TD downgrades Milestone Pharmaceuticals, suspends target on Etripamil uncertainty

April 02, 2025 07:05 AM AEDT | By Investing

Google News:

TD downgrades Milestone Pharmaceuticals, suspends target on Etripamil uncertainty

Recent News

What are next big copper projects? UBS tells when equipment makers cou...

EUR/USD poised to rack up more gains as ECB and Fed rate paths set to...

Carney launches ‘One Canadian Economy’ Act to unify trade, approvals

Trump signs orders to enhance drone defenses, support supersonic trave...

Investing.com -- TD Securities downgraded Milestone (WA:MMD) 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no safety or efficacy concerns were raised, the agency requested additional data on nitrosamine impurities based on new draft guidance published in September 2024, months after MIST had resubmitted its New Drug Application .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.

MIST has ongoing assays to address the new impurity testing requirements, with results expected in April. A Type A meeting with the FDA is anticipated in May or June to determine the path forward.

TD expressed concerns over etripamil’s commercial viability, noting Milestone Pharmaceuticals' limited capital reserves. The company had $69.7 million in cash as of Q4 2024, which may not be sufficient to support an extended regulatory timeline.

TD suspended its price target and downgraded Milestone Pharmaceuticals, citing the uncertainty surrounding the FDA review process and the company’s financial position.

The firm noted that NDA resubmission timelines remain unclear, with additional concerns over the FDA’s operational efficiency.

This article first appeared in Investing.com

Disclaimer

The content, including but not limited to any articles, news, quotes, information, data, text, reports, ratings, opinions, images, photos, graphics, graphs, charts, animations and video (Content) is a service of Kalkine Media Pty Ltd (“Kalkine Media, we or us”), ACN 629 651 672 and is available for personal and non-commercial use only. The principal purpose of the Content is to educate and inform. The Content does not contain or imply any recommendation or opinion intended to influence your financial decisions and must not be relied upon by you as such. Some of the Content on this website may be sponsored/non-sponsored, as applicable, but is NOT a solicitation or recommendation to buy, sell or hold the stocks of the company(s) or engage in any investment activity under discussion. Kalkine Media is neither licensed nor qualified to provide investment advice through this platform. Users should make their own enquiries about any investments and Kalkine Media strongly suggests the users to seek advice from a financial adviser, stockbroker or other professional (including taxation and legal advice), as necessary.
The content published on Kalkine Media also includes feeds sourced from third-party providers. Kalkine does not assert any ownership rights over the content provided by these third-party sources. The inclusion of such feeds on the Website is for informational purposes only. Kalkine does not guarantee the accuracy, completeness, or reliability of the content obtained from third-party feeds. Furthermore, Kalkine Media shall not be held liable for any errors, omissions, or inaccuracies in the content obtained from third-party feeds, nor for any damages or losses arising from the use of such content.
Kalkine Media hereby disclaims any and all the liabilities to any user for any direct, indirect, implied, punitive, special, incidental or other consequential damages arising from any use of the Content on this website, which is provided without warranties. The views expressed in the Content by the guests, if any, are their own and do not necessarily represent the views or opinions of Kalkine Media. Some of the images/music that may be used on this website are copyrighted to their respective owner(s). Kalkine Media does not claim ownership of any of the pictures displayed/music used on this website unless stated otherwise. The images/music that may be used on this website are taken from various sources on the internet, including paid subscriptions or are believed to be in public domain. We have made reasonable efforts to accredit the source wherever it was indicated as or found to be necessary.
This disclaimer is subject to change without notice. Users are advised to review this disclaimer periodically for any updates or modifications.