FDA Accepts Camzyos sNDA for Priority Review in Adolescent oHCM
Read source articleWhat happened
Bristol Myers Squibb announced the FDA has accepted for priority review its supplemental new drug application for Camzyos (mavacamten) to treat adolescents with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). This is a minor positive for BMY's growth portfolio, which already showed strong Camzyos momentum (+59% Q4'25). However, Camzyos represents only ~2% of total revenue, and the company's 2026 bridge-year thesis hinges on Eliquis volume and gross margin stability, not on Camzyos expansion. The news does not alter the key risk factors: IRA price resets on Eliquis and Revlimid erosion inflection on Jan 31, 2026.
Implication
The Camzyos sNDA acceptance adds a minor tailwind to BMY's growth portfolio, which is already performing well (FY25 growth +17%). However, Camzyos revenue is immaterial relative to Eliquis ($14.4B) and the overall $48B revenue base. The core investment thesis remains a WAIT: the next 1-2 quarters must confirm that Eliquis can meet its +10-15% growth guide without compressing gross margin below 69%. Until that evidence is in, the stock is fairly priced at $60-65. This news alone does not justify increasing exposure.
Thesis delta
The Camzyos priority review is a modest positive for the growth portfolio but does not shift the central thesis, which remains anchored to Eliquis margin defense and overall gross margin stability in 2026. The WAIT rating is maintained, with no change to the $65 base case or the $55 attractive entry.
Confidence
Moderate