Structure Therapeutics(GPCR)
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Structure Therapeutics Announces Initiation of Phase 1 Clinical Study of Oral Small Molecule Amylin Receptor Agonist ACCG-2671 for the Treatment of Obesity
Globenewswire· 2025-12-17 13:30
Core Viewpoint - Structure Therapeutics Inc. has initiated a first-in-human Phase 1 clinical study of ACCG-2671, an oral small molecule amylin receptor agonist aimed at treating obesity, marking a significant milestone in the company's development pipeline [1][3]. Company Overview - Structure Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative oral small molecule treatments for chronic metabolic conditions, particularly obesity, utilizing a next-generation structure-based drug discovery platform [7]. Product Development - ACCG-2671 is designed to leverage the metabolic benefits of amylin biology, offering a once-daily dosing regimen that enhances scalability, combinability, and patient access [1][2]. - The Phase 1 study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamic activity of ACCG-2671 in both healthy volunteers and individuals with obesity, including single-ascending and multiple-ascending dose cohorts [2]. Clinical Data and Pipeline - Preclinical data indicate that ACCG-2671 demonstrates potent target engagement and significant weight loss both as a monotherapy and in combination with GLP-1 receptor agonists, alongside a favorable safety and pharmacokinetics profile [2][4]. - The company is also advancing ACCG-3535, a second dual amylin and calcitonin receptor agonist (DACRA), and is developing selective amylin receptor agonists (SARAs) currently in preclinical stages [6]. Market Position - The company believes that amylin-based therapies will become a crucial next-generation component in the treatment landscape for obesity and related conditions, highlighting the potential of ACCG-2671 as a differentiated backbone therapy [2][3].
医药生物行业跟踪周报:全球最大单品GLP1,口服临床数据亮眼-20251214
Soochow Securities· 2025-12-14 15:19
Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology industry [1] Core Insights - The GLP-1 class of drugs has become a revolutionary therapy in the weight loss field, transitioning from an "adjunctive" role to a "core medication" status, significantly improving metabolic indicators while effectively reducing weight [19][20] - Multiple companies have disclosed promising weight loss data, with a focus on domestic companies such as Federated Pharmaceutical, Lepu Medical, and Greeley Pharmaceuticals [2][19] - The report highlights the potential of oral small molecule GLP-1 drugs, with significant clinical data from companies like Greeley Pharmaceuticals and Structure Therapeutics [21][22] Summary by Sections Investment Highlights - The report emphasizes the growth potential in the weight loss drug market, driven by drugs like Semaglutide and Tirzepatide, with notable clinical results from various companies [2][19] - The report suggests monitoring the development of domestic small nucleic acid drugs, which have shown promising results in reducing visceral fat and increasing lean body mass [2] Sub-industry Rankings - The report ranks sub-industries in the following order: Innovative Drugs > Research Services > CXO > Traditional Chinese Medicine > Medical Devices > Pharmacies [3][12] - Specific stock recommendations include Federated Pharmaceutical, Lepu Medical, and Greeley Pharmaceuticals from the GLP perspective, and companies like 3SBio, Kintor Pharmaceutical, and Innovent Biologics from the PD1/VEGF dual antibody perspective [3][15] Market Performance - The A-share pharmaceutical index has shown a year-to-date increase of 14.65%, while the Hang Seng Biotechnology Index has increased by 77.09% [11] - The report notes that the medical services sector has seen a price increase of 1.67%, while other sectors like chemical pharmaceuticals and medical devices have experienced declines [11] Clinical Development Updates - Greeley Pharmaceuticals' ASC30 achieved a 7.7% weight reduction in a 13-week study, while Structure Therapeutics' Aleniglipron showed a 15.3% reduction in a 36-week study [21][22] - The report highlights the competitive landscape of oral GLP-1 drugs, with Greeley's ASC30 demonstrating superior weight loss effects compared to Eli Lilly's Orforglipron [23]
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
Globenewswire· 2025-12-11 21:01
Core Viewpoint - Structure Therapeutics Inc. has successfully closed an upsized underwritten public offering, raising approximately $747.5 million to support its development of novel oral small molecule therapeutics for metabolic diseases, particularly obesity [1][2]. Group 1: Offering Details - The offering consisted of 9,961,538 American depositary shares (ADSs), with each ADS representing three ordinary shares, priced at $65.00 per ADS [1]. - The offering included the full exercise of the underwriters' option to purchase an additional 1,500,000 ADSs and pre-funded warrants to purchase 1,538,462 ADSs at a price of $64.9999 per warrant [1]. - The gross proceeds from the offering were approximately $747.5 million before deducting underwriting discounts and commissions [2]. Group 2: Underwriters and Management - Jefferies, Leerink Partners, Goldman Sachs & Co. LLC, Morgan Stanley, Guggenheim Securities, and BMO Capital Markets acted as joint book-running managers for the offering [2]. - LifeSci Capital and Citizens Capital Markets served as co-managers for the offering [2]. Group 3: Company Overview - Structure Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative oral small molecule treatments for chronic metabolic conditions with significant unmet medical needs [5]. - The company utilizes a next-generation structure-based drug discovery platform and has established a robust GPCR-targeted pipeline featuring multiple proprietary clinical-stage oral small molecule compounds [5]. - The aim is to surpass the scalability limitations of traditional biologic and peptide therapies, making treatments more accessible to individuals living with obesity globally [5].
美股异动 | 减肥药概念股走强 硕迪生物(GPCR.US)涨超5%
智通财经网· 2025-12-10 15:39
Group 1 - The core viewpoint of the article highlights the strong performance of U.S. weight loss drug stocks, with notable gains in companies such as Gelesis (GPCR.US), Novo Nordisk (NVO.US), Roche (RHHBY.US), and Eli Lilly (LLY.US) [1] - Gelesis reported positive top-line results for its oral small molecule GLP-1 receptor agonist, aleniglipron, in the ACCESS clinical trial [1]
速递|股价一夜大涨102%!硕迪生物公布小分子GLP-1减重2b期临床数据
GLP1减重宝典· 2025-12-10 14:14
Core Insights - Structure Therapeutics announced positive results from its oral GLP-1 receptor agonist aleniglipron in the ACCESS clinical trial, showing significant weight loss in overweight and obese adults with related complications [4][6] - The ACCESS II study demonstrated a maximum placebo-adjusted average weight loss of 15.3% with a 240mg dose, indicating the drug's tolerability aligns with GLP-1 class characteristics [6] - The company plans to engage with the FDA for a Type B meeting in the first half of next year to finalize the Phase III study protocol [6] Group 1: Clinical Trial Results - In the core IIb ACCESS study, participants receiving 120mg of aleniglipron achieved an average weight loss of 11.3% after 36 weeks, with a 10.4% rate of treatment discontinuation due to adverse events [4] - Among the 120mg group, 86% of participants lost at least 5% of their body weight, and 70% achieved over 10% weight loss [4] - The ACCESS open-label extension results indicated sustained weight loss up to 44 weeks, with improved tolerability when starting at a lower 2.5mg dose [6] Group 2: Safety and Tolerability - No drug-related liver injury, persistent liver enzyme elevation, or QTc prolongation was observed across all studies [6] - An exploratory study with a lower starting dose of 2.5mg showed improved tolerability without any treatment discontinuation due to adverse events during the initial dosing phase [6] Group 3: Future Plans and Market Potential - CEO Raymond Stevens highlighted that the latest results demonstrate aleniglipron's differentiated characteristics, offering clinically meaningful and competitive weight loss with safety suitable for chronic treatment [6] - The drug presents new treatment hope for millions of patients struggling with obesity and related complications [6]
Structure Therapeutics Announces Pricing of Upsized $650 Million Public Offering of ADSs and Pre-Funded Warrants
Globenewswire· 2025-12-10 04:15
Core Viewpoint - Structure Therapeutics Inc. has announced the pricing of its upsized public offering of American depositary shares (ADSs) aimed at raising approximately $650 million to support its development of novel oral small molecule therapeutics for metabolic diseases, particularly obesity [1][2]. Offering Details - The offering consists of 8,461,538 ADSs priced at $65.00 each and pre-funded warrants for 1,538,462 ADSs priced at $64.9999 each [1]. - The gross proceeds from the offering are expected to be around $650 million before deducting underwriting discounts and commissions [2]. - Structure Therapeutics has granted underwriters a 30-day option to purchase an additional 1,500,000 ADSs at the public offering price [2]. Underwriters - Jefferies, Leerink Partners, Goldman Sachs & Co. LLC, Morgan Stanley, Guggenheim Securities, and BMO Capital Markets are acting as joint book-running managers for the offering [3]. Regulatory Information - The offering is made under an automatic shelf registration statement on Form S-3 filed with the SEC on August 6, 2025, which became effective upon filing [4]. - A preliminary prospectus supplement and accompanying prospectus have been filed with the SEC and are available for free on the SEC's website [4]. Company Overview - Structure Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative oral small molecule treatments for chronic metabolic conditions with significant unmet medical needs [6]. - The company utilizes a next-generation structure-based drug discovery platform and has established a robust GPCR-targeted pipeline featuring multiple proprietary clinical-stage oral small molecule compounds [6].
Structure Therapeutics (GPCR) Hits 52-Week High on Weight Loss Treatment Trial
Yahoo Finance· 2025-12-09 19:23
Core Insights - Structure Therapeutics Inc. (NASDAQ:GPCR) achieved a new 52-week high following positive topline results from its clinical program for the obesity treatment candidate, aleniglipron [1][3] - The stock price surged to $94.90 during intra-day trading, ultimately closing at $69.98, reflecting a 102.49% increase [2] - Patients receiving a 120mg daily dose of aleniglipron experienced an 11.3% weight loss over 36 weeks, while those on a 240mg dose lost up to 15.3% [2] Clinical Trial Progress - Aleniglipron showed a tolerability profile consistent with GLP-1 receptor agonists and a favorable off-target safety profile [3] - Structure Therapeutics plans to advance to Phase 3 of the clinical trial by mid-2026, following discussions with the FDA in the first half of next year to finalize the trial design [4][5] - The Phase 3 trial is expected to start with a titration dose of 2.5 mg, evaluating multiple doses up to 240 mg [4] Strategic Outlook - The CEO of Structure Therapeutics, Raymond Stevens, emphasized the potential of aleniglipron to become a foundational oral therapy for obesity, highlighting its accessibility, scalability, and combinability [5]
GPCR Stock Soars 102% on Strong Phase II Obesity Data for Aleniglipron
ZACKS· 2025-12-09 15:30
Core Insights - Structure Therapeutics' shares surged 102.5% following positive top-line data from the ACCESS clinical program for aleniglipron, an investigational GLP-1 RA aimed at treating obesity and overweight patients with co-morbidities [1][3] - The 36-week phase IIb ACCESS study showed a placebo-adjusted mean weight reduction of 11.3% (27.3 lbs) at the highest 120 mg dose, meeting primary and secondary endpoints [3][4] - The ongoing ACCESS II study indicated even greater weight loss, with a 15.3% (35.5 lbs) reduction at the 240 mg dose, and sustained weight reduction observed through 44 weeks in the ACCESS OLE study [4][6] Company Developments - Structure Therapeutics plans to advance aleniglipron into phase III development, with a Type B end-of-phase 2 meeting with the FDA expected in the first half of 2026 [8][9] - The phase III study design will include a lower 2.5 mg starting dose and multiple dose levels up to 240 mg [9] - The company is also developing ANPA-0073, a phase II-ready APJR agonist for selective weight loss, alongside other obesity drug candidates in preclinical stages [10] Competitive Landscape - Eli Lilly and Novo Nordisk dominate the obesity treatment market, with their drugs Zepbound and Wegovy, respectively, experiencing stock declines following GPCR's positive results [12] - The U.S. obesity market is projected to reach $100 billion by 2030, prompting major players to optimize production and develop more effective GLP-1-based candidates [13] - Novo Nordisk is pursuing an oral version of Wegovy, while Eli Lilly is advancing several new molecules, including orforglipron and retatrutide, with regulatory applications expected soon [14][15]
Structure Therapeutics: Phase 2b Puts Aleniglipron In The Oral GLP-1 Top Tier (Rating Upgrade)
Seeking Alpha· 2025-12-09 13:30
Core Viewpoint - The article aims to provide informational content regarding investment opportunities and risks, emphasizing the importance of independent research and verification by readers [2][3]. Group 1: Company Analysis - The article does not provide specific details about any particular company or its financial performance, focusing instead on general investment advice [2][3]. Group 2: Industry Insights - There are no specific insights or analyses related to any industry mentioned in the article, as it primarily serves as a general informational piece [2][3].
Why Structure Therapeutics Stock Doubled and Then Some on Monday
The Motley Fool· 2025-12-09 00:55
Core Insights - Structure Therapeutics' investigational GLP-1 treatment, aleniglipron, showed promising results in a phase 2b study, leading to a significant stock price increase of nearly 103% on the announcement day [1][5]. Group 1: Study Results - The phase 2b study lasted 36 weeks and reported a placebo-adjusted average weight reduction of over 11% among participants [4]. - Approximately 10% of participants dropped out due to adverse events, but the overall tolerability of aleniglipron was comparable to other GLP-1 obesity treatments [4]. Group 2: Market Position and Competition - CEO Raymond Stevens highlighted that aleniglipron is differentiated and offers clinically meaningful, competitive, and dose-dependent weight loss with an appropriate safety profile for chronic use [7]. - The weight-loss drug market is becoming increasingly competitive, with existing products and ongoing developments from other biotech companies, such as Wave Life Sciences, which also reported positive clinical trial results on the same day [7][8]. Group 3: Company Overview - Structure Therapeutics has a market capitalization of $2 billion, with a current stock price of $69.98 following the announcement [5]. - The stock experienced a day's range between $44.74 and $94.90, indicating significant volatility and investor interest [5].