MONTREAL and CHARLOTTE, N.C. - Milestone Pharmaceuticals Inc . (NASDAQ:MIST), a biopharmaceutical company, has announced the resubmission of its New Drug Application (NDA) for etripamil to the U.S. Food and Drug Administration (FDA) for the management of paroxysmal supraventricular tachycardia (PSVT), a cardiovascular condition. The resubmission follows a prior Refusal to File letter from the FDA and includes restructured data sets to facilitate the agency's review process.
Etripamil, Milestone's lead investigational product, is a novel calcium channel blocker nasal spray aimed at providing rapid relief from the acute episodes of rapid heartbeat associated with PSVT and atrial fibrillation with rapid ventricular rate (AFib-RVR). The company believes that if approved, this self-administered treatment could offer a new option for patients to manage their symptoms on demand.
The resubmission is based on guidance obtained from the FDA during a Type A meeting, which took place after the initial RTF letter was received. According to Joseph Oliveto, President and CEO of Milestone Pharmaceuticals, the company has addressed all issues raised and is looking forward to the FDA's review.
PSVT affects an estimated two million people in the U.S. and is characterized by sudden episodes of rapid heartbeats that can last several hours, often resulting in severe symptoms that disrupt daily life. Similarly, AFib, a common arrhythmia, affects approximately five million Americans, with the number expected to rise to 12 million by 2030. A subset of AFib patients experience AFib-RVR, which also leads to episodes of abnormally high heart rates.
Milestone's clinical trial program for etripamil includes a completed Phase 3 trial for PSVT and a Phase 2 trial for AFib-RVR. The company's focus on developing treatments for complex heart conditions is driven by the goal of improving patient self-management and providing health care providers with new options for on-demand care.
This announcement is based on a press release statement from Milestone Pharmaceuticals Inc.
InvestingPro Insights
As Milestone Pharmaceuticals Inc. (NASDAQ:MIST) forges ahead with its FDA resubmission, investors and stakeholders are closely monitoring the company's financial health and market performance. According to recent data from InvestingPro, Milestone's market capitalization stands at approximately $108.11 million. The company's financial metrics reflect some challenges, such as a significant revenue decline over the last twelve months as of Q4 2023, with revenue shrinking by 80%. This is consistent with the broader context of the biopharmaceutical industry, where research and development efforts can often lead to variable and unpredictable revenue streams.
InvestingPro Tips highlight that Milestone is currently trading at a high Price / Book multiple of 6.45, which suggests that the stock might be valued richly in comparison to the company's book value. Despite the optimism surrounding the potential approval of etripamil, analysts also note that the company does not pay a dividend to shareholders, which is typical for many growth-focused biotech firms that reinvest earnings back into research and development.
Investors looking to gain deeper insights into Milestone Pharmaceuticals can find additional InvestingPro Tips that can help them make more informed decisions. For instance, while the company holds more cash than debt on its balance sheet, it is quickly burning through cash, which is a critical factor for investors to consider. For those interested in exploring these nuances, there are 11 additional InvestingPro Tips available, which can be accessed by visiting https://www.investing.com/pro/MIST. Use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, enhancing your investment research with valuable, real-time data and analysis.
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