Aldeyra (ALDX) ADX-2191 Failed NDA Case

• FDA stated that there was a lack of effectiveness evidence in NDA for Aldeyra's ADX-2191.

• $ALDX fell over 27%, losing $170 million of its market cap.

• Investors suspect Aldeyra of failing to disclose that the ADX-2191 application did not include adequate investigations.

On June 21, 2023, Aldeyra (ALDX) announced receipt of a CRL from the FDA for the NDA of ADX-2191 (methotrexate for injection, USP), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma (PVRL). The press release stated that “although no safety or manufacturing issues with ADX-2191 were identified, the FDA stated that there was a lack of substantial evidence of effectiveness due to a lack of adequate and well-controlled investigations’ in the literature-based NDA submission.

On this news, $ALDX fell over 27%, losing more than $170 million of its market capitalization.

Taking all representations into account, Investors have reasons to suspect Aldeyra and its Accountables of misleading and failing to disclose that the ADX-2191 application did not include adequate and well-controlled investigations and thus failed to show substantial evidence of ADX-2191's effectiveness.