Aankondiging • Sep 08

Structure Therapeutics Reports Positive Clinical Data Across Oral Small Molecule Amylin And GLP-1 Programs For Chronic Weight Management

Structure Therapeutics reported positive clinical trial results from its two lead product candidates: ACCG-2671, an oral, non-peptide, small molecule dual amylin and calcitonin receptor agonist (DACRA), and aleniglipron, an oral, non-peptide, small molecule glucagon-like peptide-1 (GLP-1) receptor agonist. Structure announced positive topline data for ACCG-2671 in a Phase 1/2a single ascending dose (SAD) trial in healthy participants without obesity. In the SAD trial, ACCG-2671 demonstrated a long half-life of approximately 6 days supporting potential once-weekly dosing, with no serious adverse events (SAEs) or events of liver enzyme elevations. Exploratory findings showed pharmacodynamic (PD) activity and evidence of target engagement, including a 3.3% mean reduction in body weight following a single dose, as well as an encouraging decrease in CTX-1, a biomarker of bone resorption relevant to bone health. Based on these encouraging findings, the Company has initiated the multiple ascending dose (MAD) portion of the Phase 1/2a clinical trial with topline data expected in the first half of 2027. Structure also reported positive 72-week results for aleniglipron in the ACCESS open-label extension (OLE) clinical trial. Participants receiving the 180 mg dose of aleniglipron achieved up to 16.2% body weight loss at 72 weeks, with no evidence of a plateau in weight loss. Compared with ACCESS participants who previously initiated dosing with a 5 mg starting dose, placebo participants who crossed over to aleniglipron in the OLE started with a lower 2.5 mg dose and demonstrated improved tolerability. Across all dose groups, fewer than 5% of participants discontinued treatment due to adverse events, and no off-target safety signals were observed. These results reinforce aleniglipron’s previously observed clinical profile, with consistent, potentially best-in-class weight loss and favorable tolerability, further supporting the ongoing Phase 3 ACCOMPLISH program which initiated in August 2026. The SAD portion of the Phase 1/2a clinical trial evaluated the safety, tolerability, pharmacokinetics (PK) and exploratory PD effects of ACCG-2671 in 31 healthy adult participants without obesity. A wide range of doses were explored in this first-in-human study to inform the appropriate starting dose and titration regimen for the MAD study. Participants received a single dose of 1, 2, 5, or 10 mg of ACCG-2671 or placebo. ACCG-2671 demonstrated a favorable plasma PK profile showing rapid absorption with Tmax at 1 – 1.5 hours. Exposure was consistent with dose proportionality, and the terminal half-life was approximately 6 days supporting further evaluation of daily and weekly dosing. ACCG-2671 was generally well tolerated with a favorable safety profile. There were no SAEs, no drug related treatment-emergent adverse events (TEAEs) leading to treatment discontinuation, and no events of drug-induced liver injury. No nausea or vomiting was reported in the placebo, 1 mg or 2 mg dose cohorts. Dose-related gastrointestinal events emerged at 5mg, with nausea (4/5 participants) and vomiting (3/5 participants), and at 10 mg (6/6 participants). These findings informed the starting doses and gradual titration strategies currently being evaluated in the ongoing MAD clinical trial. Exploratory findings with a single dose of ACCG-2671 indicated encouraging and early PD activity. A single 10 mg dose (n=6) was associated with mean body weight reductions of 3.3% at Day 24. CTX-1, a well-recognized biomarker of bone resorption, decreased by approximately 60% on Day 2 across the active dose cohorts. Together, these findings provide evidence of target engagement and support further evaluation of ACCG-2671 as a potential monotherapy as well as part of combination regimens. Structure has begun dosing in the MAD portion of the ongoing Phase 1/2a study of ACCG-2671. The randomized, placebo-controlled MAD portion will evaluate the safety, tolerability and PK of multiple ascending oral doses of ACCG-2671 administered for 84 days across five cohorts of participants living with obesity. The clinical trial will evaluate different doses and titration regimens, dosing frequencies, with daily and weekly dosing regimens, and includes a cohort of participants receiving a stable dose of an injectable GLP-1 receptor agonist, providing an initial assessment of ACCG-2671 when administered in combination with a GLP-1 receptor agonist. The encouraging SAD results observed to date, together with the data from the ongoing MAD clinical trial, could further establish ACCG-2671’s potential as a differentiated and valuable treatment option, both as monotherapy and combination therapy with GLP-1 receptor agonists. Topline data for the MAD portion of the Phase 1/2a clinical trial are expected in the first half of 2027. The ACCESS OLE clinical trial is a prespecified 36-week extension of the Phase 2b ACCESS clinical trial (NCT06693843) designed to evaluate the longer-term safety and tolerability of aleniglipron and the durability of weight loss through 72 weeks of treatment. 87% of eligible participants who completed the initial 36-week double-blind treatment period in ACCESS entered the OLE. Participants continued once-daily treatment in the OLE trial, with doses titrated every four weeks, while participants originally assigned to placebo crossed over to aleniglipron at Week 36 starting with a lower 2.5 mg dose. The OLE also evaluated whether the lower starting dose improved gastrointestinal tolerability. Since participants were titrated to the highest dose of 180 mg after Week 60, this resulted in relatively limited exposure to the 180 mg dose by Week 72. Most participants enrolled in the OLE portion of the study completed the 72 weeks on treatment. Building on previously reported interim results from the ACCESS OLE at 56 weeks in March 2026, aleniglipron demonstrated continued weight reduction at 72 weeks. Participants originally randomized to the 45 mg, 90 mg and 120 mg arms in the ACCESS trial who continued into the OLE and dosed up to 180 mg, achieved weight loss of 11.6%, 14.4% and 16.2%, respectively, with no evidence of weight loss plateau in the two top doses. More than one-third of participants in the highest dose cohorts, 90 mg and 120 mg, achieved more than 20% body weight reduction, with mean absolute body weight loss of 35.9 and 40.5 pounds, respectively. Participants, who were originally assigned to placebo in the ACCESS clinical trial and crossed over into the OLE at week 36, started with a 2.5 mg dose of aleniglipron, titrated every four weeks and achieved weight loss of 9.0%, or 22.7 pounds, after 36 weeks of treatment. Aleniglipron’s safety and tolerability profile remained consistent through 72 weeks.

Aankondiging • Dec 09

+ 1 more update

Structure Therapeutics Inc. to Report Data from ACCESS Clinical Program of Oral Small Molecule GLP-1 Receptor Agonist, Aleniglipron, on December 8, 2025

Structure Therapeutics Inc. announced positive topline data from the ACCESS clinical program of aleniglipron for the treatment of people living with obesity and/or overweight with at least one weight related co-morbidity. This includes 36-week data from the core Phase 2b ACCESS study and the ongoing exploratory ACCESS II study, and interim data from the ongoing Body Composition study and the ACCESS open label extension (OLE) study. Aleniglipron is an investigational orally-available, once-daily, nonpeptide small molecule agonist of the glucagon-like-peptide-1 (GLP-1) receptor designed to address patient needs and accessibility. In the core Phase 2b ACCESS study, aleniglipron achieved a clinically meaningful and statistically significant placebo-adjusted mean weight loss of 11.3% (27.3 lbs, p<0.0001) at the 120 mg dose at 36 weeks and across all active arms had a 10.4% adverse event (AE)-related treatment discontinuation rate. In the exploratory ACCESS II study, aleniglipron achieved a placebo-adjusted mean weight loss up to 15.3% (35.5 lbs, p<0.0001) with 240 mg dose at 36 weeks. Aleniglipron demonstrated a tolerability profile consistent with the GLP-1 receptor agonist class, and a compelling off-target safety profile. Together, these positive findings support the advancement of aleniglipron into Phase 3 clinical development. The core 36-week Phase 2b ACCESS study was a randomized, double-blind, placebo-controlled, Phase 2b dose-range finding clinical study that enrolled 230 adult participants living with obesity (body mass index (BMI) = 30 kg/m2), or overweight (BMI = 27 kg/m2) with at least one weight-related comorbidity. All participants were randomized 3:1 (active:placebo) and started at 5 mg of aleniglipron (or placebo) with a 4-week titration schedule, reaching target doses of 45 mg, 90 mg or 120 mg once-daily. Each of the three doses in the ACCESS study achieved statistical significance on the primary endpoint and all key secondary endpoints. At Week 36, key secondary endpoints in the study show that 86% of participants in the aleniglipron 120 mg dose cohort achieved at least 5% weight loss and 70% achieved at least 10% weight loss. In addition, aleniglipron demonstrated clinically meaningful improvements in systolic blood pressure (-6.4 to -7.5 mmHg) and HbA1c (-0.28% to -0.37%). Aleniglipron demonstrated a tolerability profile consistent with the GLP-1 receptor agonist class following repeated, once-daily dosing of up to 120 mg in the Phase 2b ACCESS study. As expected for the GLP1-RA drug class, the most common AEs were gastrointestinal (GI)-related and the two most common AEs in the titration phase were nausea and vomiting. AEs were generally observed early in treatment. In the Phase 2b ACCESS study, the AE-related treatment discontinuation rate ranged from 7.7% - 13.3% between all doses, with a mean 10.4% across all active arms in the study. ACCESS II is a randomized, double-blind, placebo-controlled, clinical study of aleniglipron that enrolled 85 adult participants living with obesity, or overweight with at least one weight-related comorbidity. The study was designed to evaluate two higher doses of aleniglipron. Participants started at 5 mg of aleniglipron (or placebo) and followed a 4-week titration schedule up to target doses of 120 mg, 180 mg and 240 mg. The 44-week study remains ongoing, with data from a prespecified 36-week analysis currently available. At 36 weeks, each of the three dose cohorts in the ACCESS II study met statistical significance compared to placebo. Aleniglipron demonstrated a tolerability profile consistent with the GLP-1 receptor agonist class following repeated, once- daily dosing of up to 240 mg. As expected for the GLP1-RA drug class, the most common AEs were GI-related and the two most common AEs in the titration phase were nausea and vomiting. AEs were generally observed early in treatment. Body Composition Study - Evaluating lower 2.5 mg starting dose Structure Therapeutics is currently conducting a randomized, placebo-controlled body composition study that enrolled 71 adult participants to assess the effect of aleniglipron (up to 120 mg) on body fat loss over a 40-week evaluation period. Participants in the aleniglipron treatment arm start at a 2.5 mg dose, and titrate up monthly to a target dose of 120 mg. Data from a pre-specified interim analysis after a median follow-up time of approximately 10 weeks showed that starting at a lower dose of 2.5 mg for the first four weeks meaningfully improved tolerability compared to what was observed at a starting titration dose of 5 mg in the ACCESS and ACCESS II studies, with no AE-related treatment discontinuations observed at the initial 2.5 mg dose or the subsequent 5 mg dose. ACCESS Open-Label Extension Study - Following randomized 36-week period, evaluating lower 2.5mg starting dose Following the 36-week randomized controlled portion of the Phase 2b ACCESS study, the majority of eligible ACCESS participants enrolled in ACCESS OLE. An initial analysis from the ongoing OLE demonstrates continuing weight loss in all dose cohorts out to 44 weeks, showing no evidence of weight loss plateau. In the ACCESS OLE, participants who received placebo in the initial double-blind portion transitioned to aleniglipron at a starting dose of 2.5 mg and titrate monthly to a target dose of 120 mg. Initial data from this group of participants after eight weeks of treatment are consistent with the findings from the body composition study, showing that starting at a 2.5 mg titration dose meaningfully improved tolerability compared to what was observed in the starting 5 mg titration dose in ACCESS and ACCESS II studies, with no AE-related treatment discontinuations at the initial 2.5 mg or the subsequent 5 mg dose. Aleniglipron Safety Aleniglipron demonstrated a compelling safety profile across all studies. Importantly, there were no cases of drug-induced liver injury, no persistent liver enzyme elevations, and no QTc prolongation across all aleniglipron studies. Phase 3 Preparation Data from ACCESS, ACCESS II, body composition, and the ACCESS OLE studies provide a strong foundation to advance aleniglipron into Phase 3 clinical development. The Company plans to request a Type B End-of-Phase 2 meeting with the United States Food and Drug Administration (FDA) in the first half of 2026 to finalize the Phase 3 design, which is currently designed with a starting titration dose of 2.5 mg with the intent to evaluate multiple doses up to 240 mg. Structure Therapeutics anticipates initiating the Phase 3 program by mid-2026.

Pharmaceuticals Groei van de industrie	5.95%
Inkomstengroei	n/a
Rendement op eigen vermogen	-15.86%
Nettomarge	n/a
Laatste winstupdate	30 Jun 2026

Datum	Inkomsten	G+A Uitgaven	R&D-uitgaven
30 Jun 26	-215	74	294
31 Mar 26	-170	71	249
31 Dec 25	-141	62	225
30 Sep 25	-211	58	190
30 Jun 25	-179	56	164
31 Mar 25	-143	52	131
31 Dec 24	-123	49	109
30 Sep 24	-111	47	95
30 Jun 24	-100	42	80
31 Mar 24	-98	37	78
31 Dec 23	-90	33	70
30 Sep 23	-77	26	58
30 Jun 23	-66	21	50
31 Mar 23	-58	18	41
31 Dec 22	-53	16	36
30 Sep 22	-56	15	38
31 Dec 21	-44	9	29

Gegevens	Laatst bijgewerkt (UTC-tijd)
Bedrijfsanalyse	2026/09/12 06:05
Aandelenkoers aan het einde van de dag	2026/09/11 00:00
Inkomsten	2026/06/30
Jaarlijkse inkomsten	2025/12/31

Pakket	Gegevens	Tijdframe	Voorbeeld Amerikaanse bron ^*
Financiële gegevens bedrijf	10 jaar	Resultatenrekening Kasstroomoverzicht Balans	SEC-formulier 10-K SEC-formulier 10-Q
Consensus schattingen analisten	+3 jaar	Financiële prognoses Koersdoelen analisten	Onderzoeksrapporten van analisten Blue Matrix
Marktprijzen	30 jaar	Aandelenprijzen Dividenden, splitsingen en acties	ICE Marktgegevens SEC-formulier S-1
Eigendom	10 jaar	Top aandeelhouders Handel met voorkennis	SEC-formulier 4 SEC-formulier 13D
Beheer	10 jaar	Leiderschapsteam Raad van bestuur	SEC-formulier 10-K SEC-formulier DEF 14A
Belangrijkste ontwikkelingen	10 jaar	Bedrijfsaankondigingen	SEC-formulier 8-K

Analist	Instelling
Evan Seigerman	BMO Capital Markets Equity Research
Edward Nash	Canaccord Genuity
Prakhar Agrawal	Cantor Fitzgerald & Co.

Structure Therapeutics Inkomsten in het verleden

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Recente prestatie-updates uit het verleden

Recent updates

Structure Therapeutics: The Amylin Data Changes The Math

Structure Therapeutics Reports Up to 16.2% Weight Loss in Aleniglipron Clinical Trials

Structure Therapeutics Reports Positive Clinical Data Across Oral Small Molecule Amylin And GLP-1 Programs For Chronic Weight Management

Insider exercised options and sold US$279k worth of stock

Insufficient new directors

Structure Therapeutics Inc. Announces Appointment of John Berrios as Chief Commercial Officer

Structure Therapeutics Begins Phase 3 Aleniglipron Trial and Names New Commercial Chief

Insider recently sold US$402k worth of stock

Structure Therapeutics Price Target Lowered as Phase 3 Planning and Leadership Shift Draw Focus

Structure Therapeutics Advances Aleniglipron With Positive Phase 2b Obesity Results and Phase 3 Plans

Structure Therapeutics Announces Publication In Nature Medicine Highlighting Phase 2b ACCESS Program Of Aleniglipron For Obesity

Structure Therapeutics Inc., Annual General Meeting, Jun 17, 2026

Structure Therapeutics Inc. Appoints Matthew Lang, J.D. as Chief Operating Officer and General Counsel

Structure Therapeutics Inc Reports Positive Topline Data From Phase 2 ACCESS II Trial With Once-Daily Oral Small Molecule GLP-1 Receptor Agonist Aleniglipron

Structure Therapeutics Inc. Announces Initiation of Phase 1 Clinical Study of Oral Small Molecule Amylin Receptor Agonist ACCG-2671 for the Treatment of Obesity

Structure Therapeutics Inc. has completed a Follow-on Equity Offering in the amount of $649.999846 million.

Structure Therapeutics Inc. to Report Data from ACCESS Clinical Program of Oral Small Molecule GLP-1 Receptor Agonist, Aleniglipron, on December 8, 2025

Structure Therapeutics Inc. has filed a Follow-on Equity Offering in the amount of $250 million.

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Structure Therapeutics Announces First Patients Dosed in Phase 2B ACCESS Clinical Study Evaluating Oral Small Molecule GLP-1 Receptor Agonist, GSBR-1290, for Obesity

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We're Hopeful That Structure Therapeutics (NASDAQ:GPCR) Will Use Its Cash Wisely

Structure Therapeutics: Yet Another Potential GLP-1 Entrant

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Price target decreased by 7.0% to US$76.89

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Price target decreased by 7.3% to US$82.67

High number of new directors

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High number of new directors

Structure Therapeutics Inc. Appoints Ted W. Love, M.D., to Board of Directors

No longer forecast to breakeven

Structure Therapeutics (NASDAQ:GPCR) Is In A Good Position To Deliver On Growth Plans

Forecast to breakeven in 2025

High number of new directors

Structure Therapeutics Inc. has completed an IPO in the amount of $161.1 million.

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