Latest news with #Rejuva
Yahoo
17-05-2025
- Business
- Yahoo
Fractyl Health Unveils New Rejuva® Smart GLP-1™ Pancreatic Gene Therapy Preclinical Data Highlighting Durable Potency and Safety with Limited Systemic GLP-1 Exposure at ASGCT 2025
Data suggests that single dose of RJVA-001 leads to durable metabolic improvements with low systemic GLP-1 exposure in db/db mouse model of T2D— potentially simultaneously addressing durability, adherence, and tolerability challenges seen with current GLP-1 drugs Endoscopic ultrasound-guided delivery achieves targeted pancreatic expression in a large animal model with no toxicity observed to date Data show nutrient-responsive GLP-1 secretion in human beta cells and human islets, demonstrating that Rejuva mimics natural hormone regulation rather than constant drug-driven stimulation Rejuva advancing toward first-in-human studies; first CTA module submission for RJVA-001 expected by June 2025 BURLINGTON, Mass., May 17, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company), a metabolic therapeutics company focused on pattern-breaking approaches that treat root causes of obesity and type 2 diabetes (T2D), today announced an oral presentation of new preclinical data from its Rejuva smart GLP-1 gene therapy platform at the American Society of Gene and Cell Therapy (ASGCT) 2025 Annual Meeting. The data highlight RJVA-001's potential to deliver durable, nutrient-responsive GLP-1 secretion from pancreatic beta cells—mimicking natural hormone regulation with low circulating levels of GLP-1, offering a potentially profound mechanistic advantage over pharmacologic GLP-1 drugs. RJVA-001 also showed strong efficacy, targeted delivery, and a favorable safety profile, reinforcing its readiness for first-in-human studies. The data were featured in an oral presentation at ASGCT titled 'Endoscopic Ultrasound-Guided Delivery of Human Glucagon-like Peptide-1 Pancreatic Gene Therapy: Safety and Feasibility in a Porcine Model.' 'RJVA-001 represents a fundamentally different approach to treating metabolic disease - one that delivers the power of GLP-1 in a more natural manner,' said Professor Randy Seeley, Ph.D., Henry King Ransom Professor of Surgery and Director of Michigan Nutrition Obesity Research Center at Michigan School of Medicine. 'The ability to drive durable metabolic effects with physiologic hormone levels, from a one-time treatment, would be a scientific breakthrough with huge potential implications for patients. This has the potential to reshape how we think about treating T2D and obesity at scale.' Key Data Presented at ASGCT 2025: Single-dose RJVA-001 led to durable, dose-dependent metabolic improvements in a well-established diabetic model: In db/db mice, treatment with RJVA-001 led to sustained reductions in blood sugar, improved fasting insulin levels, and improvements in body weight over six weeks— supporting Rejuva's potential for sustained disease modification on both blood sugar and body weight control. Treatment with RJVA-001 resulted in a >200 mg/dL reduction in fasting blood sugar, a >2-fold increase in fasting insulin levels, and prevention of weight gain, compared to a ~20% increase seen in vehicle-treated controls. These results demonstrate broad-based metabolic improvement in insulin secretion, weight gain, and blood sugar control in this gold-standard model of T2D. RJVA-001 achieved glycemic control and prevented weight gain with significantly lower systemic GLP-1 exposure than required by GLP-1 drugs to achieve similar effects: Circulating GLP-1 levels were more than 5-fold lower than those seen with pharmacologic GLP-1 drugs and were comparable to levels observed after gastric bypass surgery—suggesting a substantially lower risk of GLP-1-related side effects such as nausea and vomiting. In db/db mice, circulating levels of active GLP-1 were 10-20 pM with RJVA-001, compared to 50-150 pM typically reported with pharmacologic GLP-1 drugs1. Data show nutrient- and dose-responsive GLP-1 secretion in transduced human beta cells and islets, demonstrating that Rejuva mimics native hormone regulation rather than constant drug-driven stimulation: RJVA-001 activated glucose-dependent expression of GLP-1 in both in vitro and ex vivo models, consistent with physiologic endocrine function. In transduced human beta cells, GLP-1 secretion more than doubled— and GLP-1 bioactivity increased >3-fold — when shifting from low glucose to high glucose conditions. These results demonstrate tight nutrient gating and dose-responsive control of RJVA-001 drug action. Adaptive expression based on disease state: In db/db mice, RJVA-001 drove higher GLP-1 expression in diabetic animals than in healthy controls at the same dose, demonstrating the platform's ability to adapt to metabolic need. RJVA-001-treated healthy mice maintained normal weight and blood sugar, reinforcing the potential safety of this nutrient-responsive smart GLP-1. At equal dosing, db/db mice had more than twice the circulating GLP-1 levels of healthy mice, with no effect on weight or blood sugar in the healthy group. These results support the physiologic, selective, and adaptive action of RJVA-001 based on the body's metabolic state. Endoscopic ultrasound–guided delivery of RJVA-001 in large animals showed targeted pancreatic expression with no observed toxicity: In Yucatan pigs, device deployment was completed in an average procedure time of <20 minutes using a standard clinical endoscopic ultrasound technique. RJVA-001 localized to the pancreas with minimal systemic distribution and no adverse safety findings, even at doses exceeding projected clinical levels. Biodistribution studies showed vector copy number of 7 vector genomes/nucleus in the targeted splenic lobe of the pancreas (equivalent to the body and tail of the human pancreas) versus <0.2 vector genomes/nucleus in the liver. These results indicate profound de-targeting of the liver with local administration with the Rejuva catheter and ultrasound-guided route of administration. No acute or longer-term serum or histopathological evidence of toxicity was observed post-procedure. Serum lipase, neurofilament-light, troponin I, and ALT all remained below the upper limit of normal or below detection, indicating the absence of pancreatic, neuronal, cardiac, and liver toxicity, respectively. No on-target or off-target organ inflammation or other histopathological findings were observed in the study. 'We believe RJVA-001 represents a transformative advance in metabolic medicine,' said Dr. Harith Rajagopalan, Co-Founder and Chief Executive Officer of Fractyl Health. 'These data suggest that a one-time, smart GLP-1 can restore physiologic signaling in the pancreas and achieve durable disease modification in diabetes and obesity - without the high levels of systemic drug exposure that causes side effects with current GLP-1 therapies. RJVA-001 has demonstrated superior potency, durability, and convenience in preclinical models, along with a potentially improved tolerability profile than GLP-1 drugs. We believe the Rejuva platform has the potential to usher in a category-closing modality for T2D and obesity. We look forward to our upcoming CTA submission for RJVA-001 and, pending regulatory authorization, preliminary human data in 2026.' The full ASGCT presentation is available on the Fractyl Health website in the Presentations & Publications section. About Fractyl HealthFractyl Health is a metabolic therapeutics company focused on pattern-breaking approaches that treat root causes of obesity and T2D. Despite advances in treatment over the last 50 years, obesity and T2D continue to be rapidly growing drivers of morbidity and mortality in the 21st century. Fractyl Health's goal is to transform metabolic disease treatment from chronic symptomatic management to durable disease-modifying therapies that target the organ-level root causes of disease. Fractyl Health is based in Burlington, MA. For more information, visit or About Rejuva®Fractyl Health's Rejuva platform focuses on developing next-generation adeno-associated virus (AAV)-based, locally delivered gene therapies for the treatment of obesity and T2D. The Rejuva platform is in preclinical development and has not yet been evaluated by regulatory agencies for investigational or commercial use. Rejuva leverages advanced delivery systems and proprietary screening methods to identify and develop metabolically active gene therapy candidates targeting the pancreas. The program aims to transform the management of metabolic diseases by offering novel, disease-modifying therapies that address the underlying root causes of disease. The Company plans to submit the first Clinical Trial Application (CTA) module for RJVA-001 in type 2 diabetes to regulators by June 2025, and if the CTA is authorized, the Company expects to dose the first patients with RJVA-001 and report preliminary data in 2026. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the promise and potential impact of our preclinical or clinical trial data, the design, initiation, timing and results of clinical enrollment and any clinical studies or readouts, the content, information used for, timing or results of any investigational new drug (IND)-enabling studies, IND applications or Clinical Trial Applications, communications with regulators, the potential launch or commercialization of any of our product candidates or products, the potential treatment population or benefits for any of our product candidates or products, and our strategic and product development objectives and goals, including with respect to enabling long-term control over obesity and type 2 diabetes without the burden of chronic therapies, redefining the future of metabolic disease treatment, positioning our Company at the forefront of the global opportunity for metabolic care, and the timing of any of the foregoing. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the Company's limited operating history; the incurrence of significant net losses and the fact that the Company expects to continue to incur significant net losses for the foreseeable future; the Company's need for substantial additional financing; the Company's ability to continue as a going concern; the restrictive and financial covenants in the Company's credit agreement; the lengthy and unpredictable regulatory approval process for the Company's product candidates; uncertainty regarding its clinical studies; the fact that the Company's product candidates may cause serious adverse events or undesirable side effects or have other properties that may cause it to suspend or discontinue clinical studies, delay or prevent regulatory development, prevent their regulatory approval, limit the commercial profile, or result in significant negative consequences; additional time may be required to develop and obtain regulatory approval or certification for the Company's Rejuva gene therapy candidates; the Company's reliance on third parties to conduct certain aspects of the Company's preclinical studies and clinical studies; the Company's reliance on third parties for the manufacture of the materials for its Rejuva gene therapy platform for preclinical studies and its ongoing clinical studies; the regulatory approval process of the FDA, comparable foreign regulatory authorities and lengthy, time-consuming and inherently unpredictable, and even if we complete the necessary clinical studies, we cannot predict when, or if, we will obtain regulatory approval or certification for any of our product candidates, and any such regulatory approval or certification may be for a more narrow indication than we seek; and the potential launch or commercialization of any of Company's product candidates or products and our strategic and product development objectives and goals, and the other factors discussed under the caption 'Risk Factors' in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the SEC) on May 13, 2025 and in our other filings with the SEC. These forward-looking statements are based on management's current estimates and expectations. While the Company may elect to update such forward-looking statements at some point in the future, the Company disclaims any obligation to do so, even if subsequent events cause its views to change. Contacts Media Contact Jessica Cotrone, Corporate Communications jcotrone@ 978.760.5622 Investor Contact Brian Luque, Head of Investor Relations and Corporate DevelopmentIR@ 951.206.1200 _________________1 Smits MM, Holst JJ. Endogenous glucagon-like peptide (GLP)-1 as alternative for GLP-1 receptor agonists: Could this work and how? Diabetes Metab Res Rev. 2023 Nov;39(8):e3699. doi: 10.1002/dmrr.3699. Epub 2023 Jul 24. PMID: in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
17-05-2025
- Business
- Yahoo
Fractyl Health Unveils New Rejuva® Smart GLP-1™ Pancreatic Gene Therapy Preclinical Data Highlighting Durable Potency and Safety with Limited Systemic GLP-1 Exposure at ASGCT 2025
Data suggests that single dose of RJVA-001 leads to durable metabolic improvements with low systemic GLP-1 exposure in db/db mouse model of T2D— potentially simultaneously addressing durability, adherence, and tolerability challenges seen with current GLP-1 drugs Endoscopic ultrasound-guided delivery achieves targeted pancreatic expression in a large animal model with no toxicity observed to date Data show nutrient-responsive GLP-1 secretion in human beta cells and human islets, demonstrating that Rejuva mimics natural hormone regulation rather than constant drug-driven stimulation Rejuva advancing toward first-in-human studies; first CTA module submission for RJVA-001 expected by June 2025 BURLINGTON, Mass., May 17, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company), a metabolic therapeutics company focused on pattern-breaking approaches that treat root causes of obesity and type 2 diabetes (T2D), today announced an oral presentation of new preclinical data from its Rejuva smart GLP-1 gene therapy platform at the American Society of Gene and Cell Therapy (ASGCT) 2025 Annual Meeting. The data highlight RJVA-001's potential to deliver durable, nutrient-responsive GLP-1 secretion from pancreatic beta cells—mimicking natural hormone regulation with low circulating levels of GLP-1, offering a potentially profound mechanistic advantage over pharmacologic GLP-1 drugs. RJVA-001 also showed strong efficacy, targeted delivery, and a favorable safety profile, reinforcing its readiness for first-in-human studies. The data were featured in an oral presentation at ASGCT titled 'Endoscopic Ultrasound-Guided Delivery of Human Glucagon-like Peptide-1 Pancreatic Gene Therapy: Safety and Feasibility in a Porcine Model.' 'RJVA-001 represents a fundamentally different approach to treating metabolic disease - one that delivers the power of GLP-1 in a more natural manner,' said Professor Randy Seeley, Ph.D., Henry King Ransom Professor of Surgery and Director of Michigan Nutrition Obesity Research Center at Michigan School of Medicine. 'The ability to drive durable metabolic effects with physiologic hormone levels, from a one-time treatment, would be a scientific breakthrough with huge potential implications for patients. This has the potential to reshape how we think about treating T2D and obesity at scale.' Key Data Presented at ASGCT 2025: Single-dose RJVA-001 led to durable, dose-dependent metabolic improvements in a well-established diabetic model: In db/db mice, treatment with RJVA-001 led to sustained reductions in blood sugar, improved fasting insulin levels, and improvements in body weight over six weeks— supporting Rejuva's potential for sustained disease modification on both blood sugar and body weight control. Treatment with RJVA-001 resulted in a >200 mg/dL reduction in fasting blood sugar, a >2-fold increase in fasting insulin levels, and prevention of weight gain, compared to a ~20% increase seen in vehicle-treated controls. These results demonstrate broad-based metabolic improvement in insulin secretion, weight gain, and blood sugar control in this gold-standard model of T2D. RJVA-001 achieved glycemic control and prevented weight gain with significantly lower systemic GLP-1 exposure than required by GLP-1 drugs to achieve similar effects: Circulating GLP-1 levels were more than 5-fold lower than those seen with pharmacologic GLP-1 drugs and were comparable to levels observed after gastric bypass surgery—suggesting a substantially lower risk of GLP-1-related side effects such as nausea and vomiting. In db/db mice, circulating levels of active GLP-1 were 10-20 pM with RJVA-001, compared to 50-150 pM typically reported with pharmacologic GLP-1 drugs1. Data show nutrient- and dose-responsive GLP-1 secretion in transduced human beta cells and islets, demonstrating that Rejuva mimics native hormone regulation rather than constant drug-driven stimulation: RJVA-001 activated glucose-dependent expression of GLP-1 in both in vitro and ex vivo models, consistent with physiologic endocrine function. In transduced human beta cells, GLP-1 secretion more than doubled— and GLP-1 bioactivity increased >3-fold — when shifting from low glucose to high glucose conditions. These results demonstrate tight nutrient gating and dose-responsive control of RJVA-001 drug action. Adaptive expression based on disease state: In db/db mice, RJVA-001 drove higher GLP-1 expression in diabetic animals than in healthy controls at the same dose, demonstrating the platform's ability to adapt to metabolic need. RJVA-001-treated healthy mice maintained normal weight and blood sugar, reinforcing the potential safety of this nutrient-responsive smart GLP-1. At equal dosing, db/db mice had more than twice the circulating GLP-1 levels of healthy mice, with no effect on weight or blood sugar in the healthy group. These results support the physiologic, selective, and adaptive action of RJVA-001 based on the body's metabolic state. Endoscopic ultrasound–guided delivery of RJVA-001 in large animals showed targeted pancreatic expression with no observed toxicity: In Yucatan pigs, device deployment was completed in an average procedure time of <20 minutes using a standard clinical endoscopic ultrasound technique. RJVA-001 localized to the pancreas with minimal systemic distribution and no adverse safety findings, even at doses exceeding projected clinical levels. Biodistribution studies showed vector copy number of 7 vector genomes/nucleus in the targeted splenic lobe of the pancreas (equivalent to the body and tail of the human pancreas) versus <0.2 vector genomes/nucleus in the liver. These results indicate profound de-targeting of the liver with local administration with the Rejuva catheter and ultrasound-guided route of administration. No acute or longer-term serum or histopathological evidence of toxicity was observed post-procedure. Serum lipase, neurofilament-light, troponin I, and ALT all remained below the upper limit of normal or below detection, indicating the absence of pancreatic, neuronal, cardiac, and liver toxicity, respectively. No on-target or off-target organ inflammation or other histopathological findings were observed in the study. 'We believe RJVA-001 represents a transformative advance in metabolic medicine,' said Dr. Harith Rajagopalan, Co-Founder and Chief Executive Officer of Fractyl Health. 'These data suggest that a one-time, smart GLP-1 can restore physiologic signaling in the pancreas and achieve durable disease modification in diabetes and obesity - without the high levels of systemic drug exposure that causes side effects with current GLP-1 therapies. RJVA-001 has demonstrated superior potency, durability, and convenience in preclinical models, along with a potentially improved tolerability profile than GLP-1 drugs. We believe the Rejuva platform has the potential to usher in a category-closing modality for T2D and obesity. We look forward to our upcoming CTA submission for RJVA-001 and, pending regulatory authorization, preliminary human data in 2026.' The full ASGCT presentation is available on the Fractyl Health website in the Presentations & Publications section. About Fractyl HealthFractyl Health is a metabolic therapeutics company focused on pattern-breaking approaches that treat root causes of obesity and T2D. Despite advances in treatment over the last 50 years, obesity and T2D continue to be rapidly growing drivers of morbidity and mortality in the 21st century. Fractyl Health's goal is to transform metabolic disease treatment from chronic symptomatic management to durable disease-modifying therapies that target the organ-level root causes of disease. Fractyl Health is based in Burlington, MA. For more information, visit or About Rejuva®Fractyl Health's Rejuva platform focuses on developing next-generation adeno-associated virus (AAV)-based, locally delivered gene therapies for the treatment of obesity and T2D. The Rejuva platform is in preclinical development and has not yet been evaluated by regulatory agencies for investigational or commercial use. Rejuva leverages advanced delivery systems and proprietary screening methods to identify and develop metabolically active gene therapy candidates targeting the pancreas. The program aims to transform the management of metabolic diseases by offering novel, disease-modifying therapies that address the underlying root causes of disease. The Company plans to submit the first Clinical Trial Application (CTA) module for RJVA-001 in type 2 diabetes to regulators by June 2025, and if the CTA is authorized, the Company expects to dose the first patients with RJVA-001 and report preliminary data in 2026. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the promise and potential impact of our preclinical or clinical trial data, the design, initiation, timing and results of clinical enrollment and any clinical studies or readouts, the content, information used for, timing or results of any investigational new drug (IND)-enabling studies, IND applications or Clinical Trial Applications, communications with regulators, the potential launch or commercialization of any of our product candidates or products, the potential treatment population or benefits for any of our product candidates or products, and our strategic and product development objectives and goals, including with respect to enabling long-term control over obesity and type 2 diabetes without the burden of chronic therapies, redefining the future of metabolic disease treatment, positioning our Company at the forefront of the global opportunity for metabolic care, and the timing of any of the foregoing. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the Company's limited operating history; the incurrence of significant net losses and the fact that the Company expects to continue to incur significant net losses for the foreseeable future; the Company's need for substantial additional financing; the Company's ability to continue as a going concern; the restrictive and financial covenants in the Company's credit agreement; the lengthy and unpredictable regulatory approval process for the Company's product candidates; uncertainty regarding its clinical studies; the fact that the Company's product candidates may cause serious adverse events or undesirable side effects or have other properties that may cause it to suspend or discontinue clinical studies, delay or prevent regulatory development, prevent their regulatory approval, limit the commercial profile, or result in significant negative consequences; additional time may be required to develop and obtain regulatory approval or certification for the Company's Rejuva gene therapy candidates; the Company's reliance on third parties to conduct certain aspects of the Company's preclinical studies and clinical studies; the Company's reliance on third parties for the manufacture of the materials for its Rejuva gene therapy platform for preclinical studies and its ongoing clinical studies; the regulatory approval process of the FDA, comparable foreign regulatory authorities and lengthy, time-consuming and inherently unpredictable, and even if we complete the necessary clinical studies, we cannot predict when, or if, we will obtain regulatory approval or certification for any of our product candidates, and any such regulatory approval or certification may be for a more narrow indication than we seek; and the potential launch or commercialization of any of Company's product candidates or products and our strategic and product development objectives and goals, and the other factors discussed under the caption 'Risk Factors' in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the SEC) on May 13, 2025 and in our other filings with the SEC. These forward-looking statements are based on management's current estimates and expectations. While the Company may elect to update such forward-looking statements at some point in the future, the Company disclaims any obligation to do so, even if subsequent events cause its views to change. Contacts Media Contact Jessica Cotrone, Corporate Communications jcotrone@ 978.760.5622 Investor Contact Brian Luque, Head of Investor Relations and Corporate DevelopmentIR@ 951.206.1200 _________________1 Smits MM, Holst JJ. Endogenous glucagon-like peptide (GLP)-1 as alternative for GLP-1 receptor agonists: Could this work and how? Diabetes Metab Res Rev. 2023 Nov;39(8):e3699. doi: 10.1002/dmrr.3699. Epub 2023 Jul 24. PMID: while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Business Wire
14-05-2025
- Business
- Business Wire
Forge Biologics Announces AAV Development and cGMP Manufacturing Relationship with Fractyl Health to Advance Their Gene Therapy Platform for Patients with Metabolic Diseases
COLUMBUS, Ohio--(BUSINESS WIRE)--Forge Biologics ('Forge'), a leading manufacturer of genetic medicines and member of the Ajinomoto Bio-Pharma Services group, today announced an AAV development and manufacturing agreement to help advance Fractyl Health's Rejuva* pancreatic gene therapy platform for the treatment of patients with obesity and type 2 diabetes (T2D). "We developed our FUEL™ platform to provide developers like Fractyl with a more efficient and scalable manufacturing solution to help reach broader patient populations,' said John Maslowski, President and CEO of Forge. "We developed our FUEL™ platform to provide developers like Fractyl with a more efficient and scalable manufacturing solution to help reach broader patient populations,' said John Maslowski, President and CEO of Forge. 'We are proud to support Fractyl in advancing a new class of metabolic disease therapies. Their mission to break the cycle of chronic disease management for patients is one we are honored and excited to help enable.' 'We are excited to collaborate with Forge in advancing our Rejuva pancreatic gene therapy platform. Forge's expertise in large-scale, efficient AAV manufacturing is invaluable as we move forward in our mission to develop scalable treatments that aim to prevent and reverse obesity and metabolic disease,' said Harith Rajagopalan M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl Health. Through this relationship, Forge will provide Fractyl process development, cGMP manufacturing and analytical development services. Fractyl will also leverage Forge's FUEL™ platform, including its proprietary HEK293 suspension Ignition Cells™ and pEMBR™ 2.0 adenovirus helper plasmid. All development and manufacturing activities will occur at the Hearth, Forge's 200,000 square foot gene therapy manufacturing facility in Columbus, Ohio. *The Rejuva platform is in preclinical development and has not yet been evaluated by regulatory agencies for investigational or commercial use. About Forge Biologics Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company, enabling access to life-changing gene therapies by bringing them from concept to reality. Forge's 200,000 square foot facility, the Hearth, is headquartered in Columbus, Ohio, and houses 20 custom-designed cGMP suites with 20,000L of bioreactor capacity. Forge's end-to-end, scalable plasmid and AAV manufacturing services include research-grade manufacturing, process and analytical development, cGMP manufacturing, fill and finish, and integrated regulatory support to help accelerate the timelines of transformative medicines for patients with genetic diseases. To learn more, visit
Yahoo
28-04-2025
- Business
- Yahoo
Fractyl Health to Present Compelling Preclinical Data from its Rejuva® Single-Administration Smart GLP-1 Pancreatic Gene Therapy Platform at the American Society of Gene and Cell Therapy (ASGCT) 2025 Annual Meeting
BURLINGTON, Mass., April 28, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) ('the Company'), a metabolic therapeutics company focused on pattern-breaking approaches to treat the root causes of obesity and type 2 diabetes (T2D), today announced that it will deliver an oral presentation of compelling preclinical data from its Rejuva single-administration Smart GLP-1 pancreatic gene therapy platform at the American Society of Gene and Cell Therapy (ASGCT) 2025 Annual Meeting, taking place May 13-17, 2025, in New Orleans, Louisiana. Oral Presentation Details: Title: Endoscopic Ultrasound-Guided Delivery of Human Glucagon-like Peptide-1 Pancreatic Gene Therapy: Safety and Feasibility in a Porcine ModelSession: AAV Preclinical and Proof-of-Concept StudiesDate and Time: Saturday, May 17, 2025, 9:15 a.m. – 9:30 a.m. CTLocation: NOLA Theater A The presentation will be available via the Presentations & Publications section of the Fractyl website once it concludes on May 17, Fractyl HealthFractyl Health is a metabolic therapeutics company focused on pioneering new approaches to the treatment of metabolic diseases, including obesity and T2D. Despite advances in treatment over the last 50 years, obesity and T2D continue to be rapidly growing drivers of morbidity and mortality in the 21st century. Fractyl Health's goal is to transform metabolic disease treatment from chronic symptomatic management to durable disease-modifying therapies that target the organ-level root causes of disease. Fractyl Health is based in Burlington, MA. For more information, visit About Rejuva®Fractyl Health's Rejuva platform focuses on developing next-generation adeno-associated virus (AAV)-based, locally delivered gene therapies for the treatment of obesity and T2D. The Rejuva platform is in preclinical development and has not yet been evaluated by regulatory agencies for investigational or commercial use. Rejuva leverages advanced delivery systems and proprietary screening methods to identify and develop metabolically active gene therapy candidates targeting the pancreas. The program aims to transform the management of metabolic diseases by offering novel, disease-modifying therapies that address the underlying root causes of disease. The Company plans to submit the first Clinical Trial Application (CTA) module for RJVA-001 in type 2 diabetes to regulators in H1 2025, and if the CTA is authorized, expects to report preliminary data in 2026. Contacts Media Contact Jessica Cotrone, Head of Corporate Communications jcotrone@ 978.760.5622 Investor Contact Brian Luque, Head of Investor Relations and Corporate DevelopmentIR@ 951.206.1200Sign in to access your portfolio
Yahoo
04-04-2025
- Business
- Yahoo
Fractyl Health, Inc. (GUTS): Insider Were Buying In Q1 2025
We recently published a list of . In this article, we are going to take a look at where Fractyl Health, Inc. (NASDAQ:GUTS) stands against other micro-cap stocks insiders were buying in Q1 2025. The White House announced Tuesday that Trump's tariffs would take effect immediately after being unveiled on Wednesday. In anticipation of these 'reciprocal tariffs,' which will apply to all countries, the stock market reacted. By Tuesday morning, the broader market index and Nasdaq Composite dropped by about 0.2%, while blue-chip companies lost 0.06%. Amid ongoing market uncertainty, insider trading often comes under the spotlight. Executive stock purchases can signal optimism, but sales may reflect personal financial decisions or a need to diversify investments. To maintain transparency, executives typically follow pre-arranged strategies, like 10b5-1 plans. While insider trading can offer valuable information, it's important to evaluate it in the broader context of the company's financial stability and current market trends. Today, we're focusing on stocks with micro market capitalizations that have seen significant insider buying in the first quarter of the year. Using Insider Monkey's insider trading screener, we identified companies with market caps under $250 million where at least three insiders purchased shares in the past three months. From this list, we ranked the top 10 stocks with the highest number of insiders making purchases. Stocks that have been recently covered were excluded from our analysis. Our research has shown that we can outperform the market by imitating the top stock picks of the best hedge funds, focusing on insider trading and stock picks from hedge fund investor newsletters and conferences. Our quarterly newsletter's strategy selects 14 small-cap and large-cap stocks every quarter and has returned 373.4% since May 2014, beating its benchmark by 218 percentage points (). With each stock, we note the number of insiders who acquired shares in the first quarter and market capitalizations. A biologist in a lab coat studying a culture of cells to find a cure for metabolic disorders. Number of insiders buying: 5 Market Capitalization: $54.30 million Fractyl Health is a metabolic therapeutics company focused on developing treatments for type 2 diabetes (T2D) and obesity. It is developing the Revita DMR System, a procedure targeting duodenal dysfunction, and Rejuva, a gene therapy platform aimed at long-term remission of T2D by altering metabolic hormone function in the pancreas. In January, the company announced a strategic decision to focus Revita exclusively on weight maintenance, prioritizing the REMAIN-1 pivotal study to address the most pressing need in obesity care, while advancing its novel Rejuva gene therapy platform into first-in-human studies. Fractyl paused investment in its Revita programs for T2D, which consisted of the REVITALIZE-1 study, and the Germany Real-World Registry study. In March, the company announced positive early data from its REVEAL-1 cohort in the REMAIN-1 pivotal study, suggesting that Revita may help prevent weight regain after stopping GLP-1 drugs. This addresses an unmet need in obesity treatment as the demand for scalable, non-pharmacologic solutions grows with increasing GLP-1 discontinuation rates. During the first quarter, five insiders acquired approximately $193,475 worth of Fractyl Health shares at an average price of $1.24 per share. Currently, the stock trades at $1.11 per share, having declined 46.12% year-to-date and 83.53% over the past 12 months. Net loss amounted to $68.69 million, compared to net loss of $77.09 million in 2023. For the full year 2024, Fractyl Health reported revenue of $93,000, compared to $120,000 in 2023. Gross profit was $43,000, flat compared to the previous year. Based on two Wall Street analysts' estimates, Fractyl Health stock is a 'Moderate Buy' with a price target of $8.00. The average price target suggests a 620.72% potential upside from the latest price. Overall, GUTS ranks 8th on our list of micro-cap stocks insiders were buying in Q1 2025. While we acknowledge the potential of GUTS our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns, and doing so within a shorter time frame. If you are looking for an AI stock that is more promising than GUTS but that trades at less than 5 times its earnings, check out our report about the . READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
