Shares of Soligenix (NASDAQ:SNGX) are surging higher by over 300% following an update on the biopharmaceutical company's study of its HyBryte treatment. HyBryte focuses on patients with early-stage cutaneous T-cell lymphoma (CTCL). According to the press release: "Patients have responded positively to HyBryte™ therapy with 75% (3 of the 4 subjects who have completed at least 12 weeks of therapy) already achieving "Treatment Success", as predefined in the study's protocol as ≥50% improvement in their cumulat ...

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Core Insights - HyBryte therapy has shown positive responses in patients, with three out of four subjects achieving "Treatment Success" after at least 12 weeks of treatment [2][9] - The Phase 3 FLASH study demonstrated the efficacy and promising safety profile of HyBryte, addressing the limited treatment options for early-stage cutaneous T-cell lymphoma (CTCL) patients [4][10] - The interim update from Soligenix indicates ongoing collaboration with the FDA for further studies, including a confirmatory Phase 3 placebo-controlled study [6] Study Details - The open-label study (protocol HPN-CTCL-04) enrolled ten patients, with six patients treated for up to 44 weeks [3][13] - Initial results from the expanded use of HyBryte in a real-world setting were described as "promising," supporting previous positive Phase 2 and 3 clinical trial results [10] - Two of the three patients who achieved Treatment Success did so within the first 12 weeks, while the third achieved success at 18 weeks [9] Efficacy and Safety - The study revealed that 60% of patients treated with HyBryte achieved a 50% or better improvement in their mCAILS score, compared to 20% of patients treated with Valchlor [11] - HyBryte has been reported to have a favorable safety profile, with no treatment-related adverse events observed in all patients [14] Market Reaction - Following the positive news, Soligenix Inc (SNGX) shares surged by 221.5%, reaching $6.43, with a trading volume of 23.6 million shares [7][8]

Group 1 - Soligenix (NASDAQ:SNGX) stock has surged by 296% following positive data from its late-stage HyBryte treatment for early-stage cutaneous T-cell lymphoma (CTCL) [4][5] - In a 12-month study, six patients were enrolled, with four patients achieving a 50% improvement in their cumulative mCAILS score compared to baseline after at least 12 weeks of treatment [1][6] - Heavy trading activity was noted, with over 46 million SNGX shares changing hands, significantly above the daily average of approximately 222,000 shares [2] Group 2 - The company anticipates improved outcomes for patients with continued treatment and plans to embark on a confirmatory Phase 3 replication study later this year [5] - The interim data indicates that one patient has shown significant improvement over 18 weeks, contributing to the overall positive outlook for the therapy [1][6]

Study Supported by $2.6 Million FDA Orphan Products Development Grant "We are pleased with the initial study results and with the FDA's support of the IIS that provides CTCL patients an opportunity to access HyBryte™ in an open-label setting," stated Christopher J. Schaber, President and CEO of Soligenix, Inc. "CTCL is an incredibly difficult to treat orphan disease and remains an area of unmet medical need with a very limited number of safe and effective treatment options. Following the initial Phase 3 FLA ...

Core Insights - Soligenix's HyBryte™ shows promising results in treating cutaneous T-cell lymphoma (CTCL) compared to Valchlor®, with a higher percentage of patients achieving significant improvement in their condition [24][23][12] Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing treatments for rare diseases with unmet medical needs, including HyBryte™ for CTCL [20][24] - The company is advancing its pipeline, which includes other therapeutic candidates for various conditions [20] Clinical Study Results - In a recent comparability study, 60% of patients treated with HyBryte™ achieved a ≥50% improvement in their modified Composite Assessment of Index Lesion Severity (mCAILS) score after 12 weeks, compared to 20% for Valchlor® [24][23] - The study involved 10 patients, with a favorable safety profile for HyBryte™, as no adverse events related to the therapy were reported, while 60% of Valchlor® patients experienced adverse events [2][24] Treatment Efficacy - HyBryte™ demonstrated a cumulative improvement in mCAILS of 52.5% compared to 34.7% for Valchlor® after 12 weeks [23] - The treatment was well tolerated across all patients, contrasting with Valchlor®, where one patient had to withdraw due to allergic contact dermatitis [23][2] Future Developments - Following the positive results, a second Phase 3 trial (FLASH2) is expected to begin before the end of 2024 to further evaluate HyBryte™ [6][12] - The FDA has granted an Orphan Products Development grant of $2.6 million to support the evaluation of HyBryte™ for expanded treatment options [7] Industry Context - CTCL is a rare form of non-Hodgkin's lymphoma affecting approximately 31,000 individuals in the U.S. and 38,000 in Europe, with no current cure available [19][8] - The treatment landscape for CTCL is limited, with existing therapies often associated with significant side effects, highlighting the potential of HyBryte™ as a safer alternative [16][8]

Group 1 - Soligenix is developing thermostabilized subunit vaccines, including SuVax™ and MarVax™, which have shown complete protection in non-human primate studies against filoviruses [2][10][27] - The company has received Orphan Drug Designation from the FDA for both Sudan ebolavirus and Marburg marburgvirus, providing market exclusivity and various financial benefits [5][13] - The thermostabilization technology allows vaccines to remain stable at ambient temperatures, facilitating easier distribution and use [2][20][27] Group 2 - The company is focused on rare diseases with unmet medical needs, with additional products in development for conditions like cutaneous T-cell lymphoma and inflammatory diseases [8][24] - Soligenix's vaccine programs are supported by government grants and contracts from agencies like NIAID and BARDA, enhancing its financial position [4][24] - The upcoming presentation at the ASM Microbe Conference will highlight the advantages of the company's vaccine technology compared to other platforms [10][11][26]

In addition to the positive clinical results to date, Soligenix has received regulatory validation with the granting of Orphan Drug Designation and Fast Track Status by the U.S. Food and Drug Administration (FDA), and Orphan Designation by the European Medicines Agency (EMA) for HyBryte™ in the treatment of early-stage CTCL. The full article can be found at: https://prismmarketview.com/prism-marketview-highlights-soligenixs- promising-hybryte-replication-trial-setting-the-stage-for-success/ NEW YORK, June 0 ...

Core Points - Soligenix, Inc. plans to implement a reverse stock split at a ratio of 1-for-16, effective June 5, 2024, with trading on a split-adjusted basis starting June 6, 2024 [1][3] - The reverse stock split was approved by stockholders, allowing the Board of Directors to determine the specific ratio within a range of 1-for-2 to 1-for-20 [2] - Following the split, the number of outstanding shares will decrease from approximately 15.8 million to about 987,490 shares, with adjustments made for fractional shares [4] Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing treatments for rare diseases with unmet medical needs [5] - The company is advancing its product HyBryte™ (SGX301) for cutaneous T-cell lymphoma and has completed a second Phase 3 study, seeking regulatory approvals for commercialization [5] - Other development programs include treatments for psoriasis, inflammatory diseases, and a ricin toxin vaccine candidate, supported by government funding [6]

Core Viewpoint - Soligenix, Inc. is urging eligible stockholders to vote their shares at the upcoming reconvened meeting on May 30, 2024, emphasizing the importance of shareholder participation in corporate governance [1][2]. Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products for rare diseases with unmet medical needs [5]. - The company is advancing its Specialized BioTherapeutics segment, which includes HyBryte™ (SGX301), a novel photodynamic therapy for cutaneous T-cell lymphoma (CTCL), and is seeking regulatory approvals for potential worldwide commercialization [5]. - Other development programs include SGX302 for psoriasis, dusquetide (SGX942) for inflammatory diseases, and SGX945 for Behçet's Disease [5]. Public Health Solutions - The Public Health Solutions segment includes the development of RiVax®, a ricin toxin vaccine candidate, and vaccines targeting filoviruses and COVID-19 [6][7]. - The vaccine programs utilize the proprietary ThermoVax® technology and have received government funding from agencies such as NIAID, DTRA, and BARDA [7]. Voting Information - Eligible stockholders can vote by contacting the company's proxy solicitor, Alliance Advisors, and must have held shares as of the record date, April 10, 2024 [2]. - Stockholders who sold their shares after the record date are still encouraged to vote [2]. Proxy Materials - The company filed a definitive proxy statement and proxy card with the SEC on April 29, 2024, and stockholders are urged to read these documents for important information regarding the Annual Meeting [3][4].