Biogen Inc. (BIIB) said it had received a negative opinion on the Marketing Authorization Application for aducanumab, which was designed to treat early stages of Alzheimer’s disease, from the Committee for Medicinal Products for Human Use of the European Medicines Agency.
The opinion was based on data from a global, multi-study clinical development program that included about 3,600 patients.
Biogen plans to request a re-examination of the CHMP opinion. The European Commission allows such requests, upon submission of documentation with detailed grounds for the same. Within a period of 60 days from receipt of this documentation, the committee will have to re-examine the opinion.
Head of Global Safety & Regulatory Sciences and interim Head of Research & Development at Biogen, Priya Singhal, M.D., M.P.H., said, “As part of the re-examination process, we will seek to address the CHMP’s grounds for refusal, with the goal of making this medicine available in the EU. European patients deserve access to innovative treatments for Alzheimer’s disease.”
Price Target
Following the news, Needham analyst Ami Fadia maintained a Buy rating on Biogen with a price target of $386 (62.6% upside potential from current levels).
Fadia noted, “We are not surprised by this decision given the prior negative trend vote and the regulatory history in the US. We currently have 75% risk adjustment for EU sales of Aduhelm in the model to account for the risk, and wait for the final decision after re-examination.”
Consensus among analysts is a Moderate Buy based on 15 Buys and 10 Holds. The average Biogen price target stands at $346.18 and implies upside potential of 45.8% to current levels.
Risk Factors
Investors should always be aware of the risks involved in any stock. According to the TipRanks Risk Factors tool, BIIB is at risk mainly from two factors: Tech and Innovation, and Finance and Corporate, which contribute 20% and 23%, respectively, to the total 30 risks identified for the stock.
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