With Aduhelm Approval Behind Biogen, 5 Catalysts For Investors To Watch

Biogen Inc. BIIB made history of sorts with the FDA approval for its Alzheimer's treatment Aduhelm.

Notwithstanding the still-raging debate over the decision, an analyst at Morgan Stanley is looking past the decision and into key upcoming catalysts that could provide significant upside optionality for Biogen investors.

The following are five key impending catalysts for Biogen, according to analyst Matthew Harrison:

Tecfidera Decision: Morgan Stanley's probability of success for Biogen to get the decision invalidating its key Tecfidera patent reversed on appeal is significantly higher than typical precedent, Harrison said.

"We continue to believe the argument went better than expected for Biogen and see a ~50% likelihood of success that the appeal decision goes in their favor," the analyst said 

The decision is expected anytime now, and if Biogen wins, the stock is poised for 10% upside, he said. 

Zuranolone Data: Partner Sage Therapeutics, Inc. SAGE is expected to report initial data from the Phase 3 study testing zuranolone in patients with major depressive disorder in the second quarter of 2021, Harrison said.

An 85% probability exists that zuranolone meets the primary endpoint, and a 50% PoS that zuranolone achieves a 1-3-point HAM-D improvement and a 35% PoS around a 4+ point improvement, he said. 

With Morgan Stanley's base case outcome, Biogen shares could be flat to up 5%, and in the upside scenario, the stock could appreciate 5%-10%, according to Harrison.

Related Link: 5 Biogen Analysts On FDA Approval Of Alzheimer's Drug Aduhelm, Broad Label, Pricing

Gosuranemab Phase 2 Data: Gosuranemab, the analyst noted, is an anti-tau antibody designed to clear extracellular, N-terminal fragments of tau for the treatment of mild Alzheimer's disease.

The analyst gave a relatively low PoS, given management's comments around the negative read-through from Roche Holding AG's RHHBY semorinemab data, and challenging the anti-tau antibody approach.

"In a failure, we see limited downside to BIIB; in a surprising success, we believe BIIB could be up 10-20%," the analyst said. The data is due in the second quarter.

BIIB080 Phase 1b Detailed Results: BIIB080 Phase 1b data is due to be presented at the Alzheimer's Association International Conference July 26-30, Harrison said.

Initial Phase 1b data suggested that BIIB080 achieved a dose and time-dependent reduction in both CSFtotal tau and phospho-tau, he added.

"We are encouraged by these results and await more details around the initiation of the PhII trial," the analyst said.

Tofersen Phase 3 Data: Tofersen is also an antisense therapy designed to block SOD1 protein production to slow the progression of familial amyotrophic lateral sclerosis, Harrison said. The analyst noted that the data is due in the second half of 2021.

Biogen management is encouraged by initial data supporting target engagement, he added.

The Biogen Rating: Harrison rates Biogen an Outperform with a $455 price target.

BIIB Price Action: Biogen shares gained 1.91% Thursday, closing at $414.71. 

Related Link: Biogen CEO Michel Vounatsos Talks Alzheimer's Treatment Approval