ReportsLOA and PTSR Model - 0.75 Percent Nyxol in Nyctalopia (Night Blindness) due to Vitamin A Deficiency GlobalData
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来源: Pharmaceutical Technology
ReportsLOA and PTSR Model - 0.75 Percent Nyxol Eye Drop in Mydriasis GlobalData
View allCompanies IntelligenceGalera Therapeutics IncC R L IncView all
The news about the CRL and lay-offs led to a freefall of Galera’s stock. The company’s share price reduced by over 80% in pre-market trading on 10 August, compared to market close on the previous day. Galera’s current market cap is at $96.1m.
Avasopasem is an enzyme mimetic that converts superoxide-free radical molecules to hydrogen peroxide and oxygen, thereby reducing the intensity and duration of severe oral mucositis.
The company said it plans to request a Type A meeting with the US FDA to gain further insight into the CRL and discuss resubmission for the approval of avasopasem. Additionally, the company is exploring partnerships and licensing agreements for both avasopasem and its other lead drug candidate rucosopasem.