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Sagimet Biosciences Announces Participation in Two Upcoming Investor Conferences
Globenewswire· 2026-02-05 12:00
SAN MATEO, Calif., Feb. 05, 2026 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that management will participate in two upcoming investor conferences. Guggenheim Emerging Outlook: Biotech Summit 2026 in New York, NY, on February 11, 2026, with a fireside chat at 10am ET (link here).Oppenheimer 36th Annual Healthcare Life Sciences Conference on Februa ...
Weekly Buzz: Intellia Gets FDA Nod For ATTRv-PN Trial; Aprea's APR-1051 Paces; CALC Halts KOURAGE
RTTNews· 2026-01-30 17:37
FDA Approvals & Rejections - Intellia Therapeutics has received FDA approval to resume its MAGNITUDE-2 Phase 3 trial for nexiguran ziclumeran (nex-z) targeting hereditary transthyretin amyloidosis with polyneuropathy, increasing target enrollment from 50 to 60 patients [2][4] - Outset Medical's next-generation Tablo Hemodialysis System has been granted FDA 510(k) clearance, making it the first dialysis device to meet enhanced cybersecurity standards, with shipping expected to begin in Q2 2026 [6][7] - OKYO Pharma has received positive feedback from the FDA for its Phase 2b/3 trial design for Urcosimod, a candidate for neuropathic corneal pain, with plans to start the trial in the first half of 2026 [8][9] - REGENXBIO has faced clinical holds on its RGX-111 and RGX-121 gene therapy programs due to a case of CNS tumor in a child treated with RGX-111, although no similar findings were reported in other patients [10][11] - Almirall has received NMPA approval for Seysara in China for treating moderate-to-severe acne vulgaris, expanding its dermatology portfolio in the region [12][13] Clinical Trials - Breakthroughs - Aprea Therapeutics reported early clinical activity for APR-1051 in endometrial cancer, achieving a 50% reduction in target lesion size in a patient with PPP2R1A-mutated uterine serous carcinoma [19][21] - Fractyl Health's Revita demonstrated positive results in weight maintenance after GLP-1 drug discontinuation, showing a 4.5% weight regain compared to 7.5% in the sham group [22][24] - Ascletis Pharma announced positive Phase 3 results for Denifanstat in moderate-to-severe acne vulgaris, focusing on long-term safety in a trial with 240 patients [25][26] - GRI Bio reported new gene expression data from its Phase 2a study of GRI-0621 in idiopathic pulmonary fibrosis, showing significant improvements in lung injury and fibrosis progression [27][28] - Cardiff Oncology announced encouraging results from its Phase 2 trial of Onvansertib in RAS-mutated metastatic colorectal cancer, with a well-tolerated regimen and plans to advance to a registrational program [31][32] - Genentech's CT-388 Phase 2 trial for obesity showed a significant placebo-adjusted weight loss of 22.5% at 48 weeks, with a high percentage of participants achieving significant weight loss [34][36] - Sarepta Therapeutics reported positive three-year results from its EMBARK study for ELEVIDYS in Duchenne muscular dystrophy, showing significant slowing of disease progression in treated patients [38][41] Deals - YD Bio Limited has signed a letter of intent to acquire Safe Save Medical for approximately $26.87 million, aiming to enhance its capabilities in advanced cellular therapeutics [14][15][17]
Sagimet Biosciences Announces Poster Presentation at the 10th Annual MASH-TAG 2026 Conference
Globenewswire· 2026-01-08 12:00
Core Viewpoint - Sagimet Biosciences Inc. is advancing its clinical-stage biopharmaceutical development, particularly focusing on the anti-fibrotic effects of its FASN inhibitor, denifanstat, in treating MASH patients [1][3]. Group 1: Clinical Trial and Presentation - Sagimet will present a poster at the 10th Annual MASH-TAG Conference, highlighting significant improvements in fibrosis for F3 MASH patients and biomarker enhancements in qFibrosis stage 4 MASH patients from the Phase 2b FASCINATE-2 trial [1][2]. - The poster presentation is scheduled for January 10, 2026, and will be delivered by Dr. Rohit Loomba from the University of California San Diego [2]. Group 2: Company Overview - Sagimet is focused on developing novel FASN inhibitors to address dysfunctional metabolic and fibrotic pathways, particularly in conditions linked to excessive palmitate production [3]. - Denifanstat has successfully met all primary endpoints in its Phase 2b FASCINATE-2 trial and is also being tested in a Phase 3 trial for moderate-to-severe acne in partnership with a licensee in China [3]. - The company is also developing a second oral FASN inhibitor, TVB-3567, which is currently undergoing a Phase 1 clinical trial [3]. Group 3: MASH Disease Context - MASH is a severe liver disease affecting over 265 million people globally, characterized by fat accumulation in the liver, inflammation, and fibrosis, leading to serious liver-related outcomes [4]. - There are limited approved treatments for non-cirrhotic MASH and none for MASH cirrhosis, highlighting a significant unmet medical need in this area [4].
Sagimet's License Partner Ascletis Announced Acceptance of New Drug Application for Denifanstat for the Treatment of Moderate to Severe Acne by China's National Medical Products Administration
Globenewswire· 2025-12-10 12:03
Core Insights - Sagimet Biosciences Inc. has granted an exclusive license for denifanstat to Ascletis Pharma Inc. for the treatment of moderate to severe acne in China, following the acceptance of its New Drug Application (NDA) by China's National Medical Products Administration (NMPA) [1][2] - Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor, which has shown positive results in clinical trials for both acne and metabolic dysfunction associated steatohepatitis (MASH) [2][3] Company Overview - Sagimet Biosciences is focused on developing novel FASN inhibitors aimed at addressing dysfunctional metabolic and fibrotic pathways, particularly those linked to the overproduction of palmitate [3] - The company has successfully completed Phase 2b clinical trials for denifanstat in MASH and has partnered with Ascletis for its Phase 3 clinical trials in moderate-to-severe acne, where denifanstat met all primary and secondary endpoints [3] Clinical Development - Denifanstat has been well tolerated in clinical trials, with Ascletis' Phase 3 trial demonstrating success in treating moderate to severe acne vulgaris [2] - Sagimet is also testing a combination of denifanstat and resmetirom in a Phase 1 PK clinical trial, targeting cirrhotic patients with F4-stage MASH, and is developing a second oral FASN inhibitor, TVB-3567, which is currently in Phase 1 trials [3]
Sagimet Biosciences Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2025-12-09 21:05
Core Insights - Sagimet Biosciences Inc. announced the approval of inducement grants of 42,800 stock options to three newly-hired employees as part of their employment compensation [1][2] - The stock options will have an exercise price based on the closing price of Sagimet's Series A common stock on December 9, 2025, and will vest over a four-year period [3] Company Overview - Sagimet is a clinical-stage biopharmaceutical company focused on developing novel fatty acid synthase (FASN) inhibitors to address dysfunctional metabolic and fibrotic pathways, particularly related to the overproduction of palmitate [4] - The company’s lead product, denifanstat, has shown positive results in clinical trials for metabolic dysfunction associated steatohepatitis (MASH) and is also being tested in combination with resmetirom for cirrhotic patients with F4-stage MASH [4] - Another product, TVB-3567, is currently undergoing a Phase 1 first-in-human clinical trial for acne treatment [4]
Sagimet Biosciences to Participate in the 8th Annual Evercore ISI Healthcare Conference
Globenewswire· 2025-11-20 12:00
Core Insights - Sagimet Biosciences Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways [1][3] Company Overview - Sagimet is developing FASN inhibitors aimed at conditions caused by the overproduction of the fatty acid palmitate [3] - Denifanstat, an oral medication, has successfully met all primary endpoints in its Phase 2b FASCINATE-2 clinical trial for MASH and in a Phase 3 clinical trial for moderate-to-severe acne in partnership with a licensee in China [3] - A combination therapy of denifanstat and resmetirom is currently undergoing a Phase 1 PK clinical trial, with plans for development in cirrhotic patients with F4-stage MASH [3] - TVB-3567, another oral FASN inhibitor, is in a Phase 1 first-in-human clinical trial for acne [3] Upcoming Events - Management will participate in the 8th Annual Evercore ISI Healthcare Conference on December 2, 2025, with a fireside chat scheduled for 12:55 PM ET [1] - A webcast of the event will be available on Sagimet's website, with an archived replay accessible for 90 days post-event [2]
Sagimet Biosciences Advances Denifanstat: Q3 Earnings And Upcoming Catalysts
Seeking Alpha· 2025-11-18 10:48
Company Performance - Sagimet Biosciences Inc. reported a GAAP EPS loss of -$0.40 for Q3 2025, missing analyst expectations by $0.01 [1] - The company recorded a net loss of $12.91 million for the quarter [1] Market Reaction - The market reaction to the earnings report was negative, indicating a lack of forgiveness from investors [1] Analyst Background - The analyst has a Master's degree in Cell Biology and extensive experience in drug discovery, which informs their investment analysis [1] - The focus is on identifying promising biotechnology companies with innovative approaches, including novel mechanisms of action and first-in-class therapies [1] - The analyst emphasizes the importance of evaluating the science behind drug candidates, competitive landscape, clinical trial design, and market opportunities while balancing financial fundamentals [1]
Sagimet Biosciences (NasdaqGM:SGMT) Conference Transcript
2025-10-21 12:02
Summary of Sagimet Biosciences Conference Call Company Overview - **Sagimet Biosciences** is a clinical-stage biopharmaceutical company focused on developing novel fatty acid synthase (FASN) inhibitors targeting metabolic and inflammatory diseases, particularly MASH (metabolic dysfunction-associated steatotic liver disease) and acne [2][3] Core Scientific Focus - The primary drug in development is **Denifanstat**, which inhibits overactive FASN, a key enzyme in lipid synthesis implicated in various diseases [2][3] - Denifanstat targets fat accumulation, inflammation, and fibrosis, addressing root causes common to MASH and other conditions [6][8] Clinical Development and Results - **FASCINATE-2 Study**: A phase 2b clinical trial showed Denifanstat met primary and secondary endpoints, demonstrating statistically significant improvements in fibrosis in severe MASH patients [3][12] - In F3 patients, there was a 36% improvement in fibrosis over placebo for one-stage improvement and a 30% improvement for two-stage [12] - **Combination Therapy**: A phase 1 PK study combining Denifanstat with Resmetirom has been initiated, expecting top-line results in the first half of next year [4] - **Acne Program**: A phase 3 trial in China for moderate to severe acne met all primary and secondary endpoints, with plans for submission to NMPA [4][28] Mechanism of Action - Denifanstat uniquely inhibits FASN, directly affecting stellate cells and reducing fibrosis, unlike other metabolic drugs that act indirectly [6][8][13] - The drug is a once-daily oral treatment, providing a differentiated approach in managing MASH and acne [6][8] Digital Pathology and AI Integration - The use of **AI-based digital pathology** enhances the quantification of fibrosis and fat deposition, providing more precise assessments than traditional methods [16][17] - Digital pathology is expected to play a significant role in regulatory frameworks for MASH endpoints, with FDA showing interest in non-invasive measures [19][20] Market Opportunity - The acne market is seen as underdeveloped, with Denifanstat offering a new mechanism of action that could significantly impact treatment options for moderate to severe acne patients [30][31] - Approximately 50 million Americans suffer from acne, with 20% classified as moderate to severe, presenting a substantial market opportunity [31] Conclusion - Sagimet Biosciences is positioned to make significant advancements in treating metabolic and inflammatory diseases through its innovative FASN inhibitors, with promising clinical data and a strong market potential in both MASH and acne [2][3][28]
Denifanstat Advances: Sagimet Builds Momentum Toward 2026 Readouts
Seeking Alpha· 2025-10-07 13:30
Core Insights - Sagimet Biosciences Inc (NASDAQ: SGMT) has experienced a slight decline of 2% in stock price over the past month, indicating a period of sideways trading [1] Company Overview - The company is focused on biotechnology, particularly in drug development, with an emphasis on innovative therapies and unique mechanisms of action [1] - Sagimet aims to reshape treatment paradigms through first-in-class therapies and platform technologies [1] Analyst Background - The analyst has a Master's degree in Cell Biology and extensive experience in drug discovery, which informs their investment analysis [1] - The analyst has been active in the investing space for five years, with a focus on biotech equity analysis for the past four years [1] Research Approach - The research emphasizes evaluating the science behind drug candidates, the competitive landscape, clinical trial design, and potential market opportunities [1] - Financial fundamentals and valuation are also key components of the analysis, aiming to provide a comprehensive understanding of the biotech sector [1]
Sagimet Gains Momentum As FDA Eases Path For MASH Drug Development
Seeking Alpha· 2025-08-29 15:19
Core Thesis - Sagimet Biosciences Inc. (NASDAQ: SGMT) is identified as a small-cap biotech company with a novel mechanism that could provide a competitive advantage in the MASH market through the blocking of fatty acid synthase [1] Company Overview - The company is focused on innovative biotechnology solutions, particularly through unique mechanisms of action and first-in-class therapies [1] - Denifanstat is highlighted as a key product in the company's pipeline [1] Analyst Background - The analyst has a Master's degree in Cell Biology and extensive experience in drug discovery, which informs their investment analysis [1] - The analyst has been active in the investment space for five years, with a focus on biotech equity analysis for the last four years [1] Research Focus - The research emphasizes evaluating the science behind drug candidates, the competitive landscape, clinical trial design, and potential market opportunities [1] - The approach aims to balance scientific rigor with financial fundamentals and valuation [1] Market Potential - The biotech sector is characterized by the potential for breakthrough science to yield significant returns, necessitating careful scrutiny of investment opportunities [1]