Milestone Pharma Soars 21% on Landmark FDA Drug Approval
The U.S. regulator approved the company's etripamil nasal spray, the first self-administered treatment for a common heart rhythm disorder, paving the way for commercialization.
Shares of Milestone Pharmaceuticals Inc. (NASDAQ: MIST) surged more than 20% on Wednesday after the company announced it had received U.S. Food and Drug Administration (FDA) approval for its innovative treatment for a common form of arrhythmia.
The stock climbed as high as $2.91 in afternoon trading, a jump of over 21%, pushing the company’s market capitalization to approximately $205 million. The move brought the share price near its 52-week high of $3.06, reflecting investor enthusiasm for the landmark approval that transforms Milestone from a clinical-stage firm into a commercial entity.
The regulatory green light was granted for the company's etripamil nasal spray, a rapid-acting treatment for patients with paroxysmal supraventricular tachycardia (PSVT). This condition involves episodes of a rapid heart rate that begins and ends abruptly. The approval marks a significant breakthrough, as etripamil is the first and only treatment that patients can administer themselves to rapidly terminate an episode, wherever they are.
Previously, the standard of care for PSVT episodes often involved a trip to the emergency room for intravenous medication. Etripamil, a calcium channel blocker, offers a new paradigm. By allowing for on-demand, at-home use, the treatment has the potential to significantly reduce the burden on both patients and the healthcare system. Clinical trial data backing the approval showed significant efficacy, with studies demonstrating that a majority of patients who used the nasal spray converted to a normal heart rhythm within 30 minutes.
“The FDA approval of etripamil nasal spray is a monumental achievement for Milestone and a transformative moment for PSVT patients,” the company stated in its announcement, highlighting the decades-long wait for a novel, self-administered treatment. The ability to treat episodes promptly without medical intervention is expected to improve the quality of life for the estimated two million people in the U.S. living with PSVT.
Wall Street analysts have a consensus 'Moderate Buy' rating on the stock, with an average price target of $3.75, suggesting further potential upside. The approval validates the company's core scientific platform and paves the way for its first revenue stream. While some analysts, such as Jefferies, have maintained a more cautious 'Hold' rating, the overall sentiment is that this approval is a pivotal inflection point for the Montreal-based biopharmaceutical firm.
With this crucial regulatory hurdle cleared, all eyes will now be on Milestone's commercialization strategy. The company will be tasked with executing a successful market launch, including pricing, distribution, and physician education. Investors will be closely watching the initial sales figures to gauge the market uptake of this novel therapy. The company’s ability to effectively market etripamil to both cardiologists and patients will be critical to capitalizing on its first-mover advantage in the self-administered PSVT treatment landscape.