GPCR (Structure Therapeutics Inc.) PDUFA Date | FDA Catalyst & Approval Status

Jun 5, 2026

Structure Therapeutics Announces Publication in Nature Medicine Highlighting Phase 2b ACCESS Program of Aleniglipron for Obesity

Structure Therapeutics has announced a publication in Nature Medicine showcasing results from its Phase 2b ACCESS program for aleniglipron, a GLP-1 receptor agonist designed for obesity treatment. The study demonstrated dose-dependent and statistically significant weight loss reductions, with continued effectiveness noted beyond 36 weeks of treatment. The Phase 3 program is on track to begin in Q3 2026, aiming to expand the treatment options for patients with obesity. The safety profile aligns with known GI-related adverse effects typical of the GLP-1 class but showed favorable tolerability.

May 26, 2026

Structure Therapeutics Announces Participation in Upcoming Investor Conferences

Structure Therapeutics Inc. announced its participation in two healthcare conferences in June 2026. The company, which focuses on developing oral small molecule therapeutics for metabolic diseases, particularly obesity, will provide live and archived webcasts accessible through its website. This initiative highlights its commitment to engaging with investors and promoting its innovative pipeline.

May 7, 2026

Structure Therapeutics Reports First Quarter 2026 Financial Results and Recent Highlights Reported positive results from aleniglipron Phase 2 ACCESS II study with up to 16.3% body weight loss, demonstrating highest effic

Structure Therapeutics has reported positive financial results for the first quarter of 2026, highlighting successful outcomes from the aleniglipron Phase 2 ACCESS II study. The company is positioned to initiate Phase 3 clinical trials for aleniglipron, focusing on chronic weight management. Additionally, Structure Therapeutics maintains a robust cash reserve of $1.5 billion, which supports its operations through the end of 2028. Upcoming presentations at the American Diabetes Association meeting will further showcase aleniglipron and the company’s other metabolic disease candidates.

Apr 28, 2026

Structure Therapeutics to Present Aleniglipron, Amylin and Combination Data at the American Diabetes Association 86th Scientific Sessions

Structure Therapeutics will present multiple studies at the ADA 86th Scientific Sessions, focusing on aleniglipron, an oral GLP-1 receptor agonist. Key presentations include findings from the ACCESS Phase 2b trial, which highlights significant weight loss in obese patients. Additional studies will explore safety, tolerability, and combination treatments with amylin receptor agonists.

Apr 15, 2026

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

Structure Therapeutics has appointed Matthew Lang, J.D., as Chief Operating Officer and General Counsel. Lang brings over fifteen years of experience in biopharmaceutical leadership, having previously held significant roles at Metsera and Myovant Sciences. His expertise will be crucial as the company progresses aleniglipron into Phase 3 trials, aiming to address obesity with innovative therapies.

Structure Therapeutics Reports Positive Topline Data from Phase 2 ACCESS II Trial with Once-Daily Oral Small Molecule GLP-1 Receptor Agonist, Aleniglipron Placebo-adjusted mean weight loss of 16.3% (39 lbs) at 180 mg and

Structure Therapeutics announced positive topline results from the Phase 2 ACCESS II trial of aleniglipron, a small molecule GLP-1 receptor agonist. At 44 weeks, patients experienced a mean weight loss of 16.3% with the 180 mg dose. The drug exhibited a good safety profile, with low rates of adverse event-related discontinuations. The company is moving forward with plans for a Phase 3 trial, anticipated to begin in the second half of 2026, following an end-of-Phase 2 meeting with the FDA scheduled for the second quarter of 2026.

Feb 26, 2026

Structure Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Highlights Positive results from the aleniglipron Phase 2 ACCESS programs in December 2025 demonstrated significant weight los

Structure Therapeutics reported positive financial results for Q4 and full year 2025, highlighted by significant weight loss data from the aleniglipron Phase 2 ACCESS programs. The company maintains a strong cash position of $1.4 billion, allowing it to fund operations well into 2028. Anticipation builds for the initiation of Phase 3 trials for aleniglipron and upcoming data releases. Despite recent successes, the company also faces challenges, including increased R&D expenses and a substantial net loss for the year.

Dec 18, 2025

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

Structure Therapeutics has launched a Phase 1 clinical study for ACCG-2671, an oral amylin receptor agonist aimed at treating obesity. This study will assess the safety, tolerability, and pharmacokinetics of the drug in healthy volunteers and individuals with obesity. The company believes that amylin-based therapies could significantly enhance obesity treatment options.

Dec 11, 2025

Structure Therapeutics Announces Closing of Upsized $747.5 Million Public Offering of ADSs and Pre-Funded Warrants and Full Exercise of the Underwriters’ Option to Purchase Additional ADSs

Structure Therapeutics Inc. has announced the successful closing of its upsized public offering, raising approximately $747.5 million. The offering involved nearly 10 million American depositary shares (ADSs) and included the full exercise of underwriters' options for additional purchases. Financial institutions like Jefferies, Goldman Sachs, and Morgan Stanley played significant roles as managers of the offering. Funds raised will support the company's focus on developing innovative therapies for obesity and other metabolic conditions.

Dec 10, 2025

Structure Therapeutics Announces Pricing of Upsized $650 Million Public Offering of ADSs and Pre-Funded Warrants

Structure Therapeutics Inc. has announced the pricing of its upsized public offering of American depositary shares totaling approximately $650 million. The offering consists of 8,461,538 ADSs priced at $65.00 each and warrants at $64.9999. The offering aims to raise funds for the company’s ongoing development of oral small molecule therapeutics targeting metabolic diseases. This transaction is expected to close on December 11, 2025, pending customary closing conditions.

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

Structure Therapeutics Inc. plans to release topline data from its ACCESS clinical program for aleniglipron, an oral GLP-1 receptor agonist targeting obesity, on December 8, 2025. This announcement highlights the company's commitment to developing novel therapies for metabolic diseases. A conference call will follow the data release for further discussion.

Structure Therapeutics Reports Positive Topline

Structure Therapeutics reported encouraging topline data from its ACCESS program for aleniglipron, an oral GLP-1 receptor agonist aimed at treating obesity. In a 36-week Phase 2b study, a placebo-adjusted mean weight loss of 11.3% was achieved at the 120 mg dose, while up to 15.3% weight loss was observed with the 240 mg dose in exploratory studies. The company plans to advance aleniglipron into Phase 3 clinical development by mid-2026, emphasizing a strong tolerability profile and a positive safety record for an oral therapy. This development could enhance treatment options for obesity, a complex disease affecting many individuals.

Structure Therapeutics Announces Proposed $500 Million Public Offering of American Depositary Shares and Pre-Funded Warrants

Structure Therapeutics Inc. has announced a proposed underwritten public offering of $500 million of American depositary shares (ADSs) to support its clinical-stage portfolio. The offering includes a 30-day option for underwriters to purchase an additional $75 million in ADSs. The company is focused on developing innovative therapies for metabolic conditions, supported by its GPCR-targeted pipeline. However, the actual completion and terms of the offering remain uncertain due to market conditions and other factors.

Structure Therapeutics Reports Positive Topline Data from ACCESS Program for its Once-Daily Oral Small Molecule GLP-1 Receptor Agonist, Aleniglipron

Structure Therapeutics has reported positive topline results from their ACCESS program for aleniglipron, an oral GLP-1 receptor agonist aimed at obesity treatment. Notably, the Phase 2b study showed a placebo-adjusted weight loss of 11.3% with the 120 mg dose, and up to 15.3% with the 240 mg dose in the exploratory ACCESS II study, both at 36 weeks. The findings indicate potential for aleniglipron to serve as an effective treatment option, providing comprehensive data to justify moving into Phase 3 clinical development by mid-2026. Despite a reported treatment discontinuation rate due to adverse events, the drug exhibited an acceptable safety profile.

Nov 6, 2025

Structure Therapeutics Reports Third Quarter 2025 Financial Results and Recent Highlights

Structure Therapeutics reported its Q3 2025 financial results, highlighting a strong cash position of $799 million. The company is on track to release topline data from its aleniglipron studies by the end of 2025 and plans to initiate a Phase 1 study for ACCG-2671. However, the company also reported a net loss of $65.7 million for the quarter, reflecting increased R&D expenses.

Sep 2, 2025

Structure Therapeutics to Participate in Two Upcoming Healthcare Investor Conferences

Structure Therapeutics Inc. (NASDAQ: GPCR) will participate in two healthcare investor conferences in September 2025. The company is dedicated to developing novel oral small molecule therapeutics for metabolic diseases, particularly obesity. Webcasts of the events will be available on their website, ensuring accessibility for interested investors.

Aug 6, 2025

Structure Therapeutics Reports Second Quarter 2025 Financial Results and Recent Highlights Topline data from oral small molecule GLP-1 receptor agonist aleniglipron ACCESS and ACCESS II studies on track for year-end 2025

Structure Therapeutics has reported its second-quarter financial results for 2025, highlighting significant progress in its clinical studies for the oral small molecule GLP-1 receptor agonist aleniglipron. The company remains on track for topline data readouts from its ongoing ACCESS and ACCESS II studies by the end of 2025. Additionally, it has expanded its clinical development program and anticipates initiating a Phase 1 study for another candidate, ACCG-2671, by year-end 2025. Structure Therapeutics also maintains a strong cash position to support its operations and pipeline development.

Jun 20, 2025

Structure Therapeutics Announces Two Late-Breaking Poster Presentations at the American Diabetes Association 85th Scientific Sessions Including New Preclinical Data for Oral Small Molecule Amylin Agonist, ACCG-2671

Structure Therapeutics announced two late-breaking poster presentations at the ADA 85th Scientific Sessions, showcasing preclinical data for ACCG-2671, an oral small molecule amylin agonist. The data highlights its significant weight-loss effects and potential as a backbone treatment for obesity. Additionally, findings on a GLP-1 receptor agonist indicate neuroprotective benefits in a Parkinson's disease model.

May 29, 2025

Structure Therapeutics to Participate in Multiple Upcoming Healthcare Investor Conferences

Structure Therapeutics Inc. has announced its participation in several healthcare investor conferences in June 2025, including the Jefferies and Goldman Sachs conferences. The company's management will engage in fireside chats and one-on-one meetings to discuss their developments in oral small molecule therapeutics for metabolic diseases. The live webcasts will be available on their website, further enhancing accessibility for interested investors.

May 8, 2025

Structure Therapeutics Reports First Quarter 2025 Financial Results and Recent Highlights Topline data from oral small molecule aleniglipron (GSBR-1290) Phase 2b ACCESS and ACCESS II studies anticipated by year-end 2025

Structure Therapeutics has reported its Q1 2025 financial results, highlighting a solid cash position of $836.9 million. The company is advancing its oral small molecule therapeutics, with expected topline data from the Phase 2b ACCESS and ACCESS II studies for aleniglipron (GSBR-1290) by year-end 2025. Additionally, they plan to initiate a Phase 1 study for ACCG-2671, an oral small molecule amylin receptor agonist. However, the company reported a net loss of $46.8 million for the quarter, indicating challenges despite their optimistic outlook.

Structure Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Highlights Aleniglipron (GSBR-1290) ACCESS and ACCESS II studies fully enrolled; topline data from both studies anticipated by

Structure Therapeutics has reported its financial results for Q4 and full year 2024. The company has completed enrollment for its ACCESS and ACCESS II studies for aleniglipron, expecting topline data by the end of 2025. With a solid financial position of $883.5 million, Structure is geared for growth, including the expected initiation of a Phase 1 study for its oral amylin receptor agonist, ACCG-2671. However, the company also reported considerable net losses and rising R&D expenses.

Dec 17, 2024

Structure Therapeutics Announces Selection of Lead Oral Small Molecule Amylin Receptor Agonist ACCG-2671 for the Treatment of Obesity Preclinical studies with ACCG-2671 demonstrate potent target engagement, robust weight

Structure Therapeutics has selected ACCG-2671, an oral small molecule amylin receptor agonist, as its lead candidate for obesity treatment. The drug has shown promising preclinical results, demonstrating significant weight loss and a favorable safety profile. The company plans to initiate a Phase 1 clinical study by the end of 2025, with ACCG-2671 being positioned as a key component in next-generation obesity therapies. This development reflects Structure Therapeutics' commitment to innovative metabolic disease treatments using their GPCR-targeted drug discovery platform.

Nov 13, 2024

Structure Therapeutics Reports Third Quarter 2024 Financial Results and Recent Highlights First patients dosed in Phase 2b ACCESS study of GSBR-1290 for obesity Oral small molecule amylin receptor agonist development can

Structure Therapeutics, a clinical-stage biopharmaceutical company, reported its third quarter 2024 financial results, highlighting the start of patient dosing in the Phase 2b ACCESS study for GSBR-1290, an oral small molecule amylin receptor agonist aimed at treating obesity. The company reported a net loss of $34.0 million and a significant increase in R&D and G&A expenses compared to the previous year. Despite this, they maintain a strong cash position of $915.3 million, which is expected to support operations and key clinical milestones. The CEO expressed confidence in the company's future developments, with 2025 forecasted as a critical year.

Sep 17, 2024

Structure Therapeutics Strengthens Executive Team with Promotion of Blai Coll, M.D., Ph.D. to Chief Medical Officer and Appointment of Ashley Hall, J.D. as Chief Development Officer

Structure Therapeutics has promoted Blai Coll, M.D., Ph.D. to Chief Medical Officer and appointed Ashley Hall, J.D. as Chief Development Officer. These leadership changes aim to enhance the company's capability in advancing their metabolic and cardiopulmonary drug development. Dr. Coll, previously Vice President of Clinical Development, will lead the GSBR-1290 program into Phase 2b trials, while Hall will oversee various critical development operations. The company is gearing up for a significant expansion in its clinical initiatives.

Aug 8, 2024

Structure Therapeutics Reports Second Quarter 2024 Financial Results and Recent Highlights GSBR-1290 Phase 2b study in obesity on track to initiate in the fourth quarter 2024 Oral small molecule amylin receptor agonist d

Structure Therapeutics reported its financial results for the second quarter of 2024, highlighting a robust cash position of $927.1 million. The company is on track to initiate the Phase 2b study for GSBR-1290, an oral small molecule for obesity, by the end of 2024. In addition, they expect to announce a development candidate for their amylin receptor agonist program in the same quarter. However, the company saw an increase in net loss and R&D expenses compared to the previous year.

Structure Therapeutics Reports Positive Topline Data from its Phase 2a Obesity Study and Capsule to Tablet PK Study for its Oral Non-Peptide Small Molecule GLP-1 Receptor Agonist GSBR-1290 GSBR-1290 achieved a clinically

Structure Therapeutics has reported positive topline data from its Phase 2a study of GSBR-1290, a GLP-1 receptor agonist, demonstrating a significant placebo-adjusted mean weight loss of 6.2%. Additionally, the capsule to tablet pharmacokinetic study yielded favorable results regarding the drug's safety and tolerability. The company aims to initiate a Phase 2b study in the fourth quarter of 2024, expanding its exploration of GSBR-1290's potential for treating obesity. CEO Raymond Stevens emphasized the drug's promising role as a competitive treatment option in obesity management.

As of the date of this Current Report, Structure Therapeutics Inc. (the "Company") updates and supplements the risk factors disclosed in its Annual Report on Form 10-K for the fiscal year ended

Structure Therapeutics Inc. has updated its risk factors in a Current Report, referencing its Annual Report for FY 2023 and Quarterly Report for Q1 2024. The company indicated that clinical and preclinical drug development poses significant uncertainties and risks, including the potential impact of a shortage of non-human primates on their research. Despite some positive interim data for their drug GSBR-1290, challenges related to timelines and regulatory approvals persist, making future success uncertain. The company plans to submit an IND for GSBR-1290's Phase 2b study in the third quarter of 2024.

May 9, 2024

Structure Therapeutics Reports First Quarter 2024 Financial Results and Recent Highlights Topline GSBR-1290 Phase 2a 12-week obesity data on track for June 2024 Phase 2b study in obesity expected to begin as planned in t

Structure Therapeutics Inc. reported its financial results for Q1 2024, highlighting promising developments in its obesity and pulmonary fibrosis pipelines. The company expects to deliver topline data from its Phase 2a study of GSBR-1290 in June 2024 and to initiate its Phase 2b obesity study later in the year. With a robust cash position of $436.4 million, the company believes it is well-equipped to sustain its operations through 2026, despite incurring a net loss in the first quarter. Investments in research and administrative expenses have increased compared to the prior year as the company expands its capabilities as a publicly traded entity.

Mar 8, 2024

Structure Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Highlights Topline GSBR-1290 Phase 2a 12-week obesity data, as well as data from formulation bridging and titration optimizati

Structure Therapeutics has announced its financial results for Q4 and full year 2023, showing a strong cash position of $467.3 million to fund future operations through 2026. The company highlighted positive topline Phase 2a obesity data for its lead candidate GSBR-1290, showcasing proof-of-concept for the treatment. Despite reporting a net loss of $24.5 million for the quarter, Structure is well-positioned for further clinical trials, with a Phase 2b study expected to begin in Q4 2024.

Structure Therapeutics Provides Comprehensive GSBR-1290 Program Update Including Clinically Meaningful Proof-of-Concept Data From Phase 2a Clinical Study GSBR-1290 was generally well-tolerated with no treatment-related s

Structure Therapeutics provided an update on its GSBR-1290 program, showcasing clinically meaningful proof-of-concept data from Phase 2a studies. In patients with type 2 diabetes mellitus (T2DM), the drug demonstrated significant reductions in hemoglobin A1c and was well-tolerated with no serious adverse events reported. In the obesity cohort, initial data indicated notable weight loss, with full results expected in mid-2024. The company plans to initiate a Phase 2b study later in 2024, further emphasizing the potential of GSBR-1290 in treating metabolic disorders.

Nov 14, 2023

Structure Therapeutics Reports Third Quarter 2023 Financial Results and Recent Highlights Announced positive results from Phase 1b clinical study of oral GLP-1 receptor agonist, GSBR-1290, demonstrating significant weigh

Structure Therapeutics reported its financial results for the third quarter of 2023, highlighting positive Phase 1b clinical study results for its oral GLP-1 receptor agonist GSBR-1290, which demonstrated significant weight loss and an encouraging safety profile. The company successfully completed a $300 million financing that is expected to support its operations through 2026. Upcoming milestones include the expected topline results from the Phase 2a trials focused on diabetes and obesity, planned for late 2023 and early 2024. However, the company also reported a net loss of $23.9 million for the quarter, attributed primarily to increased R&D spending.

SHARE PURCHASE AGREEMENT This Share Purchase Agreement (this " Agreement ") is dated as of

On September 29, 2023, Structure Therapeutics, Inc. entered into a Share Purchase Agreement to sell Ordinary Shares and/or Non-Voting Ordinary Shares. The agreement involves an aggregate purchase price of at least $100,000,000, with conditions pertaining to the sale and purchase outlined within the document. The buyers include various Purchasers identified in the agreement, and the transaction is structured under Regulation D exemption of the Securities Act.

Structure Therapeutics Announces Positive Results from Phase 1b Clinical Study of Oral GLP-1 Receptor Agonist GSBR-1290 and Provides Program Update GSBR-1290 shown to be generally well-tolerated with no adverse event-rel

Structure Therapeutics announced positive results from its Phase 1b clinical study of the oral GLP-1 receptor agonist GSBR-1290, showing significant weight loss and a favorable safety profile with no dropouts due to adverse events. The study involved 24 participants and demonstrated a maximum weight reduction of 4.9 kg. Although there was a data collection issue for the obesity cohort in Phase 2a, topline data for type 2 diabetes is still on track for the fourth quarter of 2023, and plans for Phase 2b studies are set for 2024.

Aug 10, 2023

Structure Therapeutics Reports Second Quarter 2023 Financial Results and Recent Highlights Completed enrollment in 12-week Phase 2a study of oral GLP-1 receptor agonist, GSBR-1290 Topline data from Phase 2a and Phase 1b

Structure Therapeutics reported its second quarter financial results, highlighted successful enrollment in a 12-week Phase 2a study of GSBR-1290, an oral GLP-1 receptor agonist aimed at treating Type 2 diabetes and obesity. The company expects to release topline data from this study in the latter half of fourth quarter 2023. Financially, Structure Therapeutics maintains a robust cash position of $224.6 million, sufficient to support operations into 2025, despite a net loss of $23.3 million for the quarter due to increased research and administrative expenditures.

May 11, 2023

Structure Therapeutics Reports First Quarter 2023 Financial Results and Recent Highlights Oral GLP-1 agonist GSBR-1290 advancing into Phase 2a study in type 2 diabetes and obesity Topline data from Phase 1b multiple asce

Structure Therapeutics (GPCR) reported its financial results for Q1 2023, highlighting the advancement of its oral GLP-1 agonist GSBR-1290 into a Phase 2a study targeting type 2 diabetes and obesity. The company anticipates topline data from several studies in the second half of 2023. While their financial position remains strong with significant cash reserves, they also reported a substantial net loss and an increase in research and development expenses compared to the previous year.

Mar 30, 2023