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Why Is Gastrointestinal Healthcare Focused Ironwood Pharmaceuticals Stock Sinking On Thursday?

Why Is Gastrointestinal Healthcare Focused Ironwood Pharmaceuticals Stock Sinking On Thursday?

为什么专注于胃肠道医疗保健的Ironwood Pharmicals股票在周四下跌?
Benzinga ·  02/29 11:34

Ironwood Pharmaceuticals Inc (NASDAQ:IRWD) released topline results from its pivotal Phase 3 STARS trial of once-weekly subcutaneous apraglutide in reducing parenteral support (PS) (drugs given by routes other than the digestive tract) dependency in adult patients with short bowel syndrome with intestinal failure (SBS-IF).

Ironwood Pharmaceuticals Inc(纳斯达克股票代码:IRWD)公布了其关键的三期STARS试验的主要结果,该试验每周一次的皮下阿普拉鲁肽用于减少成年短肠综合征合并肠衰竭(SBS-IF)患者的肠外支持(PS)(通过消化道以外途径给予的药物)的依赖。

SBS-IF, a rare and severe organ failure condition in which patients are dependent on PS, affects an estimated 18,000 adult patients in the U.S., Europe, and Japan.

SBS-IF是一种罕见的严重器官衰竭疾病,患者依赖PS,估计影响了美国、欧洲和日本的18,000名成年患者。

The trial met its primary endpoint of relative change from baseline in actual weekly PS volume at week 24, comparing apraglutide versus placebo (-25.5% vs. -12.5%).

该试验达到了其主要终点,即在第24周实际每周PS量与基线相对变化,比较了阿普拉鲁肽与安慰剂(-25.5%对比-12.5%)。

In addition, there were four key secondary endpoints evaluated in statistical hierarchy.

此外,在统计层次结构中评估了四个关键的次要终点。

Apraglutide demonstrated statistical significance for the first two key secondary endpoints, with more patients in the combined population achieving at least one day/week off PS relative to baseline at week 24 versus placebo (43.0% vs. 27.5%; p=0.040) and more patients treated with apraglutide versus placebo demonstrating improvement in relative change from baseline in actual weekly PS volume at week 24 in the stoma population (-25.6% vs. -7.8%; p<0.001).

Apraglutide对前两个关键次要终点显示出统计学意义,与安慰剂相比,合并人群中在第24周实现至少一天/周的PS减少一天/周的患者比安慰剂更高(43.0%对27.5%;p=0.040),并且越来越多的患者在造口人群中在第24周的实际每周PS量与基线相比有所改善(-25.6%对比-7.8%;p:8%;p= 7.8%;p

The third and fourth key secondary endpoints were specific to colon-in-continuity patients in assessing at least one day/week off PS versus baseline and reaching enteral autonomy at week 48, which were not achieved.

第三和第四个关键次要终点是结肠连续性患者所特有的,他们评估了与基线相比至少一天/一周的时间,以及在第48周达到肠内自主权,但均未实现。

Probably, shares tanked because of this endpoint miss.

股价可能因为这个终点失误而暴跌。

Apraglutide was numerically favorable but not statistically significant relative to placebo for improving days off PS (51.8% versus 44.4%) and reaching enteral autonomy in seven out of 56 (12.5%) patients versus two out of 27 (7.4%) patients on placebo. Apraglutide was generally well-tolerated.

与安慰剂相比,Apraglutide在改善56名患者中有7名(12.5%)的休假天数(51.8%对44.4%)和达到肠内自主权方面表现良好,但与安慰剂相比,没有统计学意义。Apraglutide 的耐受性总体良好。

Ironwood Pharmaceuticals added apraglutide to its portfolio when it acquired VectivBio for $17.00 per share in an all-cash transaction with an estimated aggregate consideration of approximately $1 billion, net of VectivBio cash and debt.

Ironwood Pharmicals在全现金交易中以每股17.00美元的价格收购了VectivBio,从而在其投资组合中增加了apraglutide,扣除VectivBio的现金和债务,估计总对价约为10亿美元。

Ironwood plans to submit a new drug application and other regulatory filings for apraglutide for use in adult patients with SBS who are dependent on PS.

Ironwood计划提交阿普拉鲁肽的新药申请和其他监管文件,用于依赖PS的成年SBS患者。

Ironwood looks forward to presenting additional data from the STARS study at upcoming medical conferences later this year.

艾恩伍德期待在今年晚些时候举行的医学会议上公布STARS研究的更多数据。

Price Action: IRWD shares are down 39.50% at $9.15 on the last check Thursday.

价格走势:在周四的最后一次支票中,IRWD股价下跌39.50%,至9.15美元。

Photo by hans-reniers for Unsplash

由 hans-reniers 为 Unsplash 拍摄的照片

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