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Milestone Pharma's Next Big Move After FDA Nod

Milestone Pharmaceuticals Inc. (NASDAQ: MIST) shares more than doubled on Thursday after the company announced a key clinical and regulatory update. The firm also announced a private placement offering to capitalize on this gain and shore up its balance sheet.

The U.S. Food and Drug Administration (FDA) outlined an efficient path to registration for the company’s etripamil nasal spray. Recent interactions have management optimistic. Also, this path to registration would eliminate the need to start a new Phase 3 study.

The FDA agreed with Milestone’s plan to modify the ongoing NODE-301B study, which is now known as the RAPID study, to highlight the unique pharmacology of etripamil, including a primary endpoint of time to conversion within 30 minutes. This study, along with the recently completed NODE-301 study, which also now will use a 30-minute endpoint, will serve to fulfill the efficacy requirements for a New Drug Application (NDA) for etripamil in paroxysmal supraventricular tachycardia.

Note that the etripamil nasal spray is the company’s investigational short-acting calcium channel blocker for patients with paroxysmal supraventricular tachycardia — in simpler words, an abnormal heart rhythm.

At the same time, the company announced a private placement offering for $25 million with RTW Investments. Keep in mind that the company has a market cap of roughly $84 million, even after Thursday’s move.

The company expects that net proceeds from the private placement, along with current cash, cash equivalents and short-term investments, will be sufficient to fund planned operations through the second quarter of 2022.

Milestone Pharmaceuticals stock traded about 140% to $8.00 on Thursday, in a 52-week range of $1.69 to $24.01. The consensus price target is $4.00.