Biogen Inc (NASDAQ:BIIB) shares are trading lower Tuesday. The company reported first-quarter results before the bell and the FDA approved its ALS therapy Tuesday afternoon.
Q1 Earnings: Biogen reported first-quarter revenue of $2.46 billion, which beat average estimates of $2.34 billion. The company reported adjusted earnings of $3.40 per share, which beat estimates of $3.28 per share, according to Benzinga Pro.
Biogen reaffirmed its full-year 2023 guidance. The company still anticipates a mid-single digit revenue decline year-over-year. Full-year adjusted earnings are expected to be between $15 and $16 per share versus estimates of $15.72.
Related Link: Biogen Announces Additional Cost Cutting Initiatives, Chops Certain Stroke, Gene Therapy Programs
FDA Approval: The FDA approved Biogen and Ionis Pharmaceuticals Inc’s (NASDAQ:IONS) tofersen, which will be sold under the brand name Qalsody. The drug is approved for ALS patients who have a specific genetic mutation in the superoxide dismutase 1 gene.
“We believe this important scientific advancement will further accelerate innovative drug development for ALS,” Biogen CEO Chris Viehbacher reportedly said in a statement.
According to the CDC, between 16,000 and 32,000 Americans are currently living with ALS, but only about 2% have the gene mutation that Qalsody will target.
BIIB Price Action: Biogen shares were down 3.61% at $282.46 at the time of writing, according to Benzinga Pro.
Photo: Konstantin Kolosov from Pixabay.
