MIST

Milestone Pharmaceuticals Inc

Investing.com -- TD Securities downgraded Milestone Pharmaceuticals (NASDAQ:MIST) to "Hold" and suspended its price target, citing regulatory uncertainty and commercialization challenges for its lead drug, etripamil, following a Complete Response Letter from the U.S. Food and Drug Administration.The FDA issued a Complete Response Letter for MIST’s etripamil New Drug Application for paroxysmal supraventricular tachycardia (pSVT), citing chemistry, manufacturing, and controls issues. While no safety or efficacy concerns were raised, the agency requested additional data on nitrosamine impurities based on new draft guidance published in September 2024, months after MIST had resubmitted its New Drug Application . The FDA also flagged the need for an inspection at a third-party facility performing release testing, which changed ownership during the New Drug Application review.

The FDA said an inspection is required at a facility where the company performed release testing for the product to ensure it complies with Current Good Manufacturing Practices.

Milestone Pharmaceuticals (NASDAQ: MIST) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings...

MONTREAL and CHARLOTTE, N.C., April 03, 2024 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today announced that members of its management team will deliver a company...

MONTREAL and CHARLOTTE, N.C., April 01, 2024 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) a biopharmaceutical company focused on the development and commercialization of...

Milestone Pharmaceuticals (MIST) has released an update. Milestone Pharmaceuticals has announced the resubmission of its New Drug Application to th...

MONTREAL and CHARLOTTE, N.C., March 28, 2024 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of...

Milestone Pharmaceuticals (NASDAQ:MIST Get Free Report)s stock had its buy rating restated by research analysts at HC Wainwright in a research note issued on Friday...

- On track to resubmit NDA for etripamil in PSVT early 2Q 2024 - Recent financing extends cash runway into 2026 - FDA reiterated prior guidance on regulatory pathway for AFib-RVR, End of Phase 2...