Why Is Small Cap Amylyx Pharmaceuticals Stock Trading Higher On Wednesday?
Why Is Small Cap Amylyx Pharmaceuticals Stock Trading Higher On Wednesday?
Amylyx Pharmaceuticals Inc (NASDAQ:AMLX) acquired avexitide from Eiger BioPharmaceuticals Inc (OTC:EIGRQ) for $35.1 million.
Amylyx Pharmaceuticals Inc (納斯達克:AMLX) 以3510萬美元從Eiger BioPharmaceuticals Inc (場外交易:EIGRQ) 收購了avexitide。
Avexitide is an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist that has been evaluated in five clinical trials for post-bariatric hypoglycemia (PBH) and has also been studied in congenital hyperinsulinism (HI), two indications characterized by hyperinsulinemic hypoglycemia.
Avexitide是一種探究性的、首創的胰高血糖素樣肽-1（GLP-1）受體拮抗劑，已經在五個臨床試驗中用於後減重手術低血糖症（PBH），並在先天性高胰島素血癥（HI）中進行了研究。這兩種適應症的特徵都是高胰島素性低血糖。
The FDA has granted avexitide Breakthrough Therapy Designation for both indications, Rare Pediatric Disease Designation in congenital HI, and Orphan Drug Designation for hyperinsulinemic hypoglycemia (which includes PBH and congenital HI).
美國食品藥品監督管理局（FDA）已將avexitide授予了突破性療法指定，用於兩個適應症，分別是先天性HI罕見兒科病指定以及高胰島素性低血糖孤兒藥指定（其中包括PBH和先天性HI）。
Also Read: Amylyx Pharmaceuticals' Investigational Drug Shows Improved Pancreatic Function In Patients With Inherited Disorder.
此外，Amylyx Pharmaceuticals的研究藥物在患有遺傳性疾病的患者中顯示出胰腺功能的改善。
Avexitide is designed to bind to the GLP-1 receptor on pancreatic islet beta cells and block the effect of GLP-1 to mitigate hypoglycemia by decreasing insulin secretion and stabilizing glucose levels.
Avexitide旨在結合胰島β細胞上的GLP-1受體，並阻止GLP-1的作用，以減輕低血糖，通過減少胰島素分泌和穩定血糖水平。
As part of the transaction, Amylyx assumed certain contractual obligations from Eiger, including a 3% royalty on future sales of avexitide in PBH, if approved, to certain academic institutions.
作爲交易的一部分，Amylyx承擔了從艾格公司轉移而來的某些合同義務，包括在PBH中如果Avexitide獲得批准，向某些學術機構支付未來銷售額的3%版稅。
In previous Phase 2 and Phase 2b studies in PBH, avexitide showed statistically significant reductions in hypoglycemic events characterized by low blood glucose.
在先前針對PBH的二期和二十億研究中，Avexitide在低血糖的表現方面表現出顯著的統計學減少。
Amylyx expects to begin the Phase 3 program for avexitide in PBH in Q1 2025.
Amylyx預計將在2025年第一季度開始PBH的三期項目。
The results from the Phase 2 PREVENT study showed that, compared with placebo, avexitide 30 mg twice daily (BID) and 60 mg once daily (QD) significantly increased mean plasma glucose nadir (prespecified primary endpoint) and lowered insulin peak, corresponding to 50% and 75% fewer participants requiring rescue during mixed meal tolerance testing, respectively.
Phase 2 PREVENt研究結果顯示，與安慰劑相比，每日30mg的BID（分爲兩次服用）和每日60mg的QD（一次服用）的Avexitide顯著增加平均血漿葡萄糖谷底值（預先指定的主要終點），並降低胰島素峯值，相應地減少了需要混合餐耐受試驗中的救援的參與者數量，分別爲50%和75%。
Avexitide was generally well tolerated.
Avexitide通常耐受性良好。
A Phase 2b open-label cross-over study of higher dose avexitide (45 mg BID and 90 mg QD) showed that Avexitide reduced the frequency of hypoglycemia by up to 65% and the amount of time in hypoglycemia by up to 64%.
一項二十億的開放標籤交叉研究表明，較高劑量的Avexitide（每日45mg的BID和每日90mg的QD）可以將低血糖發作的頻率降低多達65%，低血糖持續時間縮短多達64%。
Price Action: AMLX shares are up 21.2% at $1.99 at last check Wednesday.
目前爲止，AMLX股價上漲21.2%，最後檢查的報價爲1.99美元。
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譯文內容由第三人軟體翻譯。
