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As Regulators Gear Up To Decide On Bristol Myers' Schizophrenia Treatment, Neurocrine Biosciences' Data Disappoints Investors

As Regulators Gear Up To Decide On Bristol Myers' Schizophrenia Treatment, Neurocrine Biosciences' Data Disappoints Investors

當監管機構決定布里斯托爾·邁耶斯治療精神分裂症的時候,神經分泌生物科學的數據令投資者失望。
Benzinga ·  08/28 11:16

Wednesday, Neurocrine Biosciences, Inc. (NASDAQ:NBIX) topline data for its Phase 2 clinical study of NBI-1117568 (NBI-'568) in adults with schizophrenia.

週三,Neurocrine Biosciences, Inc.(納斯達克股票代碼:NBIX)公佈了其針對精神分裂症成人 NBI-1117568(NBI-'568)的2期臨床研究的頭條數據。

NBI-'568 is the first investigational, oral, muscarinic M4 selective agonist.

NBI-'568是首款研究性口服毒素M4選擇性激動劑。

The new data showed that the once-daily 20 mg dose of NBI-'568 induced an average 18.2-point reduction from baseline in the Positive and Negative Syndrome Scale (PANSS) after six weeks, compared to 10.8 points in the placebo group.

新數據顯示,六週後,每天一次的20毫克劑量的NBI-'568使陽性和陰性綜合徵量表(PANSS)的基線平均下降18.2點,而安慰劑組的這一比例爲10.8個百分點。

Also Read: Regulators Expected To Approve Innovative Schizophrenia Treatment From Bristol Myers, Karuna.

另請閱讀:監管機構預計將批准卡魯納州布里斯托爾·邁爾斯的創新精神分裂症治療方法。

That 7.5-point difference reached statistical significance with a p-value of p=0.011.

7.5 個百分點的差異達到了統計學顯著性,p 值爲 p=0.011。

The company noted that none of the other three higher-dosing groups (30, 40, and 60 mg) reached statistical significance.

該公司指出,其他三個高劑量組(30、40和60 mg)均未達到統計學意義。

William Blair notes that while this effect size is in line with what was demonstrated by Bristol Myers Squibb Co (NYSE:BMY) acquired Karuna's KarXT, the 7.5 delta versus placebo is lower than the 11.6 difference in the Phase 3 EMERGENT-2 study.

威廉·布萊爾指出,儘管這種效應大小與百時美施貴寶公司(紐約證券交易所代碼:BMY)收購Karuna的KarXT所證明的效果一致,但7.5 delta與安慰劑的差異低於3期Emergent-2研究中的11.6差異。

It was also lower than the 0.75 effect size and 11.6-point delta from placebo from the EMERGENT-1 Phase 2 study and the 12.7-point and 11.1-point improvement over placebo with AbbVie Inc's (formerly Cerevel's) (NYSE:ABBV) emraclidine.

它也低於Emergent-1第二階段研究中安慰劑的0.75個效應大小和11.6個百分點的增量,以及艾伯維公司(前身爲Cerevel's)(紐約證券交易所代碼:ABBV)emraclidine的安慰劑的12.7點和11.1個百分點的改善。

"We do highlight that the placebo improvement of 10.8 points is greater than what was seen in prior Phase II studies of KarXT and emraclidine, which is unsurprising given potential expectation bias around a more well-validated mechanism and is more in line with prior studies of antipsychotics historically," William Blair analyst adds.

威廉·布萊爾分析師補充說:「我們確實強調,安慰劑10.8個百分點的改善幅度大於先前對karXT和emraclidine的II期研究的改善,考慮到圍繞更有效的機制可能存在預期偏差,這並不奇怪,而且更符合先前對抗精神病藥物的研究。」

Price Action: NBIX stock is down 18.90% at $123.71 at the last check on Wednesday.

價格走勢:在週三的最後一次支票中,NBIX股價下跌18.90%,至123.71美元。

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