Soligenix Advances Phase 3 Trials for HyBryte in Cutaneous T-Cell Lymphoma Treatment

- Soligenix's HyBryte for cutaneous T-cell lymphoma (CTCL) has a second Phase 3 trial underway with enrollment of approximately 80 subjects, interim analysis in Q2 2026, and top-line results in H2 2026.
- Previous Phase 3 trials showed statistical significance in primary endpoints across multiple cycles, following FDA NDA submission and RTF letter.
- The program targets unmet needs in rare dermatological cancers with ongoing FDA discussions for development path.
Sources & Citations
1 sourceMore Stories
Health Matters newsletter: Health, politics and access - The Hindu
• Global health news was dominated by climate-linked crises, conflict, and infectious diseases, including a European heatwave linked to over 10,000 deaths. • Significant health threats emerged globally, including the first detection of H5 bird flu in New Zealand, an ongoing Ebola outbreak in Congo, and cyclosporiasis in the U.S.
Read original · thehindu.comNational COVID-19 trends, July 21 - The Sick Times
• Indicators suggest a summer COVID-19 wave is currently underway across the United States. • The South and West regions are showing the most definitive signals of increasing cases, though potential outbreaks are appearing nationwide.
Read original · thesicktimes.org
The Sick TimesGilead to Present Twice-Yearly HIV Data at AIDS 2026
• Gilead Sciences will present clinical data for its HIV pre-exposure prophylaxis (PrEP) drug, lenacapavir, at the AIDS 2026 conference from July 26-31. • The data reveals high efficacy in two studies: PURPOSE 1 recorded zero new HIV infections, while PURPOSE 2 reported only one infection among participants continuing the treatment.
Read original · stocktitan.netHealth Bulletin 20/July/2026
• A NEET aspirant has alleged a major result discrepancy after their score plummeted from 609 to 167, highlighting ongoing concerns regarding OMR sheet errors. • A doctors' body is demanding a National Medical Commission (NMC) inquiry into the Sri Aurobindo Institute of Medical Sciences (SAIMS) in Indore.
Read original · medicaldialogues.in
Medical DialoguesHealth Matters newsletter: Health, politics and access - The Hindu
• Global health news this week was dominated by climate-linked crises, conflict, and infectious disease outbreaks. • An early European heatwave caused over 10,000 estimated deaths, with a significant spike in mortality reported in the Paris region.
Read original · thehindu.comHelus Pharma Completes Enrollment in Phase 3 APPROACH Study of HLP003 in Adjunctive Treatment of Major Depressive Disorder Ahead of Schedule
• Helus Pharma has completed enrollment ahead of schedule for the Phase 3 APPROACH study, which evaluates HLP003 as an adjunctive treatment for Major Depressive Disorder. • The company is continuing enrollment for EMBRACE, a second pivotal study within the Phase 3 PARADIGM Program, while rolling participants into the EXTEND study for long-term safety data.
Read original · investingnews.comPoynter’s PolitiFact launches service providing reliable, engaging health information to consumers and news organizations - Poynter
• PolitiFact, a project of the Poynter Institute, has launched "Well Informed," a new service designed to provide reliable health information to consumers and news organizations. • The initiative utilizes research-backed stories and social videos to help the public distinguish credible medical evidence from health-related misinformation.
Read original · poynter.org
PoynterAbortion pill access, THC sodas, cyclospora: Morning Rounds
• Morning Rounds reports on several diverse health and legal stories, including the current status of cyclospora outbreaks and the availability of THC-infused sodas in grocery stores. • The coverage also highlights a specific criminal case involving a fugitive in Rhode Island who maintained a double life.
Read original · statnews.com
StatnewsRare disease biotechs lobby Trump, PBMs skirt state laws
• Rare disease biotechnology companies are lobbying the Trump administration to prevent the implementation of Medicare price caps on their medications. • Pharmacy Benefit Managers (PBMs) are reportedly bypassing state laws designed to regulate their practices and pricing structures.
Read original · statnews.com
StatnewsFDA drug approval affects healthcare around the world, but political shortcuts could hurt the agency’s international reputation
• The FDA has introduced a new fast-track program for the approval of biologics, which are complex drugs used to treat conditions such as cancer and sickle cell disease. • Traditionally, the agency requires a rigorous process involving an investigational new drug application followed by three distinct phases of human clinical trials.
Read original · theconversation.com
The ConversationTrump’s deep public health cuts hinder response to record US cyclosporiasis outbreak | Health
• The U.S. is facing a record-breaking cyclosporiasis outbreak, with Michigan officials describing it as potentially the largest in the country's history. • The crisis follows a March 2025 decision by the Trump administration to cut $12 billion in public health funding, targeting disease monitoring and laboratory capacity.
Read original · theguardian.comMedical Bulletin 20/July/2026
• Researchers have discovered a strong link between gum disease and heart valve damage, suggesting that oral health significantly impacts cardiovascular wellness. • The study indicates that targeting gum disease and inflammation could open new avenues for the prevention and treatment of heart valve issues.
Read original · medicaldialogues.in
