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Maridebart Cafraglutide

Generic Name
Maridebart Cafraglutide
Clinical Trials
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Amgen's Stelara Biosimilar Generates $150 Million in First Quarter, Highlighting Biosimilar Strategy Success

• Amgen's biosimilar of Johnson & Johnson's Stelara achieved $150 million in first-quarter sales, contributing to the company's $735 million total biosimilar revenue, which grew 35% year-over-year. • The biotech company's strategic investment in biosimilars now accounts for approximately 9% of total revenue, offsetting pressure on branded products while outperforming some of its innovative medicines. • Amgen continues expanding its biosimilar portfolio with recent launches of Eylea copycat and upcoming Soliris biosimilar, while also developing competitors to blockbuster checkpoint inhibitors Opdivo and Keytruda.

Amgen Reports Strong Global Demand in Q1 2025, Bolstering Long-Term Growth Outlook

• Amgen announced positive first quarter 2025 financial results, citing strong global demand across its product portfolio and successful new product launches. • Chairman and CEO Bob Bradway expressed confidence in Amgen's long-term growth prospects, supported by recent successful Phase 3 clinical trial results for several products. • The biotechnology company, which employs over 28,000 people globally, continues to focus on its mission of harnessing biology and technology to combat serious diseases.

Amgen Launches Phase 3 Trials for Monthly Obesity Drug MariTide

• Amgen has initiated two pivotal Phase 3 trials of MariTide for obesity treatment, targeting both diabetic and non-diabetic populations with a three-tiered dosing strategy. • In previous Phase 2 trials, MariTide demonstrated approximately 20% weight loss over one year, though market reception was mixed regarding its competitive positioning. • The monthly dosing regimen of MariTide represents a potential differentiating factor in the increasingly competitive obesity drug market, with the company expressing confidence in the program's progression.

Amgen Launches Phase III MARITIME Trials for Novel Obesity Drug MariTide

• Amgen has initiated Phase III MARITIME studies for MariTide, targeting obesity and overweight conditions, with a focus on evaluating body weight changes over a 72-week period. • The trial incorporates carefully designed titration regimens to optimize dosing while minimizing common side effects like nausea and vomiting, demonstrating a patient-focused approach. • William Blair analyst Matt Phipps has issued a Buy rating for Amgen, citing the company's strategic positioning and MariTide's promising development program as key growth drivers.

Novo Nordisk Launches Home Delivery Service for Wegovy at $499 Monthly for Cash-Paying Patients

• Novo Nordisk introduces NovoCare Pharmacy, a direct-to-patient delivery service offering all Wegovy dose strengths at $499 per month for cash-paying and eligible commercially insured patients without coverage. • The launch comes as Wegovy supply stabilizes, with FDA confirming Novo Nordisk can now meet market demand following previous shortages that limited new prescriptions since 2022. • Currently, over 55 million Americans have coverage for weight management medicines, with 90% of insured Wegovy patients paying $0-$25 monthly for their prescriptions.

Amgen Charts Growth Strategy Amid Patent Cliff: Biosimilars and Therapeutic Innovation Take Center Stage

• Amgen reports strong 2024 performance with $33.4 billion revenue, but faces patent expiration challenges for blockbusters Otezla and Enbrel, driving strategic pivot towards biosimilars and portfolio diversification. • Company targets $4 billion in biosimilar sales by 2030, launching Wezlana and Pavblu, while advancing development in four key therapeutic areas: oncology, general medicine, inflammation, and rare disease. • Strategic initiatives include expansion of BiTE platform in oncology, development of obesity drug MariTide, and international market penetration for rare disease treatments following Horizon Therapeutics acquisition.

WEGOVY's Market Dominance Grows with Expanded Cardiovascular Indication and Strong Clinical Results

• Novo Nordisk's WEGOVY has secured FDA approval for cardiovascular risk reduction in March 2024, becoming the first obesity medication authorized to reduce cardiovascular death, heart attack, and stroke risks. • Phase IIIb STEP UP trial demonstrates superior efficacy of WEGOVY 7.2mg compared to 2.4mg dosage, showing significant weight loss benefits at 72 weeks in adults with obesity. • WEGOVY generated impressive US sales of $6.4 billion in 2024, with market presence now extending to over 15 global markets including recent approval in Japan.

FDA Places Amgen's Obesity Drug AMG 513 Trial on Clinical Hold

• Amgen disclosed during Q4 earnings that the FDA has placed their obesity drug AMG 513 clinical trial on hold, though executives believe the issue is not related to the medication itself. • Regeneron Pharmaceuticals announced its first-ever quarterly dividend of $0.88 per share after 37 years, signaling confidence despite current commercial challenges with Eylea and Dupixent. • The development comes as Amgen continues late-stage testing of another obesity treatment, MariTide, while working with regulators to determine a path forward for the AMG 513 study.

FDA Places Clinical Hold on Amgen's Novel Obesity Drug Candidate AMG 513

• The FDA has imposed a clinical hold on Amgen's early-stage obesity drug candidate AMG 513, potentially delaying the company's entry into the competitive weight loss market. • Amgen executives maintain that the clinical hold is not related to the drug itself, though specific details about the reason for the pause remain undisclosed. • The company is actively engaging in discussions with the FDA to address the hold and resume the clinical trial program.

Amgen's MariTide Weight Loss Drug Shows Promise Despite Market Skepticism

• Amgen's phase 2 clinical trial for MariTide demonstrated a 20% average body weight reduction over 52 weeks, though falling short of analyst expectations of 25%. • The monthly injectable weight loss treatment shows continued efficacy without plateauing, suggesting potential for greater weight reduction with extended use. • Market reaction to the trial results triggered a significant stock decline, creating potential investment opportunities given Amgen's strong product portfolio and 3.5% dividend yield.

FDA Expands Enhertu Approval for Most Common Form of Breast Cancer

The FDA has approved Daiichi Sankyo and AstraZeneca's Enhertu for expanded use in patients with metastatic, hormone-positive breast cancer expressing low and ultra-low levels of HER2. This significant expansion covers treatment after hormone therapy for the most prevalent breast cancer type, potentially benefiting a broader patient population.

FDA Approves Lumakras and Vectibix Combination for KRAS G12C-Mutated Metastatic Colorectal Cancer

• The FDA has approved Lumakras (sotorasib) combined with Vectibix (panitumumab) for treating KRAS G12C-mutated metastatic colorectal cancer in adults after prior chemotherapy. • CodeBreaK 300 trial data showed the combination significantly improved progression-free survival compared to standard of care in chemorefractory patients. • Patients on Lumakras and Vectibix had a median progression-free survival of 5.6 months, compared to 2 months on standard of care, with a 26% overall response rate. • This approval provides a new targeted treatment option for a subset of colorectal cancer patients with limited alternatives, emphasizing the importance of biomarker testing.

FDA Approves Sotorasib Plus Panitumumab for KRAS G12C-Mutated Metastatic Colorectal Cancer

• The FDA has approved sotorasib (Lumakras) in combination with panitumumab (Vectibix) for treating KRAS G12C-mutated metastatic colorectal cancer in adults who have received prior chemotherapy. • This approval is based on the Phase 3 CodeBreaK 300 trial, which demonstrated a significant improvement in progression-free survival compared to standard of care. • The combination therapy led to a median progression-free survival of 5.6 months, a substantial increase compared to the 2 months observed with standard treatments. • The FDA also approved the therascreen KRAS RGQ PCR Kit as a companion diagnostic to identify patients eligible for this targeted treatment approach.

Amgen Defends MariTide, Merck Plans for Keytruda Patent Expiry at JPM25

• Amgen executives defended MariTide's clinical profile at JPM25, highlighting its potential for less frequent dosing and comparable weight loss to existing drugs. • Merck anticipates a smooth transition after Keytruda's patent expiry in 2028, planning to introduce a subcutaneous version and leverage other pipeline assets. • Viking Therapeutics is seeking a global partnership to expand its presence in the obesity market, emphasizing long-term supply agreements for VK2735.

Amgen's MariTide Shows Promise with Monthly Dosing in Obesity Treatment

• Amgen's MariTide (maridebart cafraglutide) presents a potential long-acting therapy for obesity and related conditions with a convenient once-monthly dosing regimen. • Phase II trial data demonstrated up to 20% average weight loss in patients without type 2 diabetes and up to 17% in those with type 2 diabetes at week 52. • Amgen is investing $1.02 billion to expand manufacturing capabilities, addressing supply challenges in the obesity treatment market. • Phase III trials for MariTide are planned to launch in the first and second halves of 2025, expanding its study across various diseases.

JPM25: Pfizer Focuses on Obesity, Regeneron Anticipates Key Data, BioNTech Expands Cancer Pipeline

• Pfizer is prioritizing its oral obesity drug, danuglipron, with late-stage studies planned for the second half of 2025, aiming for a novel mechanism of action. • Regeneron anticipates Phase III data readouts for itepekimab in COPD and fianlimab in melanoma, potentially expanding its portfolio alongside Dupixent. • BioNTech is advancing its mRNA-based cancer immunotherapies, including BNT327/PM8002 for solid tumors and BNT323/DB-1303, an ADC for endometrial cancer. • Sarepta Therapeutics reported strong initial sales for Elevidys in Duchenne muscular dystrophy and is pursuing a Phase III trial for limb-girdle muscular dystrophy.

Viking Therapeutics Initiates Phase 2 Trial of Oral VK2735 for Obesity

• Viking Therapeutics has commenced a Phase 2 clinical trial for oral VK2735, a dual GLP-1/GIP agonist, to treat obesity. • The VENTURE-Oral Dosing Trial will evaluate the safety, tolerability, pharmacokinetics, and weight loss efficacy over 13 weeks in approximately 280 adults. • Prior Phase 1 data showed promising weight reductions up to 8.2% and encouraging tolerability with the oral tablet formulation of VK2735. • Viking plans to initiate Phase 3 development for the subcutaneous formulation of VK2735 in the first half of 2025, following positive Phase 2 results.

Growing Evidence Supports GLP-1s' Role in Combating Heart Disease

Recent studies and FDA approvals highlight the cardiovascular benefits of GLP-1 agonists, initially developed for diabetes and obesity. The SELECT trial and Dandelion Health study underscore their potential in reducing major adverse cardiovascular events, suggesting a broader application beyond weight loss and diabetes management.

MHRA Approves Amgen's Imdylltra (Tarlatamab) for Advanced Small Cell Lung Cancer

• The UK's MHRA has granted conditional marketing authorization to Amgen's Imdylltra (tarlatamab) for extensive-stage small cell lung cancer (ES-SCLC). • The approval is for adult patients who have progressed after at least two prior lines of therapy, including platinum-based chemotherapy. • Tarlatamab demonstrated a 41% objective response rate and a 9.7-month median duration of response in the Phase 2 DeLLphi-301 trial. • Imdylltra, a bispecific T-cell engager targeting DLL3, offers a new treatment option for ES-SCLC patients with limited alternatives.

FDA Approves Zepbound as First Drug for Obstructive Sleep Apnea in Obese Adults

• The FDA has approved Zepbound (tirzepatide) as the first medication for treating moderate-to-severe obstructive sleep apnea (OSA) in obese adults. • Clinical trials showed Zepbound significantly reduced breathing disruptions and promoted weight loss compared to placebo, with nearly half of patients experiencing remission of OSA symptoms. • The drug is intended for use alongside a reduced-calorie diet and increased physical activity, offering a new approach to managing OSA and obesity. • While Zepbound shows promise, it's not suitable for all OSA patients, and continued weight loss is required for sustained effectiveness; common side effects include gastrointestinal issues.
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