Lilly's GLP-1/GIP Dual Agonist Brenipatide Shows Promise in Treating Alcohol and Tobacco Use Disorders

United States, 2025-11-10 — Rhythm Pharmaceuticals (NASDAQ: RYTM) presented new data from its Phase III TRANSCEND trial at ObesityWeek® 2025, demonstrating significant efficacy of its targeted drug Setmelanotide in patients with acquired hypothalamic obesity. The TRANSCEND Phase III trial data showed:

- Compared with placebo, patients receiving Setmelanotide combined with GLP-1 therapy (n=9) experienced an average BMI reduction of 27.1% (p<0.0001); patients not using GLP-1 (n=72) experienced an average BMI reduction of 19.0% (p<0.0001).

- Patients and their caregivers in the trial reported that Setmelanotide improved appetite, weight, energy, and physical activity levels, significantly enhancing quality of life.

- In terms of cardiometabolic indicators, Setmelanotide treatment significantly improved blood pressure, blood lipids, and blood chemistry parameters, demonstrating broad cardiometabolic benefits.

Acquired Hypothalamic Obesity is a complex condition that not only affects body weight and appetite but also has a significant impact on daily life. Setmelanotide has demonstrated consistent and durable efficacy in BMI reduction and cardiometabolic improvements, showing potential to transform patients' lives. Additionally, related research includes hyperphagia and genetic variant analysis in early-onset obesity patients, covering data from 212 participants, further enriching the understanding of obesity etiology and personalized treatment. The TRANSCEND Phase III trial data provides crucial evidence for the clinical value of Setmelanotide in treating rare neuroendocrine disorders and lays the foundation for the future development of combination therapies.

Germany, 2025-11-13 – ITM Isotope Technologies Munich SE (ITM), a leading biotech company in radiopharmaceuticals, announced that the FDA has accepted the company's NDA for 177Lu-edotreotide (ITM-11). The FDA has set the Prescription Drug User Fee Act (PDUFA) target review date for August 28, 2026.

177Lu-edotreotide is ITM's proprietary, targeted radiopharmaceutical candidate for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The COMPETE trial is a prospective, randomized, controlled, open-label Phase 3 clinical study that enrolled 309 patients with inoperable and progressive Grade 1 or 2 GEP-NETs as first- or second-line therapy. The study demonstrated that, compared to the molecular targeted drug everolimus, the 177Lu-edotreotide treatment group showed significantly prolonged median progression-free survival (PFS) and a higher objective response rate (ORR). Additionally, 177Lu-edotreotide is being evaluated in the COMPOSE Phase 3 trial for the treatment of well-differentiated but more aggressive Grade 2 or 3 SSTR-positive GEP-NET tumors.

United States, November 13, 2025 - Clinical-stage biotechnology company PepGen (NASDAQ: PEPG) announced that the USPTO has granted the company a new composition patent for its innovative molecule PGN-EDODM1. PGN-EDODM1 is based on PepGen's proprietary Enhanced Delivery Oligonucleotide (EDO) platform, incorporating unique peptide and linker chemistries. The patent is expected to be valid in the United States until the second half of 2042 and can apply for an extension after FDA approval.

This patent protection highlights the innovation and differentiation of the company's peptide-conjugated oligonucleotide candidate drug, PGN-EDODM1. PGN-EDODM1 is designed to treat Type 1 Myotonic Dystrophy (DM1) by utilizing EDO technology to precisely deliver therapeutic oligonucleotides into cells, aiming to restore the normal function of the critical RNA splicing protein MBNL1, thereby correcting the abnormal splicing caused by CUG repeat expansion in the DMPK transcript. Compared with traditional oligonucleotide therapies that rely on the degradation of the DMPK transcript, PGN-EDODM1 releases MBNL1 while preserving DMPK function, potentially offering better therapeutic advantages. The U.S. FDA has granted PGN-EDODM1 Orphan Drug and Fast Track designations.

PepGen is a clinical-stage biotechnology company dedicated to developing a new generation of oligonucleotide therapies. Its EDO platform enhances cellular uptake and activity of oligonucleotides through cell-penetrating peptides. The company is developing multiple therapy candidates targeting the root causes of severe neuromuscular diseases based on this platform.

United States, 2025-11-14 — Biotechnology company Animate Biosciences announced the launch of its breakthrough platform, AnimateIQ™, for developing peptide therapies targeting inflammatory and fibrotic diseases. Leveraging its platform, Animate extracts insights from multi-omics data of regenerative species and uses generative AI to transform them into precisely designed, highly tolerable peptide therapies. The company currently leads in pipelines for pulmonary and skin inflammation and fibrosis, while also collaborating in cardiac fibrosis, committed to building a scalable pipeline of drug candidates covering both rare and common diseases.

The company was founded and is led by several senior experts in the fields of biotechnology, drug discovery, and regenerative biology. The core team also includes professionals in protein chemistry, biology, AI, and computational biology, and is supported by world-class advisors in pulmonology, dermatology, oncology, and other fields, such as top experts from Johns Hopkins, UCSF, Harvard Medical School, and Mount Sinai.

On 2025-11-10, Novartis' Lutetium [¹⁷⁷Lu] Texiveptide Injection received the registration and marketing approval certificate issued by NMPA, with the approval number HJ20250133.

On November 14, 2025, PegBio's Vipenatide Injection received the registration and marketing approval certificate issued by the NMPA, with the approval number H20250066. This drug is a PEGylated exenatide.

United States, 2025-11-13 — Pfizer announced the completion of its acquisition of Metsera (NASDAQ: MTSR), a clinical-stage biopharmaceutical company. This move aims to accelerate the development of next-generation therapies for obesity and cardiometabolic diseases, further enhancing Pfizer's internal medical product portfolio.

The acquisition price is $65.60 per share in cash, with an enterprise value of approximately $7 billion, and includes a contingent value right (CVR) of up to $20.65 per share tied to three clinical and regulatory milestones. Metsera has become a wholly owned subsidiary of Pfizer, and its stock will cease trading on NASDAQ after the closing. Through this acquisition, Pfizer has introduced a series of high-potential obesity treatment candidates currently in clinical stages:

- MET-097i: A GLP-1 receptor agonist administered weekly or monthly, soon to enter Phase III clinical trials;

- MET-233i: A monthly injectable amylin analog in Phase I clinical trials, can be used as monotherapy or in combination with MET-097i;

- Oral GLP-1 RA Candidate: In Phase I Clinical Trials;

- And other pre-clinical nutritional stimulation hormone therapies.

These candidates not only complement Pfizer's existing internal medicine pipeline but also have the potential to shape the treatment landscape for obesity and cardiometabolic diseases. This acquisition further solidifies Pfizer's leading position in the fields of obesity and cardiometabolic diseases, providing strong support for the company to advance innovative therapies and commercialization strategies on a global scale. The acquisition is expected to have a dilutive effect on finances in the short term until 2030, primarily due to investments in the development of late-stage candidates.

United States, 2025-11-14 — Merck announced a definitive agreement to acquire Cidara Therapeutics for $221.50 per share in cash, or approximately $9.2 billion. Cidara is a biopharmaceutical company focused on Drug-Fc Conjugate (DFC) technology. This acquisition will support Merck's long-term strategic initiatives in the antiviral field, particularly the development of innovative biologic therapies with extended dosing advantages.

Cidara has established an innovative DFC technology platform based on its proprietary Cloudbreak® platform. This technology stably conjugates small molecule or peptide active ingredients with the Fc fragment of human antibodies, combining the targeted potency of small-molecule drugs with the long half-life characteristics of antibodies to form a new drug framework that is "long-acting, precise, and broad-spectrum." The core product being acquired, CD388, is a long-acting, strain-insensitive antiviral drug developed using this technology, aimed at providing seasonal prevention for high-risk influenza populations. CD388 does not rely on immune system response and may offer potential advantages for immunocompromised individuals. The product is currently in Phase III ANCHOR clinical trials and has received FDA Fast Track and Breakthrough Therapy designations.

Cidara has deep expertise in the anti-infective field and developed the long-acting peptide antifungal drug rezafungin (Rezafungin, Rezzayo®), known for its once-weekly dosing. The drug has been approved and launched in Europe and was previously advanced through an NDA submission in the U.S. by Cidara. In April 2024, the company announced the divestiture of all rights to rezafungin to Mundi Pharma to focus resources on advancing the Cloudbreak® platform and antiviral pipeline.

Denmark, 2025-11-12 — Clinical-stage biotechnology company Ascendis Pharma (NASDAQ: ASND) released its Q3 2025 financial report as of 2025-09-30. Total revenue for the third quarter reached €213.6 million, with YORVIPATH® contributing €143 million and SKYTROFA® contributing €50.7 million. Operating profit was €11 million, achieving profitability, but net loss was €61 million (loss per share €1.00), showing year-over-year improvement. As of September 30, the company's total cash and cash equivalents amounted to €0.54 billion.

- YORVIPATH® (TransCon PTH): More than 4,250 registered patients in the U.S., with over 2,000 prescribing physicians; approved and commercialized in the Japanese market. Clinical data from the PaTHway series shows that YORVIPATH significantly improves renal function in adult patients with hypoparathyroidism.

- SKYTROFA® (TransCon hGH): The US FDA approved the label expansion for adult growth hormone deficiency, while initiating a "basket" trial targeting various growth disorders.

- TransCon CNP (navepegritide): The NDA application for use in children with achondroplasia has been granted Priority Review by the FDA, with a PDUFA target date of 2025-11-30. The European MAA has been submitted and is currently under review. Latest clinical data shows that TransCon CNP can improve physical function in children, particularly showing significant effects in younger children with more severe baseline genu varum.

- TransCon CNP + TransCon hGH Combination Therapy: Phase 3 clinical trial planned to commence this quarter, with 52-week COACH trial data expected to be released by early 2026.

- TransCon IL-2 β/γ (onvapegleukin alfa): Combination therapy with paclitaxel for advanced ovarian cancer shows good safety; median overall survival data for the first 70 patients is expected to be released in Q1 2026.

United States, 2025-11-13 — Biopharmaceutical company Palatin Technologies (NYSE American: PTN) released its first-quarter financial results for the fiscal year ending 2025-09-30 and disclosed updates on its product pipeline based on the melanocortin receptor (MCR) system.

This quarter, the company's collaboration and licensing revenue was $8.8 million, with total operating expenses amounting to approximately $4.19 million (including R&D expenses of $2.53 million and SG&A expenses of $1.66 million); net profit was $4.68 million, with basic earnings per share of $4.81 and diluted earnings per share of $4.26, compared to a net loss of approximately $7.82 million and a loss per share of $19.71 for the same period last year. As of 2025-09-30, cash and cash equivalents were approximately $1.27 million, excluding additional upcoming milestone payments and net proceeds from financing, with cash expected to support operations at least until the end of December 2026. The company has completed a follow-on offering raising $18.2 million (including the exercise of the over-allotment option).

Key Product Pipelines and R&D Progress:

- Oral MC4R small molecule PL7737: Preclinical study data currently completed shows significant weight loss and high oral bioavailability. The company is conducting IND-supportive toxicology studies, with plans to submit an IND and initiate a Phase I single ascending dose/multiple ascending dose (SAD/MAD) trial in the first half of 2026, initially enrolling patients with hypothalamic obesity, and has already received FDA orphan drug designation.

- Next-generation selective peptide MC4R agonist (weekly subcutaneous injection): This series of peptide candidates is designed for weekly administration, with plans to submit an IND and initiate Phase I SAD/MAD trials by mid-2026. Indications also include hypothalamic obesity and support the potential for combination therapy with tirzepatide.

- Outward Licensing Cooperation: The company signed a research, licensing, and patent transfer agreement with Boehringer Ingelheim in the field of retinal diseases. In August 2025, it received an upfront payment of approximately €2 million (about $2.3 million), and in September, achieved a research milestone payment of €5.5 million (about $6.5 million). It can obtain up to €260 million (approximately $0.3 billion) in development, regulatory, and commercial milestones, as well as corresponding sales royalties in the future.

Denmark, 2025-11-13 – Zealand Pharma (NASDAQ: ZEAL), a biopharmaceutical company focused on the development of innovative peptide-based drugs, released its Q3 2025 financial report and provided an update on the company’s clinical progress. The company demonstrated strong financial performance, with cumulative revenue reaching DKK 915 million as of the third quarter (compared to DKK 54 million in the same period last year). Operating expenses amounted to DKK 1.479 billion (excluding transaction costs related to the collaboration with Roche), operating profit reached DKK 7.666 billion, and cash and cash equivalents totaled DKK 16.17 billion, establishing a solid financial foundation for key clinical milestones in 2026.

In the pipeline, significant progress has been made in the field of weight loss and obesity:

- Petrelintide (Amylin analog) completed the 28-week primary endpoint follow-up in the Phase 2 ZUPREME-1 monotherapy trial in overweight and obese patients, with 42-week topline data expected to be announced in H1 2026. The Phase 2 ZUPREME-2 trial evaluating patients with type 2 diabetes has also completed full enrollment. The company plans to initiate the Phase 3 clinical trial of Petrelintide monotherapy in H2 2026 and advance the Phase 2 study of the fixed-dose combination with CT-388.

- Survodutide (GC/GLP-1 dual receptor agonist) completed the primary endpoint follow-up for the last participant in the 76-week Phase 3 SYNCHRONIZETM-1 trial, with data expected to be released in H1 2026; SYNCHRONIZETM-2 is also progressing concurrently.

- Development of Dapiglutide has been temporarily put on hold to optimize the portfolio and focus resources on projects with potential for clinical differentiation.

In the field of rare diseases and chronic inflammation:

- Glepaglutide (for the treatment of short bowel syndrome) is planned to initiate Phase 3 clinical trials in Q4 2025, with potential regulatory approval expected in the EU in H1 2026.

- Dasiglucagon (Congenital Hyperinsulinism Treatment) NDA resubmission depends on the upgrade of third-party production facility inspections; the company has implemented a backup supply plan.

- ZP9830 (Kv1.3 Ion Channel Inhibitor) Phase I Single-Dose Clinical Data Expected to be Released in 2026H1.