Biogen Inc (NASDAQ: BIIB) has an imminent stock catalyst in the form of an Adcom meeting for its Alzheimer’s treatment candidate aducanumab, which it is co-developing with Japan’s Eisai Co., Ltd (Pink: ESALY).
Significant Binary Event For Biogen: The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee is scheduled to meet Friday to discuss Biogen’s BLA for aducanumab solution for intravenous infusion in the treatment of Alzheimer’s disease.
The BLA was accepted for review in early August.
Ahead of the meeting Wednesday, the drug regulator will release briefing documents with details about the BLA and comments by FDA staffers for the committee.
The AdCom briefing document release and meeting could potentially drive a highly significant binary event in biotech, H.C. Wainwright analyst Andrew Fein said in a note.
And BMO Capital Markets analyst George Farmer said heavy scrutiny of FDA advisory committee background materials is expected after the Wednesday release and ahead of Friday’s meeting.
“We think the documents will reveal significant FDA statistician concern over the nature of the post-hoc analysis of the Phase 3 trials on which management is relying upon to support an a-mab clinical benefit,” the analyst said.
He cautioned against reading too much into the document content to predict Friday’s AdCom outcome, as a combination of factors such as the impact of aducanumab on Alzheimer’s disease biomarkers — and the huge unmet medical need — could sway the committee to rule in favor of an approval.
Related Link: The Week Ahead In Biotech (Nov. 1-7): Adcom Test For Biogen’s Aducanumab, Alzheimer’s Conference, SMID-cap Earnings
Credit Suisse’s Evan Siegerman said the FDA panel is critical in determining the final vote.
“We continue to believe that the drug will be approved given the high unmet need; there are no approved, disease modifying therapies, constituting high unmet need in AD, which remains the 6th leading cause of death in the world,” the analyst said.
Biogen recently reiterated that aducanumab has substantial evidence of efficacy and it would not have filed if it believed otherwise, he said.
While concurring it will likely be a challenging AdCom meeting, Siegerman highlighted the possibility of aducanumab being approved even if the AdCom verdict is unfavorable.
Not all are optimistic.
Wedbush said it lacks confidence in the aducanumab story and await a better entry point.
Against the backdrop of falling sales of Spinraza and overly optimistic expectations for Tecfidera, Biogen has a lot riding on aducanumab approval, said SVB Leerink’s Marc Goodman.
The FDA has set a PDUFA date of March 7 for approving aducanumab.
Stock Implication: An approval and fulsome aducanumab label could make Biogen stock worth $308 per share, Wedbush analyst Laura Chico said.
An approval with a smaller orrestricted market opportunity yields minimal upside and would suggest a value of $276 per share, the analyst said.
An outright rejection will likely send the stock to a support around $181 per share, according to Wedbush.
BIIB Price Action: At last check, Biogen shares were down 2.09% at $243.79.
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