minimum threshold. According to CEO Schaber:

We look forward to working with Dr. Kim on this important study as well as embarking on our confirmatory Phase 3 replication study later this year. We’ll continue to provide additional updates on IIS as data becomes available.

SGNX defines treatment success as 50% or more reduction in the patient’s cumulative mCAILS score versus baseline. Soligenix stock does not currently pay a dividend. 

Soligenix topped EPS estimates in fiscal Q1

The massive surge in Soligenix stock on Tuesday is coupled with a huge increase in its trading volume as well. 

More than 90 million shares of the biopharmaceutical firm have so far exchanged hands today. In comparison, its daily trading volume sits at less than a quarter-million on average. 

In May, SGNX reported 18 cents of per-share loss for its first financial quarter that topped Street estimates by 2 cents. Chief executive Christopher J. Schaber said at the time:

Recently, we completed a public offering with gross proceeds of approximately $4.75 million, which will allow us to continue to move our rare disease pipeline forward.

Soligenix had just over $7.0 million in cash at the end of March, 2024. Dr. Schaber also confirmed in a recent statement that his company is managing cash burn meticulously to hit its near-term milestones. 

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