Synaptigen Introduced as Natural Brain Support Option for Aging Adults in 2025
This press release is for informational purposes only. The statements below are not medical advice and have not been evaluated by the Food and Drug Administration (FDA). Synaptigen is not intended to diagnose, treat, cure, or prevent any disease. Some links included in this release may be affiliate in nature. See full disclaimer at the end.
Synaptigen Introduced as Natural Brain Support Option for Aging Adults in 2025
A New Plant-Based Formula Aims to Support Memory, Mental Agility, and Neuronal Clarity Without Stimulants
In 2025, a new pineal-focused supplement called Synaptigen is gaining widespread attention among adults seeking cognitive clarity and long-term brain health. At a time when digital burnout, information overload, and lifestyle-related inflammation are on the rise, this daily-use capsule supports mental clarity and focus without using stimulants or synthetic nootropics.
The formula uses a blend of probiotic strains, botanical extracts, and prebiotic fibers to help nourish the brain from within—an approach that aligns with recent neuroscience linking the gut microbiome to cognition, emotional regulation, and memory performance. Formulated to be stimulant-free, Synaptigen offers a gentler daily option for those looking to promote brain wellness well into old age.
Explore the Full Synaptigen Formula
Why Interest in 'A Breakthrough Natural Solution That Supports A Healthy Memory Well Into Old Age' Is Surging in 2025
The global surge in cognitive wellness awareness is no longer limited to older adults. In 2025, younger generations are taking proactive steps toward preserving mental clarity—driven by trends on TikTok, neuroscience podcasts, and global wellness data. Google Trends shows a steep climb in searches for 'pineal gland detox,' 'gut-brain axis,' and 'mental fog remedies' over the past 18 months, pointing to a cultural shift in how people perceive brain health.
Meanwhile, studies on microbiome influence over memory and focus have been widely shared in mainstream media. The connection between sugar accumulation in neurons and early cognitive decline—sometimes referred to as 'Type 3 Diabetes' in research circles—has caught public attention. Individuals are actively seeking natural ways to combat this silent cognitive erosion, especially through ingredients like inulin, peppermint, and specific strains of probiotics.
Synaptigen addresses this demand with a plant-based, gut-brain support approach that avoids stimulants, synthetic nootropics, or sedative herbs. By blending modern nutritional science with microbiome-targeted delivery, it appeals to wellness-focused consumers who want long-term results without side effects.
Synaptigen's Ingredient-First Response to These Trends
As the conversation around 'natural mental support' grows more nuanced, Synaptigen takes an ingredient-first stance that aligns with consumer demand for transparency and simplicity. Rather than focusing on hype-based trends, the formula was designed around peer-reviewed data linking gut health, inflammation control, and nutrient signaling to memory function and cognitive sharpness.
Its inclusion of Lactobacillus paracasei, Lactobacillus reuteri, and Bifidobacterium lactis BL-04 targets gut flora balance—an emerging area of interest among researchers studying Alzheimer's prevention and age-associated memory impairment. Unlike stimulant-based supplements that create short-term energy spikes, Synaptigen focuses on consistent nourishment of the gut-brain axis.
Also featured is inulin, a natural prebiotic fiber shown to feed beneficial bacteria and reduce systemic inflammation—an issue many associate with cognitive fatigue. Strawberry extract, peppermint oil, and tricalcium phosphate round out the formula, providing natural support for taste, cellular signaling, and digestive balance.
See What Makes Synaptigen's Daily Use Formula Unique
Ingredient Spotlight – What's Inside the 'Wealth Resin' Formula
Synaptigen's formula is carefully constructed around what the developers describe as a 'Wealth Resin' system—a reference to the foundational role these ingredients play in promoting clarity, cellular communication, and inner calm. The blend is anchored in plant-based, probiotic-forward nutrition rather than synthetic nootropics or aggressive adaptogens.
Key inclusions like Lactobacillus paracasei and Lactobacillus reuteri have been shown in animal studies to help modulate blood sugar and promote gut balance, two factors now widely discussed in connection with early memory preservation. Meanwhile, Bifidobacterium lactis BL-04® is supported by published research for its potential in supporting immune signaling, cognitive stress recovery, and healthy inflammatory responses.
Inulin, a prebiotic fiber, plays a dual role: it feeds healthy bacteria and may help mitigate sugar-related brain stress. Coupled with tricalcium phosphate, the formula adds a layer of support for neural conductivity. Lastly, strawberry extract and peppermint oil are used not just for palatability—but also for their roles in oxidative stress modulation and calm mental focus.
Each capsule is free from stimulants, non-GMO, and designed for easy daily use. It represents a simplified, intuitive format for those seeking clarity without relying on caffeine, racetams, or synthetic compounds.
What Reddit, Podcasts & TikTok Creators Are Saying
In 2025, consumer health conversations are no longer confined to journals and wellness blogs—platforms like Reddit, TikTok, and Spotify-hosted wellness podcasts have emerged as driving forces behind supplement trends. Synaptigen has organically surfaced in several of these online discussions, not through direct advertising, but as part of broader conversations around pineal gland detox, mental fog, and holistic clarity.
On Reddit, threads in communities like r/Biohackers, r/Supplements, and r/Nootropics have increasingly explored natural alternatives to prescription memory enhancers, with users citing ingredients like inulin, Bifidobacterium strains, and peppermint extract as part of their brain-support routines. The microbiome-brain connection is a recurring topic, especially among users seeking cognitive performance without stimulant dependence.
Podcasts focused on holistic health and modern neuroscience have echoed these themes. Mentions of neuro-gut connectivity, age-related 'brain burnout,' and the potential role of dietary fibers in memory recall are trending topics. Even TikTok creators in the wellness space—many of whom speak to an audience in their 30s and 40s—have drawn attention to the shift away from synthetic focus aids toward plant-based, probiotic-friendly options.
Explore Online Conversations About Synaptigen
Who Might Be Drawn to This Type of Supplementation in 2025
The rising popularity of cognitive health supplements in 2025 is not limited to seniors. In fact, a growing segment of users exploring products like Synaptigen includes midlife professionals, creative workers, health-conscious Millennials, and individuals experiencing burnout symptoms associated with prolonged digital exposure or high-stress environments.
Many are seeking solutions for mental sharpness, task-switching fatigue, and long-term cognitive protection without pharmaceutical intervention. Synaptigen's non-stimulant formula appeals to those who are wary of traditional nootropics that rely heavily on caffeine, L-theanine, or synthetic racetams.
Additionally, individuals recovering from brain fog related to poor sleep, stress, or high sugar intake may find the formula aligned with their wellness goals. The inclusion of gut-focused probiotics also positions Synaptigen within the broader trend of microbiome support for mood balance and clarity.
It may also appeal to spiritual consumers who are exploring pineal gland awakening as part of a holistic lifestyle, given the natural, non-toxic, and anti-inflammatory properties of the included plant-based nutrients.
Spiritual Optimization & Pineal Curiosity – 2025 Market Reflections
In 2025, the intersection of spirituality, wellness, and neuroscience is more visible than ever. Consumers are not just seeking physical health—they're also exploring tools that support inner clarity, calm awareness, and meditative focus. This has fueled the rise of a supplement subcategory often referred to as 'pineal support' or 'third eye clarity,' where Synaptigen has found cultural resonance.
The pineal gland, long regarded in both ancient traditions and modern metaphysical communities as the seat of intuition and circadian rhythm, is gaining renewed attention. On platforms like YouTube and TikTok, interest in pineal gland detox, decalcification, and pineal-activated consciousness has sparked millions of views—often converging with broader wellness habits like grounding, breathwork, and intermittent fasting.
While Synaptigen does not position itself as a spiritual supplement, its clean-label formulation—free from fluoride, artificial additives, or sedatives—makes it attractive to users who align cognitive clarity with spiritual hygiene. Ingredients like peppermint and strawberry extract, already known for their antioxidant properties, have also been discussed for their roles in ritual wellness routines.
This convergence of brain health and spiritual alignment has helped carve a niche for supplements like Synaptigen that aim to support mental performance and emotional grounding without pharmacological interference.
Learn Why Pineal Support Supplements Are Gaining Popularity
The Public Debate Around Ingredients – Signals, Skepticism, and Saturation
As the wellness industry continues to evolve in 2025, public skepticism around cognitive supplements remains high—and rightfully so. The category is saturated with overhyped claims, proprietary blends lacking transparency, and trendy ingredients that don't hold up under scrutiny. Consumers are demanding data-backed formulations that prioritize ingredient synergy and measurable outcomes over marketing flash.
Within this climate, many ingredients found in Synaptigen—such as Lactobacillus paracasei, inulin, and peppermint extract—have been extensively researched in independent academic settings. However, the use of probiotics for brain health is still emerging in mainstream awareness, prompting questions about effectiveness, dosage reliability, and long-term benefit.
While some critics argue that the connection between gut bacteria and cognition is still too early to commercialize, others point to growing scientific consensus around the microbiome's influence on inflammation, memory signaling, and mood regulation. Peer-reviewed trials, including those cited on the official Synaptigen page, offer a foundation for the formula's relevance.
What sets Synaptigen apart in a crowded field is its ingredient transparency, modest positioning, and absence of exaggerated medical claims. It invites curiosity rather than convincing—and supports its efficacy through formulation integrity rather than hyperbole.
About Synaptigen
Synaptigen is a natural daily-use brain support formula designed to promote cognitive clarity, memory retention, and sustained mental energy without relying on stimulants or synthetic nootropics. Developed with a science-forward mindset, the formula blends probiotics, prebiotics, and antioxidant-rich botanicals that support the gut-brain connection—an increasingly researched area in modern nutritional neuroscience.
Rather than positioning itself as a cure or quick-fix, Synaptigen is built for long-term use. Its ingredients have been individually studied for their roles in promoting healthy glucose metabolism, reducing neuron-damaging sugar buildup, and supporting microbiome balance. Each capsule is manufactured in a GMP-certified facility, non-GMO, and free from additives commonly flagged by health-conscious users.
The product also comes bundled with digital health content designed to complement the supplement's function—including sleep optimization guides and cognitive focus techniques—at no additional charge with qualifying orders.
Learn More About Synaptigen's Mission and Formula Design
Contact Synaptigen – Daily Brain Support Backed by Microbiome Research
– Daily Brain Support Backed by Microbiome Research Email : [email protected]
: [email protected] Phone (US) : 1-800-390-6035
: 1-800-390-6035 INT : +1 208-345-4245
: +1 208-345-4245 Website: https://getsynaptigen.com
This press release is for informational purposes only. The information contained herein does not constitute medical advice, diagnosis, or treatment and has not been evaluated by the Food and Drug Administration (FDA). Synaptigen is not intended to diagnose, treat, cure, or prevent any disease. Always consult your physician or qualified healthcare provider before beginning any new supplement, routine, or health program.
Some links in this release may be promotional in nature and may lead to third-party websites. The publisher or author may receive compensation through affiliate commissions if a purchase is made through these links. This compensation does not affect the price you pay and helps support continued research and content publication. Results described or implied may not be typical and should not be interpreted as guarantees.
Statements made about ingredients or outcomes reflect public discussion and historical usage only, and are not endorsed by medical professionals or regulatory agencies. Always do your own research and make informed decisions.
Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same.
Ahmedabad Plane Crash
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
an hour ago
- Business Wire
Bristol Myers Squibb's Application for Breyanzi (lisocabtagene maraleucel) Accepted for Priority Review by U.S. Food and Drug Administration (FDA) in Fifth Cancer Type for Relapsed or Refractory Marginal Zone Lymphoma (MZL)
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Breyanzi ® (lisocabtagene maraleucel; liso-cel) as a potential treatment for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 5, 2025. BMY announces an FDA acceptance of the regulatory filing with priority review for their personalized treatment option for adult patients with relapsed or refractory marginal zone lymphoma #MZL Share 'While initial therapy for MZL can be effective, multiple relapses over the course of several years are common, leaving patients in need of a new treatment option that can provide high, lasting response rates,' said Rosanna Ricafort, vice president, Senior Global Program Lead for Hematology and Cell Therapy, Bristol Myers Squibb. 'This FDA acceptance brings us one step closer to potentially standardizing CAR T cell therapy as a treatment option for MZL, while building on our commitment to bring this personalized therapy to as many eligible patients as possible.' The application is based on results from the primary analysis of the MZL cohort in TRANSCEND FL, an open-label, multicenter, Phase 2, single-arm study, which was shared in an oral presentation during the 2025 International Conference on Malignant Lymphoma (ICML) in June 2025. The development progress of Breyanzi reflects BMS' continued efforts to collaborate across the healthcare ecosystem, with the ultimate goal of reaching more patients and democratizing access to cell therapy. Recently, the FDA approved streamlined patient monitoring requirements and the removal of the REMS program for Breyanzi, easing known barriers to treatment and administration while maintaining patient safety. About TRANSCEND FL TRANSCEND FL (NCT04245839) is an open-label, global, multicenter, Phase 2, single-arm study to determine the efficacy and safety of Breyanzi in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including follicular lymphoma and marginal zone lymphoma. The primary outcome measure is overall response rate. Secondary outcome measures include complete response rate, duration of response, and progression-free survival. About MZL Marginal zone lymphoma (MZL) is the third most common lymphoma, accounting for about 7% of all non-Hodgkin lymphoma cases. Most patients with MZL are at a median age of 67 years when they are diagnosed. MZL develops when white blood cells cluster together to form lumps in a person's lymph nodes or organs. Initial therapy often leads to remission, but relapse is common, sometimes occurring several times over many years. A small portion of MZL cases transform into diffuse large-B-cell lymphoma, a more aggressive lymphoma. About Breyanzi Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. Breyanzi is made from a patient's own T cells, which are collected and genetically reengineered to become CAR T cells that are then delivered via infusion as a one-time treatment. The treatment process includes blood collection, CAR T-cell creation, potential bridging therapy, lymphodepletion, administration, and side-effect monitoring. Breyanzi is approved in the U.S. for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior line of therapy, has received accelerated approval for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of therapy and relapsed or refractory follicular lymphoma (FL) in the third-line plus setting, and is approved for the treatment of relapsed or refractory mantle cell lymphoma (MCL) in the third-line plus setting. Breyanzi is also approved in Japan, the European Union (EU), Switzerland, the United Kingdom, and Canada for the treatment of relapsed or refractory LBCL after at least one prior line of therapy; in Japan for the treatment of patients with relapsed or refractory high-risk FL after one prior line of systemic therapy, and in patients with relapsed or refractory FL after two or more lines of systemic therapy; and in the EU for the treatment of relapsed or refractory FL after two or more lines of systemic therapy. Bristol Myers Squibb's clinical development program for Breyanzi includes clinical studies in several types of lymphoma. For more information, visit Breyanzi U.S. FDA-Approved Indications BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have: refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or relapsed or refractory disease after two or more lines of systemic therapy. Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma. adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor. Breyanzi U.S. Important Safety Information WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids. Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. Cytokine Release Syndrome Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. In clinical trials of BREYANZI, which enrolled a total of 702 patients with non-Hodgkin lymphoma (NHL), CRS occurred in 54% of patients, including ≥ Grade 3 CRS in 3.2% of patients. The median time to onset was 5 days (range: 1 to 63 days). CRS resolved in 98% of patients with a median duration of 5 days (range: 1 to 37 days). One patient had fatal CRS and 5 patients had ongoing CRS at the time of death. The most common manifestations of CRS (≥10%) were fever, hypotension, tachycardia, chills, hypoxia, and headache. Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, diffuse alveolar damage, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). Ensure that 2 doses of tocilizumab are available prior to infusion of BREYANZI. Neurologic Toxicities Neurologic toxicities that were fatal or life-threatening, including immune effector cell-associated neurotoxicity syndrome (ICANS), occurred following treatment with BREYANZI. Serious events including cerebral edema and seizures occurred with BREYANZI. Fatal and serious cases of leukoencephalopathy, some attributable to fludarabine, also occurred. In clinical trials of BREYANZI, CAR T cell-associated neurologic toxicities occurred in 31% of patients, including ≥ Grade 3 cases in 10% of patients. The median time to onset of neurotoxicity was 8 days (range: 1 to 63 days). Neurologic toxicities resolved in 88% of patients with a median duration of 7 days (range: 1 to 119 days). Of patients developing neurotoxicity, 82% also developed CRS. The most common neurologic toxicities (≥5%) included encephalopathy, tremor, aphasia, headache, dizziness, and delirium. CRS and Neurologic Toxicities Monitoring Monitor patients daily for at least 7 days following BREYANZI infusion for signs and symptoms of CRS and neurologic toxicities and assess for other causes of neurological symptoms. Continue to monitor patients for signs and symptoms of CRS and neurologic toxicities for at least 2 weeks after infusion and treat promptly. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. Manage neurologic toxicity with supportive care and/or corticosteroid as needed. Advise patients to avoid driving for at least 2 weeks following infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic toxicity occur at any time. Hypersensitivity Reactions Allergic reactions may occur with the infusion of BREYANZI. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO). Serious Infections Severe infections, including life-threatening or fatal infections, have occurred in patients after BREYANZI infusion. In clinical trials of BREYANZI, infections of any grade occurred in 34% of patients, with Grade 3 or higher infections occurring in 12% of all patients. Grade 3 or higher infections with an unspecified pathogen occurred in 7%, bacterial infections in 3.7%, viral infections in 2%, and fungal infections in 0.7% of patients. One patient who received 4 prior lines of therapy developed a fatal case of John Cunningham (JC) virus progressive multifocal leukoencephalopathy 4 months after treatment with BREYANZI. One patient who received 3 prior lines of therapy developed a fatal case of cryptococcal meningoencephalitis 35 days after treatment with BREYANZI. Febrile neutropenia developed after BREYANZI infusion in 8% of patients. Febrile neutropenia may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad- spectrum antibiotics, fluids, and other supportive care as medically indicated. Monitor patients for signs and symptoms of infection before and after BREYANZI administration and treat appropriately. Administer prophylactic antimicrobials according to standard institutional guidelines. Avoid administration of BREYANZI in patients with clinically significant, active systemic infections. Viral reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. In clinical trials of BREYANZI, 35 of 38 patients with a prior history of HBV were treated with concurrent antiviral suppressive therapy. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines. Prolonged Cytopenias Patients may exhibit cytopenias not resolved for several weeks following lymphodepleting chemotherapy and BREYANZI infusion. In clinical trials of BREYANZI, Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in 35% of patients, and included thrombocytopenia in 25%, neutropenia in 22%, and anemia in 6% of patients. Monitor complete blood counts prior to and after BREYANZI administration. Hypogammaglobulinemia B-cell aplasia and hypogammaglobulinemia can occur in patients receiving BREYANZI. In clinical trials of BREYANZI, hypogammaglobulinemia was reported as an adverse reaction in 10% of patients. Hypogammaglobulinemia, either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion, was reported in 30% of patients. Monitor immunoglobulin levels after treatment with BREYANZI and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement as clinically indicated. Live vaccines: The safety of immunization with live viral vaccines during or following BREYANZI treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during BREYANZI treatment, and until immune recovery following treatment with BREYANZI. Secondary Malignancies Patients treated with BREYANZI may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing. Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS) Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. Three of 89 (3%) safety evaluable patients with R/R CLL/SLL developed IEC-HS. Time to onset of IEC-HS ranged from 7 to 18 days. Two of the 3 patients developed IEC-HS in the setting of ongoing CRS and 1 in the setting of ongoing neurotoxicity. IEC-HS was fatal in 2 of 3 patients. One patient had fatal IEC-HS and one had ongoing IEC-HS at time of death. IEC-HS is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of IEC-HS should be administered per current practice guidelines. Adverse Reactions The most common adverse reaction(s) (incidence ≥30%) in: LBCL are fever, cytokine release syndrome, fatigue, musculoskeletal pain, and nausea. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, platelet count decrease, and hemoglobin decrease. CLL/SLL are cytokine release syndrome, encephalopathy, fatigue, musculoskeletal pain, nausea, edema, and diarrhea. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, hemoglobin decrease, platelet count decrease, and lymphocyte count decrease. FL is cytokine release syndrome. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, and white blood cell decrease. MCL are cytokine release syndrome, fatigue, musculoskeletal pain, and encephalopathy. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, and platelet count decrease. Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide. Bristol Myers Squibb: Unlocking the Full Potential of Cell Therapy A pioneer in harnessing the immune system to fight cancer and an established leader in cell therapy, Bristol Myers Squibb is uniquely positioned to unlock the full potential of this technology across blood cancers and within new frontiers, including autoimmune disease. Bristol Myers Squibb is currently the only company with two approved CAR T cell therapies with two distinct targets, available in major markets around the world. Our bold vision for the future is one in which hundreds of thousands of patients can be treated with cell therapy's transformational potential. The building blocks to realize this ambition—a promising and differentiated pipeline, extensive translational and clinical data sets, a deep bench of talent, and robust manufacturing capabilities—are in our cells. We are laser-focused on advancing the field of cell therapy toward a true revolution for patients. Learn more about the science behind cell therapy and ongoing progress at Bristol Myers Squibb here. Cautionary Statement Regarding Forward-Looking Statements This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that Breyanzi (lisocabtagene maraleucel) may not receive regulatory approval for the additional indication described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether Breyanzi for such indication will be commercially successful. No forward-looking statement can be guaranteed. It should also be noted that acceptance of the sBLA does not change the standards for FDA approval. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb's business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2024, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
Epoch Times
2 hours ago
- Epoch Times
Freeze-Dried Fruit Sold at Sam's Club Stores Recalled Nationwide
Georgia-based Dohler Dry Ingredient Solutions, LLC, is recalling its dried fruit products due to contamination with Listeria monocytogenes bacteria, the company said in a July 31 announcement published by the Food and Drug Administration (FDA). The product—Member's Mark Freeze Dried Fruit Variety Pack—was sold in 15-count boxes. The items were distributed between July 1 and July 25 via Sam's Club retail stores across 43 states.
Business Upturn
2 hours ago
- Business Upturn
PolTREG Doses First Patient in Phase II Trial for Pre-Symptomatic Type 1 Diabetes with PTG-007
By GlobeNewswire Published on August 4, 2025, 23:31 IST PolTREG Doses First Patient in Phase II Trial for Pre-Symptomatic Type 1 Diabetes with PTG-007 PTG-007, an autologous cell therapy will be administered to 150 high-risk children aged 3–18, including a placebo-controlled arm. A parallel study presented to FDA and to be conducted by Immuthera has been received favorably, may include Polish patients in the U.S. Statistical analysis, and could be treated as pivotal. The project has received an $11.3 million non-dilutive grant from the Polish Medical Research Agency. PolTREG is developing Multi-edited, Allogeneic CAR-Tregulatory cell therapies which can be used to treat patients diagnosed with T1D (Stage 3), which, in combination with PTG-007 in Stage 1 and Stage 2, will provide clinical solutions for patients across all Stages of T1D. 4 August 2025 – PolTREG S.A. (Warsaw Stock Exchange: PTG), a pioneer in cell therapies for autoimmune diseases, and its U.S. subsidiary Immuthera, announced that they have administered the first dose of PTG-007 to a patient in their Phase II clinical trial for pre-symptomatic type 1 diabetes. The trial, called 'Pre-Treg' will enroll up to 150 genetically high-risk children and adolescents (aged 3–18) who have not yet developed clinical symptoms of the disease. If successful, PolTREG aims to develop and register the world's first therapy to prevent the onset of type 1 diabetes symptoms. The company has proposed a parallel study to Pre-Treg to the U.S. Food and Drug Administration (FDA) in a recent Pre-IND meeting. The FDA's response was that the U.S. Trial could potentially be registrational. Further, patients enrolled in Poland at Stage 1 of the disease may, upon completion of enrollment, be included in the U.S. statistical analysis of the study. 'Long-term data from our clinical program of PTG-007 in symptomatic type 1 diabetes confirm both the safety and efficacy of the therapy. Modern medicine is increasingly focusing on interventions applied earlier or even before the first clinical symptoms appear. Our therapy fits perfectly into this paradigm. By administering it at the earliest stage of disease development, we anticipate highly promising outcomes—possibly even halting disease progression before clinical symptoms emerge. If the trial confirms the therapy's efficacy, we have the opportunity to develop and register the world's first drug to prevent the clinical onset of type 1 diabetes. We believe this therapy holds significant market and partnership potential' – said Prof. Piotr Trzonkowski, CEO and Co-Founder of PolTREG S.A. The Phase II study will include 150 participants in a randomized, placebo-controlled design. Recruitment is ongoing at three academic centers in Poland, with six additional clinical hospitals set to begin enrollment shortly. PolTREG has been awarded a non-dilutive grant of PLN 31.7 million (approx. $11.3 million) from the Polish Medical Research Agency to support the execution of this Phase II trial. PreTreg is one of PolTREG's flagship programs. In type 1 diabetes, the autoimmune destruction of insulin-producing pancreatic islets underscores the importance of early intervention. In the pre-symptomatic phase, a sufficient number of islets remain to maintain normal glucose regulation, and the autoimmune process is still limited and more readily controllable. Preventive therapy at this stage could halt the autoimmune attack, leaving patients genetically predisposed but clinically healthy for life. Upon successful completion of this trial and confirmation of safety and efficacy, PolTREG could establish the first approved drug to prevent symptomatic type 1 diabetes. Type 1 diabetes progresses through three stages. Stages 1 and 2 is considered presymptomatic and occurs in young children, typically 3 years old or older. Because these patients are not yet sick, safety is the highest priority. PTG-007's 12 year safety data makes it an ideal treatment for this age group and this stage of disease. Diagnosis of Type 1 Diabetes occurs in Stage 3 when symptoms occur which can lead to potentially life threatening complications such as diabetic ketoacidocis, heart and blood vessel disease, nerve damage, eye damage, kidney disease, and foot damage. These patients are typically older and require supplemental insulin. Due to the complications in Stage 3, more aggressive treatments are warranted. PolTREG and Immuthera are developing Tregulatory cell therapies that have clinically derived edits to improve function, modifications to make them 'off-the-shelf' (allogeneic), and a Chimeric Antigen Receptor to improve targeting of the disease causing cells that drive the autoimmune response. Taken together, PolTREG and Immuthera have a pipeline of Tregulatory cell therapies that will cover the full spectrum of presymptomatic and symptomatic Type 1 Diabetes. PolTREG is also expanding its U.S. presence. In mid-June, the company established its wholly owned U.S. subsidiary, Immuthera, registered as a Delaware C Corporation. In recent weeks, prominent experts in diabetes and neuroimmunology—Prof. Jay Skyler, Prof. Desmond Schatz, and Prof. Lawrence Steinman—joined the company's Scientific Advisory Board. In late July, PolTREG received the formal outcome of its pre-IND meeting with the FDA and is now preparing its IND submission. The company has partnered with Noble Capital Markets, Inc. and Kinexum Services LLC to support its U.S. regulatory strategy, and is collaborating with Swiss-based Antion Biosciences to develop next-generation allogeneic Treg therapies. About PolTREG: PolTREG is a global leader in developing autoimmune therapies based on T-regulatory cells (Tregs). Its lead product, PTG-007, autologous Treg treatment for early-onset Type-1 Diabetes (T1D) is ready for Phase 2/3 clinical testing, for which the company is seeking a partnership. PolTREG has established a robust platform encompassing a wide range of cell therapy approaches, including polyclonal TREG, CAR-TREG, allogeneic TREG, antigen-specific TREG, and TCR-TREG therapies. About Immuthera: Immuthera is pioneering novel cell-based therapies for clinical development in the United States and Canada. Immuthera will be clinically developing assets initially developed by PolTREG under the US FDA regulatory framework. Immuthera will have full access to PolTREG's Research and Development capabilities and asset pipeline along with the ability to explore novel modalities developed by US Institutions. Immuthera is currently seeking investment to pursue the manufacture and clinical development of these assets in the United States. For further information please contact: PolTREG Piotr TrzonkowskiChief Executive Officer [email protected] +48 512 532 401 Important information The contents of this announcement include statements that are, or may be deemed to be, 'forward-looking statements'. These forward-looking statements can be identified by the use of forward-looking terminology, including the words 'believes', 'estimates,' 'anticipates', 'expects', 'intends', 'may', 'will', 'plans', 'continue', 'ongoing', 'potential', 'predict', 'project', 'target', 'seek' or 'should', and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The company's actual results may differ materially from those predicted by the forward-looking statements. The company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law. Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.
