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 (纳斯达克:AMLX) 以3510万美元从Eiger BioPharmaceuticals Inc (场外交易:EIGRQ) 收购了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是一种探究性的、首创的胰高血糖素样肽-1（GLP-1）受体拮抗剂，已经在五个临床试验中用于后减重手术低血糖症（PBH），并在先天性高胰岛素血症（HI）中进行了研究。这两种适应症的特征都是高胰岛素性低血糖。
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).
美国食品药品监督管理局（FDA）已将avexitide授予了突破性疗法指定，用于两个适应症，分别是先天性HI罕见儿科病指定以及高胰岛素性低血糖孤儿药指定（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的研究药物在患有遗传性疾病的患者中显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旨在结合胰岛β细胞上的GLP-1受体，并阻止GLP-1的作用，以减轻低血糖，通过减少胰岛素分泌和稳定血糖水平。
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.
作为交易的一部分，Amylyx承担了从艾格公司转移而来的某些合同义务，包括在PBH中如果Avexitide获得批准，向某些学术机构支付未来销售额的3%版税。
In previous Phase 2 and Phase 2b studies in PBH, avexitide showed statistically significant reductions in hypoglycemic events characterized by low blood glucose.
在先前针对PBH的二期和二十亿研究中，Avexitide在低血糖的表现方面表现出显著的统计学减少。
Amylyx expects to begin the Phase 3 program for avexitide in PBH in Q1 2025.
Amylyx预计将在2025年第一季度开始PBH的三期项目。
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研究结果显示，与安慰剂相比，每日30mg的BID（分为两次服用）和每日60mg的QD（一次服用）的Avexitide显著增加平均血浆葡萄糖谷底值（预先指定的主要终点），并降低胰岛素峰值，相应地减少了需要混合餐耐受试验中的救援的参与者数量，分别为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%.
一项二十亿的开放标签交叉研究表明，较高剂量的Avexitide（每日45mg的BID和每日90mg的QD）可以将低血糖发作的频率降低多达65%，低血糖持续时间缩短多达64%。
Price Action: AMLX shares are up 21.2% at $1.99 at last check Wednesday.
目前为止，AMLX股价上涨21.2%，最后检查的报价为1.99美元。
- Why Is Neurodegenerative Diseases-Focused Amylyx Pharmaceuticals Stock Plunging On Friday?
- 为什么以神经退行性疾病为重点的Amylyx Pharmaceuticals股票在周五暴跌？