Biogen delayed Leqembi submission brings questions, says Barclays

Barclays says Biogen and partner Eisai announced Sunday night a delay to its application submission for a Leqembi subcutaneous formulation for Q1, attributing the delay to recent feedback from FDA and bureaucratic technicalities. The firm says a second high-profile delay in the past month will raise another round of questions on the joint venture’s ability to execute and any confidence on a meaningful near- or mid-term inflection in Leqembi sales. The analyst keeps an Equal Weight rating on Biogen with a $230 price target. If the ubcutaneous Leqembi launch in the U.S. is effectively delayed into the second half of 2025, the inflection in sales over 2025 and 2026 “will be meaningfully at risk (again),” the analyst tells investors in a research note.