AbbVie (NYSE:ABBV) unit Allergan has received a Complete Response Letter (CRL) from the FDA regarding its marketing application seeking approval of DARPin drug abicipar pegol for the treatment of neovascular age-related macular degeneration (wet AMD).
The agency cited an unfavorable benefit/risk ratio.
The company plans to meet with the regulator to discuss next steps.
Allergan in-licensed exclusive global rights to the candidate from Molecular Partners (OTCPK:MLLCF) in August 2021 in a deal valued as high as $420M.
Wet AMD-related tickers: REGN, NVS, RGNX, ADVM, OCUL, OTCPK:CKDXY, OTLK, ISEE, OTCPK:BAYRY, OTCQX:RHHBY
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