Why Is Cumberland Pharmaceuticals Stock Trading Over 100% on Tuesday?
Why Is Cumberland Pharmaceuticals Stock Trading Over 100% on Tuesday?
On Monday, the FDA approved Cumberland Pharmaceuticals Inc's (NASDAQ:CPIX) supplemental New Drug Application (sNDA) for its Acetadote (N-acetylcysteine for injection) product.
周一,美国食品药品管理局批准了坎伯兰制药公司(纳斯达克股票代码:CPIX)的Acetadote(注射用N-乙酰半胱氨酸)产品的补充新药申请(snDa)。
Acetadote is an intravenous (IV) formulation of N-acetylcysteine (NAC) indicated to prevent or lessen liver injury after ingestion of potentially toxic quantities of acetaminophen.
Acetadote 是一种静脉注射 (IV) 的 N-乙酰半胱氨酸 (NAC) 配方,用于预防或减少摄入潜在毒性的对乙酰氨基酚后的肝损伤。
Acetaminophen, a common over-the-counter pain reliever and fever reducer, is the leading cause of acute liver failure in the United States.
对乙酰氨基酚是一种常见的非处方止痛药和退烧药,是美国急性肝衰竭的主要原因。
Each year, thousands of individuals experience accidental or intentional acetaminophen poisoning, leading to serious liver damage.
每年都有成千上万的人发生意外或故意的对乙酰氨基酚中毒,从而导致严重的肝损伤。
The newly approved dosing regimen simplifies the administration of Acetadote by combining the first two bags of the standard regimen into a single, slower infusion.
新批准的给药方案将标准方案的前两袋组合成一次较慢的输液,从而简化了Acetadote的给药。
This streamlined approach has been implemented in hospitals across multiple countries. It has been demonstrated to reduce the frequency of medication errors and potentially serious non-allergic anaphylactoid reactions (NAARs) without compromising the effectiveness of Acetadote.
这种简化的方法已在多个国家的医院中实施。事实证明,它可以在不影响Acetadote有效性的前提下减少用药错误和潜在的严重非过敏性过敏反应(NAAR)的频率。
By simplifying the dosing regimen, healthcare providers can administer the life-saving treatment more efficiently, potentially improving patient outcomes.
通过简化给药方案,医疗保健提供者可以更有效地管理挽救生命的治疗,从而有可能改善患者的预后。
For the third quarter, Cumberland Pharmaceuticals reported net revenues of $9.1 million, down from $10.1 million a year ago.
坎伯兰制药公司公布的第三季度净收入为910万美元,低于去年同期的1,010万美元。
Last month, the FDA granted Orphan Drug Designation and Rare Pediatric Disease Designation to Ifetroban for cardiomyopathy associated with Duchenne muscular dystrophy (DMD).
上个月,美国食品药品管理局向Ifetroban授予了治疗与杜兴氏肌营养不良症(DMD)相关的心肌病的孤儿药称号和罕见儿科疾病称号。
Cumberland is completing the FIGHT DMD Phase 2 trial investigating the pharmacokinetics, safety, and efficacy of once daily oral Ifetroban in patients with DMD. Results will be announced later this year.
坎伯兰正在完成Fight DMD 2期试验,该试验旨在调查DMD患者每天口服一次的Ifetroban的药代动力学、安全性和有效性。结果将于今年晚些时候公布。
Price Action: CPIX stock is up 142.7% at $3.01 at the last check on Tuesday.
价格走势:在周二的最后一次支票中,CPIX股价上涨142.7%,至3.01美元。
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