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Aldeyra Therapeutics Gets CRL From FDA For NDA Of ADX-2191 To Treat Primary Vitreoretinal Lymphoma

Biotechnology company Aldeyra Therapeutics, Inc. (ALDX) announced Wednesday the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the 505(b)(2) New Drug Application (NDA) of ADX-2191 (methotrexate for injection, USP), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma (PVRL).

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Aldeyra Therapeutics (ALDX) Receives CRL from FDA for ADX-2191

Aldeyra Therapeutics (ALDX) Receives CRL from FDA for ADX-2191
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Aldeyra Therapeutics Provides Regulatory Update on ADX-2191

Based on U.S. Food & Drug Administration (FDA) Determination of Lack of Adequate and Well Controlled Investigations in the Scientific Literature, Complete Response Letter Received for New Drug Application (NDA) of ADX-2191 (methotrexate injection, USP) for the Treatment of Primary Vitreoretinal Lymphoma (PVRL) Due to Shortage of Methotrexate, Lack of Approved Therapy for PVRL, and Inbound Requests for ADX-2191, Expanded Access Program Planned to be Discussed with FDA

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Aldeyra Therapeutics (ALDX) Receives CRL from FDA for ADX-2191

Ptoddc bradyAccess programDrug administrationComplete response letterNew drug applicationChief executive officerExpanded access program

RedHill Biopharma Announces Q1/2023 Financial Results and Operational Highlights

Q1/23 Talicia net revenues of $3.4 million; Cash balance of $28.8 million as of March 31, 2023[1]; Extinguishment of all debt obligations in exchange for the.

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