Aldeyra Therapeutics slumps as FDA declines to approve eye cancer drug

Aldeyra Therapeutics

21/06/2023 15:34

** Shares of drug developer Aldeyra Therapeutics  ALDX.O 
drop ~23% to $8.16
    ** ALDX says U.S. Food and Drug Administration (FDA) has
declined to approve its treatment, ADX-2191, for a rare and
fatal eye cancer, primary vitreoretinal lymphoma (PVRL)
    ** There was “lack of substantial evidence of effectiveness”
of the drug in the co's application - FDA
    ** Based on previous discussions with the FDA, ALDX did not
conduct any clinical trials of ADX-2191 
    ** ALDX does not currently believe that clinical studies are
feasible 
    ** FDA did not identify any safety or manufacturing issues
with ADX-2191 - co
    ** ALDX plans to hold discussions with the FDA to make
ADX-2191 available to PVRL patients under the "Expanded Access
Program"
    ** The program could allow patients to access ALDX's drug
for treatment without FDA approval and outside of clinical
studies
    ** Currently, there are no FDA-approved treatments for PRVL
    ** As of last close, ALDX up ~53% YTD 

 (Reporting by Bhanvi Satija in Bengaluru)
 ((Bhanvi.Satija@thomsonreuters.com; Outside U.S. +91
9873062788;))