Theratechnologies down as FDA declines to approve new form of fat reduction drug

Theratechnologies

24/01/2024 12:55

** U.S.-listed shares of Canadian drugmaker
Theratechnologies  THTX.O  fall 29.7% to $1.21 premarket 
    ** THTX says the U.S. FDA has declined to approve the new,
more concentrated formulation of its fat reduction drug Egrifta
SV
    ** Egrifta SV is already approved in the U.S. to reduce
excess abdominal fat in HIV-infected patients with a rare
condition called lipodystrophy  
    ** Lipodystrophy impacts patients' ability to accumulate and
maintain healthy fat in certain parts of the body 
    ** Co says FDA has requested clarifications around
manufacturing of the reconstituted drug 
    ** Agency has also requested additional information related
to the immune response of the new formulation of the drug - THTX
     ** Co plans to address the FDA's requests and questions "as
swiftly as possible" 
    ** Agency's decision does not affect commercial availability
of already approved formulation of Egrifta SV - THTX   
    ** Stock has fallen 55.9% in the last 12 months 

 (Reporting by Sneha S K)
 ((Sneha.SK@thomsonreuters.com;))