Ultime notizie per Soligenix (NASDAQ:SNGX) Azioni

Soligenix

Soligenix Inc is a late-stage biopharmaceutical company based in the United States. It focuses on developing and commercializing products to treat rare diseases where there is an unmet medical need. The company operates through two business segments namely Specialized BioTherapeutics and Public Health Solutions. It generates maximum revenue from Public Health Solutions with active development programs for RiVax, its ricin toxin vaccine candidate, SGX943, its therapeutic candidate for antibiotic resistant and emerging infectious disease, and its research programs to identify and develop novel vaccine candidates targeting viral infection including Ebola, Marburg and SARS-CoV-2 (the cause of COVID-19).

Soligenix Inc

WIIM

SNGX

Soligenix shares are trading lower after the company announced its interim results from the ongoing open-label investigator-initiated study of HyBryte.

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News

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Watching Soligenix; Zacks Small-Cap Research Gives Stock $35 Price Valuation

Biotech

General

Soligenix Announces Interim Results From Ongoing Open-Label Investigator-Initiated Study Of HyBryte; Says Following 18 Weeks Of Treatment, 75% Of Patients Achieved 'Treatment Success'

<h3>Gainers</h3>
<ul>
<li>OneMedNet (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ONMD#NASDAQ">ONMD</a>) shares rose 15.3% to $0.52 during Friday's after-market session. The market value of their outstanding shares is at $14.5 million. </li>
<li>Wellgistics Health (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/WGRX#NASDAQ">WGRX</a>) stock rose 14.18% to $3.3. The market value of their outstanding shares is at $171.4 million. </li>
<li>Aclarion (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACON#NASDAQ">ACON</a>) stock rose 11.52% to $9.29. The company's market cap stands at $4.7 million. As per the news, the Q4 earnings report came out 2 days ago. </li>
<li>180 Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATNF#NASDAQ">ATNF</a>) stock increased by 10.95% to $0.95. The company's market cap stands at $3.6 million. </li>
<li>Titan Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TTNP#NASDAQ">TTNP</a>) stock rose 10.8% to $4.0. The company's market cap stands at $3.6 million. </li>
<li>Radiopharm Theranostics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RADX#NASDAQ">RADX</a>) stock increased by 10.11% to $4.9. The market value of their outstanding shares is at $38.1 million. </li>
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<h3>Losers</h3>
<ul>
<li>Longevity Health Holdings (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/XAGE#NASDAQ">XAGE</a>) shares decreased by 18.5% to $0.11 during Friday's after-market session. The market value of their outstanding shares is at $3.3 million. </li>
<li>Climb Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CLYM#NASDAQ">CLYM</a>) shares declined by 11.72% to $1.13. The company's market cap stands at $76.2 million. </li>
<li>Citius Oncology (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CTOR#NASDAQ">CTOR</a>) shares decreased by 8.97% to $0.61. The market value of their outstanding shares is at $43.7 million. </li>
<li>Virax Biolabs Group (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VRAX#NASDAQ">VRAX</a>) stock declined by 7.28% to $1.02. The market value of their outstanding shares is at $4.4 million. </li>
<li>Pasithea Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KTTA#NASDAQ">KTTA</a>) stock fell 7.05% to $1.32. The company's market cap stands at $3.5 million. </li>
<li>Soligenix (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNGX#NASDAQ">SNGX</a>) shares decreased by 6.67% to $2.03. The company's market cap stands at $6.4 million. 
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This article was generated by Benzinga's automated content engine and reviewed by an editor.

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Longevity Health Holdings, Inc. - Common Stock

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Soligenix Reports Publication Describing Preclinical Efficacy Of CiVax, A Thermostabilized Subunit Vaccine Against SARS-CoV-2

Soligenix Reported Revenues Of $0.1M For Year Ended December 31, 2024, Compared To $0.8M YoY;  Company's Cash Position Was $7.8M

Events

Soligenix To Present At USCLC Workshop 'Cutaneous Lymphomas in Special Populations' March 6 And AAD Annual Meeting, March 7-11

<a href="https://scr.zacks.com/files/News/2025/Zacks_SCR_Research_02242025_SNGX_Bautz.pdf" title="https://scr.zacks.com/files/News/2025/Zacks_SCR_Research_02242025_SNGX_Bautz.pdf">https://scr.zacks.com/files/News/2025/Zacks_SCR_Research_02242025_SNGX_Bautz.pdf</a>

Soligenix shares are trading higher after the company announced interim data from its investigator-initiated study of HyBryte for early-stage cutaneous T-cell lymphoma, which showed over 70% of patients who completed at least 18 weeks of therapy achieved "Treatment Success."

Market-Moving Exclusives

Exclusives

EXCLUSIVE: Soligenix Tells Benzinga 'Patients have responded positively to HyBryte therapy, with over 70% (5 of the 6 subjects who have completed at least 18 weeks of therapy) already achieving "Treatment Success'

EXCLUSIVE: Soligenix Tells Benzinga 'Study Supported by $2.6 Million FDA Orphan Products Development Grant'

On Tuesday, Soligenix Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNGX#NASDAQ">SNGX</a>) announced an interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte (synthetic hypericin) treatment for up to 12 months in patients with early-stage cutaneous T-cell lymphoma (CTCL), a type of cancer that starts in the T-lymphocytes, a type of white blood cell that fights infection.
Cutaneous T-cell lymphoma&nbsp;is a group&nbsp;of rare blood cancers&nbsp;that affects the skin.
Nine patients have been enrolled and treated with HyBryte over up to 54 weeks.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/41968331/soligenix-kickstarts-dusquetide-mid-stage-study-for-patients-with-inflamed-blood-vessels" rel="noreferrer noopener">Soligenix Kickstarts Dusquetide Mid-Stage Study For Patients With Inflamed Blood Vessels</a>
Patients have responded positively to HyBryte therapy, with over 70% (5 of the 6 subjects who have completed at least 18 weeks of therapy) already achieving "Treatment Success."
Treatment Success is predefined in the study's protocol as a greater than or equal to 50% improvement in the cumulative mCAILS (modified Composite Assessment of Index Lesion Severity) score compared to the baseline.
Three of the five Treatment Successes were achieved within the first 12 weeks of treatment, with two patients achieving a "complete response" by 18 weeks.
Of the remaining patients, two have recently started the study, and two had to drop out for logistical reasons. One showed a substantial improvement (&gt;30%) by their Week 18 visit. In addition, HyBryte appears to be safe and well-tolerated in all patients.
In December, Soligenix announced that patient enrollment had opened for its confirmatory Phase 3 study evaluating HyBryte (synthetic hypericin) for CTCL.
The confirmatory Phase 3 study, FLASH2, builds on the previous statistically significant Phase 3 (FLASH) study, as well as a recent comparative study (HPN-CTCL-04) and an ongoing investigator-initiated study, each further supporting the design of <a target="_blank" href="https://www.benzinga.com/general/biotech/24/12/42505309/exclusive-soligenix-starts-confirmatory-late-stage-trial-for-hybryte-for-type-of-blood-cancer" rel="noreferrer noopener">the FLASH2 clinical trial</a>.
The active ingredient in HyBryte is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by safe, visible light approximately 24 hours later.
Price Action: SNGX stock closed at $3.13 on Monday.
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Health Care

EXCLUSIVE: Soligenix's Cancer Candidate Shows Encouraging Action With Extended Treatment At One Year

EXCLUSIVE: Soligenix Tells Benzinga HyBryte Expanded Treatment Continues To Demonstrate Outcomes In -Early-Stage Cutaneous T-Cell Lymphoma

On Monday, Soligenix, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNGX#NASDAQ">SNGX</a>) said it has opened patient enrollment for its confirmatory Phase 3 study evaluating HyBryte (synthetic hypericin) for cutaneous T-cell lymphoma (CTCL).
The confirmatory Phase 3 study, FLASH2, builds on the previous statistically significant Phase 3 (FLASH) study, as well as a recent comparative study (HPN-CTCL-04) and an ongoing investigator-initiated study, each further supporting the design of the FLASH2 clinical trial.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/41968331/soligenix-kickstarts-dusquetide-mid-stage-study-for-patients-with-inflamed-blood-vessels" rel="noreferrer noopener">Soligenix Kickstarts Dusquetide Mid-Stage Study For Patients With Inflamed Blood Vessels</a>
The FLASH2 study is expected to enroll patients in the U.S. and Europe, and a formal interim analysis is anticipated early in 2026.
The company looks forward to providing periodic updates on the trial's progress in 2025
FLASH2 will enroll approximately 80 subjects with early-stage CTCL, a group of rare blood cancers that affect the skin.
The study replicates the double-blind, placebo-controlled design used in the first Phase 3 FLASH study, which consisted of three 6-week treatment cycles (18 weeks total). The primary efficacy assessment occurred at the end of the initial 6-week cycle (Cycle 1).
However, this second study extends to 18 weeks of continuous treatment (no "between-cycle" treatment breaks), with the primary endpoint assessment occurring at the end of the 18-week timepoint.
In the first Phase 3 study, a treatment response of 49% (p&lt;0.0001 vs patients receiving placebo in Cycle 1) was observed in patients completing 18 weeks (3 cycles) of therapy.
The extended treatment for a continuous 18 weeks in a single cycle is expected to statistically demonstrate the effect of HyBryte over a more prolonged, "real world" treatment course.
In July, Soligenix shared an interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte treatment for up to 12 months in patients with <a href="https://www.benzinga.com/general/biotech/24/07/39692597/nano-cap-soligenix-stock-surges-over-200-on-tuesday-heres-why" target="_blank" rel="noreferrer noopener">early-stage CTCL</a>.
Price Action: SNGX stock closed at $3.14 on Friday.

EXCLUSIVE: Soligenix Starts Confirmatory Late-Stage Trial For HyBryte For Type Of Blood Cancer

EXCLUSIVE: Soligenix Tells Benzinga Co. Initiates Confirmatory Phase III Trial Of HyBryte For The Treatment Of Cutaneous T-Cell Lymphoma

Soligenix Announced That Analysis Of The Post-treatment Data From The Open-label Study Comparing HyBryte (Synthetic Hypericin) To Valchlor (Mechlorethamine) Has Demonstrated Continued Improvement In HyBryte-treated Patients And Their Individual Lesions Even After Stopping Treatment

Soligenix Reveals Formation Of European Medical Advisory Board To Provide Additional Medical/Clinical Strategic Guidance; Phase 3 Clinical Study Of HyBryte In CTCL Initiating In 2024

On Thursday, Soligenix Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNGX#NASDAQ">SNGX</a>) opened patient enrollment for its DUS-AUBD-01 Phase 2 study evaluating SGX945 (dusquetide) for Behçet's Disease, an inflammatory disorder of the blood vessels (vasculitis).
The company looks forward to completing enrollment and announcing study results in the first half of 2025.
The pilot clinical trial of SGX945 will be an open-label study that will enroll approximately 25 patients aged 18 years or older with mild to moderate Behçet's Disease and active oral and/or genital ulcers.
Patients will receive SGX945 as a twice-weekly 4-minute intravenous (IV) infusion for 4 weeks, followed by 4 weeks of follow-up.
Efficacy endpoints will include the extent of lesion clearance, timeline to lesion clearance, and patient reported quality of life assessments.&nbsp;&nbsp;
Dusquetide, the active ingredient in SGX945 (Behçet's Disease) and <a target="_blank" href="https://www.soligenix.com/pipeline-programs/sgx942-treatment-for-oral-mucositis/" rel="noreferrer noopener">SGX942 (oral mucositis)</a>, is an innate defense regulator (IDR), a new class of short, synthetic peptides.
Dusquetide has demonstrated safety and tolerability in a Phase 1 study in 84 healthy human volunteers.
In Phase 2 and 3 clinical studies with dusquetide in over 350 subjects with oral mucositis due to chemoradiation therapy for head and neck cancer, positive efficacy results were demonstrated, including potential long-term <a target="_blank" href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5470438/" rel="noreferrer noopener">ancillary benefits</a>.
There are approximately 18,000 known cases of Behçet's Disease in the U.S., 350,000 in Turkey, and over 50,000 in Europe. There are as many as 1 million people worldwide living with Behçet's Disease.
In July, The Princeton, New Jersey-based company announced an interim update on the open-label, investigator-initiated study (IIS) evaluating extended Hybryte treatment for up to 12 months in patients with early-stage cutaneous&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/07/39692597/nano-cap-soligenix-stock-surges-over-200-on-tuesday-heres-why" rel="noreferrer noopener">T-cell lymphoma (CTCL)</a>.
Patients have responded positively to HyBryte therapy. Three of the four subjects who have completed at least 12 weeks of therapy already achieved "Treatment Success."
Price Action: At the last check on Thursday, SNGX stock traded higher by 1.10% to $3.67 premarket.
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Soligenix Kickstarts Dusquetide Mid-Stage Study For Patients With Inflamed Blood Vessels

Soligenix Initiates A Phase 2 Clinical Trial Of SGX945 For The Treatment Of Behçet's Disease; Says Study DUS-AUBD-01 Opens Patient Enrollment

Press Releases

HyBryte™ Expanded Treatment Continues to Demonstrate Positive Outcomes in Early-Stage Cutaneous T-Cell Lymphoma

Soligenix to Present at Upcoming Investor Conferences

Soligenix Targets Psoriasis With New Therapy

Small Cap

Soligenix to Present at BIO CEO & Investor Conference

HyBryte™ Treatment Studies Presented at Two Medical Conferences in March

Earnings

Soligenix Announces Recent Accomplishments and Year End 2024 Financial Results

Soligenix Announces Publication Demonstrating CiVax™ Booster Induces Rapid Broad Protection Against COVID-19 Variants

IBN Initiates Coverage of Soligenix Inc.

Positive Outcome in 75% of CTCL Patients Treated with HyBryte™ for 18 Weeks

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Interview

Soligenix Aims To Push The Boundaries In Treating Rare Diseases

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Soligenix&#39;s Leadership Aims To Drive Growth In Rare Disease Markets In 2025 And 2026

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Improving Patient Quality Of Life: Soligenix Progresses Treatment For Painful Ulcers Associated With Rare Behçet&#39;s Disease

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Soligenix Reports It Is On Cusp Of Treating Rare Cancer CTCL

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Soligenix, A Pharmaceutical Firm Tackling Potentially Lucrative Unmet Medical Needs

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