Latest news with #HyBryte
Business Upturn
5 days ago
- Business
- Business Upturn
NetworkNewsAudio Announces Audio Press Release (APR) on Promising First-Line Therapy for Rare Skin Cancer
AUSTIN, Texas, Aug. 08, 2025 (GLOBE NEWSWIRE) — via IBN – NetworkNewsAudio announces the Audio Press Release (APR) titled 'Late-Stage Pipeline Wins Boost Investor Confidence in High-Growth Therapeutic Areas,' featuring Soligenix Inc. (NASDAQ: SNGX). To hear the NetworkNewsAudio version, visit To read the original editorial, visit Soligenix Inc. is advancing HyBryte, its late-stage therapy for cutaneous T-cell lymphoma (CTCL), a rare and chronic cancer that primarily affects older adults. HyBryte has shown strong promise as a first-line treatment option for early-stage CTCL, a market estimated at nearly $1 billion globally, with 70% of that opportunity in the U.S. The therapy has already received orphan drug designations in both the U.S. and Europe, as well as FDA Fast Track status. Unlike traditional treatments that can take a year or more to show efficacy, HyBryte demonstrated statistically significant results in just six weeks in its initial phase 3 trial. A second confirmatory phase 3 study, FLASH2, is now underway in the U.S. and Europe and is designed to provide further validation of HyBryte's safety and effectiveness, with top-line results expected in 2026. HyBryte's safety profile stands out in a treatment space where many existing options carry significant side effects, including DNA damage and long-term carcinogenic risks. The therapy's use of synthetic hypericin activated by non-carcinogenic visible light — rather than ultraviolet light — offers a safer alternative, especially for older patients. With minimal systemic absorption and strong responses across both patch and plaque lesions, HyBryte has the potential to redefine the standard of care for CTCL. Soligenix's advancements in this rare disease area highlight the growing urgency and opportunity in addressing complex conditions that disproportionately affect aging populations. About Soligenix Inc. Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Its Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte(TM) ('SGX301' or synthetic hypericin) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma ('CTCL'). With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. Development programs in this business segment also include expansion of synthetic hypericin ('SGX302') into psoriasis, the company's first-in-class innate defense regulator ('IDR') technology, dusquetide ('SGX942') for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and ('SGX945') in Behçet's disease. The company's Public Health Solutions business segment includes development programs for RiVax(R), its ricin toxin vaccine candidate, as well as its vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax(TM), the company's vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of Soligenix's vaccine programs incorporates the use of its proprietary heat stabilization platform technology, known as ThermoVax(R). To date, this business segment has been supported with government grants and contract funding from the National Institute of Allergy and Infectious Diseases ('NIAID'), the Defense Threat Reduction Agency ('DTRA') and the Biomedical Advanced Research and Development Authority ('BARDA'). For further information, visit the company's website at Soligenix Inc. About NetworkNewsAudio NetworkNewsAudio, a service of NetworkNewsWire (NNW), a multifaceted financial news and publishing company powered by IBN ('InvestorBrandNetwork'), allows you to sit back and listen to market updates, interviews and company press releases. NetworkNewsAudio keeps you informed on publicly traded companies we're watching. The audio clips provide snapshots of position, opportunity and momentum. NetworkNewsAudio is a Brand Awareness Distribution Solution from NetworkNewsWire. For more information, visit: NetworkNewsWire (NNW) is a comprehensive provider of news aggregation and syndication, enhanced press release services and a full array of social communication solutions. As a multifaceted financial news and distribution company with an extensive team of journalists and writers, NNW has the unparalleled ability to reach a wide audience of investors, consumers, journalists and the general public. With an ever-growing distribution network of more than 5,000 key syndication outlets across the nation, NNW cuts through the overload of information in today's markets bringing its clients unparalleled visibility, recognition and brand awareness. NetworkNewsWire is where news, content and information converge. Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: Forward-Looking Statements This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company's SEC filings. These risks and uncertainties could cause the company's actual results to differ materially from those indicated in the forward-looking statements. Corporate Communications IBNAustin, Texas 512.354.7000 Office [email protected]
Business Upturn
6 days ago
- Business
- Business Upturn
Soligenix Inc. (NASDAQ: SNGX) Proprietary Platform Aims to Meet Growing Need for Effective CTCL Therapy
NEW YORK, Aug. 07, 2025 (GLOBE NEWSWIRE) — via InvestorWire — Soligenix Inc. (NASDAQ: SNGX) today announces its placement in an editorial published by NetworkNewsWire ('NNW'), one of 70+ brands within the Dynamic Brand Portfolio@IBN (InvestorBrandNetwork ) , a specialized communications platform with a focus on financial news and content distribution for private and public companies and the investment community. To view the full publication, 'Clinical Progress in Rare Disease Signals Long-Term Revenue Potential for Innovators,' please visit: . As the American population gets older, chronic and rare diseases are becoming a significant healthcare issue, particularly for older adults. The aging population's increasing life expectancy also leads to more complex healthcare needs, especially for conditions that are both chronic and difficult to diagnose. Many of these rare conditions lack FDA-approved treatments, and their symptoms in seniors are frequently mistaken for normal signs of aging, causing diagnostic delays that can last for years. There are more than 30 million Americans who have a rare disease, so there is a growing need for accurate diagnoses and effective treatments. The Trump administration's 'Make America Healthy Again' initiatives have highlighted this problem and focused on improving access to treatments and speeding up medical innovation. Soligenix Inc. (NASDAQ: SNGX) is working to advance this mission with its HyBryte(TM) platform, a new therapy for cutaneous T-cell lymphoma (CTCL), a rare form of skin cancer that largely impacts older adults. The company has successfully established U.S.-based manufacturing for HyBryte's active ingredient, demonstrating the kind of domestic innovation that can significantly help this underserved patient group. About Soligenix Inc. Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Its Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte(TM) ('SGX301' or synthetic hypericin) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma ('CTCL'). With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. Development programs in this business segment also include expansion of synthetic hypericin ('SGX302') into psoriasis, the company's first-in-class innate defense regulator ('IDR') technology, dusquetide ('SGX942') for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and ('SGX945') in Behçet's disease. The company's Public Health Solutions business segment includes development programs for RiVax(R), its ricin toxin vaccine candidate, as well as its vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax(TM), the company's vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of Soligenix's vaccine programs incorporates the use of its proprietary heat stabilization platform technology, known as ThermoVax(R). To date, this business segment has been supported with government grants and contract funding from the National Institute of Allergy and Infectious Diseases ('NIAID'), the Defense Threat Reduction Agency ('DTRA') and the Biomedical Advanced Research and Development Authority ('BARDA'). For further information, visit the company's website at . NOTE TO INVESTORS: The latest news and updates relating to SNGX are available in the company's newsroom at About NetworkNewsWire NetworkNewsWire ('NNW') is a specialized communications platform with a focus on financial news and content distribution for private and public companies and the investment community. It is one of 60+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today's market, NNW brings its clients unparalleled recognition and brand awareness. NNW is where breaking news, insightful content and actionable information converge. For more information, please visit Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: NetworkNewsWireNew York, Office [email protected]
Cision Canada
7 days ago
- Business
- Cision Canada
Clinical Progress in Rare Disease Signals Long-Term Revenue Potential for Innovators
NetworkNewsWire Editorial Coverage NEW YORK, Aug. 6, 2025 /CNW/ -- As the American population gets older, chronic and rare diseases are becoming a significant healthcare issue, particularly for older adults. The aging population's increasing life expectancy also leads to more complex healthcare needs, especially for conditions that are both chronic and difficult to diagnose. Many of these rare conditions lack FDA-approved treatments, and their symptoms in seniors are frequently mistaken for normal signs of aging, causing diagnostic delays that can last for years. There are more than 30 million Americans who have a rare disease, so there is a growing need for accurate diagnoses and effective treatments. The Trump administration's "Make America Healthy Again" initiatives have highlighted this problem and focused on improving access to treatments and speeding up medical innovation. Soligenix Inc. (NASDAQ: SNGX) (Profile) is working to advance this mission with its HyBryte(TM) platform, a new therapy for cutaneous T-cell lymphoma (CTCL), a rare form of skin cancer that largely impacts older adults. The company has successfully established U.S.-based manufacturing for HyBryte's active ingredient, demonstrating the kind of domestic innovation that can significantly help this underserved patient group. Soligenix is one of several notable companies dedicated to making an impact in the pharmaceutical field, alongside Amgen Inc. (NASDAQ: AMGN), Amicus Therapeutics Inc. (NASDAQ: FOLD), Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) and Citius Oncology Inc. (NASDAQ: CTOR). Soligenix's HyBryte program is a promising treatment option for cutaneous T-cell lymphoma (CTCL), a rare cancer that largely impacts older adults. In 2024, the global market for CTCL therapies in the seven major markets (the United States, EU4, the United Kingdom, and Japan) was estimated to be around $995 million. Soligenix is conducting a second confirmatory phase 3 clinical trial for HyBryte, which is a crucial step in moving the therapy toward global commercialization. One of HyBryte's most important strengths in the treatment of cutaneous T-cell lymphoma (CTCL) is its consistently favorable safety record. Click here to view the custom infographic of the Soligenix Inc. editorial. Chronic Conditions Demand Targeted Innovation Chronic rare diseases are becoming a major challenge for the aging population in the United States. As life expectancy rises, healthcare needs become more complex, especially for conditions that are long-lasting and hard to diagnose. With tens of millions of Americans living with a rare disease, many of whom are seniors whose symptoms might be dismissed as normal signs of aging, there is a clear and growing need for better care. Since rare diseases can present subtly or mimic common age-related issues, older adults often face diagnostic delays of years, which can hinder access to effective care and lead to worse outcomes. The problem is made worse by the limited number of FDA-approved treatments. With thousands of uncommon diseases identified, most still do not have approved therapies, which highlights the importance of ongoing investment in research and development. Seniors are particularly susceptible to underdiagnosis and undertreatment, especially when the healthcare system isn't prepared to recognize the subtle ways these conditions manifest in older adults. President Trump's "Make America Healthy Again" initiative has drawn attention to the increasing burden of chronic and rare diseases. These efforts, which include policies aimed at accelerating research, improving diagnostic tools, and expanding access to care, are designed to meet the needs of older Americans facing these complicated health challenges. Savvy companies such as Soligenix Inc. are stepping up to address this need. The company's HyBryte program is a promising treatment option for cutaneous T-cell lymphoma (CTCL), a rare cancer that largely impacts older adults. Soligenix has recently completed the successful U.S. manufacturing transfer of HyBryte's active ingredient, which helps the company's mission to provide effective, innovative treatments to patients who need them most. Growing CTCL Market Highlights Urgency Cutaneous T-cell lymphoma (CTCL) is a rare type of non-Hodgkin's lymphoma (NHL) that mainly affects the skin. Unlike other lymphomas, CTCL involves malignant T-cells that move to the skin's surface, where they form patches, lesions, or tumors. This chronic cancer is most often seen in older adults, making it particularly relevant to the aging population. Despite its rarity, CTCL is a serious medical issue, affecting over 40,000 NHL patients worldwide. Currently, there is no cure for CTCL, and treatments are typically focused on managing symptoms and slowing the disease's progression. Mycosis fungoides (MF) is the most common subtype of CTCL, accounting for about 90% of all cases. In its early stages (I–IIA), MF has a relatively high five-year survival rate of 88%, but it remains a lifelong illness. As a chronic condition with no approved first-line therapy for early-stage patients, CTCL represents a clear unmet medical need. In 2024, the global market for CTCL therapies in the seven major markets (the United States, EU4, the United Kingdom, and Japan) was estimated to be around $995 million, with the U.S. making up approximately 70% of that total. Additionally, DelveInsight notes that "the expected launch of therapies such as HyBryte . . . will also boost the CTCL market growth." In the absence of novel therapies, treatment choices remain scarce, particularly for individuals diagnosed in the early phases of the disease. Numerous patients cycle through multiple therapies with minimal results, underscoring the urgent demand for more precise and effective treatment options. HyBryte (synthetic hypericin) from Soligenix represents a compelling candidate to serve as a first-line treatment for early-stage CTCL. Addressing a crucial unmet need, HyBryte has the potential to greatly enhance patient well-being and emerge as a top therapeutic choice within this largely unaddressed segment of the market. Pivotal Trial Advances Global Approval Soligenix is currently conducting a second confirmatory phase 3 clinical trial for HyBryte, called FLASH2, which is a crucial step in moving the therapy toward global commercialization for the treatment of early-stage CTCL. The FLASH2 study is designed to confirm the positive results of the first FLASH study and has been accepted by the European Medicines Agency (EMA), with ongoing discussions with the U.S. Food and Drug Administration (FDA). The EMA's validation of the trial design shows its strength and its alignment with international standards for therapeutic approval. The FLASH2 study is similar to its predecessor but features a longer, 18-week double-blind, placebo-controlled treatment period, which is three times longer than the original six-week period in the first FLASH trial. This extended timeline is expected to provide more comprehensive data on HyBryte's safety and effectiveness. Importantly, key elements such as the patient inclusion and exclusion criteria and the primary endpoint are consistent between the two studies, which supports the integrity and comparability of the trial outcomes. An estimated 80 patients will be enrolled at clinical sites in both the United States and Europe. This multinational approach is intended to support broad regulatory submissions and clear the way for HyBryte's commercial launch on a global scale. With enrollment on schedule, Soligenix expects to report top-line results in 2026. These data could significantly strengthen the case for HyBryte to become the first approved front-line treatment for early-stage CTCL. As Soligenix continues to advance this promising therapy, FLASH2 represents a potentially transformative milestone in the company's efforts to address a long-standing unmet medical need within the rare disease and oncology communities. Trial Results Reinforce HyBryte's Promise Soligenix's HyBryte has reached a key milestone with the successful completion of its first phase 3 clinical trial, known as the FLASH study, delivering statistically significant positive results and marking a major step forward in the treatment of early-stage cutaneous T-cell lymphoma (CTCL). Recognized for addressing a critical unmet medical need, HyBryte has been granted orphan drug designation in both the United States and European Union, along with Fast Track status by the FDA. In contrast to many existing CTCL therapies that often require a year or more to demonstrate effectiveness, HyBryte produced statistically meaningful clinical responses in only six weeks. Continued treatment further increased efficacy, with response rates climbing to 40% at 12 weeks and reaching 49% at 18 weeks. Importantly, the therapy proved effective across both surface-level patch lesions and deeper plaque lesions, a distinction that sets it apart from many current early-stage CTCL treatments, which tend to show efficacy primarily in patch-type disease. This broader impact across lesion types underscores HyBryte's differentiated potential in managing this heterogeneous and challenging condition. The structure and outcomes of the study reinforce the promise of HyBryte as a practical, noninvasive therapeutic option that could redefine care for CTCL patients. HyBryte also stands out for its strong safety and tolerability profile. Results from the FLASH trial showed very few adverse events, which is a notable advantage compared to other CTCL treatments that can cause significant short- and long-term side effects. This makes HyBryte especially well-suited for older patients who may be dealing with other health issues and are particularly sensitive to treatment-related complications. Another innovative feature of HyBryte is its use of visible fluorescent light rather than traditional ultraviolet (UV) light for activation. This approach eliminates the carcinogenic risks that are commonly associated with conventional phototherapy, providing a safer treatment experience while preserving therapeutic efficacy. The activation of synthetic hypericin by safe, visible light enhances both safety and convenience for patients. Taken together, the results from the FLASH and ongoing FLASH2 studies establish HyBryte as a compelling front-runner to become the first approved primary treatment for early-stage CTCL, offering a faster-acting, safer, and more comprehensive alternative to existing standards of care. Safety and Market Potential Align One of HyBryte's most important strengths in the treatment of cutaneous T-cell lymphoma (CTCL) is its consistently favorable safety record, as demonstrated across several clinical trials. In contrast to many currently approved therapies for early-stage CTCL, which are frequently linked to serious or even life-threatening side effects, HyBryte has shown excellent tolerability with no safety issues reported so far. Its unique mechanism of action does not involve DNA damage—an important advantage in a therapeutic space where numerous treatments pose risks such as melanoma, other forms of cancer, significant skin injury, and accelerated skin aging. This strong safety profile takes on even greater importance given that existing CTCL treatments are only sanctioned for use after other options have failed, and none are approved for initial, front-line use. In such a landscape, safety considerations weigh heavily in treatment decisions, especially for older patients who may also be managing other medical conditions. HyBryte's properties, including low systemic absorption, its nonmutagenic active compound, and the use of visible, non-carcinogenic light for activation, set it apart as a particularly safe and practical option. With no first-line therapies currently available, HyBryte is well positioned to fill that critical gap by combining safety with clinical effectiveness. Beyond its strong therapeutic potential, HyBryte also presents a substantial commercial opportunity in a market that remains largely underserved. Analysts estimate the global CTCL treatment market to exceed $990 million, highlighting the significant demand for innovative and effective therapies. As clinical development progresses, HyBryte has the potential not only to transform outcomes for patients but also to emerge as a new standard of care in CTCL management, meeting urgent clinical needs while offering a scalable solution for healthcare providers and investors alike. Advancements in Oncology Research The world of pharmaceutical research is continually evolving, and recent announcements from several key players in the biopharma space highlight significant progress. From promising clinical trial results to strategic partnerships aimed at broadening market reach, these developments offer new hope for patients and clinicians alike. Amgen Inc. is reporting results on its phase 3 FORTITUDE-101 clinical trial evaluating first-line bemarituzumab plus chemotherapy (mFOLFOX6). According to the company, the trial met its primary endpoint of overall survival (OS) at a prespecified interim analysis. The company noted that "bemarituzumab plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS as compared to placebo plus chemotherapy in people living with unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer with FGFR2b overexpression and who are non-HER2 positive." Gastric cancer is the fifth leading cause of cancer-related death worldwide, with nearly one million new cases and more than 650,000 deaths globally each year, highlighting a critical unmet medical need. Amicus Therapeutics Inc. recently announced the publication of a post-hoc analysis of data from the ERT-experienced cohort of the PROPEL study. The study evaluated cipaglucosidase alfa-atga + miglustat (cipa+mig) in adults with late-onset Pompe disease (LOPD). The report was published in " Muscle and Nerve." In this new publication, based on a within group effect-size analysis, subjects who switched from alglucosidase alfa to cipa+mig achieved improvements or stability in most of the outcomes measured. Tonix Pharmaceuticals Holding Corp. is reporting the publication of a paper in the peer-reviewed journal " Cancer Cell." The paper, titled "A CXCR4 Partial Agonist, Improves Immunotherapy by Targeting Immunosuppressive Neutrophils and Cancer-Driven Granulopoiesis," represents a collaboration between scientists at Tonix and Columbia University's Medical School and presents data demonstrating that treatment with murine TNX-1700 (mTNX-1700) increased survival and decreased metastases in animal models of gastric cancer. Citius Oncology Inc. announced the execution of a distribution services agreement with Cencora (formerly AmerisourceBergen), a global pharmaceutical services company. This agreement marks another significant step forward in the company's commercial launch strategy for LYMPHIR (denileukin diftitox-cxdl), its FDA-approved immunotherapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL). This new agreement expands Citius Oncology's commercial distribution network, providing additional access and product availability upon launch. The agreement with Cencora, a leader in specialty pharmaceutical distribution and services, builds on a previously announced distribution services agreement to support long-term scalability and market reach of LYMPHIR. These recent developments underscore the dynamic and hopeful landscape of cancer treatment. From innovative therapies showing promise in clinical trials for conditions such as gastric cancer and late-onset Pompe disease, to strategic commercial moves ensuring that approved treatments like LYMPHIR can reach patients more effectively, the biopharmaceutical industry continues to push the boundaries of what's possible. For more information, visit Soligenix Inc. About NetworkNewsWire NetworkNewsWire ("NNW") is a specialized communications platform with a focus on financial news and content distribution for private and public companies and the investment community. It is one of 70+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today's market, NNW brings its clients unparalleled recognition and brand awareness. NNW is where breaking news, insightful content and actionable information converge. For more information, please visit Please view full terms of use and disclaimers on the NNW website applicable to all content provided by NNW, wherever published or re-published: NetworkNewsWire is powered by IBN DISCLAIMER: NetworkNewsWire (NNW) is the source of the Article and content set forth above. References to any issuer other than the profiled issuer are intended solely to identify industry participants and do not constitute an endorsement of any issuer and do not constitute a comparison to the profiled issuer. The commentary, views and opinions expressed in this release by NNW are solely those of NNW. Readers of this Article and content agree that they cannot and will not seek to hold liable NNW for any investment decisions by their readers or subscribers. 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Globe and Mail
05-08-2025
- Business
- Globe and Mail
Soligenix Inc. (NASDAQ: SNGX) Innovative Platform Provides Novel Treatment for Underserved CTCL Space
NEW YORK, Aug. 05, 2025 (GLOBE NEWSWIRE) -- via InvestorWire — Soligenix Inc. (NASDAQ: SNGX) today announces its placement in an editorial published by NetworkNewsWire ("NNW"), one of 70+ brands within the Dynamic Brand Portfolio @ IBN (InvestorBrandNetwork), a specialized communications platform with a focus on financial news and content distribution for private and public companies and the investment community. To view the full publication, 'Late-Stage Pipeline Wins Boost Investor Confidence in High-Growth Therapeutic Areas,' please visit: As America's population ages, chronic and rare diseases are emerging as a pressing healthcare challenge — one that disproportionately affects older adults. With more than 30 million Americans living with a rare disease, the need for accurate diagnoses and effective treatments is growing urgent. Many of these conditions remain without FDA-approved therapies, and symptoms in seniors are often misattributed to typical aging, leading to years-long diagnostic delays. Recognizing this crisis, the Trump administration's 'Make America Healthy Again' initiatives have emphasized improving access to treatments and accelerating medical innovation. Advancing this mission, Soligenix Inc. (NASDAQ: SNGX) is making strides with its HyBryte(TM) platform, a novel therapy aimed at treating cutaneous T-cell lymphoma (CTCL), a rare skin cancer that primarily affects older adults. With successful U.S.-based manufacturing of HyBryte's active ingredient now in place, Soligenix exemplifies the kind of domestic innovation poised to make a meaningful impact on this underserved patient population. About Soligenix Inc. Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Its Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte(TM) ('SGX301' or synthetic hypericin) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma ('CTCL'). With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. Development programs in this business segment also include expansion of synthetic hypericin ('SGX302') into psoriasis, the company's first-in-class innate defense regulator ('IDR') technology, dusquetide ('SGX942') for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and ('SGX945') in Behçet's disease. The company's Public Health Solutions business segment includes development programs for RiVax(R), its ricin toxin vaccine candidate, as well as its vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax(TM), the company's vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of Soligenix's vaccine programs incorporates the use of its proprietary heat stabilization platform technology, known as ThermoVax(R). To date, this business segment has been supported with government grants and contract funding from the National Institute of Allergy and Infectious Diseases ('NIAID'), the Defense Threat Reduction Agency ('DTRA') and the Biomedical Advanced Research and Development Authority ('BARDA'). For further information, visit the company's website at . About NetworkNewsWire NetworkNewsWire ('NNW') is a specialized communications platform with a focus on financial news and content distribution for private and public companies and the investment community. It is one of 60+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today's market, NNW brings its clients unparalleled recognition and brand awareness. NNW is where breaking news, insightful content and actionable information converge. For more information, please visit
Cision Canada
04-08-2025
- Business
- Cision Canada
Late-Stage Pipeline Wins Boost Investor Confidence in High-Growth Therapeutic Areas
NEW YORK, Aug. 4, 2025 /CNW/ -- As America's population ages, chronic and rare diseases are emerging as a pressing healthcare challenge — one that disproportionately affects older adults. With more than 30 million Americans living with a rare disease, the need for accurate diagnoses and effective treatments is growing urgent. Many of these conditions remain without FDA-approved therapies, and symptoms in seniors are often misattributed to typical aging, leading to years-long diagnostic delays. Recognizing this crisis, the Trump administration's "Make America Healthy Again" initiatives have emphasized improving access to treatments and accelerating medical innovation. Advancing this mission, Soligenix Inc. (NASDAQ: SNGX) (Profile) is making strides with its HyBryte(TM) platform, a novel therapy aimed at treating cutaneous T-cell lymphoma (CTCL), a rare skin cancer that primarily affects older adults. With successful U.S.-based manufacturing of HyBryte's active ingredient now in place, Soligenix exemplifies the kind of domestic innovation poised to make a meaningful impact on this underserved patient population. The company is one of several impressive companies committed to making an impact in the pharmaceutical space, including Pfizer Inc. (NYSE: PFE), Merck & Co Inc. (NYSE: MRK), Bristol-Myers Squibb Co. (NYSE: BMY) and Insmed Inc. (NASDAQ: INSM). Soligenix Inc.'s HyBryte platform represents a promising therapeutic option for cutaneous T-cell lymphoma, a rare cancer that often affects older adults. A second confirmatory phase 3 clinical trial for HyBryte is underway and represents a pivotal step in advancing the therapy toward global commercialization for the treatment of early-stage CTCL. HyBryte received both U.S. and EU orphan drug designations as well as Fast Track status from the FDA, underscoring the serious unmet medical need it addresses. A critical attribute of HyBryte in the treatment of CTCL is its consistently strong safety profile, demonstrated across multiple clinical studies. Click here to view the custom infographic of the Soligenix Inc. editorial. Continued Investment in Rare Diseases Is Key Chronic rare diseases are emerging as a major challenge within the aging U.S. population. As life expectancy increases, so too does the complexity of healthcare needs, particularly when it comes to conditions that are both long-lasting and difficult to diagnose. Tens of millions of Americans are facing life with a rare disease, and many of them are seniors whose symptoms can easily be dismissed as normal signs of aging. Because rare diseases often present subtly or mimic more common age-related issues, diagnosis in older adults can be delayed by years, hindering access to effective care and worsening outcomes. Compounding the issue is the limited availability of FDA-approved treatments. With thousands of rare diseases identified, the vast majority remain without approved therapies, underscoring the importance of continued investment in research and development. Seniors, in particular, are vulnerable to underdiagnosis and undertreatment, especially when the healthcare system is not attuned to the nuanced presentation of rare conditions in older adults. In response, the "Make America Healthy Again" initiative has spotlighted the growing burden of chronic and rare diseases. Through targeted policies aimed at accelerating research, improving diagnostic tools and expanding access to care, these efforts seek to address the needs of older Americans grappling with complex, often overlooked, health challenges. Companies such as Soligenix Inc. are rising to meet this need. The firm's HyBryte program represents a promising therapeutic option for cutaneous T-cell lymphoma, a rare cancer that often affects older adults. Soligenix has recently completed the successful U.S. manufacturing transfer of HyBryte's active ingredient, advancing its mission to bring effective, innovative treatments to patients most in need. A Rare Cancer with Unmet Needs Cutaneous T-cell lymphoma (CTCL) is a rare form of non-Hodgkin's lymphoma (NHL) that primarily affects the skin. Unlike other lymphomas, CTCL involves malignant T-cells that migrate to the skin's surface, forming patches, lesions or tumors. This chronic cancer most commonly appears in older adults, making it particularly relevant to the aging population. Despite its rarity, CTCL remains a serious medical concern, affecting more than 40,000 NHL patients globally. There is currently no known cure for CTCL, and treatment is often limited to managing symptoms and slowing disease progression. The most prevalent subtype of CTCL is mycosis fungoides (MF), which accounts for approximately 90% of all CTCL cases. In its early stages (I–IIA), MF has a relatively high five-year survival rate of 88%, but it remains a lifelong illness. As a chronic condition with no approved first-line therapy for early-stage patients, CTCL represents a clear unmet medical need. The global market opportunity for CTCL therapies in the seven major markets (the United States, EU4, the United Kingdom and Japan) was estimated at about $995 million in 2024, with the U.S. accounting for some 70% of that. In addition, DelveInsight notes that "the expected launch of therapies such as HyBryte . . . will also boost the CTCL market growth." Without these new therapies, effective treatment options remain limited, especially for those diagnosed in the early stages. Many patients undergo a series of therapies with limited success, underscoring the need for innovative, targeted treatments. Soligenix's HyBryte (synthetic hypericin) offers a promising solution as a potential first-line therapy for early-stage CTCL. By addressing this critical gap in care, HyBryte has the potential to significantly improve quality of life for thousands of patients and become a leading treatment option in this underserved market. Bolstering the Case for HyBryte Soligenix's second confirmatory phase 3 clinical trial for HyBryte, known as FLASH2, is currently underway and represents a pivotal step in advancing the therapy toward global commercialization for the treatment of early-stage CTCL. Designed to reinforce the positive findings of the initial FLASH study, FLASH2 has been accepted by the European Medicines Agency (EMA), while discussions with the U.S. Food and Drug Administration (FDA) remain ongoing. This validation by European regulators underscores the robustness of the trial design and its alignment with international standards for therapeutic approval. The FLASH2 study maintains a similar structure to its predecessor but features an extended double-blind, placebo-controlled treatment duration of 18 weeks, three times longer than the original six-week period in the first FLASH trial. This longer timeline is expected to provide even more comprehensive data on HyBryte's safety and efficacy. Importantly, key elements such as the patient inclusion and exclusion criteria and the primary endpoint remain consistent between the two studies, supporting the integrity and comparability of the trial outcomes. Approximately 80 patients will be enrolled across clinical sites in both the United States and Europe. This multinational approach is intended to support broad regulatory submissions and pave the way for HyBryte's commercial launch on a global scale. With enrollment progressing on schedule, Soligenix anticipates reporting top-line results in 2026, data that could significantly bolster the case for HyBryte as the first approved front-line treatment for early-stage CTCL. As Soligenix continues to advance this promising therapy, FLASH2 stands as a potentially transformational milestone in the company's effort to address a long-standing unmet medical need within the rare disease and oncology communities. A Critical Advancement in Treatment Soligenix's HyBryte achieved positive, statistically significant results in its first phase 3 clinical trial, known as the FLASH study, marking a critical advancement in the treatment of early-stage CTCL. HyBryte received both U.S. and EU orphan drug designations as well as Fast Track status from the FDA, underscoring the serious unmet medical need it addresses. Unlike many CTCL therapies that require a year or more to demonstrate efficacy, HyBryte showed a statistically significant treatment response in just six weeks, with response rates improving to 40% at 12 weeks and 49% at 18 weeks. The therapy demonstrated effectiveness across both patch and deeper plaque lesions, an important distinction given that many current early-stage CTCL treatments are primarily effective only on patch-type manifestations. This broader lesion response highlights HyBryte's unique therapeutic potential within a complex and varied disease presentation. The study's design and outcomes also reflect the treatment's clinical promise as a practical, noninvasive solution that could change the standard of care for CTCL patients. Safety and tolerability further set HyBryte apart. The FLASH trial reported minimal adverse events, a significant benefit when compared to other CTCL therapies that are often associated with both acute and chronic side effects. This favorable safety profile may make HyBryte especially appealing to older patients who are frequently managing multiple health conditions. Additionally, HyBryte's use of visible fluorescent light rather than ultraviolet (UV) light avoids the carcinogenic risks typically associated with conventional phototherapy. This novel light-based activation of synthetic hypericin enhances patient safety while maintaining therapeutic efficacy. Collectively, the FLASH and FLASH2 study results position HyBryte as a strong candidate to become the first approved front-line treatment for early-stage CTCL, offering a faster, safer, and more effective alternative to existing therapies. Consistent, Strong and Safe A critical attribute of HyBryte in the treatment of CTCL is its consistently strong safety profile, demonstrated across multiple clinical studies. Unlike many current therapies for early-stage CTCL, which are typically associated with severe and sometimes fatal side effects, HyBryte has been well tolerated and shows no evidence of safety concerns to date. Its mechanism of action is not linked to DNA damage, a significant distinction that positions it as a potentially safer alternative in a treatment landscape where many options carry risks such as melanoma, other malignancies, severe skin damage and premature skin aging. This favorable safety profile is especially relevant given that all currently available CTCL therapies are only approved following the failure of other treatments, and none have been approved for front-line use. In this context, safety becomes a decisive factor in selecting a treatment course, particularly for older adults who are often managing multiple health conditions. HyBryte's minimal systemic absorption, non-mutagenic compound and use of a non-carcinogenic visible light source make it uniquely positioned as a safe and effective treatment option. As the CTCL community awaits a first-line therapy, HyBryte stands out as a promising candidate capable of meeting both efficacy and safety demands. In addition to its strong clinical profile, HyBryte represents a significant commercial opportunity in an area of high unmet medical need. With an estimated global CTCL market potential exceeding $990 million, the therapy is well positioned to address a meaningful segment of the CTCL population. As development advances, HyBryte offers the potential not only to improve patient outcomes but also to establish itself as a valuable new standard in CTCL treatment. Advancing Rare Disease Care In an era where precision medicine and urgent unmet needs converge, several pharmaceutical leaders are stepping up with bold new advances in cancer and complex disease treatment, from improving survival outcomes in prostate and lung cancer to advancing novel therapies for pulmonary hypertension. These developments reflect a broader commitment across the life sciences industry to accelerate innovation and deliver life-extending, quality-of-life-enhancing options for patients with high-need conditions. Pfizer Inc. is reporting positive topline results from the overall survival (OS) analysis from its phase 3 EMBARK study. The study evaluated XTANDI(R) (enzalutamide), in combination with leuprolide and as a monotherapy, in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC) with biochemical recurrence (BCR) at high risk for metastasis. The announcement was made with Astellas Pharma U.S. Inc. XTANDI is the first and only androgen receptor inhibitor-based regimen to demonstrate overall survival benefit in nmHSPC with high-risk biochemical recurrence BCR. Merck & Co Inc. announced that the first patient has been dosed in the IDeate-Prostate01 phase 3 trial. The phase 3 study evaluates the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) versus docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC) with disease progression during or after treatment with an androgen receptor pathway inhibitor. I-DXd is being jointly developed by Merck and Daiichi Sankyo. While localized prostate cancer has a five-year survival rate of more than 90%, survival decreases to 31% in the advanced or metastatic stage, the company noted, reinforcing the need for new approaches to improve outcomes. Bristol-Myers Squibb Co. has received critical approval from the European Commission (EC) for a key perioperative regimen. The regimen is for neoadjuvant Opdivo (R) (nivolumab) and chemotherapy followed by surgery and adjuvant Opdivo for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients whose tumors have PD-L1 expression ≥1%. The EU approval is based on results from the CheckMate-77T trial, which showed perioperative Opdivo improved event-free survival compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo. Insmed Inc. announced positive topline results from its randomized, double-blind, placebo-controlled phase 2b study evaluating the efficacy and safety of treprostinil palmitil inhalation powder (TPIP), administered once daily in patients with pulmonary arterial hypertension (PAH). According to the announcement, the study met primary and all secondary efficacy endpoints. Insmed noted that it plans to immediately engage with the U.S. Food and Drug Administration regarding a phase 3 trial design for PAH. Insmed plans to initiate a phase 3 trial in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) before the end of 2025 and a phase 3 trial in patients with PAH in early 2026. These announcements spotlight the momentum building across rare-disease research, with these companies contributing key pieces to the larger puzzle of patient-centered medical breakthroughs. As regulatory engagement continues and phase 3 trials advance, the coming years may bring meaningful shifts in standard-of-care therapies, offering hope to patients facing some of the most challenging diagnoses in medicine today. For more information, visit Soligenix Inc. NetworkNewsWire ("NNW") is a specialized communications platform with a focus on financial news and content distribution for private and public companies and the investment community. 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