Why Is Eye Disease-Focused Outlook Therapeutics Stock Trading Lower On Wednesday?
Why Is Eye Disease-Focused Outlook Therapeutics Stock Trading Lower On Wednesday?
Outlook Therapeutics Inc. (NASDAQ:OTLK) revealed preliminary topline results of NORSE EIGHT, the second of two clinical trials evaluating ONS-5010 in wet AMD patients.
Outlook Therapeutics Inc. (纳斯达克:OTLK) 公布了 NORSE EIGHt 阶段二的初步头条结果，这是评估 ONS-5010 对湿性AMD患者的两项临床试验中的第二项。
In the NORSE EIGHT trial, ONS-5010 did not meet the pre-specified noninferiority endpoint at week 8 set forth in the special protocol assessment (SPA) with the FDA.
在 NORSE EIGHt 试验中，ONS-5010在第8周未达到FDA特别协议评估（SPA）中制定的非劣效性终点。
The pre-specified noninferiority endpoint was measured by mean change in best corrected visual acuity (BCVA) from baseline to week 8.
预先指定的非劣效性终点通过基线到第8周的最佳矫正视力（BCVA）平均变化来衡量。
Also Read: Why Is Eye Disease-Focused Outlook Therapeutics Stock Trading Higher On Friday?
也可参阅：为什么以眼病为重点的 Outlook Therapeutics 股票在周五交易时上涨？
The difference in the means between the ONS-5010 and Roche Holdings AG's (OTC:RHHBY) Lucentis (ranibizumab) in the NORSE EIGHT trial was -2.257 BCVA letters, while the lower bound of the pre-specified noninferiority margin in the SPA was -3.5; the hypothesis of noninferiority was not met (p>0.025).
在 NORSE EIGHt 试验中，ONS-5010和罗氏控股（场外交易:RHHBY）的Lucentis（伦比珠单抗）之间的平均BCVA变化为-2.257个字母，而SPA中预先指定的非劣效性边界的下限为-3.5；非劣效性假设未得到满足 (p>0.025)。
In the intent-to-treat (ITT) primary dataset, NORSE EIGHT demonstrated a mean +4.2 letter improvement in BCVA in the ONS-5010 arm and +6.3 letter improvement in BCVA in the ranibizumab arm.
在意向治疗（ITT）主要数据集中，NORSE EIGHt 在ONS-5010组显示BCVA平均+4.2个字母的改善，而在伦比珠单抗组中显示BCVA平均+6.3个字母的改善。
However, the preliminary data from the trial demonstrated an improvement in vision and the presence of biologic activity, as well as a continued favorable safety profile for ONS-5010.
然而，试验的初步数据显示了视力的改善和生物活性的存在，同时 ONS-5010 仍保持有利的安全性格。
Data analysis is ongoing as month 3 data from NORSE EIGHT are being collected. The data is expected to be available in January 2025.
数据分析正在进行中，NORSE EIGHt 的第3个月数据正在收集中。预计数据将于2025年1月公布。
Upon receipt of the full month 3 efficacy and safety results for NORSE EIGHT, Outlook Therapeutics plans to resubmit the U.S. marketing application for ONS-5010 in the first quarter of calendar 2025.
在收到 NORSE EIGHt 第 3 个月的疗效和安全性结果后，Outlook Therapeutics 计划在 2025 年日历第一季度重新提交美国的 ONS-5010 营销申请。
ONS-5010/Lytenava (bevacizumab gamma) has already been granted Marketing Authorization in the European Union and the U.K.
ONS-5010/Lytenava（贝伐珠单抗伽马）在欧盟和英国已获得营销授权。
Outlook Therapeutics intends to continue efforts to launch in Europe in 2025, either directly or with a licensing partner.
Outlook Therapeutics 打算在 2025 年继续努力在欧洲推出产品，可以是直接推出或与授权合作伙伴合作。
If approved by the FDA, Outlook Therapeutics plans to commercialize ONS-5010/Lytenava (bevacizumab-vikg) directly in the U.S. It is also assessing partnering options for Lytenava (bevacizumab gamma) in Europe and other regions outside of the U.S.
如果获得 FDA 批准，Outlook Therapeutics 计划直接在美国商业化 ONS-5010/Lytenava（贝伐珠单抗-维克）产品。同时也在评估在欧洲和美国以外其他地区合作伙伴的选择。
Price Action: OTLK stock is down 80% at $0.97 during the premarket session at last check Wednesday.
价格走势：OTLk 股票在上周三的盘前交易中下跌了 80%，最新报价为 $0.97。
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Photo by Amanda Dalbjörn on Unsplash.
摄影师 Amanda Dalbjörn 在 Unsplash 上的照片。
