Why Is Gastrointestinal Healthcare Focused Ironwood Pharmaceuticals Stock Sinking On Thursday?
Why Is Gastrointestinal Healthcare Focused Ironwood Pharmaceuticals Stock Sinking On Thursday?
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（納斯達克股票代碼：IRWD）公佈了其關鍵的三期STARS試驗的主要結果，該試驗每週一次的皮下阿普拉魯肽用於減少成年短腸綜合徵合併腸衰竭（SBS-IF）患者的腸外支持（PS）（通過消化道以外途徑給予的藥物）的依賴。
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是一種罕見的嚴重器官衰竭疾病，患者依賴PS，估計影響了美國、歐洲和日本的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%).
該試驗達到了其主要終點，即在第24周實際每週PS量與基線相對變化，比較了阿普拉魯肽與安慰劑（-25.5％對比-12.5％）。
In addition, there were four key secondary endpoints evaluated in statistical hierarchy.
此外，在統計層次結構中評估了四個關鍵的次要終點。
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對前兩個關鍵次要終點顯示出統計學意義，與安慰劑相比，合併人群中在第24周實現至少一天/周的PS減少一天/周的患者比安慰劑更高（43.0％對27.5％；p=0.040），並且越來越多的患者在造口人群中在第24周的實際每週PS量與基線相比有所改善（-25.6％對比-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.
第三和第四個關鍵次要終點是結腸連續性患者所特有的，他們評估了與基線相比至少一天/一週的時間，以及在第48周達到腸內自主權，但均未實現。
Probably, shares tanked because of this endpoint miss.
股價可能因爲這個終點失誤而暴跌。
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.
與安慰劑相比，Apraglutide在改善56名患者中有7名（12.5％）的休假天數（51.8％對44.4％）和達到腸內自主權方面表現良好，但與安慰劑相比，沒有統計學意義。Apraglutide 的耐受性總體良好。
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在全現金交易中以每股17.00美元的價格收購了VectivBio，從而在其投資組合中增加了apraglutide，扣除VectivBio的現金和債務，估計總對價約爲10億美元。
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計劃提交阿普拉魯肽的新藥申請和其他監管文件，用於依賴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時候舉行的醫學會議上公佈STARS研究的更多數據。
Price Action: IRWD shares are down 39.50% at $9.15 on the last check Thursday.
價格走勢：在週四的最後一次支票中，IRWD股價下跌39.50％，至9.15美元。
Photo by hans-reniers for Unsplash
由 hans-reniers 爲 Unsplash 拍攝的照片