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Biogen's Gosuranemab Fails in Phase II Brain Disorder Study

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Biogen Inc. BIIB announced that its phase II study – PASSPORT – evaluating its pipeline candidate, gosuranemab (BIIB092), in patients with progressive supranuclear palsy (PSP) failed to meet its primary endpoint. Notably, patients with PSP suffer from gradual deterioration and death of specific volumes of the brain that leads to loss of balance, slowing of movement, difficulty moving the eyes, and dementia.

Data from the study showed that improvement in PSP patients treated with gosuranemab as measured by PSP rating scale at week 52 was not statistically significant. Moreover, the candidate failed to demonstrate efficacy in patients on key clinical secondary endpoints. Based on these data, the company has decided to discontinue further development of gosuranemab for PSP and other primary tauopathies.

However, Biogen stated that it will continue the development of gosuranemab for treating mild cognitive impairment due to Alzheimer’s disease. Currently, the candidate is being evaluated in the phase II TANGO study for this indication.

Please note that Biogen has in-licensed gosuranemab from Bristol-Myers BMY.

Year to date, Biogen has declined 1.4% against the industry’s 7.2% growth.

However, earlier this month, Biogen’s shares received a boost when it presented mixed new data from the ENGAGE and EMERGE phase III studies on its lead Alzheimer’s candidate, aducanumab, at the Clinical Trials on Alzheimer's Disease.

In October, Biogen revealed plans to pursue U.S. regulatory approval of aducanumab based on positive results from a new analysis of larger dataset from the discontinued ENGAGE and EMERGE studies. In March, Biogen and Eisai had announced discontinuation of ENGAGE and EMERGE, following a futility analysis. However, new analysis of the larger dataset showed a different outcome than the one predicted at the time of the futility analysis.

Biogen has a diversified pipeline with several promising candidates in different stages of clinical development.Between now and the end of 2020, important data readouts are expected across clinical programs in multiple sclerosis, epilepsy, Parkinson’s disease and others. The company successfully completed a phase II study evaluating its fully humanized IgG1 monoclonal antibody, BIIB059, in cutaneous lupus erythematosus and systemic lupus erythematosus earlier this month.

Biogen Inc. Price

Biogen Inc. Price

Biogen Inc. price | Biogen Inc. Quote

Zacks Rank & Stocks to Consider

Biogen currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Alkermes plc ALKS and Anika Therapeutics Inc. ANIK. Both the stocks sport a Zacks Rank #1 (Strong Buy), You can see the complete list of today’s Zacks #1 Rank stocks here.

Alkermes’ earnings estimates increased from 36 cents to 52 cents for 2019 and changed from a loss of 11 cents to earnings of 59 cents for 2020 over the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, the average beat being 236.8%.

Anika’s earnings estimates increased from $1.75 to $2.03 for 2019 and from $1.38 to $1.62 for 2020 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, the average beat being 53.31%. Share price of the company has gained 58.1% so far this year.

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