Kailera, Hengrui's GLP-1/GIP candidate delivers weight, menstrual benefits to women with PMOS. October 2, 2026 | Kailera Therapeutics and Hengrui Pharma's weekly injection showed benefits beyond weight loss in a mid-stage trial, leading to more regular menstrual cycles in patients with polyendocrine metabolic ovarian syndrome. Kailera Therapeutics and Hengrui Pharma's investigational GLP-1/GIP dual receptor agonist helped women with polyendocrine metabolic ovarian syndrome lose up to 20.2% of their weight in a mid-stage study, while also increasing the frequency of menstrual cycles. The Phase 2 performance of the asset, a weekly injectable called ribupatide, was "compelling, with supportive menstrual effects," analysts at Leerink Partners wrote on Thursday. "These findings provide early support for activity beyond weight loss." The mid-stage study, conducted in China, involved 158 women aged 18 to 40 years who were diagnosed with polyendocrine metabolic ovarian syndrome (PMOS) and who had obesity or overweight. Patients were randomly assigned to receive 1 mg, 2 mg or 4 mg ribupatide or placebo. The primary outcome was weight loss at 32 weeks. Higher doses of ribupatide led to greater weight reduction: 15.1% for 2 mg and 20.2% for 4 mg, according to the study's abstract presented Thursday at the European Association for the Study of Diabetes meeting in Milan. The lowest dose of ribupatide, meanwhile, elicited a 10% reduction in body weight at 32 weeks. Across all doses tested, ribupatide's effect was significantly greater than the 2.6% weight loss in placebo comparators. Aside from the weight benefits, all three ribupatide groups experienced an increase in menstrual frequency, while menstrual cycles in the placebo arm grew more infrequent. Women with PMOS typically have irregular menstruation and often miss cycles. As for safety, there were no cases of serious adverse events or adverse events that led to study discontinuations. Obesity treatments such as Novo Nordisk's Wegovy (semaglutide) and Eli Lilly's Zepbound (tirzepatide) aren't indicated for PMOS, a hormonal disorder formerly called polycystic ovary syndrome that is driven by dysregulated ovarian and neuroendocrine hormones and insulin in women. But increasingly, patients are resorting to these medicines to manage their symptoms, including weight gain and insulin resistance, according to a Reuters December 2025 report. The publication cited a Truveta report showing that in 2025, 17.6% of women with PMOS were on semaglutide or tirzepatide medication, as compared with only 2.4% in 2021 - though the firm concedes that this growth could also have been driven by the increasing prevalence of GLP-1 drugs. Despite the potentially high off-label use among women with PMOS, not a lot of companies are running drug development programs dedicated to the condition. One of the few is AI-focused PostEra, which is working on an early molecule called PERA-5720, currently undergoing preclinical research for a regulatory filing that would enable in-human testing. Aside from the ribupatide data in PMOS, Kailera and Hengrui had four other presentations at EASD, including one for an early-stage study of the GLP-1/GIP/glucagon triple-receptor agonist HRS-4729 and two for the oral GLP-1 drug HRS-7535. Taken together, these readouts are supportive of the companies' broader obesity pipeline, Leerink said on Thursday. Kailera launched in October 2024 with $400 million, formed around a clutch of assets licensed from China drugmaker Hengrui. Kailera has the global right to develop and commercialize these assets outside of the Greater China region.

PostEra's Fertility programs acquired by EMD Serono, Inc. Sep 09, 2026, 10:00 ET BOSTON, Sept. 9, 2026 /PRNewswire/ - PostEra, a biotechnology company specializing in artificial intelligence for small molecule drug discovery and reproductive endocrinology, today announced that EMD Serono, Inc., the Healthcare business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, has acquired two of PostEra's programs directed at fertility indications. Over the last 2 years PostEra has used its AI platform, Proton, to develop novel small molecule treatments in Women's Health and Fertility; large markets almost entirely dependent on injectable medications, with unmet needs around patient convenience that need to be addressed by today's biopharma industry. Within Fertility, Proton was used to develop a series of novel Follicle-Stimulating Hormone Receptor (FSHR) agonists for ovarian stimulation in IVF. In parallel, PostEra also developed novel small molecule agonists of the Luteinizing Hormone/Choriogonadotropin Receptor (LHCGR) for male infertility and ovulation trigger in IVF. Standalone, the LHCGR agonist has shown the potential in preclinical studies to offer an oral alternative to injectable hCG regimens used for selected male infertility patients. A combination of the FSHR and the LHCGR agonists could potentially transform the current IVF protocol from injections to an all-oral regimen; a step-change in treatment for women undergoing IVF. EMD Serono has acquired PostEra's FSHR and LHCGR agonist programs. Following completion of the transaction, EMD Serono will assume sole responsibility for the continued development and potential commercialization of the programs worldwide. Both programs are currently in preclinical development, and their safety and efficacy in humans have not been established. "We view this transaction as validation of both the very real opportunity in Women's Health and reproductive endocrinology and also of the strength of our Proton platform in delivering high quality clinical candidates against challenging targets. Both FSHR and LHCGR are targets which have been validated by biologics, but over the past few decades there has been little progress in drugging them with orally bioavailable small molecules. Our work in FSHR and LHCGR is a clear benchmark of how the Proton platform can move the needle in challenging medicinal chemistry, and unlock a new era in fertility treatments.", said Dr. Lee, PostEra's Chief Scientific Officer. "Our AI benchmark at PostEra has always been high quality chemical matter. We judge ourselves not simply on whether we can beat a metric, or top a leaderboard, but can we actually develop promising novel therapies that have the potential to help human health. For our Fertility pipeline, we are so pleased that EMD Serono, Inc. a globally-recognized player in this space will take these programs forward", added Aaron Morris, PostEra's Chief Executive Officer. SOURCE PostEra