Benzinga - Biogen Inc (NASDAQ: NASDAQ:BIIB) shares traded higher 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 Times report citing a congressional investigation released on Thursday, the FDA's actions "raise serious concerns" about potential lapses in protocols.
The committee also criticized Biogen for setting "an unjustifiably high price" on its Aduhelm drug despite knowing the elevated prices would be a challenge for patients 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 FDA needs to make changes to ensure that its process for reviewing Alzheimer's candidates doesn't create doubts about the honesty and fairness of the review process.
In July, the FDA accepted a Biologics License Application for Biogen's next Alzheimer's candidate, lecanemab, under the accelerated approval pathway and granted Priority Review. Biogen also announced positive topline results from a global Phase 3 Alzheimer’s disease clinical trial of lecanemab in late September. The Prescription Drugs User Fee Act (PDUFA) action date is set for Jan. 6, 2023.
Biogen discovers, develops and delivers innovative 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 to Benzinga Pro.
Photo: Michal Jarmoluk from Pixabay.
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