Amgen Valuation Hinges on CNPV Program and Obesity Market Growth

Amgen (AMGN) is back in focus after reporting positive topline Phase 3 data from its OASIZ 301 trial of dazodalibep in Sjögren's disease. The drug has shown significant promise, which has contributed to the company's strong momentum over the past few months.

The share price of AMGN has surged by 17.2% over the past 90 days and 29.3% year-to-date. However, some analysts believe that the recent autoimmune excitement may have simply flipped sentiment rather than being based on a fundamental revaluation of the company's worth.

One narrative suggests that Amgen is overvalued by 18%, with a fair value of $359.98. This view relies on a top-line fallacy, assuming that macro obesity market growth and FDA's CNPV (Commissioner’s National Priority Voucher) tailwinds will automatically trigger a re-rating.

However, the CNPV program has several challenges, including regulatory friction and structural transparency questions. Moreover, competitors such as Novo Nordisk have already secured fast-track approvals for their products, making it difficult for Amgen to enter the market.