Pfizer Secures Metsera in $10 Billion Deal After Fierce Bidding War with Novo Nordisk

2025-11-05 United States, Novo Nordisk presented multiple exploratory follow-up analyses from the OASIS 4 Phase III trial of its oral semaglutide (25 mg, Wegovy® oral version) at ObesityWeek® 2025. The data showed that the drug not only effectively reduced weight but also improved blood glucose control and cardiovascular risk factors, with consistent performance across various patient subgroups. Key findings include:

1. Weight Loss and Cardiometabolic Improvement Association

- Oral semaglutide 25 mg significantly improved glycemic parameters (HbA1c, fasting blood glucose, fasting insulin) and cardiovascular risk markers (C-reactive protein, triglycerides, non-HDL cholesterol) over 64 weeks.

- Among participants with prediabetes at baseline, 71.1% returned to normal blood sugar levels by week 64, compared to only 33.3% in the placebo group.

- Patients with weight loss ≥15% showed more significant improvements in blood pressure, inflammation, and lipid levels.

2. Comparable to the effect of injectable formulations

- Indirect comparison with the STEP 1 injectable semaglutide study shows that oral and injectable formulations are comparable in terms of weight loss percentage, cardiovascular benefits, and quality of life improvement.

3. Women in different menopausal stages all benefit. Analysis across the OASIS 4 and STEP studies shows:

- Pre-menopausal women lost an average of 18.2%, perimenopausal women 15%, and post-menopausal women 15.7%.

- The proportions of ≥15% weight loss were 58.1%, 56.5%, and 53.4%, respectively, with effects consistent with the injectable formulation.

4. Improve Physical Function

- Among participants who self-assessed as having poor physical fitness, 77.3% achieved improvement at 64 weeks, compared to only 42.9% in the placebo group.

Adverse events of oral semaglutide 25mg were mainly mild to moderate gastrointestinal reactions (nausea 46.6%, vomiting 30.9%), generally transient; the discontinuation rate due to adverse events was 6.9%, similar to placebo at 5.9%; the incidence of severe adverse events was low (3.9% vs 8.8%). The overall safety profile is consistent with the injectable formulation Wegovy®, supported by more than 37 million patient-years of exposure data. OASIS 4 is a 64-week randomized, double-blind, placebo-controlled Phase III trial, enrolling 307 obese adults with BMI ≥30 kg/m² or overweight adults with BMI ≥27 kg/m² and at least one obesity-related comorbidity. All participants received lifestyle intervention. Currently, oral Wegovy® is under application for FDA approval, and if approved, it will be fully produced at Novo Nordisk’s plant in North Carolina.

2025-11-05 Denmark & USA: At ObesityWeek® 2025, Novo Nordisk presented the latest analysis results from the STEP UP Phase IIIb trial, showing that Wegovy® (semaglutide 2.4 mg approved dose and 7.2 mg high dose) not only achieves significant weight loss but also helps obese patients reach key therapeutic goals such as BMI and waist-to-height ratio, thereby reducing the risk of obesity-related complications. Study highlights:

1. The compliance rate of BMI and waist-to-height ratio significantly increased.

- In the STEP UP trial, 19.5% (7.2 mg group) and 13.2% (2.4 mg group) of obese patients taking Wegovy® achieved a BMI <27 and waist-to-height ratio <0.53, while none in the placebo group met the criteria.

- The blood pressure, cholesterol, and blood glucose levels of those who met the criteria have returned to healthy levels, indicating a significant reduction in cardiovascular disease risk.

2. Higher doses of Wegovy® result in more significant weight loss

- The average weight loss in the 7.2 mg high-dose group was 21%, with about one-third of patients losing ≥25% of their body weight.

3. Reduced Risk of Obesity-Related Complications

- More than half of the patients who achieved both BMI and waist-to-height ratio targets had all four major cardiovascular risk indicators return to healthy levels.

Wegovy® 7.2 mg high dose is currently being submitted for approval to the EMA, the UK, and other countries, with regulatory decisions in European markets expected to be completed around the end of the year; an FDA application is also in the planning.

On 2025-11-06, the multiple clinical applications for HRS-7535 tablets developed by Shandong Shengdi Pharmaceutical were accepted by the CDE.

On November 6, 2025, Qilu Pharmaceutical's semaglutide injection received clinical tacit approval from the CDE for long-term weight management in adult patients based on controlled diet and increased physical activity.

On 2025-11-07, Tongrui Biopharmaceutical's 64Cu-TR2205 Injection was registered for a clinical trial (CTR20254382) in the CTR. This is a Phase I, prospective, randomized, open-label, single-dose study evaluating the safety, tolerability, pharmacokinetics, and radiation dosimetry of 64Cu-TR2205 Injection for diagnosing PSMA-positive recurrent metastatic prostate cancer patients.

TR2205 is a peptide ligand targeting prostate-specific membrane antigen (PSMA). When combined with the radioactive nuclide 64Cu, it forms the radiopharmaceutical 64Cu-TR2205, which can be used for diagnosing prostate cancer. This drug specifically identifies PSMA-positive prostate cancer cells, enabling precise tumor imaging and providing crucial evidence for clinical diagnosis.

On 2025-11-07, the clinical application for Chongqing Paikin Biotech's injectable recombinant acylated glucagon-like peptide-2 analog (CXSL2500952) was accepted by the CDE.

On 2025-11-07, Hengrui Medicine's Leuprolide Acetate Microspheres for Injection received clinical trial approval (CYHL2500159) from the CDE for prostate cancer.

On 2025-11-07, Novo Nordisk's CagriSema injection received CDE acceptance for multiple clinical applications.

United States, November 7, 2025 – Altimmune (NASDAQ: ALT) announced the AI pathology analysis results of its candidate drug pemvidutide in the IMPACT IIb study. The results showed that, compared to placebo, pemvidutide significantly reduced liver fibrosis area in MASH patients at 24 weeks and improved multiple non-invasive fibrosis detection markers. Relevant data will be presented on November 8 at the late-breaking abstract poster session of the 2025 American Association for the Study of Liver Diseases (AASLD) Annual Meeting in Washington, D.C.

Analysis results from the AI pathology tool Liver Explore™ showed that 31% of patients receiving pemvidutide 1.8 mg achieved a ≥60% reduction in total fibrosis area (vs. 8% in the placebo group, p=0.0003); significant improvements were observed in 34% (p<0.0001) and 27% (p=0.0063) of patients with early-stage and late-stage fibrosis, respectively. Non-invasive test (NITs) results also demonstrated that the pemvidutide group outperformed the placebo group in metrics such as the PRO-C3:CTX-III ratio and PRO-C6, indicating fibrosis regression and potential reduction in cardiovascular risk. The IMPACT IIb study enrolled 212 patients with F2-F3 stage MASH, who were randomly assigned in a 1:2:2 ratio to receive subcutaneous injections of pemvidutide (1.2 mg or 1.8 mg) or placebo once weekly for 48 weeks.

Pemvidutide is a GC/GLP-1 dual receptor agonist with a 1:1 balance, which improves liver fat, inflammation, and fibrosis while promoting metabolism and weight control. The drug has been granted Fast Track designation by the FDA for the treatment of MASH and alcohol use disorder (AUD).

United States, 2025-11-07 — Neurogastrx announced the Phase II proof-of-concept study results of its oral candidate drug NG101 (mosapride mesylate) at ObesityWeek® 2025. The study demonstrated that NG101 significantly reduces gastrointestinal adverse effects caused by GLP-1RAs (such as semaglutide), decreasing the incidence of nausea by 40% and vomiting by 67%.

This placebo-controlled clinical study enrolled 90 subjects and showed that, in addition to significantly reducing the incidence of nausea and vomiting, NG101 also decreased the duration and severity of symptoms: only 22% of patients reported symptoms lasting more than one day (vs. 51% in the placebo group), with a 70% reduction in nausea severity (p=0.0138). Patient-reported outcome (PRO) results also indicated a 31% decrease in moderate-to-severe nausea scores, with overall good tolerability.

NG101 is a peripherally selective dopamine D2 receptor antagonist that specifically targets the Area Postrema outside the blood-brain barrier, inhibiting nausea and vomiting induced by GLP-1 agonists through D2 receptor blockade. NG101 is currently in further clinical development and will be evaluated in combination with various GLP-1 drugs in the future.

Denmark, 2025-11-07 – Ascendis (NASDAQ: ASND) presented the latest pooled analysis results at the American Society of Nephrology’s Kidney Week 2025, showing that its long-acting parathyroid hormone drug TransCon PTH (palopegteriparatide) continued to significantly improve renal function in patients with hypoparathyroidism through year three in Phase III (PaTHway) and Phase II (PaTH Forward) clinical trials. The pooled analysis included 141 adult patients (average age 49 years), with results indicating:

- 70.3% of patients had an eGFR increase ≥5 mL/min/1.73m², with an average increase of approximately 9–10 mL/min/1.73m²;

- The improvement was most significant in the first 6 months of treatment, then continued to increase;

- More than 91% of patients摆脱常规治疗 (no need for active vitamin D and ≤600 mg calcium supplementation), and over 84% maintained normal blood calcium levels;

- 24h urinary calcium excretion decreased and remained within the normal range.

Researchers pointed out that renal impairment is a severe complication of hypoparathyroidism. TransCon PTH, by simulating the normal physiological rhythm of PTH, can improve calcium homeostasis while protecting renal function. The drug demonstrated good safety, with no new safety signals identified. TransCon PTH is a once-daily prodrug of parathyroid hormone (1-34) that maintains stable physiological PTH levels over 24 hours. It has been approved under the trade name YORVIPATH® in the United States, the European Union, and the European Economic Area for the treatment of adult hypoparathyroidism.

United States, 2025-11-07 — Merck announced at the American Heart Association (AHA) 2025 Scientific Sessions and simultaneously published in JAMA the Phase III pivotal trial data of its oral PCSK9 inhibitor candidate Enlicitide decanoate in adults with heterozygous familial hypercholesterolemia (HeFH), from the CORALreef HeFH study. The study showed that once-daily oral Enlicitide reduced low-density lipoprotein cholesterol (LDL-C) by 59.4% at 24 weeks (p<0.001), with a sustained significant reduction of 61.5% at one-year follow-up.

CORALreef HeFH Trial Included 303 Adults with HeFH, All Patients Were on Stable Background Lipid-Lowering Therapy, Including Moderate to High-Intensity Statins. The Main Study Results Include:

- LDL-C significantly decreased, with 67.3% of patients achieving a ≥50% reduction and LDL-C <55 mg/dL at 24 weeks, compared to only 1% in the placebo group;

- Non-HDL cholesterol (non-HDL-C) decreased by 53.0%, apolipoprotein B (ApoB) decreased by 49.1%, and lipoprotein(a) decreased by 27.5%;

- The effect of LDL-C reduction became apparent in the 4th week and lasted for at least one year;

- Safety comparable to placebo, with low incidence of adverse events and discontinuation rates (Enlicitide 2.0% vs placebo 3.0%).

Enlicitide is a novel small-molecule macrocyclic peptide that increases the number of LDL receptors on the cell surface by inhibiting the binding of PCSK9 to LDL receptors, thereby reducing LDL-C in the blood. It has the potential to become the first approved oral PCSK9 inhibitor, offering efficacy similar to injectable monoclonal antibody PCSK9 inhibitors but with the convenience of a once-daily oral formulation. The CORALreef clinical trial program has evaluated more than 19,000 patients with high cholesterol, including multiple Phase III studies such as CORALreef Lipids, CORALreef AddOn, and CORALreef Outcomes, while also covering pediatric patients, combination therapy, and extended follow-up trials. The safety and cholesterol-lowering efficacy of Enlicitide are being further validated.

United States, 2025-11-07 — Merck presented for the first time its Phase III pivotal trial CORALreef Lipids data on Enlicitide decanoate, an oral PCSK9 inhibitor candidate, at the American Heart Association (AHA) Scientific Sessions 2025. The study showed that once-daily oral administration of the drug reduced low-density lipoprotein cholesterol (LDL-C) by 55.8% over 24 weeks (primary analysis, p<0.001), with a subsequent reanalysis showing a reduction of up to 59.7%, demonstrating significant efficacy and clear clinical relevance.

CORALreef Lipids Trial Includes 2,912 Patients with Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk Who Are Using Statins or Intolerant to Statins. Results Show:

- 67.5% of patients achieved the stringent goal of LDL-C reduction ≥50% and LDL-C <55 mg/dL within 24 weeks, compared to only 1.2% in the placebo group;

- Non-HDL cholesterol (non-HDL-C) decreased by 53.4%, apolipoprotein B (ApoB) decreased by 50.3%, and lipoprotein(a) decreased by 28.2%;

- One-year follow-up showed a sustained reduction in LDL-C of 47.6%-52.4%.

- Safety is comparable to placebo, with low rates of serious adverse events and discontinuation (3.1% vs 4.1%, respectively).

On 2025-11-06, the active pharmaceutical ingredient semaglutide (registration number: Y20250001109) from Fujian Jinuo Houpu was registered for inactive status in the CDE’s excipient and packaging material registration system.

United States, 2025-11-07 — Rhythm Pharmaceuticals (NASDAQ: RYTM) announced that the FDA has extended the review period for its supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide) for the treatment of acquired hypothalamic obesity by three months. The PDUFA goal date has been postponed from the original 2025-12-20 to 2026-03-20.

This delay stems from the FDA's request in October for the company to conduct an additional sensitivity analysis on the efficacy data from the pivotal Phase III clinical trial, without requiring new clinical data. The FDA considered this supplementary material as a "major amendment," thus extending the review period. This revision is unrelated to the safety or manufacturing process of setmelanotide.

On November 6, 2025, Lisata Therapeutics (NASDAQ: LSTA) released its Q3 2025 earnings report, announcing that its oncology treatment candidate Certepetide (formerly LSTA1) has continued to demonstrate positive results across multiple clinical studies. Additionally, the company recently achieved two significant strategic partnerships, further expanding the global application potential of its technology platform. Lisata signed a global licensing agreement with Catalent, granting the latter the rights to use Certepetide within its SMARTag® Antibody-Drug Conjugate (ADC) technology platform to enhance tumor targeting and penetration efficiency of ADC drugs. Preclinical animal studies conducted by Catalent showed that this combination significantly improves drug efficacy and optimizes the distribution of cytotoxic payloads within tumors. Furthermore, Lisata entered into a strategic alliance with GATC Health, leveraging its Multiomics Advanced Technology™ AI-driven multi-omics platform for drug discovery and combination therapy screening, exploring Certepetide’s potential in additional indications.

Certepetide is a patented cyclic RGD peptide that improves the delivery and accumulation of anticancer drugs within solid tumors by activating a tumor-specific "C-end rule" active transport mechanism. The drug has received FDA Fast Track designation and multiple Orphan Drug designations, covering various malignant tumors such as pancreatic cancer, cholangiocarcinoma, osteosarcoma, and glioma.

Currently, the company's key clinical projects include:

- ASCEND Study: In patients with metastatic pancreatic cancer, combination therapy with standard chemotherapy demonstrated improvements in overall survival (OS) and progression-free survival (PFS); final results are expected to be announced in the first quarter of 2026.

- BOLSTER Study: Completed early enrollment in the first-line treatment of cholangiocarcinoma, with results expected to be read out in Q4 2025.

- CENDIFOX Study: Combination with FOLFIRINOX Neoadjuvant Regimen Shows Trend of Converting Immune "Cold" Tumors to "Hot" Tumors.

Financially, the company operates debt-free and held approximately $19 million in cash as of 2025-09-30, which is expected to support operations until 2027Q1.

United States, 2025-11-06: Amphastar Pharmaceuticals (NASDAQ: AMPH) released its Q3 2025 earnings report. The company achieved net revenue of $191.8 million, which was basically flat compared to the same period last year, with a net profit of $17.4 million (earnings per share of $0.37). Notably, BAQSIMI® (glucagon nasal spray) generated $53.6 million in sales for the third quarter of 2025 alone, representing a 33% year-over-year increase, while generic glucagon recorded $13.5 million in sales for the quarter, reflecting a 49% year-over-year decline.

Amphastar currently has: 1) 3 ANDA projects and 1 insulin biosimilar under FDA review, targeting a market size of over $2 billion; 2) 3 biosimilars and 2 complex generic drugs in development, with a potential market size exceeding $7 billion; 3) multiple self-innovated products in development, covering injectable and nasal spray formulations. Collaborating with Nanjing Angji Biotechnology to advance innovative peptide drugs, the three peptide drugs under their cooperation include: 1) an endogenous anticancer peptide with a novel mechanism of action, potentially inhibiting the growth and metastasis of various refractory cancers; 2) a peptide-docetaxel conjugate that enhances selectivity and bioavailability while reducing toxicity; 3) an anti-VEGFR peptide eye drop for treating wet age-related macular degeneration (wAMD), which is expected to replace conventional intravitreal injections.

United States, 2025-11-06: Protagonist Therapeutics (NASDAQ: PTGX) announced its Q3 2025 financial report. The company holds $679 million in cash, cash equivalents, and marketable securities. This quarter's revenue was $4.71 million, primarily from collaborative R&D services with Takeda; R&D expenses were $40 million, a year-over-year increase of approximately 11%; net loss was $39.3 million, with a loss per share of $0.62. Cash reserves of $679 million are expected to support operations through the end of 2028. Key R&D progress includes:

1) Icotrokinra (oral IL-23 receptor antagonist): Following the submission of a New Drug Application (NDA) to the FDA in July, the company submitted a marketing application to the EMA in September for the treatment of adult and adolescent patients with moderate to severe plaque psoriasis. The clinical program in collaboration with partner Johnson & Johnson (J&J) is further expanding to include IL-23 pathway-related diseases such as psoriatic arthritis, ulcerative colitis, and Crohn's disease. Recently, key data on icotrokinra have been published in NEJM, NEJM Evidence, and at the annual meeting of the European Academy of Dermatology and Venereology (EADV), demonstrating significant efficacy and sustained response in patients with psoriasis and ulcerative colitis.

2) Rusfertide (a subcutaneous hepcidin mimetic): This drug is used for the treatment of polycythemia vera (PV), has been granted Breakthrough Therapy Designation by the FDA, and will be featured in four presentations at the American Society of Hematology (ASH) Annual Meeting in December, including the results of the 52-week VERIFY Phase III study. In collaboration with Takeda, an NDA submission is expected in the fourth quarter of this year.

3) Early-stage R&D pipeline continues to advance:

- The first subject has completed dosing in the Phase I trial of PN-881 (a first-in-class oral IL-17 peptide antagonist).

- PN-477sc and PN-477o (triple GLP/GIP/GCG receptor agonists) are proceeding with pre-IND studies as planned, with clinical trials expected to commence in mid-2026 and the second half of 2026, respectively.

- The company's oral hepcidin project is expected to confirm the development candidate molecule by the end of the year.

2025-11-08, Copenhagen/New York, After weeks of a fierce bidding war, Pfizer finally defeated its rival Novo Nordisk to secure the acquisition of Metsera, a rising biotechnology company in the weight-loss field.

According to the final agreement announced on the evening of November 7, Pfizer will acquire Metsera for $65.60 per share in cash (approximately $7.6 billion), plus up to $20.65 per share in contingent value rights (CVR), for a total consideration of approximately $10 billion ($86.25 per share). The Metsera board stated in a declaration that Pfizer's revised acquisition proposal "represents the best interests of shareholders in terms of value and deal certainty" and reiterated its support for the Pfizer transaction.

Metsera was initially acquired by Pfizer for $4.9 billion in September. On October 30, Novo Nordisk suddenly launched a competing bid of $850 million, triggering multiple rounds of price increases and legal battles between the two parties. Ultimately, Pfizer was confirmed as the winner on the evening of November 7.

Novo Nordisk Subsequently Issues Statement Confirming No Further Increase in Acquisition Bid

This transaction marks a crucial step for Pfizer in the global weight-loss treatment field and reflects the intense competition among large pharmaceutical companies in the obesity market — a market whose potential scale is expected to exceed $150 billion by 2030.

On 2025-11-06, the U.S. government reached separate agreements with Lilly and Novo Nordisk to significantly reduce the prices of obesity medications and expand patient access starting in 2026. This initiative covers Medicare Part D, Medicaid, and direct payment channels, and is expected to benefit tens of millions of American patients.

1. Lilly: Zepbound and Orforglipron Affordable for the People

- Medicare beneficiaries will only need to pay $50 per month to access Zepbound or Orforglipron after the drugs receive FDA approval.

- The lowest dose of Zepbound multi-dose injection pen is priced at $299, and the highest dose is $449, with the same price for refills; the starting dose of Orforglipron is $149, up to $399.

- Self-paying patients can purchase through the LillyDirect digital health platform and enjoy the same discounts.

- Lilly will continue to offer insulin at a monthly out-of-pocket cost of no more than $35 and will add Emgality, Trulicity, and Mounjaro to the LillyDirect out-of-pocket channel, with discounts of up to 50-60%.

2. Novo Nordisk: Wegovy® and Ozempic® Accessible Through Medicare and Medicaid

- Starting from 2026, Medicare Part D will cover the majority of beneficiaries through a pilot program, reducing the prices of the obesity drugs Wegovy® and Ozempic®, while also offering discounts through Medicaid and direct payment channels.

- The company expects global sales growth to be negatively impacted by a low single-digit percentage, but emphasizes the public health benefits brought by expanding patient accessibility.

This price reduction and Medicare coverage mark a significant advancement in the accessibility of obesity treatments in the U.S., expected to substantially lower patients' financial burden, encourage more individuals with obesity to receive standardized care, and mitigate risks associated with cardiovascular diseases, diabetes, and cancer related to obesity. The actions by Lilly and Novo Nordisk also reflect collaboration between pharmaceutical companies and policymakers to collectively address the public health challenge of obesity by balancing innovation, pricing, and accessibility.