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Amgen, a key player in the biotechnology sector, recently disclosed its financial performance for 2024, reporting a notable revenue increase of 19% to $334.24 billion. This exceeded the annual forecast of $331.9 billion. However, the company also faced challenges with its obesity drug pipeline. The FDA placed a hold on the Phase 1 trial of AMG 513, citing the need to protect participants from unreasonable risk, a move Amgen is currently addressing by exploring avenues to resume research.
The setback with AMG 513 hasn't deterred the company from advancing MariTide, another promising obesity therapy in their portfolio. MariTide, which operates through a dual mechanism with monthly or less frequent dosing, has generated significant interest and is hoped to compete with notable drugs like Wegovy and Zepbound. Despite its unique positioning, the stock saw a decline due to higher-than-expected side effects and unmet market expectations.
Further controversy arose when analysts flagged potential issues with MariTide's impact on bone density, leading to a significant market reaction. Amgen refuted these claims, maintaining there’s no correlation between MariTide dosing and bone density changes, supported by findings from both Phase I and II studies.
In a strategic shift, Amgen opted to suspend the development of certain early-stage products, such as AMG 786, to focus resources on MariTide and some preclinical assets. This decision aligns with Amgen's commitment to high-impact areas like common internal medicine diseases, rare diseases, inflammation, and oncology, sectors that have shown consistent sales growth.
MariTide's development is a highlight among Amgen's pipeline, with Phase III studies scheduled to commence later this year. Data from these trials will further ascertain its potential as a long-term obesity treatment. With an aim to secure a formidable position in the obesity market, Amgen emphasizes MariTide's potential in providing effective long-term therapeutic options for weight management.
As the competitive landscape intensifies with significant rivals like Novo Nordisk's Wegovy and Eli Lilly's Zepbound, Amgen’s strategic focus remains on leveraging MariTide's distinct dosing regimen and expanding its production capabilities. The company is poised to address unmet clinical needs in obesity treatment, promoting a future where such therapies are more accessible and efficient in tackling obesity-related conditions.

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