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Biotech Stocks Facing FDA Decision In April 2023

H Lundbeck
H Lundbeck

The FDA decision on Aripiprazole 2-month, ready-to-use, long-acting injectable, proposed for the treatment of schizophrenia in adults and for maintenance monotherapy treatment of bipolar I disorder in adults, is due on April 27, 2023.

The 2-month, ready-to-use, long-acting injectable of Aripiprazole in 960 mg and 720 mg prefilled syringes is intended for dosing every two months via intramuscular injection in the gluteal muscle.

It is being co-developed by Otsuka America Pharmaceutical, Inc., and H. Lundbeck A/S (HLBBF.OB).

If approved, Aripiprazole 2-month ready-to-use (RTU), long-acting injectable (LAI) would be the first 2- month, LAI antipsychotic indicated for both treatment of schizophrenia and the maintenance treatment of bipolar I disorder in the U.S.

HLBBF.OB closed Thursday’s trading at $4.37.