GPCR 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-06

• Data from the ACCESS clinical program supported and informed the advancement of aleniglipron into Phase 3 development. The Company received positive end-of-Phase 2 correspondence from the U.S. Food and Drug Administration (“FDA”) and clear guidance on the Phase 3 program.

• In August 2026, we initiated the Phase 3 ACCOMPLISH program, which includes two clinical trials evaluating aleniglipron. ACCOMPLISH-1 will evaluate aleniglipron in adults living with obesity or overweight with a weight-related comorbidity and will enroll up to 3,600 patients. ACCOMPLISH-2 will evalu…

• ACCOMPLISH-1 and ACCOMPLISH-2 are randomized, double-blind, placebo-controlled trials designed to evaluate the long-term efficacy and safety of three maintenance doses of aleniglipron. Participants in the clinicla trials will be randomized to one of four treatment arms to evaluate three doses (45 mg…

• In addition, we are conducting an ongoing 30-week trial to evaluate the potential to include patients with T2DM with obesity/overweight and a starting dose of 2.5 mg and target dose of 180 mg of aleniglipron. We anticipate data from the T2DM trial in the fourth quarter of 2026.

• We are also conducting an ongoing SWITCH trial to assess the transition or switching from an approved injectable GLP-1 receptor agonist to once-daily oral aleniglipron for weight loss maintenance. This trial assesses different aleniglipron starting doses and weight loss maintenance over 12 weeks. We…

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• We believe that the data from the ACCESS clinical program supports and informs the advancement to Phase 3. The Company received positive end-of-Phase 2 correspondence from the U.S. Food and Drug Administration (the “FDA”) and clear guidance on the Phase 3 program. Accordingly, we are on track to ini…

• In addition, we are conducting an ongoing 30-week study to evaluate the potential to include patients with type 2 diabetes mellitus (“T2DM”) with obesity/overweight and a starting dose of 2.5 mg and target dose of 180 mg of aleniglipron. We anticipate data from the T2DM study in the fourth quarter o…

• We are also conducting an ongoing SWITCH study to assess the transition or switching from an approved injectable GLP-1 receptor agonist to once-daily oral aleniglipron for weight loss maintenance. This study assesses different aleniglipron starting doses and weight loss maintenance over 12 weeks. We…

• loss compared to semaglutide or ACCG-3535 monotherapy. We expect to initiate a Phase 1 study for ACCG-3535 in the fourth quarter of 2026.

• Beyond our GLP-1R and amylin receptor programs, we are developing next generation oral incretins for potential combination therapy with GLP-1R or amylin candidates. These include small molecule candidates targeting glucose-dependent insulinotropic polypeptide receptor (“GIPR”) and GCG receptor (“GCG…

相对上期新增的文字 · 来源:10-Q · 2026-08-06

• Clinical trials may not be conducted as planned or completed on schedule, if at all.

• Any inability to successfully complete preclinical and clinical development could result in additional costs to us or impair our ability to generate revenue from future product sales and regulatory and commercialization milestones. In addition, if we make manufacturing or formulation changes to our …

• candidates, we cannot guarantee that we will not encounter delays or unexpected results in bridging trials or implementing necessary changes to the manufacturing process. Clinical trial delays could also shorten any periods during which we may have the exclusive right to commercialize our product ca…

• Moreover, if any of our product candidates are associated with undesirable side effects in clinical trials or have characteristics that are unexpected, we may elect to abandon their development or limit their development to more narrow uses or subpopulations in which the undesirable side effects or …

• We are early in our development efforts for our product candidates, and we will need to successfully complete pivotal clinical trials in order to seek FDA or applicable foreign authority approval to market aleniglipron, ACCG-2671, ACCG-3535, LTSE-2578 and any future product candidates we may develop…

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• Clinical studies may not be conducted as planned or completed on schedule, if at all. For example, in September 2023, we reported that a data collection omission had occurred at a clinical site that impacted the obesity cohort (120 mg dose level) of the Phase 2a study for aleniglipron, where weight …

• Any inability to successfully complete preclinical and clinical development could result in additional costs to us or impair our ability to generate revenue from future product sales and regulatory and commercialization

• milestones. In addition, if we make manufacturing or formulation changes to our product candidates, we may need to conduct additional testing to bridge our modified product candidate to earlier versions. For example, to facilitate potential commercial-scale manufacturing, we expect to transition fro…

• harmed and our ability to generate revenue through their sale may be delayed or eliminated. Any of these occurrences may harm our business, financial condition and prospects significantly.

• We are early in our development efforts for our product candidates, and we will need to successfully complete pivotal clinical studies in order to seek FDA or applicable foreign authority approval to market aleniglipron, ACCG-2671, LTSE-2578, ACCG-3535 and any future product candidates we may develo…

相对上期删除的文字 · 来源:10-Q · 2026-05-07

• (1)Contract, instruction or written plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act.

• (2)“Non-Rule 10b5-1 trading arrangement” as defined in Item 408(c) of Regulation S-K under the Exchange Act.

• (3)The plan provides for the sale of an aggregate of up to approximately the number of ADSs that have vested or may vest for each officer during the plan period, net of any ADSs the Company withholds to satisfy income tax withholding and remittance obligations in connection with the net settlement o…