FDA Events for Milestone Pharmaceuticals (MIST)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Milestone Pharmaceuticals (MIST).
Over the past two years, Milestone Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Etripamil. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Etripamil - FDA Regulatory Timeline and Events
Etripamil is a drug developed by Milestone Pharmaceuticals for the following indication: For Treatment in Paroxysmal Supraventricular Tachycardia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Etripamil
- Announced Date:
- July 11, 2025
- Estimated Event Date Range:
- December 13, 2025 - December 13, 2025
- Target Action Date:
- December 13, 2025
- Indication:
- For Treatment in Paroxysmal Supraventricular Tachycardia
Announcement
Milestone® Pharmaceuticals Inc announced that The FDA has assigned a new Prescription Drug User Fee Act (PDUFA) target action date of December 13, 2025.
AI Summary
Milestone® Pharmaceuticals Inc. announced that the FDA has set a new PDUFA target action date of December 13, 2025 for its investigational drug CARDAMYST™ (etripamil nasal spray). The drug is being developed to treat paroxysmal supraventricular tachycardia (PSVT) and is designed for self-administration during rapid heart episodes. This updated timeline comes after Milestone submitted its response to address issues noted in a previous Complete Response Letter. The new date gives the FDA additional time to review the updated data and any further information the company provided. Milestone views this as a major milestone in its journey to bring CARDAMYST to market and is hopeful that the review process will lead to a positive approval decision, potentially offering a new treatment option for patients in need.
Read Announcement- Drug:
- Etripamil
- Announced Date:
- July 11, 2025
- Indication:
- For Treatment in Paroxysmal Supraventricular Tachycardia
Announcement
Milestone® Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review Milestone's response to issues raised in the Complete Response Letter (CRL) for CARDAMYST™ (etripamil) nasal spray, an investigational, novel therapy for the treatment of patients with paroxysmal supraventricular tachycardia (PSVT).
AI Summary
Milestone® Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its response to the issues raised in the Complete Response Letter for CARDAMYST™ (etripamil) nasal spray. This drug is an investigational, novel therapy designed for patients with paroxysmal supraventricular tachycardia (PSVT). With this acceptance, the FDA has set a new Prescription Drug User Fee Act (PDUFA) target action date of December 13, 2025, signaling a critical step toward the potential approval of the treatment.
Milestone sees this review as a significant milestone for CARDAMYST. The acceptance of their response to the FDA’s concerns moves them closer to launching a treatment that could offer patients a self-administered option for managing PSVT. This development underlines the company’s commitment to advancing new therapies and providing earlier treatment choices for patients in need.
Read Announcement- Drug:
- Etripamil
- Announced Date:
- June 16, 2025
- Indication:
- For Treatment in Paroxysmal Supraventricular Tachycardia
Announcement
Milestone® Pharmaceuticals Inc announced submission of its response to the U.S. Food and Drug Administration (FDA)'s Complete Response Letter (CRL) regarding its New Drug Application (NDA) for CARDAMYST™ (etripamil) nasal spray, a prescription medication in development for the conversion of acute episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.
AI Summary
Milestone® Pharmaceuticals Inc. announced that it has submitted its response to the U.S. Food and Drug Administration’s (FDA) Complete Response Letter for its New Drug Application for CARDAMYST™ (etripamil) nasal spray. This prescription medication is being developed to convert acute episodes of paroxysmal supraventricular tachycardia (PSVT) to a normal sinus rhythm in adults, and it is intended for self-administration during a heart rhythm episode.
The company’s response follows a productive Type A meeting with the FDA, which provided clear guidance on the next steps. The FDA will review the submission and determine the acceptance of the response and the corresponding Prescription Drug User Fee Act date within the next 30 days. If approved, CARDAMYST could become the first self-administered rapid response treatment option for managing PSVT.
Read Announcement- Drug:
- Etripamil
- Announced Date:
- March 28, 2025
- Indication:
- For Treatment in Paroxysmal Supraventricular Tachycardia
Announcement
Milestone® Pharmaceuticals Inc. announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for CARDAMYST™ (etripamil) nasal spray, a prescription medication in development for the conversion of acute episodes of PSVT to sinus rhythm in adults.
AI Summary
Milestone® Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for CARDAMYST™ (etripamil) nasal spray. This medication is being developed as a treatment for converting acute episodes of paroxysmal supraventricular tachycardia (PSVT) into normal sinus rhythm in adults. The FDA did not raise any concerns about the clinical safety or the efficacy of etripamil. However, two key issues related to Chemistry, Manufacturing, and Controls (CMC) were identified. The agency requires additional data on nitrosamine impurities and an inspection at a facility that performs release testing for the drug, as the facility underwent a change in ownership. Milestone remains focused on addressing these issues and aims to collaborate with the FDA for a potential resubmission.
Read Announcement- Drug:
- Etripamil
- Announced Date:
- March 20, 2025
- Indication:
- For Treatment in Paroxysmal Supraventricular Tachycardia
Announcement
Milestone® Pharmaceuticals Inc announced that it will present a moderated poster presentation at the American College of Cardiology annual meeting (ACC25), to be held March 29th to 31st, 2025 in Chicago, Illinois.
AI Summary
Milestone® Pharmaceuticals Inc. announced it will present a moderated poster presentation at the American College of Cardiology’s annual meeting (ACC25) in Chicago, Illinois, from March 29-31, 2025. The presentation, titled “Consistency and Predictiveness of Conversion Among Multiple Episodes of Paroxysmal Supraventricular Tachycardia (PSVT) Treated with Etripamil: Outcomes from the NODE-303 trial,” will be led by Dr. James Ip, an associate professor at Weill Cornell Medicine.
The poster details how etripamil, a novel calcium channel blocker nasal spray, has shown promising results by converting multiple PSVT episodes back to normal sinus rhythm. Data presented indicate that successfully converting an early PSVT episode is predictive of success in subsequent episodes. If approved, etripamil could offer patients a convenient self-management option and potentially improve quality of life for those affected by PSVT.
Read Announcement- Drug:
- Etripamil
- Announced Date:
- February 19, 2025
- Indication:
- For Treatment in Paroxysmal Supraventricular Tachycardia
Announcement
Milestone® Pharmaceuticals Inc. announced that it has received Notice of Allowance from the United States Patent and Trademark Office (USPTO) on a new Method of Use patent for etripamil nasal spray (proposed trade name CARDAMYST™), its lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT).
AI Summary
Milestone® Pharmaceuticals Inc. announced that it has received a Notice of Allowance from the United States Patent and Trademark Office for its new Method of Use patent. This patent application covers the repeat dose regimen for etripamil nasal spray, which is proposed to be marketed under the trade name CARDAMYST™. The regimen, established in the RAPID Phase 3 study for managing paroxysmal supraventricular tachycardia (PSVT), directs patients to take a second dose ten minutes after the first if symptoms persist. With this development, Milestone aims to extend the intellectual property protection of CARDAMYST in the United States until July 2042, adding up to six years of potential protection. This milestone supports the company’s commitment to innovation in cardiology, positioning CARDAMYST as a promising treatment option currently under review with the FDA as part of its New Drug Application.
Read Announcement- Drug:
- Etripamil
- Announced Date:
- September 6, 2024
- Indication:
- For Treatment in Paroxysmal Supraventricular Tachycardia
Announcement
Milestone® Pharmaceuticals Inc announced its licensing partner, Ji Xing Pharmaceuticals Ltd, released positive topline results from a multi-center, randomized, double-blind, placebo-controlled trial in China evaluating the efficacy and safety of etripamil nasal spray in paroxysmal supraventricular tachycardia (PSVT).
AI Summary
Milestone® Pharmaceuticals announced that its licensing partner, Ji Xing Pharmaceuticals Ltd, released positive topline results from a Phase 3 trial in China. This multi-center, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of etripamil nasal spray in treating paroxysmal supraventricular tachycardia (PSVT). In the trial of 500 patients, a significantly higher percentage of those self-administering etripamil converted from PSVT to normal sinus rhythm within 30 minutes compared to placebo (40.5% versus 15.9%, with a hazard ratio of 3.00 and p<0.001). Statistically significant improvements were also seen at 10, 15, 45, and 60 minutes. The safety profile was consistent with earlier studies, with treatment emergent adverse events comparable to placebo and no serious adverse events linked to etripamil.
These results support Ji Xing’s efforts toward regulatory approval in China, offering hope for millions living with PSVT.
Read Announcement- Drug:
- Etripamil
- Announced Date:
- August 26, 2024
- Indication:
- For Treatment in Paroxysmal Supraventricular Tachycardia
Announcement
Milestone® Pharmaceuticals Inc. announced an upcoming data presentation on etripamil at the annual meeting of the European Society of Cardiology, ESC Congress 2024 in London, United Kingdom on August 30, 2024.
AI Summary
Milestone® Pharmaceuticals Inc. announced that it will present new data on its investigational etripamil nasal spray at the ESC Congress 2024 in London on August 30, 2024. The data comes from the NODE-303 Phase 3 trial, which examines the use of etripamil for treating paroxysmal supraventricular tachycardia (PSVT). It focuses on patient-reported outcomes, including insights into patient experience, satisfaction, and quality of life when using the nasal spray for self-administration without medical supervision.
Professor John Camm will lead the moderated poster presentation titled “Quality of Life Measures with Etripamil Self-Administration for Acute Episodes of Paroxysmal Supraventricular Tachycardia” at the event. This presentation highlights Milestone’s commitment to enhancing cardiovascular care by exploring innovative treatment approaches that enable patients to manage their conditions more actively.
Read Announcement- Drug:
- Etripamil
- Announced Date:
- May 29, 2024
- Indication:
- For Treatment in Paroxysmal Supraventricular Tachycardia
Announcement
Milestone® Pharmaceuticals Inc announced that the United States Food and Drug Administration (FDA) accepted the Company's New Drug Application (NDA) on May 26, 2024 for CARDAMYST (etripamil) nasal spray, its lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT).
AI Summary
Milestone® Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) on May 26, 2024 for CARDAMYST (etripamil) nasal spray. This investigational product is designed to treat paroxysmal supraventricular tachycardia (PSVT), a condition characterized by episodes of rapid heartbeats. The FDA has set the Prescription Drug User Fee Act (PDUFA) target date for review at 10 months from the acceptance date. Milestone is optimistic that CARDAMYST will offer a convenient and effective treatment option, allowing patients to self-manage their condition without immediate medical supervision. The product is supported by the largest clinical data package for an acute self-administered therapy for PSVT, moving the company closer to providing patients and caregivers a much-needed sense of security and improved quality of life.
Read Announcement- Drug:
- Etripamil
- Announced Date:
- May 29, 2024
- Indication:
- For Treatment in Paroxysmal Supraventricular Tachycardia
Announcement
Milestone® Pharmaceuticals Inc announced that The FDA Prescription Drug User Fee Act (PDUFA) target date is 10 months from the acceptance date of May 26, 2024.
AI Summary
Milestone® Pharmaceuticals Inc received FDA acceptance for its New Drug Application (NDA) for CARDAMYST (etripamil) nasal spray on May 26, 2024. This key step in the drug’s development is aimed at treating paroxysmal supraventricular tachycardia (PSVT), a heart condition that causes rapid and sometimes dangerous episodes of abnormal heartbeats.
A major highlight of this announcement is that the FDA Prescription Drug User Fee Act (PDUFA) target date has been set at 10 months from the acceptance date. This means that the FDA is expected to complete its review by March 26, 2025. Milestone is optimistic that meeting this target will bring them closer to providing a new, convenient, and effective on-demand treatment option for PSVT patients, while also offering a sense of security and improved daily management for those affected by this condition.
Read Announcement- Drug:
- Etripamil
- Announced Date:
- April 17, 2024
- Indication:
- For Treatment in Paroxysmal Supraventricular Tachycardia
Announcement
Milestone® Pharmaceuticals Inc announced that it will present data on etripamil at the 30th Annual Cardiovascular Nursing Symposium held by the Preventive Cardiovascular Nurses Association on April 18-20th in Orlando, FL.
AI Summary
Milestone® Pharmaceuticals Inc has announced that it will present new data on its investigational treatment, etripamil, at the 30th Annual Cardiovascular Nursing Symposium. This event, hosted by the Preventive Cardiovascular Nurses Association, will be held from April 18-20 in Orlando, FL. The symposium offers an important platform for experts in cardiovascular care to share research and real-world insights aimed at improving patient outcomes.
At the conference, Milestone® will showcase data highlighting the potential of etripamil, a novel calcium channel blocker delivered via nasal spray. Designed to be self-administered during symptomatic heart rate episodes, etripamil is being studied for its effect on conditions such as paroxysmal supraventricular tachycardia. The information shared in this presentation is expected to contribute to the broader conversation about patient-centered treatment strategies in cardiovascular medicine.
Read Announcement- Drug:
- Etripamil
- Announced Date:
- April 8, 2024
- Indication:
- For Treatment in Paroxysmal Supraventricular Tachycardia
Announcement
Milestone® Pharmaceuticals Inc announced new clinical data demonstrating real-world application of etripamil, an investigational new drug, for conversion of recurrent paroxysmal supraventricular tachycardia (PSVT).
AI Summary
Milestone® Pharmaceuticals Inc. announced new clinical data on the use of etripamil, an investigational nasal spray, for converting paroxysmal supraventricular tachycardia (PSVT) to a normal heart rhythm. In a Phase 3 study conducted across North and South America, patients were able to self-administer the drug at home during multiple PSVT episodes. The study showed that etripamil induced conversion to sinus rhythm with a median time of 17 minutes, achieving about 60% effectiveness at 30 minutes and nearly 70% at 60 minutes.
These findings build on earlier Phase 3 studies and support etripamil’s potential as a fast, reliable treatment option for recurrent PSVT. Adverse events were mostly limited to the nasal administration site, with fewer side effects reported in successive treatments. This real-world study may mark a significant shift in managing PSVT by giving patients an effective, self-administered treatment alternative.
Read Announcement
Milestone Pharmaceuticals FDA Events - Frequently Asked Questions
As of now, Milestone Pharmaceuticals (MIST) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Milestone Pharmaceuticals (MIST) has reported FDA regulatory activity for Etripamil.
The most recent FDA-related event for Milestone Pharmaceuticals occurred on July 11, 2025, involving Etripamil. The update was categorized as "PDUFA Date," with the company reporting: "Milestone® Pharmaceuticals Inc announced that The FDA has assigned a new Prescription Drug User Fee Act (PDUFA) target action date of December 13, 2025."
Currently, Milestone Pharmaceuticals has one therapy (Etripamil) targeting the following condition: For Treatment in Paroxysmal Supraventricular Tachycardia.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:MIST) was last updated on 7/12/2025 by MarketBeat.com Staff
