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<title>Ascletis Pharma Inc — News on 6ix</title>
<link>https://6ix.com/company/ascletis-pharma-inc</link>
<description>Latest news and press releases for Ascletis Pharma Inc on 6ix.</description>
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<title>Ascletis Completes Enrollment in U.S. Phase II Study of ASC30, an Oral Small Molecule GLP-1R Agonist, for the Treatment of Diabetes</title>
<link>https://6ix.com/company/ascletis-pharma-inc/news/ascletis-completes-enrollment-in-us-phase-ii-study-of-asc30-an-oral-small-molecule-glp-1r-agonist-for-the-treatment-of-diabetes</link>
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<pubDate>Mon, 27 Apr 2026 00:10:00 GMT</pubDate>
<description>Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today completion of enrollment in its 13-week U.S. Phase II study (NCT07321678) evaluating ASC30, an oral small molecule GLP-1 receptor (GLP-1R) agonist, for the treatment of type 2 diabetes mellitus (T2D). T2D is the second indication for ASC30, following its first indication of obesity. Topline data from the Phase II study for the treatment of T2D are expected in the third quarter of 2026.</description>
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<title>Ascletis Announces Fixed-Dose Combination of ASC30, Once-Daily Oral Small Molecule GLP-1R Agonist, and ASC39, Once-Daily Oral Small Molecule Amylin-Selective Amylin Receptor Agonist, for Clinical Development</title>
<link>https://6ix.com/company/ascletis-pharma-inc/news/ascletis-announces-fixed-dose-combination-of-asc30-once-daily-oral-small-molecule-glp-1r-agonist-and-asc39-once-daily-oral-small-molecule-amylin-selective-amylin-receptor-agonist-for-clinical-development</link>
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<pubDate>Tue, 07 Apr 2026 11:00:00 GMT</pubDate>
<description>Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces that it has selected ASC30_39 FDC, a fixed-dose combination (FDC) of ASC30, once-daily oral small molecule GLP-1R agonist and ASC39, once-daily oral small molecule amylin-selective amylin receptor agonist, for clinical development. Ascletis expects to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for ASC30_39 FDC oral tablets for the treatment of obesity in the third quarter of 2026.</description>
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<title>Ascletis Announces Positive Topline Results from U.S. Phase II, 24-Week Study for Its Ultra-Long-Acting Subcutaneous Depot Formulations of Small Molecule GLP-1R Agonist ASC30 for Obesity</title>
<link>https://6ix.com/company/ascletis-pharma-inc/news/ascletis-announces-positive-topline-results-from-us-phase-ii-24-week-study-for-its-ultra-long-acting-subcutaneous-depot-formulations-of-small-molecule-glp-1r-agonist-asc30-for-obesity</link>
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<pubDate>Tue, 10 Mar 2026 10:00:00 GMT</pubDate>
<description>Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces positive topline results from a U.S. Phase II, 24-week study for its subcutaneous (SQ) depot formulations of small molecule GLP-1 receptor (GLP-1R) agonist ASC30 for obesity (NCT06679959). All 65 participants enrolled in three cohorts utilizing two formulations (A1 and A2) were obese or overweight with at least one weight-related comorbidity.</description>
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<title>Ascletis Selects Oral Amylin Receptor Peptide Agonist, ASC36, for Clinical Development</title>
<link>https://6ix.com/company/ascletis-pharma-inc/news/ascletis-selects-oral-amylin-receptor-231500116</link>
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<pubDate>Tue, 10 Feb 2026 23:15:00 GMT</pubDate>
<description>Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces that it has selected ASC36 oral tablets, its first oral amylin receptor peptide agonist, for clinical development. Ascletis expects to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for ASC36 oral tablets for the treatment of obesity in the second quarter of 2026.</description>
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<title>Ascletis Announces Positive Topline Results from Its Phase III Open-Label Study of Denifanstat (ASC40), a First-in-Class, Once-Daily Oral FASN Inhibitor for Acne</title>
<link>https://6ix.com/company/ascletis-pharma-inc/news/ascletis-announces-positive-topline-results-from-its-phase-iii-open-label-study-of-denifanstat-asc40-a-first-in-class-once-daily-oral-fasn-inhibitor-for-acne</link>
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<pubDate>Thu, 29 Jan 2026 11:00:00 GMT</pubDate>
<description>Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") today announced positive topline results from the Phase III open-label study (NCT06248008) evaluating denifanstat (ASC40), a first-in-class, once-daily oral small molecule fatty acid synthase (FASN) inhibitor, in patients with moderate-to-severe acne vulgaris.</description>
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<title>Ascletis Announces First Participants Dosed in a 13-week U.S. Phase II Study with ASC30, an Oral Small Molecule GLP-1R Agonist for the Treatment of Diabetes</title>
<link>https://6ix.com/company/ascletis-pharma-inc/news/ascletis-announces-first-participants-dosed-001000514</link>
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<pubDate>Mon, 26 Jan 2026 00:10:00 GMT</pubDate>
<description>Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that the first participants have been dosed in a U.S. 13-week Phase II study (NCT07321678) with ASC30, an oral small molecule GLP-1 receptor (GLP-1R) agonist for the treatment of type 2 diabetes mellitus. Topline data from the Phase II study are expected in the third quarter of 2026.</description>
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<title>Ascletis Selects a Next-Generation Once-Monthly Subcutaneously Administered GLP-1R/GIPR/GCGR Triple Peptide Agonist, ASC37, for Clinical Development</title>
<link>https://6ix.com/company/ascletis-pharma-inc/news/ascletis-selects-a-next-generation-once-monthly-subcutaneously-administered-glp-1rgiprgcgr-triple-peptide-agonist-asc37-for-clinical-development</link>
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<pubDate>Tue, 20 Jan 2026 09:00:00 GMT</pubDate>
<description>Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces that it has selected ASC37 injection, a next-generation, once-monthly, subcutaneously administered GLP-1R/GIPR/GCGR[1] triple peptide agonist, as a clinical development candidate. Ascletis expects to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for ASC37 injection for the treatment of obesity in the second quarter of 2026.</description>
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<title>Ascletis Announces U.S. FDA IND Clearance for 13-Week Phase II Study of Its Oral Small Molecule GLP-1, ASC30, in Participants with Diabetes</title>
<link>https://6ix.com/company/ascletis-pharma-inc/news/ascletis-announces-us-fda-ind-clearance-for-13-week-phase-ii-study-of-its-oral-small-molecule-glp-1-asc30-in-participants-with-diabetes</link>
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<pubDate>Mon, 05 Jan 2026 00:10:00 GMT</pubDate>
<description>Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that it recently received the Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for the Phase II study of its oral small molecule GLP-1, ASC30, in participants with diabetes. The Phase II study is a 13-week, randomized, double-blind, placebo-controlled and multi-center study to evaluate the efficacy, safety, and tolerability of ASC30 in participants with type 2 diabetes mellitus. The primary end</description>
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<title>Ascletis Announces Positive Topline Results from U.S. Phase I Study of ASC50, a Potential Best-in-Class Oral Small Molecule IL-17 Inhibitor</title>
<link>https://6ix.com/company/ascletis-pharma-inc/news/ascletis-announces-positive-topline-results-from-us-phase-i-study-of-asc50-a-potential-best-in-class-oral-small-molecule-il-17-inhibitor</link>
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<pubDate>Mon, 15 Dec 2025 09:00:00 GMT</pubDate>
<description>Ascletis Pharma Inc. (HKEX:1672, "Ascletis") announces positive topline results from a randomized, double-blind, placebo-controlled Phase I clinical trial in the U.S., evaluating the safety, tolerability, pharmacokinetics and peripherally circulating interleukin-17A (IL-17A) target engagement profile of ASC50 (NCT07024602) in a single ascending dose (SAD) study in healthy participants. Forty-six healthy participants received 10 mg, 30 mg, 100 mg, 200 mg, 400 mg, or 600 mg of ASC50 or matching pl</description>
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<title>Ascletis Announces China National Medical Products Administration Acceptance of New Drug Application for Denifanstat (ASC40), a First-in-Class FASN Inhibitor for Acne Treatment</title>
<link>https://6ix.com/company/ascletis-pharma-inc/news/ascletis-announces-china-national-medical-products-administration-acceptance-of-new-drug-application-for-denifanstat-asc40-a-first-in-class-fasn-inhibitor-for-acne-treatment</link>
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<pubDate>Wed, 10 Dec 2025 09:15:00 GMT</pubDate>
<description>Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that its New Drug Application (NDA) for denifanstat (ASC40), a first-in-class, once-daily oral small molecule fatty acid synthase (FASN) inhibitor for the treatment of moderate-to-severe acne vulgaris, has been accepted by the China National Medical Products Administration (NMPA).</description>
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<title>Ascletis' Oral Small Molecule GLP-1, ASC30, Demonstrated Placebo-Adjusted Weight Loss of 7.7% with Better Gastrointestinal Tolerability in Its 13-Week U.S. Phase II Study in Participants with Obesity or Overweight</title>
<link>https://6ix.com/company/ascletis-pharma-inc/news/ascletis-oral-small-molecule-glp-1-asc30-demonstrated-placebo-adjusted-weight-loss-of-77percent-with-better-gastrointestinal-tolerability-in-its-13-week-us-phase-ii-study-in-participants-with-obesity-or-overweight</link>
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<pubDate>Mon, 08 Dec 2025 09:40:00 GMT</pubDate>
<description>Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today positive topline results in its 13-week Phase II study evaluating ASC30, an oral small molecule GLP-1 receptor (GLP-1R) agonist for the treatment of obesity (NCT07002905) in 125 participants with obesity or overweight with at least one weight-related comorbidity at multiple sites across the U.S. Three dose levels of ASC30 oral tablets were investigated (20 mg, 40 mg and 60 mg). At 13 weeks, all three doses of ASC30 met the primary end</description>
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<title>Ascletis Selects Its First Oral GLP-1R/GIPR/GCGR Triple Peptide Agonist, ASC37, for Clinical Development</title>
<link>https://6ix.com/company/ascletis-pharma-inc/news/ascletis-selects-its-first-oral-glp-1rgiprgcgr-triple-peptide-agonist-asc37-for-clinical-development</link>
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<pubDate>Sun, 30 Nov 2025 10:15:00 GMT</pubDate>
<description>Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces that it has selected ASC37 oral tablets, its first oral GLP-1R/GIPR/GCGR[1] triple peptide agonist, as a clinical development candidate. Ascletis expects to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for ASC37 oral tablets for the treatment of obesity in the second quarter of 2026.</description>
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<title>ObesityWeek 2025: Breakthrough Results Reshaping the Obesity Market Landscape | DelveInsight</title>
<link>https://6ix.com/company/ascletis-pharma-inc/news/obesityweek-2025-breakthrough-results-reshaping-the-obesity-market-landscape-or-delveinsight-1</link>
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<pubDate>Thu, 13 Nov 2025 22:31:00 GMT</pubDate>
<description>The annual conference presented over 100 scientific sessions featuring innovations from leading pharmaceutical companies, including Novo Nordisk, Eli Lilly and Company, Viking Therapeutics, Ascletis Pharma, Skye Bioscience, Palatin Technologies, Inc., Neurogastrx, Inc., OrsoBio, Metsera, and others, revealing not only significant advances in drug efficacy but also reshaping the multibillion-dollar obesity therapeutics market. These presentations collectively demonstrate that obesity management h</description>
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<title>Ascletis Announces Co-formulation of ASC36, Once-Monthly Next-Generation Amylin Receptor Agonist and ASC35, Once-Monthly Next-Generation GLP-1R/GIPR Dual Agonist for Clinical Development</title>
<link>https://6ix.com/company/ascletis-pharma-inc/news/ascletis-announces-co-formulation-of-asc36-once-monthly-next-generation-amylin-receptor-agonist-and-asc35-once-monthly-next-generation-glp-1rgipr-dual-agonist-for-clinical-development</link>
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<pubDate>Wed, 12 Nov 2025 23:30:00 GMT</pubDate>
<description>Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces the co-formulation of ASC36, a once-monthly next-generation amylin receptor agonist and ASC35, a once-monthly next-generation GLP-1R/GIPR dual agonist for clinical development. Ascletis expects to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for co-formulation of ASC36 and ASC35 for the treatment of obesity in the second quarter of 2026.</description>
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<title>Ascletis Presents Full Analysis of Phase Ib Study of ASC30 Oral Tablet, Phase Ib Study of ASC30 Injection, and Preclinical Study of Combination of ASC31 and ASC47 at ObesityWeek® 2025</title>
<link>https://6ix.com/company/ascletis-pharma-inc/news/ascletis-presents-full-analysis-of-phase-ib-study-of-asc30-oral-tablet-phase-ib-study-of-asc30-injection-and-preclinical-study-of-combination-of-asc31-and-asc47-at-obesityweekr-2025</link>
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<pubDate>Wed, 05 Nov 2025 00:10:00 GMT</pubDate>
<description>Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces multiple poster presentations of the full analysis of the Phase Ib study of ASC30 once-daily oral tablet, Phase Ib study of ASC30 once-monthly injection, and preclinical study of the combination of ASC31 and ASC47 at ObesityWeek® 2025 in Atlanta, Georgia.</description>
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<title>Ascletis Selects a Best-in-Class Once-Monthly Subcutaneously Administered Amylin Receptor Agonist, ASC36, for Clinical Development</title>
<link>https://6ix.com/company/ascletis-pharma-inc/news/ascletis-selects-a-best-in-class-once-monthly-subcutaneously-administered-amylin-receptor-agonist-asc36-for-clinical-development</link>
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<pubDate>Thu, 30 Oct 2025 00:10:00 GMT</pubDate>
<description>Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces that it has selected ASC36, a once-monthly, potentially best-in-class subcutaneously administered amylin receptor agonist, as a clinical development candidate. Ascletis expects to submit an Investigational New Drug Application (IND) for ASC36 for the treatment of obesity to the U.S. Food and Drug Administration (FDA) in the second quarter of 2026.</description>
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<title>Ascletis to Present Study Results of ASC30 Oral Tablet, ASC30 Injection, and Combination of ASC31 and ASC47 at ObesityWeek® 2025</title>
<link>https://6ix.com/company/ascletis-pharma-inc/news/ascletis-to-present-study-results-of-asc30-oral-tablet-asc30-injection-and-combination-of-asc31-and-asc47-at-obesityweekr-2025</link>
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<pubDate>Mon, 27 Oct 2025 10:00:00 GMT</pubDate>
<description>Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces multiple poster presentations of its obesity assets including ASC30, and combination of ASC31 and ASC47 at ObesityWeek® 2025 in Atlanta, Georgia.</description>
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<title>Ascletis Completes Enrollment in U.S. Phase IIa Study for Its Once-Monthly Subcutaneous Depot Treatment Formulation of Small Molecule GLP-1R Agonist ASC30 for Obesity</title>
<link>https://6ix.com/company/ascletis-pharma-inc/news/ascletis-completes-enrollment-in-us-phase-iia-study-for-its-once-monthly-subcutaneous-depot-treatment-formulation-of-small-molecule-glp-1r-agonist-asc30-for-obesity</link>
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<pubDate>Mon, 20 Oct 2025 00:10:00 GMT</pubDate>
<description>Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces the recent completion of enrollment in the U.S. Phase IIa study for its once-monthly subcutaneous (SQ) depot formulation (treatment formulation) of small molecule GLP-1 receptor (GLP-1R) agonist ASC30 for the treatment of obesity (NCT06679959). All 65 participants are obese or overweight with at least one weight-related comorbidity.</description>
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<title>Ascletis Completes Denifanstat (ASC40) Pre-NDA Consultation with China National Medical Products Administration</title>
<link>https://6ix.com/company/ascletis-pharma-inc/news/ascletis-completes-denifanstat-asc40-pre-nda-consultation-with-china-national-medical-products-administration</link>
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<pubDate>Tue, 14 Oct 2025 10:00:00 GMT</pubDate>
<description>Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that it recently completed the pre-New Drug Application (NDA) consultation with China National Medical Products Administration (NMPA) for denifanstat (ASC40) for the treatment of moderate-to-severe acne vulgaris and plans to submit an NDA soon. The pre-NDA consultation was initiated from June 2025 and completed in October 2025.</description>
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<title>Ascletis Selects a Best-In-Class Once-Monthly Subcutaneously Administered GLP-1R/GIPR Dual Peptide Agonist, ASC35, for Clinical Development</title>
<link>https://6ix.com/company/ascletis-pharma-inc/news/ascletis-selects-a-best-in-class-once-monthly-subcutaneously-administered-glp-1rgipr-dual-peptide-agonist-asc35-for-clinical-development</link>
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<pubDate>Mon, 13 Oct 2025 00:10:00 GMT</pubDate>
<description>Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces that it has selected ASC35, a once-monthly, potentially best-in-class subcutaneously administered GLP-1 receptor (GLP-1R)/GIP receptor (GIPR) dual peptide agonist, as a clinical development candidate. Ascletis expects to submit an Investigational New Drug Application (IND) for ASC35 for the treatment of obesity to the U.S. Food and Drug Administration (FDA) in the second quarter of 2026.</description>
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