Alembic Pharmaceuticals secures tentative FDA nod for prostate cancer drug
Alembic Pharmaceuticals just got a tentative thumbs-up from the US Food and Drug Administration for its darolutamide tablets (300 mg), used to treat advanced prostate cancer.
The news sent Alembic's stock up nearly 3% on Thursday.
This approval brings the company's total US Food and Drug Administration nods to 238, showing the company's steady progress in the generics game.
Darolutamide a generic of Bayer's Nubeqa
Darolutamide is basically a generic version of Bayer's Nubeqa, which has an estimated market size of $3.16 billion for the 12 months ending March 2026.
Just last month, Alembic also secured final approval for fingolimod capsules (used for multiple sclerosis), adding another win to its lineup.
Despite this month's gains, though, Alembic's stock is still down 14% over the past year, so it's been a bit of a rollercoaster for investors.