Home Equities Score Why Biogen Inc. (BIIB) is stock facing headwinds despite recent FDA approval?

Why Biogen Inc. (BIIB) is stock facing headwinds despite recent FDA approval?

Biogen Inc. (BIIB) shares lost 0.01% in after-hours on Thursday, June 24, 2021, and closed the day at $349.13 per share. Earlier in the morning session, BIIB’s stock lost 6.11% to close Thursday’s session at $349.16. BIIB shares have risen 30.19% over the last 12 months, and they have moved down by 8.96% in the past week. Over the past three months, the stock has gained 27.44%, while over the past six months, it has declined 40.86%.

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Let’s have a look at its recent news and developments.


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FDA Approval of Biogen Alzheimer’s Drug

On June 23, 2021, Eisai Co., Ltd., and Biogen Inc announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer’s disease (AD).

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The approval is based on the recently published results of a Phase 2b clinical trial of 856 patients with mild cognitive impairment (MCI) due to AD and mild AD with confirmed presence of amyloid pathology.

Why BIIB stock is facing tough competition?

After the controversial approval of Biogen’s Alzheimer’s disease therapy, investors speculated what it meant for other companies with similar drugs in late-stage trials.

Now other companies, recently such as Eli Lilly is nearly ready to take another shot at getting approval for a possible Alzheimer’s drug, which is putting pressure on BIIB stock and it declined yesterday. Eli Lilly said on Thursday that it plans to submit its potential treatment donanemab to the Food and Drug Administration later this year.

Commencing late-stage study on Lupus Candidate

On June 17, 2021, BIIB said that it has dosed the first patient in the phase III study, TOPAZ-1, that will evaluate its humanized IgG1 monoclonal antibody (mAb) candidate, BIIB059, in patients with active systemic lupus erythematosus (SLE). The late-stage study will be conducted across several sites globally and aims to enrol 540 active SLE patients, which will include African-American and Hispanic/Latinx communities.

Biogen stopped antibody drug development

On June 16, 2021, Biogen’announced to stop the development of an antibody-drug that was intended for treating Alzheimer’s disease after a study showed no benefit to patients.

The investigational antibody, gosuranemab, (BIIB092), didn’t show efficacy compared with a placebo in patients with mild cognitive impairment due to Alzheimer’s and mild Alzheimer’s disease dementia.

Update about 2nd Eye Disease Gene Therapy

On June 15, 2021, Biogen announced that a phase III study evaluating timrepigene emparvovec (BIIB111), a gene therapy candidate for the one-time treatment of choroideremia, a rare inherited retinal disease failed to meet its primary or key secondary endpoints.

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Conclusion

As we discussed above, Biogen is facing tough competition because more companies are seeking approval for their Alzheimer’s drug after FDA approved controversial Biogen treatment. That’s was the reason BIIB stock dipped on Thursday.

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