What’s Going On With Biogen Stock Today?

Biogen Inc BIIB shares tradedhigher Thursday morning before pulling back. Reports indicate that the FDA's process for approving Biogen's Alzheimer's drug Aduhelm was filled with "irregularities."

What To Know: According to a New York Timesreportciting a congressional investigation released on Thursday, the FDA's actions "raise serious concerns" about potential lapses in protocols.

The committeealso criticized Biogen for setting "an unjustifiably high price" on its Aduhelm drug despite knowingthe elevatedprices would be a challenge forpatients in need. The company reportedly planned to use aggressive marketing tactics to push back against uproar over high prices.

The congressional report indicates that the FDAneeds to make changes to ensure that itsprocessfor reviewing Alzheimer's candidates doesn'tcreate doubts about the honesty and fairness of the review process.

In July, theFDAaccepted aBiologics License Applicationfor Biogen's next Alzheimer's candidate, lecanemab, under the accelerated approval pathway and granted Priority Review. Biogen alsoannounced positive topline results from aglobal Phase 3Alzheimers diseaseclinical trial of lecanemab in late September.The Prescription Drugs User Fee Act (PDUFA)action date is set for Jan.6, 2023.

Biogen discovers, developsand deliversinnovative therapies for people living with serious neurological diseases.

Check This Out:Biogen's 2nd Alzheimer's Antibody, BeiGene's Cancer Drug Label Expansion, Adcom Test For Regeneron And More: January PDUFA Catalysts For Biotech Investors

BIIB Price Action: Biogen has a 52-week high of $311.88 and a 52-week low of $187.16.

Biogen shares are up 0.7% at $275.97 Thursday afternoon, according toBenzinga Pro.

Photo:Michal Jarmolukfrom Pixabay.