Soleno falls after FDA rejects peer Applied's genetic disease drug

Soleno Therapeutics

29/11/2024 17:40

** Shares of Soleno Therapeutics  SLNO.O  fall 6.1% to
$52.41
    ** On Tuesday, U.S. FDA extended the review of SLNO's drug
to treat a rare genetic disorder Prader–Willi syndrome
    ** Investors are overreading into Applied's  APLT.O  FDA
outcome - brokerage Baird
    ** On Friday, FDA rejects APLT's drug to treat galactosemia,
a rare genetic metabolic disease
    ** Baird says SLNO's drug DCCR meets FDA's standard of
substantial evidence of effectiveness at face value
    ** In SLNO's study, in consultation with the FDA, DCCR met
the main goal, whereas APLT's drug missed the main goal in its
study - brokerage
    ** SLNO has FDA's breakthrough designation for DCCR, while
APLT does not - Baird
    ** SLNO has a stronger application for approval and more
external validation from the FDA - brokerage
    ** FDA will decide on SLNO's drug by Mar. 27
    ** YTD, SLNO up 28.8%

 (Reporting by Puyaan Singh)
 ((Puyaan.Singh@thomsonreuters.com;))