Commercial RiskRisks include commercial risk with Enhanze, failure to generate favorable clinical data from ongoing programs, partnership risk, and possible long-term dilution risk.
Manufacturing IssuesJanssen, a J&J subsidiary, is working with the FDA to resolve manufacturing issues cited by a letter from the agency in December 2024.
Revenue GuidanceThe company assumes no milestone revenue in the first half and expects $100M-$130M in collaboration revenue for the full year, which is roughly $30M lower than the previous guidance due to the amivantamab CRL.