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Milestone Pharmaceuticals Inc (NASDAQ:MIST) shares are trading higher by 19.4% to $2.03 Monday morning after the company announced plans to resubmit the New Drug Application (NDA) for etripamil to the U.S. Food and Drug Administration (FDA) for paroxysmal supraventricular tachycardia (PSVT).
After receiving a Refusal to File letter, the company held a Type A Meeting with the FDA, where it was indicated that the timing of adverse events (AEs) had minimal impact on the overall safety profile of etripamil. The company will restructure data sets and reformat certain files to address FDA concerns and plans to resubmit the NDA in the second quarter of 2024.
The FDA hasn’t requested additional clinical trials before resubmission. Milestone Pharmaceuticals expects its existing cash reserves to fund operations until mid-2025, including the expected Prescription Drug User Fee Act (PDUFA) date for the NDA resubmission.
If approved, the company anticipates a $75 million payment under an existing royalty agreement to fund the potential commercial launch of etripamil for PSVT. CEO Joseph Oliveto expressed gratitude for FDA guidance and reiterated commitment to bringing the treatment to patients.
See Also: Why Aclarion (ACON) Shares Are Down Over 60% Today
An investor can make a few decisions when deciding whether a stock is a good buy. In addition to valuation metrics and price action which you can find on Benzinga's quote pages – like Milestone Pharmaceuticals‘s page for example – there are factors like whether or not a company pays a dividend or buys a large portion of its stock each quarter.
These are known as capital allocation programs. Milestone Pharmaceuticals does not pay a dividend, but obviously has a few ways it can return value to shareholders. Feel free to search Benzinga's dividend calendar for the next company that is due to pay a dividend and determine what kind of yield you can earn for holding a share of the company.
For example, if you're looking to earn an annualized return of 13.51%, you'll need to buy a share of Brompton Split Banc by the Feb. 28, 2024. Once done, you can expect to receive a nominal payout of $0.1 on Mar. 14, 2024.
Buyback programs are obviously different and highly variable. A company can approve a buyback program and purchase shares as it sees fit over the course of time in which the buyback was authorized. Looking through the latest news on Milestone Pharmaceuticals will often yield whether or not the company has approved a buyback program recently. Buyback programs usually serve as a support for share prices, serving as a backstop for demand.
According to data from Benzinga Pro, MIST has a 52-week high of $4.49 and a 52-week low of $1.33.
Posted In: MIST
